Document ID: EPA-HQ-OPP-2007-0312-0006
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2009-06-03T04:00Z

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF PREVENTION, PESTICIDE

								AND TOXIC SUBSTANCES

MEMORANDUM

Date:  10/1/08.

SUBJECT:	Triflumizole.  Section 3 Registration Request for New Uses on
Leafy Greens (Subgroup 4A) Except Spinach, Head and Stem Brassica
(Subgroup 5A), Cilantro, Swiss Chard, Pineapple, Papaya, Black Sapote,
Canistel, Mamey Sapote, Mango, Sapodilla, Star Apple, and Hops.  Summary
of Analytical Chemistry and Residue Data.

PC Code:  128879	DP Num:  346779

Decision Nos.:  383407 and 385797	Registration No.:  400-518

Petition Nos.:  7E7258 and 7E7286	Regulatory Action:  Section 3
Registration

Risk Assessment Type:  NA	Case No.:  NA

TXR No.:  NA	CAS No.:  68694-11-1

MRID No.:  47224001-06 & 47271301-02	40 CFR:  §180.476

FROM:	W. Cutchin, Chemist

		Alternative Risk Integration Assessment (ARIA)

		Risk Integration, Minor Use, and Emergency Response Branch (RIMUERB)		
Registration Division (RD; 7505P)

THROUGH:	W. Donovan, Ph.D., Senior Chemist

		Reregistration Branch 3/Health Effects Division (RRB3/HED; 7509P)

TO:		Barbara Madden, Minor Use Team Leader

		RIMUERB/RD (7505P)		

		

This document was originally prepared under contract by Dynamac
Corporation (2275 Research Boulevard, Suite 300; Rockville, MD 20850),
reviewed and revised to reflect current Office of Pesticide Programs
(OPP) policies

I.	 CONCLUSIONS

Regulatory Recommendations

Pending submission of a revised Section B (see requirements under
Directions for Use) and the submission of a revised Section F (see
requirements under Proposed Tolerances), there are no residue chemistry
issues that would preclude granting a registration for the requested
uses of triflumizole on head and stem Brassica, leafy greens except
spinach, Swiss chard, cilantro leaves, hops, pineapple, papaya,
canistel, mango, sapodilla, sapote (black and mamey), and star apple. 
The proposed uses and the submitted data support the following
tolerances for the combined residues of triflumizole and its metabolites
containing the FA-1-1 moiety, calculated as parent, in/on:

Brassica, head and stem, subgroup 5A	8.0 ppm

Leafy greens subgroup 4A, except spinach	35 ppm

Coriander, leaves	35 ppm

Swiss chard	18 ppm

Pineapple	4.0 ppm

Papaya	2.5 ppm

Sapote, black	2.5 ppm

Canistel	2.5 ppm

Sapote, mamey	2.5 ppm

Mango	2.5 ppm

Sapodilla	2.5 ppm

Star apple	2.5 ppm

Hop, dried cones	50 ppm

The proposed uses and the submitted data support the following
tolerances for the combined residues of triflumizole, and its
metabolites containing the FA-1-1 moiety, and its sulfate metabolite
calculated as parent, in/on:

Cattle, fat	0.10 ppm

Cattle, meat byproducts	0.20 ppm

Goat, fat	0.10 ppm

Goat, meat byproducts	0.20 ppm

Horse, fat	0.10 ppm

Horse, meat byproducts	0.20 ppm

Sheep, fat	0.10 ppm

Sheep, meat byproducts	0.20 ppm

A human health risk assessment for triflumizole is forthcoming.

Residue Chemistry Deficiencies

860.1200  Directions for Use

A revised Section B is required to modify the existing rotational crop
restrictions and to specify minimum spray volumes when Procure® 480SC
Fungicide is applied by aerial treatments.  Since uses are being
proposed for leafy greens subgroup 4A except spinach and head and stem
Brassica vegetables subgroup 5A and new use on Brassica leafy greens
subgroup 5B (PP#7E7183) was recently approved, the rotational crop
restriction which states “do not plant leafy vegetables or non-leafy
Brassica vegetables or fruiting vegetables within 30 days after
application” should be amended to “do not plant spinach or fruiting
vegetables within 30 days after application.”  The remainder of
rotational crop restrictions is appropriate and is consistent with the
available field rotational crop data.  In addition, label revision is
required to specify minimum spray volumes of 2 gallons of water per acre
(or 10 gallons of water per acre for tree or orchard) for aerial
applications.

860.1550 Proposed Tolerances

The petitioner needs to submit a revised Section F to amend the proposed
tolerance level for Brassica, head and stem, subgroup 5A, from 5.0 ppm
to 8.0 ppm and to reflect the recommended commodity definition,
coriander leaves.

NOTES TO PM

When the permanent tolerances recommended in this registration action
become final, the time-limited tolerances for the following RACs,
established under Section 18 emergency exemptions [40 CFR §180.476(b)],
may be removed:  broccoli (1.0 ppm); cabbage, Chinese, napa (20 ppm),
coriander leaves (20 ppm), dandelion, leaves (7.0 ppm); kohlrabi (20
ppm); parsley leaves (20 ppm); and Swiss chard (7.0 ppm).

The tolerance listing for triflumizole under 40 CFR §180.476(a)
currently includes tolerances on grape pomace (15 ppm) and grape, raisin
waste (10 ppm).  These commodities are no longer regulated livestock
feedstuffs and they should be deleted from 40 CFR §180.476(a).  In
addition, the current tolerance on apple pomace (2 ppm) is based on the
processing factor for dry apple pomace.  As the apple processing study
indicates that residues do not concentrate in wet apple pomace, a
separate tolerance on apple pomace is not necessary and should also be
deleted.

With regards to tolerances for animal commodities, apples and pineapples
are the only crops with registered triflumizole uses that also have
regulated livestock feedstuffs (wet apple pomace and pineapple process
residue).  As these feedstuffs are not fed to either poultry or swine,
there is no potential for transferring triflumizole residues to poultry
or swine commodities.  Therefore, the current tolerances on eggs;
poultry fat, meat, and meat byproducts; and hog fat, meat and meat
byproducts should all be deleted.  See the conclusions paragraph of
Section 860.1480 of this document for more specific recommendations
regarding these tolerance levels.  

II.	ACTION REQUESTED

The Interregional Research Project No. 4 (IR-4) has submitted petitions,
PP#7E7258 and PP#7E7286, for the establishment of permanent tolerances
for the combined residues of the fungicide triflumizole,
1-(1-4-chloro-2-(trifluoromethyl)phenyl)imino)-2-propoxyethyl)-1H-imidaz
ole, and its metabolites containing the
4-chloro-2-trifluoromethylaniline moiety, calculated as the parent
compound, in/on the following raw agricultural commodities:

PP#7E7258:

Leafy greens subgroup 4A, except spinach	35 ppm

Cilantro, leaves	35 ppm

Swiss chard	18 ppm

Pineapple	4.0 ppm

Papaya	2.5 ppm

Sapote, black	2.5 ppm

Canistel	2.5 ppm

Sapote, mamey	2.5 ppm

Mango	2.5 ppm

Sapodilla	2.5 ppm

Star apple	2.5 ppm

Hop, dried cones	50 ppm

PP#7E7286:

Brassica, head and stem, subgroup 5A	5.0 ppm

The proposed new uses have been made on behalf of the Agricultural
Experiment Stations of AZ, CA, GA, NM, OR, TN, and TX (lettuce); CA, OK,
and TX (Swiss chard); HI (papaya and pineapple); ID and WA (hops); and
CA and TX (head and stem Brassica).

III.	EXECUTIVE SUMMARY

Triflumizole is a broad spectrum fungicide used to control plant
diseases by inhibiting ergosterol biosynthesis in fungi.  It treats
powdery mildew, leaf spot, scab, and various blights, rusts and rots. 
It is currently registered for foliar treatments of food crops such as
hazelnuts, pome fruits, leafy and cucurbit vegetables, grapes,
strawberries, and cherries and for pre-plant seed piece treatment of
pineapples.

Permanent tolerances are established for the combined residues of
triflumizole and its metabolites containing the
4-chloro-2-trifluoromethylaniline moiety (FA-1-1), calculated as parent,
in/on various crops at levels ranging from 0.05 ppm on filberts to 15
ppm in grape pomace [40 CFR §180.476(a)(1)].  Tolerances are also
established for the combined residues of triflumizole,
4-chloro-2-hydroxy-6-trifluoromethylaniline sulfate, and other
metabolites containing the FA-1-1 moiety, calculated as parent, in
livestock commodities [40 CFR §180.476(a)(2)].  In addition,
time-limited tolerances are established on various Brassica vegetables,
Swiss chard, coriander leaves, parsley, and dandelion in conjunction
with Section 18 emergency uses [40 CFR §180.476(b)]; these time-limited
tolerances expire 12/31/09.

The end-use product, relevant to these tolerance petitions and Section 3
registration request, is Procure® 480SC Fungicide (EPA Reg. No.
400-518), a flowable concentrate (FlC) formulation containing 4 lb
ai/gal.  Procure® 480SC Fungicide is proposed for multiple broadcast
foliar applications at maximum seasonal rates of 1.0 lb ai/A on head and
stem (subgroup 5A), leafy greens (subgroup 4A) except spinach, Swiss
chard and cilantro; 1.9 lb ai/A on papayas, canistel, mango, sapodilla,
sapote (black and mamey), and star apple; and 2.0 lb ai/A on hops.  The
formulation is also proposed for post-harvest fruit dip treatment of
pineapples at 0.5 lb ai/100 gal water.  Foliar applications may be made
using ground or aerial equipment.  The proposed preharvest intervals
(PHIs) for foliar uses range from 0 to 7 days.

The nature of the residue in plants is adequately understood based on
acceptable metabolism data on apples, cucumbers, grapes, and pears.  The
residues of concern are triflumizole and its metabolites containing the
4-chloro-2-trifluoromethylaniline moiety.

The nature of the residue in livestock is also adequately understood
based on acceptable metabolism data on lactating goats and poultry.  The
residues of concern are the combined residues of triflumizole, the
metabolite 4-chloro-2-hydroxy-6-trifluoromethyl aniline sulfate, and
other metabolites containing the 4-chloro-2-trifluoromethylaniline
moiety, calculated as the parent compound.

The nature of the residue in rotational crops is adequately understood. 
The residues of concern in rotational crops include triflumizole and all
metabolites containing the FA-1-1 moiety for purposes of risk assessment
and the tolerance expression.  The rotational crop restrictions in the
product labels, which are based on acceptable limited rotational crop
field trial data, are appropriate and preclude the need for rotational
crop tolerances.

An adequate gas chromatograph/nitrogen-phosphorus detection (GC/NPD)
method is available (Method I in PAM Vol. II) for enforcing tolerances
for triflumizole residues of concern in/on plant commodities.  This
common moiety method involves alkaline hydrolysis of parent and its
metabolites to FA-1-1, which is then distilled and partitioned into
hexane.  Residues of FA-1-1 are purified using a silica gel column and
determined by GC/NPD.  Residues are expressed in terms of triflumizole,
and the method limit of quantitation (LOQ) is 0.5 ppm for plant
commodities.

There are also adequate methods are available for determining residues
of triflumizole, its sulfate metabolite, and other metabolites
containing the 4-chloro-2-trifluoromethylaniline moiety in livestock
commodities.  A GC/NPD method for triflumizole and its metabolites
containing the 4-chloro-2-trifluoromethylaniline moiety in meat, milk,
poultry, and eggs is published in PAM, Vol. II as Method II.  Another GC
method for the triflumizole metabolite
2-hydroxy-4-chloro-6-trifluoromethylaniline sulfate in meat, milk,
poultry, and eggs is published in PAM, Vol. II as Method III.  The LOQ
for all matrices were reported as 0.05 ppm.

Data are available on the recovery of triflumizole through FDA
Multiresidue Method Testing Protocols.  The FDA PESTDATA database, dated
06/2005 (PAM Vol. I, Appendix I), indicates that triflumizole is
completely recovered using Multiresidue Method Section 302 (Protocol D)
without cleanup.  No information was listed for Methods 303 and 304.

Samples collected from the field and processing studies were analyzed
for the combined residues of triflumizole and its metabolites
convertible to FA-1-1 using a GC/mass selective detection (MSD) method
(GC/MSD, Morse Method Meth-115, Revision #2 or #3), which was derived
from the tolerance enforcement method.  This method was adequately
validated prior to and in conjunction with the analysis of field and
processing samples.  LOQs for triflumizole ranged from 0.01 ppm to 0.066
ppm.  LOQs for FA-1-1 ranged from 0.003 ppm to 0.030 ppm.

Concurrent storage stability studies were conducted for all crops except
hops in order to validate sample storage conditions and durations.  The
stability studies indicate that the combined residues of triflumizole
are reasonably stable in/on frozen lettuce, papaya fruit, pineapple
fruit, pineapple juice, pineapple process residue, and Swiss chard at
the maximum storage durations of commodity samples; no correction of
residues needs to be applied to these studies.  However, in frozen
stability studies conducted concurrently with the Brassica head and stem
field trials, the combined triflumizole residues were shown to decline
on average by 58% in broccoli stored for 7.6 months (equivalent to 0.25%
decline per day) and an average of 50% in cabbage stored for 8.5 months
(equivalent to 0.19% decline per day).  Based on these data, the
combined residues in/on broccoli and cabbage were corrected for
potential declines during frozen storage.

The only livestock feedstuff associated with the proposed uses is
pineapple process residue, a feedstuff which is fed to beef and dairy
cattle but not to poultry or swine.  Processing data are available which
indicate that triflumizole residues of concern do not concentrate in
pineapple process residue.  The only other livestock feedstuff from a
registered triflumizole use is wet apple pomace.  It is noted that a
tolerance of 2.0 ppm is currently listed for “apple pomace” under 40
CFR §180.476.  ARIA has recommended previously for the deletion of the
tolerance on apple pomace since it is based on dry apple pomace, a
commodity which is no longer regulated, and because the apple processing
study indicated that residues do not concentrate in wet apple pomace. 
It was further recommended that the established tolerances for grape
pomace (15.0 ppm) and grape raisin waste (10.0 ppm) should be deleted
from the 40 CFR §180.476, as these are no longer regulated livestock
feedstuffs.  Based on the previously reviewed cattle feeding study and
the revised dietary burden, tolerances are required meat byproducts and
fat of cattle, sheep, goat, and horse, but below established levels. 
Specifically, ARIA recommends lowering the present fat tolerance levels
from 0.5 ppm to 0.10 ppm, and also lowering the meat byproduct tolerance
levels from 0.5 ppm to 0.20 ppm.  All other established livestock
tolerances should be removed from 40 CFR 180.476a(2).

The submitted residue data for head and leaf lettuce are adequate to
support the establishment of a tolerance for leafy greens (subgroup 4A)
except spinach.  The maximum combined residues of triflumizole and its
aniline-containing metabolites were 8.3 ppm in/on field-grown head
lettuce, 24 ppm in/on field-grown leaf lettuce, and 17 ppm in/on
greenhouse-grown leaf lettuce treated according to the proposed use rate
and PHI.  ARIA recommends for the proposed tolerance of 35 ppm on leafy
greens (subgroup 4A) except spinach.

No data have been submitted for triflumizole residues of concern on
cilantro.  Cilantro is not currently a member of the leafy greens
(subgroup 4A).  However, since the commodity definition for parsley has
been determined to be equivalent to cilantro and parsley is now a member
of leafy greens (subgroup 4A), the data for head and leaf lettuce are
adequate to support a tolerance on cilantro leaves.  The petitioner
needs to submit a revised Section F to reflect the recommended commodity
definition, coriander leaves.

The submitted residue data for Swiss chard are adequate.  The maximum
combined residues of triflumizole and its aniline-containing metabolites
were 9.2 ppm in/on Swiss chard treated according to the proposed use
rate and PHI.  ARIA recommends for the proposed tolerance of 18 ppm on
Swiss chard.

The submitted residue data for broccoli and cabbage are adequate to
support the establishment of a tolerance for Brassica head and stem
(subgroup 5A).  The maximum combined residues of triflumizole and its
aniline-containing metabolites (corrected for residue decline) were 6.79
ppm in/on broccoli and 1.81 ppm in/on cabbage following treatments
according to the proposed use rate and PHI.  ARIA recommends a tolerance
of 8.0 ppm on Brassica head and stem (subgroup 5A).  The petitioner
needs to submit a revised Section F to amend the proposed tolerance
level from 5.0 ppm to 8.0 ppm.

The submitted residue data for hops are adequate to support the
establishment of the requested tolerance.  The maximum combined residues
of triflumizole and its aniline-containing metabolites in/on dried hop
cones were 25.9 ppm and 16.8 ppm following treatments of the crops with
WP and FlC formulations, respectively, according to the proposed maximum
seasonal rate and PHI.  Based on these data, ARIA recommends for the
proposed tolerance of 50 ppm in/on dried hop cone.

The submitted residue data for papaya are adequate.  The maximum
combined residues of triflumizole and its aniline-containing metabolites
were 0.92 ppm in/on papaya following treatments according to the
proposed use rate and PHI.  ARIA recommends for the proposed tolerance
of 2.5 ppm on papaya.  The submitted data for papaya may be translated
to support the proposed uses on black sapote, canistel, mamey sapote,
mango, sapodilla, and star apple.

The submitted postharvest data for pineapple reflect the proposed use
pattern and are adequate to fulfill data requirements.  The maximum
combined residues of triflumizole and its aniline-containing metabolites
in/on pineapple fruit were 3.70 ppm (when treated with triflumizole
without fruit wax or oil), 2.28 ppm (treated with triflumizole and a
fruit wax), and 1.85 ppm (treated with triflumizole and a fruit oil). 
ARIA recommends for the proposed tolerance of 4.0 ppm on pineapple.

The submitted pineapple processing study is adequate.  The combined
triflumizole residues did not concentrate in process residue (processing
factor of 0.84x) and marginally concentrated in juice (1.09x) processed
from pineapples bearing quantifiable residues.  These data indicate that
tolerances are not required for the processed commodities of pineapple.

Analytical standards for triflumizole and its regulated metabolites are
currently available in the EPA National Pesticide Standards Repository.

IV.	BACKGROUND

Triflumizole is a broad spectrum, imidazole fungicide (group 3) that
inhibits ergosterol biosynthesis in fungi.  The nomenclature of
triflumizole and its common analyte, FA-1-1, and the physicochemical
properties of triflumizole are presented below in Tables 1 and 2.

Common name	FA-1-1

IUPAC name	4-chloro-2-trifluoromethylaniline

Table 2.  Physicochemical Properties of Triflumizole.

Parameter	Value	Reference

Melting point/range	63.5C	DEB# 6410, J. Smith, 1/7/92

pH	Not available

	Bulk Density	0.50-0.70 (at 20ºC)

	Water solubility (g/L at 20ºC)	0.0125 (at pH 5.9)

	Solvent solubility (g/100 mL at 20ºC)	Chloroform	222

Acetone	144

n-Hexane	1.76

Methanol	49.6

Xylene	63.9

	Vapor pressure (at 25ºC)	1.4 x 10-6 mmHg

	Dissociation constant, pKa	3.7

	Octanol/water partition coefficient, Log(KOW) at 25ºC	25

	UV/visible absorption spectrum	Not available

	

V.	RESULTS/DISCUSSION

860.1200  Directions for Use

IR-4 provided a copy of the existing label for Procure® 480SC Fungicide
(EPA Reg. No. 400-518; 4 lb/gal FlC) and included in Section B of the
petition descriptions of the proposed uses on head and stem Brassica,
leafy greens except spinach, Swiss chard, cilantro, hops, pineapple,
papaya, canistel, mango, sapodilla, sapote (black and mamey), and star
apple.  The proposed new uses are summarized below in Table 3.

Table 3.  Summary of Directions for Use of Triflumizole.

Applic. Timing;

Type; and

Equip.	Formulation

[EPA Reg. No.]	Applic. Rate 

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

(lb ai/A)	PHI

(days)	Use Directions and Limitations

Head and stem Brassica vegetables subgroup 5A [broccoli; Chinese
broccoli (gai lon), Brussels sprouts, cabbage, Chinese cabbage (napa),
Chinese mustard cabbage (gai choy), cauliflower, cavalo broccoli, and
kohlrabi]

Broadcast foliar;

At first indication of disease;

Ground or aerial equipment	4 lb/gal FlC

[400-518]	0.125-0.25	Not specified (NS)	1.0	0	A minimum retreatment
interval (RTI) of 7 days is specified.  Apply in a minimum of 10 gal/A
for ground applications.

Leafy greens subgroup 4A except spinach [head and leaf lettuce including
head lettuce and leaf lettuce, cos (romaine) and butterhead varieties
(both field and greenhouse), amaranth, arugula, chervil, edible-leaved
chrysanthemum, garland chrysanthemum, corn salad, garden cress, upland
cress, dandelion, dock, endive, orach, parsley, garden purslane, winter
purslane, and radicchio]

Cilantro and Swiss chard

Broadcast foliar;

At first indication of disease;

Ground or aerial equipment	4 lb/gal FlC

[400-518]	0.125-0.25	NS	1.0	0	A minimum RTI of 7 days is specified. 
Apply in a minimum of 10 gal/A for ground applications.  Greenhouse
applications may be made for head lettuce and leaf lettuce.

Pineapple

Post-harvest fruit dip	4 lb/gal FlC

[400-518]	0.5 lb ai/100 gal	1	NS	Not applic-able	Dipping solution is to
include either fruit wax, at a ratio of 1 gallon of wax to 8 gallons of
water, or fruit oil, at a ratio of approximately 1 gallon of oil to 10
gallons of water.  After harvest, dip fruit in fungicide solution for
approximately 30 seconds, remove fruit and allow to air dry.  Do not
store fruit in the packing house.  

Canistel, Mango, Papaya, Sapodilla, Sapote (Black), Sapote (Mamey), and
Star Apple

Broadcast foliar;

At first indication of disease;

Ground or aerial equipment	4 lb/gal FlC

[400-518]	0.375	5 (implied)	1.9	0	A minimum RTI of 14 days is specified.
 Apply in a minimum of 75 gal/A for ground applications.  Spray
solutions should include appropriate surfactant.

Hops

Broadcast foliar;

At first indication of disease;

Ground or aerial equipment	4 lb/gal FlC

[400-518]	0.5	4 (implied)	2.0	7	A minimum RTI of 10 days is specified. 
Apply in a minimum of 50 gal/A for ground applications.

The following rotational crop restrictions are specified:  (1) do not
plant leafy vegetables or non-leafy Brassica vegetables or fruiting
vegetables within 30 days after application; (2) do not plant bulb
vegetables or root vegetables within 60 days after application; and (3)
do not plant cotton, small cereal grains and all other crops not
registered on the label for 4 lb/gal FlC formulation, within one year
after application.

For all proposed uses except pineapple, a restricted entry interval of
12 hours is specified.  The general use directions for the 4 lb/gal FlC
formulation (from the label included in the petitions) specify that no
more than two sequential applications of triflumizole be made before
alternating to a registered fungicide with a different mode of action. 
The grazing of livestock on treated orchard ground cover is prohibited.

Conclusion:  The proposed use directions are adequate to allow
evaluation of the residue data relative to the proposed use.  However, a
revised Section B is required to modify the existing rotational crop
restrictions and to specify minimum spray volumes when Procure® 480SC
Fungicide is applied by aerial treatments.  Since uses are being
proposed for leafy greens subgroup 4A except spinach and head and stem
Brassica vegetables subgroup 5A and new use on Brassica leafy greens
subgroup 5B (PP#7E7183) was recently approved, the rotational crop
restriction which states “do not plant leafy vegetables or non-leafy
Brassica vegetables or fruiting vegetables within 30 days after
application” should be amended to “do not plant spinach or fruiting
vegetables within 30 days after application.”  The remainder of
rotational crop restrictions is appropriate and is consistent with the
available field rotational crop data.  In addition, label revision is
required to specify minimum spray volumes of 2 gallons of water per acre
(or 10 gallons of water per acre for tree or orchard) for aerial
applications.

860.1300 Nature of the Residue - Plants

The nature of the residue in plants is adequately understood based on
acceptable metabolism studies conducted on apples, cucumbers, grapes,
and pears (PP#5G3232, 7/3/85, N. Dodd).  The Agency determined that the
residues of concern include triflumizole and its metabolites containing
the 4-chloro-2-trifluoromethyaniline moiety, calculated as triflumizole.
 This conclusion was reaffirmed in a meeting of the Metabolism
Assessment Review Committee (MARC) on 2/26/02 (DP# 280869, 3/13/02, J.
Tyler) but may need to be revisited if additional food/feed crops are
proposed for registration in the future.

860.1300 Nature of the Residue - Livestock

The nature of the residue in livestock is also adequately understood
based on acceptable metabolism data on lactating goats and poultry.  The
residues of concern were determined to be the combined residues of
triflumizole, the metabolite 4-chloro-2-hydroxy-6-trifluoromethyl
aniline sulfate, and other metabolites containing the
4-chloro-2-trifluoromethylaniline moiety, calculated as the parent
compound (DP# 280869, 3/13/02, J. Tyler).

860.1340 Residue Analytical Methods

Analytical enforcement methods

An adequate GC/NPD method is listed as Method I in PAM, Vol. II for
determining the combined residues of triflumizole and its metabolites
containing the FA-1-1 moiety in plant commodities (G. Kramer, 12/16/94).
 This common moiety method involves alkaline hydrolysis of parent and
its metabolites to FA-1-1 coupled with distillation of FA-1-1 into
hexane.  Residues are filtered through anhydrous sodium sulfate,
purified using a silica gel SPE column, and determined as FA-1-1 by
GC/NPD.  Residues are expressed in terms of triflumizole.  The method
LOQ is 0.5 ppm for plant commodities.

There are also adequate methods are available for determining residues
of triflumizole, its sulfate metabolite, and other metabolites
containing the 4-chloro-2-trifluoromethylaniline moiety in livestock
commodities (G. Kramer, 12/16/94).  A GC/NPD method for triflumizole and
its metabolites containing the 4-chloro-2-trifluoromethylaniline moiety
in meat, milk, poultry, and eggs is published in PAM, Vol. II as Method
II.  Another GC/NPD method for the triflumizole metabolite
2-hydroxy-4-chloro-6-trifluoromethylaniline sulfate in meat, milk,
poultry, and eggs is published in PAM, Vol. II as Method III.  The
method LOQ is 0.05 ppm for livestock commodities.

Data-collection methods

Samples collected from the field and processing studies were analyzed
for the combined residues of triflumizole and its metabolites
convertible to FA-1-1 using GC/MSD (Morse Method Meth-115, Revision #2
or #3), which was derived from the tolerance enforcement method.  A
complete review of Meth-115, Revision #2 may be found in a 3/11/02 memo
(DP# 274589, J. Tyler).  Revision #3 was recently reviewed in a 12/7/07
memo (DP#s 338653 and 341963, J. Tomerlin).  The general principle of
the data-collection method involves the conversion of residues to FA-1-1
by refluxing under acidic and then basic conditions and FA-1-1 is then
distilled and partitioned into hexane.  Following cleanup using a silica
solid phase extraction (SPE) cartridge, residues of FA-1-1 are
determined by GC/MSD and expressed in parent equivalents.  This method
was adequately validated prior to and in conjunction with the analysis
of field and processing samples.  LOQs for triflumizole ranged from 0.01
ppm (pineapple and hops) to 0.066 ppm (Swiss chard).  LOQs for FA-1-1
ranged from 0.003 ppm (cabbage) to 0.030 ppm (broccoli).

860.1360 Multiresidue Methods

Data are available on the recovery of triflumizole through FDA
Multiresidue Method Testing Protocols.  The FDA PESTDATA database, dated
06/2005 (PAM Vol. I, Appendix I), indicates that triflumizole is
completely recovered using Multiresidue Method Section 302 (Protocol D)
without cleanup.  No information was listed for Methods 303 and 304.

860.1380 Storage Stability

Previously submitted storage stability indicate that triflumizole per se
is stable under frozen storage conditions for up to 12 months in/on
apples, grapes, and cherries (PP#6F3372 and DP# 242429, J. Tyler,
4/30/01), 10 months in/on cucurbit vegetables and strawberries (DP#
271003, J. Tyler, 3/11/02; and DP# 274589, J. Tyler, 3/11/02), and 3.2
months in/on hazelnuts (DP# 312293, J. Tyler, 5/18/05).

The storage durations and conditions of samples collected from the
supporting field and processing studies are presented in Table 4. 
Concurrent storage stability studies were conducted for all crops except
hops in order to validate sample storage conditions and durations.  It
is noted that these data did not include zero-day data; the PM needs to
remind IR-4 that storage stability studies should always include a
zero-day sampling interval to establish the residue levels present at
the time samples are placed into storage [see OPPTS 860.1380(d)(6)(i)].

The stability studies indicate that the combined residues of
triflumizole are reasonably stable in/on frozen lettuce, papaya fruit,
pineapple fruit, pineapple juice, pineapple process residue, and Swiss
chard at the maximum storage durations of commodity samples; no
correction of residues needs to be applied to these studies.  However,
in frozen stability studies conducted concurrently with the Brassica
head and stem field trials, the combined triflumizole residues were
shown to decline on average by 58% in broccoli stored for 7.6 months
(equivalent to 0.25% decline per day) and an average of 50% in cabbage
stored for 8.5 months (equivalent to 0.19% decline per day).  Based on
these data, the combined residues in/on broccoli and cabbage were
corrected for potential declines during frozen storage, according to the
equation RS = RF ÷ [1 – (%decline/day x DAYS)], where RS is the
starting residue concentration, RF is the final residue concentration,
and DAYS is the number of days in storage.

Table 4.  Summary of Storage Conditions and Durations of Samples from
the Crop Field Trials and Processing Study.

Matrix

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

Broccoli, flower head

(47271302)	≤-8 at the field sites

-20 ± 5 at the analytical facility	63-253 days 

(2.1-8.3 months)	Concurrent storage stability data showed residue
declines of 37-74% over 232 days (7.6 months) of frozen storage.  The
overall average decline of 58% over 7.6 months (0.25%/day decrease) was
used to correct residue values.

Cabbage head with wrapper leaves

≤-1.7 at the field sites

-20 ± 5 at the analytical facility	53-266 days

(1.7-8.7 months)	Concurrent storage stability data showed residue
declines of 57-74% over 245/246 days (~8 months) and 15-70% over 259/260
days (~8.5 months) of storage.  The overall average decline of 50% over
8.5 months (0.19%/day decrease) was used to correct residue values. 

Hops

(47224005)	Frozen at the field sites

-20 ± 5 at the analytical facility	92-224 days

(3.0-7.4 months)	No data were submitted.

Lettuce, head and leaf

(47224002)

≤-0.6 at the field sites

-21 ± 7 at the analytical facility	55-222 days

(1.8-7.3 months)	Concurrent storage stability data indicate relative
stability of triflumizole (287 days; 9.4 months), FM-6-1 (294 days; 9.7
months), and FA-1-1 (297 days; 9.8 months).

Papaya

(47224004) 	In coolers at the HI field sites

≤-25 at the FL field site

<-15 at the analytical facility	352-562 days

(11.6-18.5 months)	Concurrent storage stability data indicate relative
stability of triflumizole (571 days), FM-6-1 (559 days), and FA-1-1 (565
days).

Pineapple fruit

(47224003)	Coolers with blue ice at the field sites

<-15 at the analytical facility	695-803 days

(22.9-26.4 months)	Concurrent storage stability data showed an overall
average residue decline of 23% over 833-846 days (~27-28 months) of
storage.  Since the overall average decline is less than 30%, residue
values were not corrected for decline in storage.

Pineapple process residue	Coolers with blue ice at the field and
processing sites

<-15 at the analytical facility	734 days

(24.1 months)	Concurrent storage stability data showed stability of
residues for up to 833 days (triflumizole), 837 days (FM-6-1), or 846
days (FA-1-1); however the data may indicate apparent decline of FA-1-1
residues in/on pineapple matrices.

Pineapple juice

722 days

(23.7 months)

	Swiss chard, foliage

(47224001)

≤-10 at the field sites

-21 ± 7 at the analytical facility	79-194 days

(2.6-6.4 months)	Concurrent storage stability data showed residue
declines of 3-40%, with an overall average decline of 22%, over 219-242
days (~8.0 months).  Since the overall average decline is less than 30%,
no corrections for in-storage dissipation of residues have been made to
residue data at this time.

860.1400 Water, Fish, and Irrigated Crops

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

860.1460 Food Handling

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

860.1480 Meat, Milk, Poultry, and Eggs

The only livestock feedstuff associated with the proposed uses is
pineapple process residue, a feedstuff which is fed to beef and dairy
cattle but not to poultry or swine.  Processing data are available which
indicate that triflumizole residues of concern do not concentrate in
pineapple process residue.  The only other livestock feedstuff with
registered triflumizole use is wet apple pomace.  It is noted that a
tolerance of 2.0 ppm is currently listed for “apple pomace” under 40
CFR §180.476.  ARIA has recommended (DP# 338653, 12/7/07, J. Tomerlin)
for the deletion of the tolerance on apple pomace since it is based on
dry apple pomace, a commodity which is no longer regulated, and because
the apple processing study indicated that residues do not concentrate in
wet apple pomace.  It was further recommended that the established
tolerances for grape pomace (15.0 ppm) and grape raisin waste (10.0 ppm)
should be deleted from the 40 CFR §180.476, as these are no longer
regulated livestock feedstuffs.

The theoretical dietary burden of triflumizole to beef and dairy cattle,
based on reasonably balanced diets, is presented in Table 5.  The
current dietary burden calculation does not include wet apple pomace as
a feedstuff because use of pineapple process residue results in a higher
burden and current policy does not recommend including both of these
feedstuffs.

Table 5.  Calculation of Dietary Burdens of Triflumizole Residues to
Beef Cattle and Dairy Cattle

Feedstuff	Type1	% Dry Matter2	% Diet2	Tolerance

    (ppm)	Dietary Burden

	Beef Cattle	Dairy Cattle

Beef Cattle	Dairy Cattle

Pineapple process residue	R	25	10	10	4.0	1.6	1.6

Other R without registered uses	R	--	20-35	--	--

	CC without registered uses	CC	--	40-55	--	--

	PC without registered uses	PC	--	15	--	--

	TOTAL BURDEN	--	--	100	--	1.6	1.6

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

2  Table 1 Feedstuffs (June 2008).  

3  Contribution = ([tolerance /% DM] X % diet). 

A previously submitted livestock feeding study was conducted in
conjunction with a petition on apples, pears, and grapes
(PP#6F3372/FAP#6H5497, DEB# 4277 & 4278, MRID 40752005-08, S. Malak,
3/16/90), and the results of this study are shown in Table 6.

Table 6.  Results of Triflumizole Cattle Feeding Study in ppm as FA-1-1
(a) and Triflumizole Equivalents (b)*

Feeding Level

(ppm)	Milk	Muscle	Fat	Kidney	Liver

	a	b	a	b	a	b	a	b	a	b

10	0.01	0.02	<0.01	<0.01	0.07	0.12	0.26	0.46	0.28	0.5

50	0.07	0.12	0.06	0.12	0.27	0.45	0.97	1.72	2.6	4.6

* FA-1-1 residues multiplied by 1.77 to convert to triflumizole.

Using the results from the cattle feeding study and the dietary burden,
projected residues for cattle commodities were calculated (see Table 7).
 Since the LOQ for the enforcement method is 0.05 ppm, only residues in
liver and kidney would be detectable.

Table 7.  Projected Residues in Beef and Milk in ppm as FA-1-1 (a) and
Triflumizole Equivalents (b)*

	Milk	Muscle	Fat	Kidney	Liver

	a	b	a	b	a	b	a	b	a	b

Residues at 10 ppm Feeding level 	0.01	0.02	0.01	0.01	0.07	0.12	0.26
0.46	0.28	0.5

Projected Residues**	0.0016	0.0032	0.0016	0.0016	0.0112	0.0192	0.0416
0.0736	0.0448	0.08

* FA-1-1 residues multiplied by 1.77 to convert to triflumizole.

** [Dietary Burden (1.6 ppm)/Feeding Level (10 ppm)] * Cattle Feeding
Study Residues

Conclusion:  Since there are no longer any poultry or swine feed items
of regulatory interest, the current tolerances on eggs; poultry fat,
meat, and meat byproducts; and hog fat, meat and meat byproducts should
all be deleted.  Based on the previously reviewed cattle feeding study
and the revised dietary burden, tolerances are required meat byproducts
and fat of cattle, sheep, goat, and horse, but below established levels.
 Specifically, ARIA recommends lowering the present fat tolerance levels
from 0.5 ppm to 0.10 ppm, and also lowering the meat byproduct tolerance
levels from 0.5 ppm to 0.20 ppm.  All other established livestock
tolerances should be removed from 40 CFR 180.476a(2).

860.1500 Crop Field Trials

Leafy Greens (Subgroup 4A) Except Spinach

Lettuce (Head and Leaf)

47224002.der.doc

IR-4 has submitted field trial data for triflumizole on head and leaf
lettuce.  Sixteen lettuce field trials were conducted during the 2005
and 2006 growing seasons.  These trials included:  seven trials on head
lettuce in Zones 2 (MD and NJ; 2 trials) and 10 (CA and NM; 5 trials);
seven trials on leaf lettuce in Zones 2 (GA; 2 trials) and 10 (CA and
NM; 5 trials); and two greenhouse trials on leaf lettuce in Zones 2 (NJ)
and 9 (CO).  Although the locations of the field trials conducted for
lettuce are not in strict accordance with OPPTS Guideline 860.1500, the
total number of field trials is adequate.

At each trial, four foliar (directed or broadcast) applications of a 4
lb/gal FlC formulation of triflumizole were made at ~0.25 lb
ai/A/application, with a 6- to 8-day RTI, for a total seasonal rate of
~1.0 lb ai/A (1x the proposed maximum seasonal rate).  Applications were
made using ground-based equipment in 15-61 gal/A spray volumes, without
an adjuvant.  Samples of mature lettuce were harvested from each site on
the day of the last application.  Additional samples were collected from
the NM05 head lettuce field trial and the CA27 leaf lettuce field trial
at 2/3, 7/8, and 14 days after the last application to evaluate residue
decline.

Samples of head and leaf lettuce were analyzed for the combined residues
of triflumizole and its aniline-containing metabolites using Cornell
method entitled, “Residue Analysis of Triflumizole in Lettuce by
GC/MSD Detection,” Version #2.  The method converts triflumizole and
all aniline-containing metabolites to the metabolite FA-1-1 for
determination, and combined residues are reported in ppm triflumizole
equivalents.  This method is adequate for data collection based on
acceptable method recoveries.  The lowest level of method validation
(LLMV) was 0.050 ppm each for triflumizole and metabolites FM-6-1 and
FA-1-1.  The calculated LOQ and limit of detection (LOD) for residues of
triflumizole in/on head lettuce were 0.042 ppm and 0.01 ppm,
respectively.  The calculated LOQ and LOD for FA-1-1 on leaf lettuce
were 0.035 ppm and 0.01 ppm, respectively.  The LOQ and LOD were
estimated as 0.036 ppm and 0.01 ppm, respectively, for FM-6-1 on head
lettuce and as 0.024 ppm and 0.008 ppm, respectively, for FM-6-1 on leaf
lettuce.  The LOQs and LODs for triflumizole in/on leaf lettuce and
FA-1-1 in/on head lettuce were not reported.

The maximum storage duration of treated lettuce samples, from harvest to
analysis, was 222 days (7.3 months).  Concurrent storage stability data
indicate relative stability of triflumizole (287 days; 9.4 months),
FM-6-1 (294 days; 9.7 months), and FA-1-1 (297 days; 9.8 months) in/on
lettuce.

The results of the field trials (see Table 8 below) indicate that the
maximum combined residues of triflumizole and its aniline-containing
metabolites were 8.3 ppm in/on field-grown head lettuce, 24 ppm in/on
field-grown leaf lettuce, and 17 ppm in/on greenhouse-grown leaf lettuce
harvested the day of the last of four foliar spray applications of the 4
lb/gal FlC formulation of triflumizole at total seasonal rates of ~1.0
lb ai/A.  The combined residue levels of triflumizole and its
aniline-containing metabolites were generally higher in/on the leaf
lettuce samples than in/on the head lettuce samples; residue levels
in/on greenhouse-grown leaf lettuce samples were comparable to those
in/on field-grown leaf lettuce samples.  Residue decline data generated
from the NM05 head lettuce and CA27 leaf lettuce field trials show that
the combined triflumizole residue levels appear to decrease in/on
lettuce with increasing sampling intervals.

Table 8.  Summary of Residue Data from Lettuce Field Trials with
Triflumizole.

Commodity	Total Applic. Rate

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

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

Proposed use pattern = Maximum seasonal rate of 1.0 lb ai/A with a 0-day
PHI

Field Trials

Head lettuce	0.995-1.051	0	14	0.68	8.3	7.6	2.1	3.0	2.4

Leaf lettuce	0.990-1.009	0	14	1.2	24	21	11	11	7.4

Greenhouse Trials

Leaf lettuce	1.019-1.040	0	4	9.3	17	15	11	12	3.6

Conclusion:  The submitted residue data for head and leaf lettuce, which
are the representative commodities of leafy greens (subgroup 4A) except
spinach, are adequate to fulfill data requirements.  The number and
locations of crop field trials are in accordance with OPPTS Guideline
860.1500.  The trials reflect the proposed use pattern.

The residue data for head and leaf lettuce were entered into the
Agency’s tolerance spreadsheet as specified by the Guidance for
Setting Pesticide Tolerances Based on Field Trial Data to determine an
appropriate tolerance level; see Appendix I.  Based on the residue data
for head and leaf lettuce, ARIA recommends for the proposed tolerance of
35 ppm for the combined residues of triflumizole and its metabolites
containing the FA-1-1 moiety, calculated as parent, in/on leafy greens
(subgroup 4A) except spinach.

Cilantro Leaves

No data have been submitted for triflumizole residues of concern on
cilantro.  Cilantro is not currently a member of the leafy greens
(subgroup 4A).  However, since the commodity definition for parsley has
been determined to be equivalent to cilantro (Reviewer’s Guide, B.
Schneider, 6/14/06) and parsley is now a member of leafy greens
(subgroup 4A), the data for head and leaf lettuce are adequate to
support a tolerance on cilantro leaves.

Conclusion:  ARIA concludes that the data for the head and leaf lettuce
are adequate to support the requested tolerance of 35 ppm on cilantro
leaves.  The petitioner should submit a revised section F reflecting the
recommended commodity definition, coriander leaves.

Leaf Petioles (Subgroup 4B)

Swiss Chard

47224001.der.doc

IR-4 has submitted field trial data for triflumizole on Swiss chard. 
Three Swiss chard trials were conducted in Zones 2 (MD), 6 (TX), and 12
(OR) during the 2005 growing season.  At each trial, four foliar
(directed or broadcast) applications of a 4 lb/gal FlC formulation of
triflumizole were made at ~0.25 lb ai/A/application, with a 6- to 8-day
retreatment interval, for a total seasonal rate of ~1.0 lb ai/A (1x the
proposed maximum seasonal rate).  Applications were made using
ground-based equipment in 18-33 gal/A spray volumes, without an
adjuvant.  Samples of mature Swiss chard were harvested from each site
on the day of the last application.

Samples of Swiss chard were analyzed for combined residues of
triflumizole and its aniline-containing metabolites using a GC/MSD
method entitled, “Residue Analysis of Triflumizole on Swiss Chard by
GC/MSD Detection," Version #1.  The method converts triflumizole and all
aniline-containing metabolites to the metabolite FA-1-1 for
determination, and combined residues are reported in ppm triflumizole
equivalents.  This method is adequate for data collection based on
acceptable method recoveries.  The LLMV was 0.050 ppm each for
triflumizole and metabolites FM-6-1 and FA-1-1.  The calculated LOQ and
LOD for residues of triflumizole in/on Swiss chard were 0.066 ppm and
0.022 ppm, respectively.  The calculated LOQ and LOD for residues of
FM-6-1 in/on Swiss chard were 0.095 ppm and 0.032 ppm, respectively, and
the calculated LOQ and LOD for residues of FA-1-1 in/on Swiss chard were
0.027 ppm and 0.009 ppm, respectively.

The maximum storage duration of samples of treated Swiss chard from
harvest to analysis was 194 days (6.4 months).  To support this storage
interval, a concurrent freezer storage stability study was conducted
using control samples of Swiss chard fortified separately with
triflumizole, FM-6-1, and FA-1-1 each at 5.0 ppm.  The fortified samples
were stored under the same conditions (-21 ± 7ºC) as the field trial
samples.  At 219-242 days, the stored samples were analyzed in
triplicate along with a control sample and control samples freshly
fortified with each analyte.  At the 219- to 242-day storage interval,
concurrent recovery samples had percent recoveries of 73, 71, and 75%
for triflumizole, FM-6-1, and FA-1-1, respectively.  The average
recovery from the stored samples (corrected for concurrent recoveries)
at 219-242 days was 97%, 76% and 60% for parent, FM-6-1, and FA-1-1,
respectively.  These recoveries correlate to declines of 3-40%, with an
overall average decline of 22% over 219-242 days (~8.0 months) of
storage.  Because the method converts parent and all metabolites to a
common moiety, corrections for the individual residue cannot be
determined.  Since the overall average decline is less than 30%, no
corrections for in-storage dissipation of residues have been made to
residue data at this time.

The results of the field trials (see Table 9 below) indicate that the
maximum combined residues of triflumizole and its aniline-containing
metabolites were 9.2 ppm triflumizole equivalents in/on Swiss chard
harvested the day of the last of four foliar spray applications of the 4
lb/gal FlC formulation of triflumizole at total seasonal rates of ~1.0
lb ai/A.

Table 9.  Summary of Residue Data from Swiss Chard Field Trials with
Triflumizole.

Commodity	Total Applic. Rate

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

	N	Min.	Max.	HAFT	Median	Mea	Std. Dev.

Proposed use pattern = Maximum seasonal rate of 1.0 lb ai/A with a 0-day
PHI

Swiss chard	0.997-1.028	0	6	2.2	9.2	8.5	5.4	5.5	2.7

Conclusion:  The submitted residue data for Swiss chard are adequate to
fulfill data requirements.  The number and locations of crop field
trials are in accordance with OPPTS Guideline 860.1500.  The trials
reflect the proposed use pattern.

The residue data for Swiss chard were entered into the Agency’s
tolerance spreadsheet as specified by the Guidance for Setting Pesticide
Tolerances Based on Field Trial Data to determine an appropriate
tolerance level; see Appendix I.  ARIA recommends for the proposed
tolerance of 18 ppm for the combined residues of triflumizole and its
metabolites containing the FA-1-1 moiety, calculated as parent, in/on
Swiss chard.

Brassica Head and Stem (Subgroup 5A)

Broccoli

47271302.der.doc

IR-4 has submitted field trial data for triflumizole on broccoli.  Nine
broccoli trials were conducted in Zones 2 (MD; 1 trial), 6 (TX; 1
trial), 10 (CA and NM; 6 trials), and 12 (OR; 1 trial) during the 2006
growing season.  At each trial, four foliar (directed or broadcast)
applications of an FlC formulation of triflumizole were made at ~0.25 lb
ai/A/application, with a 6- to 8-day retreatment interval, for a total
seasonal rate of ~1.0 lb ai/A (1x the proposed maximum seasonal rate). 
Additional applications were made at some sites [MD03 (5 applications),
OR07 (5 applications), and TX03 (6 applications)] because broccoli
plants had not reached maturity at those sites.  Applications were made
using ground-based equipment in 13-57 gal/A spray volumes, without an
adjuvant.  Samples of mature broccoli flower head were harvested from
each site on the day of the last application.  Additional samples were
collected at the CA11 trial site at 1, 4, 7, and 11 days after the last
application to evaluate residue decline.

Samples of broccoli flower head were analyzed for combined residues of
triflumizole and its aniline-containing metabolites using Morse
Laboratories GC/MSD method Meth-115, Revision #3 entitled,
“Determination of Triflumizole in Crops.”  Samples were analyzed
using the “moist and watery samples” variation of the method. 
Method Meth-115 converts triflumizole and all aniline-containing
metabolites to the metabolite FA-1-1 for determination, and combined
residues are reported in ppm triflumizole equivalents.  This method is
adequate for data collection based on acceptable method recoveries.  The
LLMV was 0.050 ppm each for triflumizole and metabolites FM-6-1 and
FA-1-1.  The calculated LOQ and LOD for residues of triflumizole in/on
broccoli were 0.032 ppm and 0.011 ppm, respectively.  The calculated LOQ
and LOD for residues of FM-6-1 in/on broccoli were 0.060 ppm and 0.020
ppm, respectively, and the calculated LOQ and LOD for residues of FA-1-1
in/on broccoli were 0.030 ppm and 0.010 ppm, respectively.

The maximum storage duration of samples of treated broccoli, from
harvest to analysis, was 253 days (8.3 months).  To support this storage
interval, a concurrent freezer storage stability study was conducted
using control samples of broccoli fortified separately with
triflumizole, FM-6-1, and FA-1-1 each at 5.0 ppm.  The fortified samples
were stored under the same conditions (-20 ± 5ºC) as the field trial
samples.  At 232 days, the stored samples were analyzed in triplicate
along with a control sample and control samples freshly fortified with
each analyte.  At the 232-day storage interval, concurrent recovery
samples had percent recoveries of 91, 86, and 78% for triflumizole,
FM-6-1, and FA-1-1, respectively.  The average recovery from the stored
samples (corrected for concurrent recoveries) at 232 days was 36%, 26%
and 63% for parent, FM-6-1, and FA-1-1, respectively.  These recoveries
correlate to declines of 37-74% over 232 days (7.6 months) of storage
and indicate that there is the potential for residue decline in frozen
broccoli.  Because the method converts parent and all metabolites to a
common moiety, corrections for the individual residue cannot be
determined.  Therefore, the overall average decline of 58% over 7.6
months (0.25%/day decrease) was used to correct residue values according
to the equation RS = RF ÷ [1 – (0.0025 x DAYS)], where RS is the
starting residue concentration, RF is the final residue concentration,
and DAYS is the number of days in storage.

The results of the field trials (see Table 10 below) indicate that the
maximum combined residues of triflumizole and its aniline-containing
metabolites (uncorrected for storage declines) were 4.04 ppm
triflumizole equivalents in/on broccoli flower head harvested the day of
the last of 4-6 foliar spray applications of the 4 lb/gal FlC
formulation of triflumizole at total seasonal rates of 1.0-1.517 lb
ai/A.  The average uncorrected residues were 1.11 ppm and the HAFT
residues were 3.94 ppm.  When corrected for potential declines of
0.25%/day during storage, maximum combined residues were 6.79 ppm in/on
18 samples of broccoli harvested at 0-day PHI.  The average corrected
residues were 1.79 ppm and the HAFT residues were 6.62 ppm.

Table 10.  Summary of Residue Data from Broccoli Crop Field Trials with
Triflumizole.

Commodity	Total Applic. Rate

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

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

Broccoli, flower head	1.0-1.517	0	Uncorrected

	18	0.280	4.04	3.94	0.800	1.11	1.09

	Corrected3

	18	0.489	6.79	6.62	1.18	1.79	1.81

1	Uncorrected

	2	0.776	0.888	0.832	0.832	0.832	0.0796

	Corrected

	2	0.976	1.12	1.048	1.048	1.048	0.102

4	Uncorrected

	2	0.432	0.74	0.586	0.586	0.586	0.218

	Corrected

	2	0.542	0.928	0.735	0.735	0.735	0.273

7	Uncorrected

	2	0.097	0.291	0.194	0.194	0.194	0.137

	Corrected

	2	0.121	0.361	0.241	0.241	0.241	0.171

11	Uncorrected

	2	0.367	0.457	0.412	0.412	0.412	0.064

	Corrected

	2	0.453	0.564	0.224	0.509	0.224	0.079

1  Combined residues of triflumizole and its aniline-containing
metabolites, expressed as ppm triflumizole parent equivalents.

2  HAFT = Highest Average Field Trial.

3  Residues were corrected for declines of 0.25%/day during frozen
storage according to the equation 

RS = RF ÷ [1 – (0.0025 x DAYS)], where RS is the starting residue
concentration, RF is the final residue concentration, and DAYS is the
number of days in storage. 

Residue decline data indicate that combined triflumizole residue levels
appear to decrease in/on broccoli flower head with increasing PHIs.

Cabbage

47271301.der.doc

IR-4 has submitted field trial data for triflumizole on cabbage.  Nine
cabbage trials were conducted in Zones 1 (NY; 1 trial), 2 (MD, NJ, and
TN; 3 trials), 3 (FL; 1 trial), 5 (WI; 1 trial), 6 (TX; 1 trial), 8 (CO;
1 trial), and 10 (CA; 1 trial) during the 2006-2007 growing season. 
Each field test consisted of one untreated plot and one treated plot. 
At each trial, either four foliar broadcast applications (6 trials) or
four foliar directed applications (3 trials) of a 4 lb/gal FlC
formulation of triflumizole were made at 0.242-0.270 lb
ai/A/application, with a 6- to 8-day retreatment interval, for a total
seasonal rate of 0.987-1.044 lb ai/A (~1x the proposed maximum seasonal
rate).  At the TN site, an additional application was made due to
immaturity of the cabbage crop, for a total seasonal rate of 1.29 lb
ai/A.  Applications were made using ground-based equipment in ~20-58
gal/A spray volumes, without an adjuvant.  Samples of mature cabbage
head with wrapper leaves were harvested from each site on the day of the
last application.

Samples of cabbage head were analyzed for combined residues of
triflumizole and its aniline-containing metabolites using Morse
Laboratories GC/MSD method Meth-115, Revision #3 entitled,
“Determination of Triflumizole in Crops.”  Samples were analyzed
using the “moist and watery samples” variation of the method. 
Method Meth-115 converts triflumizole and all aniline-containing
metabolites to the metabolite FA-1-1 for determination, and combined
residues are reported in ppm triflumizole equivalents.  This method is
adequate for data collection based on acceptable method recoveries.  The
LLMV was 0.050 ppm each for triflumizole and metabolites FM-6-1 and
FA-1-1.  The calculated LOQ and LOD for residues of triflumizole in/on
cabbage were 0.030 ppm and 0.010 ppm, respectively.  The calculated LOQ
and LOD for residues of FM-6-1 in/on cabbage were 0.043 ppm and 0.014
ppm, respectively, and the calculated LOQ and LOD for residues of FA-1-1
in/on cabbage were 0.009 ppm and 0.003 ppm, respectively.

The maximum storage duration of samples of treated cabbage, from harvest
to analysis, was 266 days (8.7 months).  To support this storage
interval, a concurrent freezer storage stability study was conducted
using control samples of cabbage fortified separately with triflumizole,
FM-6-1, and FA-1-1 each at 5.0 ppm.  The fortified samples were stored
under the same conditions (-20 ± 5ºC) as the field trial samples.  At
245/246 and 259/260 days, the stored samples were analyzed in triplicate
along with a control sample and control samples freshly fortified with
each analyte.  At the 245/246-day storage interval, concurrent recovery
samples had percent recoveries of 94, 91, and 98% for triflumizole,
FM-6-1, and FA-1-1, respectively.  At the 259/260-day storage interval,
concurrent recovery samples had percent recoveries of 85, 94, and 88%
for triflumizole, FM-6-1, and FA-1-1, respectively.  The average
recovery from the stored samples (corrected for concurrent recoveries)
at 245/246 days was 43%, 26% and 43% for parent, FM-6-1, and FA-1-1,
respectively, and the average recovery from the stored samples
(corrected for concurrent recoveries) at 259/260 days was 72%, 30% and
85% for parent, FM-6-1, and FA-1-1, respectively.  These recoveries
correlate to declines of 57-74% over 245/246 days (~8 months) and 15-70%
over 259/260 days (~8.5 months) of storage and indicate that there is
the potential for residue decline in frozen cabbage.  Because the method
converts parent and all metabolites to a common moiety, corrections for
the individual residue cannot be determined.  Therefore, the overall
average decline of 50% over 8.5 months (0.19%/day decrease) was used to
correct residue values according to the equation RS = RF ÷ [1 –
(0.0019 x DAYS)], where RS is the starting residue concentration, RF is
the final residue concentration, and DAYS is the number of days in
storage.

The results of the field trials (see Table 11 below) indicate that the
maximum combined residues of triflumizole and its aniline-containing
metabolites (uncorrected for storage declines) were 1.15 ppm
triflumizole equivalents in/on samples of cabbage head with wrapper
leaves harvested on the day of the last of 4-5 foliar spray applications
of the 4 lb/gal FlC formulation of triflumizole at total seasonal rates
of 0.987-1.29 lb ai/A.  The average uncorrected residues were 0.530 ppm
and the HAFT residues were 1.09 ppm.  When corrected for potential
declines of 0.19%/day during storage, maximum combined residues were
1.81 ppm in/on 18 samples of cabbage harvested at 0-day PHI.  The
average corrected residues were 0.743 ppm, and the HAFT residues were
1.70 ppm.  No residue decline data were generated.

Table 11.  Summary of Residue Data from Cabbage Field Trials with
Triflumizole.

Commodity	Total Applic. Rate 

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

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

Proposed use pattern = Maximum seasonal rate of 1.0 lb ai/A with a 0-day
PHI

Cabbage head with wrapper leaves	0.987-1.29	0	Uncorrected

	18	0.165	1.15	1.09	0.512	0.530	0.301

	Corrected

	18	0.208	1.81	1.70	0.602	0.743	0.481

Conclusion:  The submitted residue data for broccoli and cabbage, which
are the representative commodities of Brassica head and stem (subgroup
5A), are adequate to fulfill data requirements.  The number and
locations of crop field trials are in accordance with OPPTS Guideline
860.1500.  The trials reflect the proposed use pattern.

The residue data (corrected for residue decline) for broccoli and
cabbage were entered into the Agency’s tolerance spreadsheet as
specified by the Guidance for Setting Pesticide Tolerances Based on
Field Trial Data to determine an appropriate tolerance level; see
Appendix I.  The spreadsheet recommends individual tolerances of 8.0 ppm
for broccoli and 3.0 ppm for cabbage.  These recommended levels do not
vary by more than a factor of 5x.  Based on the residue data for
broccoli, ARIA recommends a tolerance of 8.0 ppm for the combined
residues of triflumizole and its metabolites containing the FA-1-1
moiety, calculated as parent, in/on Brassica head and stem (subgroup
5A).  The petitioner needs to submit a revised Section F to amend the
proposed tolerance level from 5.0 ppm to 8.0 ppm in/on Brassica head and
stem (subgroup 5A).

Miscellaneous Commodities

Hops

47224005.der.doc (includes MRID 47224006)

IR-4 has submitted field trial data for triflumizole on hops.  Three
hops trials were conducted in Zones 11 (ID and WA) and 12 (OR) during
the 2002 (MRID 47224005; OR and WA trials) and 2006 (MRID 47224006; ID
trial) growing seasons.  Each field trial consisted of one untreated
plot and one treated plot, except at the ID site which had two treated
plots.  At each trial, four foliar spray applications of a 50% WP
formulation of triflumizole were made at 0.486-0.519 lb
ai/A/application, with a 10-day RTI, for a total seasonal rate of
2.020-2.037 lb ai/A (~1x the maximum proposed seasonal rate). 
Applications were made using ground-based equipment in 49-102 gal/A
spray volumes, without an adjuvant.  At the ID trial site, a
side-by-side test was conducted using the 4 lb/gal FlC formulation of
triflumizole applied as four foliar spray applications at 0.501-0.509 lb
ai/A/application, with a 10-day RTI, for a total seasonal rate of 2.014
lb ai/A, using ground-based equipment in 101-102 gal/A spray volumes,
without an adjuvant.  Samples of mature hops were harvested from each
plot 7 and 14 days after the last application.  Immediately upon
harvest, the hop cone samples were dried in hop kilns for ~1 day and
then placed in freezers within 1 hour of drying.

Samples of dried hop cones were analyzed for the combined residues of
triflumizole and its aniline-containing metabolites using Morse
Laboratories GC/MSD method Meth-115 entitled, “Determination of
Triflumizole in Crops,” Revisions #2 (2002 samples) and #3 (2006
samples).  The method converts triflumizole and all aniline-containing
metabolites to the metabolite FA-1-1 for determination, and combined
residues are reported in ppm triflumizole equivalents.  This method is
adequate for data collection based on acceptable method recoveries.  The
reported LOQs were 0.01 ppm (Revision #2) and 0.02 ppm (Revision #3)
each for triflumizole and FA-1-1.  The LODs were not reported.

The maximum storage duration of samples of treated hop cones from
harvest to analysis was 111 days (3.7 months).  No supporting storage
stability data were submitted for hops.

The results of the field trials (see Table 12 below) indicate that the
maximum combined residues of triflumizole and its aniline-containing
metabolites were 25.9 ppm in/on dried hop cones harvested 7 days
following the last of four foliar spray applications of the 50% WP
formulation of triflumizole at total seasonal rates of ~2.0 lb ai/A; at
a 14-day PHI, the maximum combined residues were 23.2 ppm.  The maximum
combined residues of triflumizole and its aniline-containing metabolites
were 16.8 ppm in/on dried hop cones harvested 7 days following the last
of four foliar spray applications of the 4 lb/gal FlC formulation of
triflumizole at a total seasonal rate of ~2.0 lb ai/A; at a 14-day PHI,
maximum residues from this trial were 13.7 ppm.

The average combined residues from the 4 lb/gal FlC trial (15.5 ppm at a
7-day PHI and 12.6 ppm at a 14-day PHI) were comparable to those from
the 50% WP trials (14.0 ppm at a 7-day PHI and 12.2 ppm at a 14-day
PHI).

Table 12.  Summary of Residue Data from Hop Field Trials with
Triflumizole.

Commodity	EP	Total Applic. Rate

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

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

Proposed use pattern = Maximum seasonal rate of 2.0 lb ai/A with a 7-day
PHI

Hop, cone, dried	50% WP	2.020-2.037	7	8	4.64	25.9	22.3	12.7	14.0	8.09

	14	8	3.55	23.2	21.8	7.42	12.2	8.10

	4 lb/gal FlC	2.014	7	3	14.4	16.8	15.5	15.3	15.5	1.21

	14	3	11.5	13.7	12.6	12.5	12.6	1.10

Conclusion:  The submitted residue data hops are adequate to fulfill
data.  The number and locations of crop field trials are in accordance
with OPPTS Guideline 860.1500.  The trials reflect the proposed use
pattern.

The residue data for hops were entered into the Agency’s tolerance
spreadsheet as specified by the Guidance for Setting Pesticide
Tolerances Based on Field Trial Data to determine an appropriate
tolerance level; see Appendix I.  ARIA recommends for the proposed
tolerance of 50 ppm for the combined residues of triflumizole and its
metabolites containing the 4-chloro-2-trifluoromethylaniline moiety
(FA-1-1), calculated as parent, in/on dried hop cone.

Papaya

47224004.der.doc

IR-4 has submitted field trial data for triflumizole on papaya.  Four
papaya trials were conducted in the U.S. in Zone 13 (FL and HI) during
the 2005 growing season.  At each trial, five foliar directed spray
applications of the 4 lb/gal flowable concentrate (FlC) formulation of
triflumizole were made at ~0.38 lb ai/A/application, with a 12- to
14-day retreatment interval, for a total seasonal rate of ~1.9 lb ai/A
(1x the proposed maximum seasonal rate).  Applications were made using
ground-based equipment in 89-192 gal/A spray volumes, with a surfactant
adjuvant.  Samples of mature papaya fruit were harvested from each site
on the day of the last application.

Samples of papaya were analyzed for the combined residues of
triflumizole and its aniline-containing metabolites using a GC/MSD
working method adapted with minor modifications from the Morse
Laboratories method, “Analytical Method for the Determination of
Triflumizole in Crops.”  The method converts triflumizole and all
aniline-containing metabolites to the metabolite FA-1-1 for
determination, and combined residues are reported in ppm triflumizole
equivalents.  This method is adequate for data collection based on
acceptable method recoveries.  The LLMV was 0.050 ppm each for
triflumizole and metabolites FM-6-1 and FA-1-1.  The calculated LOQ and
LOD for residues of triflumizole in/on papaya fruit were 0.033 ppm and
0.011 ppm, respectively.  The calculated LOQs for residues of FM-6-1 or
FA-1-1 in/on papaya fruit were each 0.021 ppm and the calculated LODs
for residues of FM-6-1 or FA-1-1 in/on papaya fruit were each 0.007 ppm.

The maximum storage duration of samples of treated papaya, from harvest
to analysis, was 562 days (18.5 months).  Storage stability data for
papaya fruit submitted in conjunction with the field trial data indicate
apparent stability of residues of triflumizole (18.8 months), FM-6-1
(18.4 months), and FA-1-1 (18.6 months) in/on papaya fruit under frozen
storage conditions.

The results of the field trials (see Table 13 below) indicate that the
maximum combined residues of triflumizole and its aniline-containing
metabolites were 0.92 ppm triflumizole equivalents in/on papaya fruit
harvested the day of the last of five foliar spray applications of the 4
lb/gal FlC formulation of triflumizole at total seasonal rate of ~1.9 lb
ai/A.

Table 13.  Summary of Residue Data from Papaya Field Trials with
Triflumizole.

Commodity	Total Applic. Rate

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

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

Proposed use pattern = Maximum seasonal rate of 1.9 lb ai/A with a 0-day
PHI

Papaya fruit	1.863-1.920	0	8	0.200	0.920	0.886	0.688	0.628	0.297

Conclusion:  The submitted residue data for papaya are adequate to
fulfill data requirements.  The number and locations of crop field
trials are in accordance with OPPTS Guideline 860.1500.  The trials
reflect the proposed use pattern.

The residue data for papaya were entered into the Agency’s tolerance
spreadsheet as specified by the Agency’s Guidance for Setting
Pesticide Tolerances Based on Field Trial Data to determine an
appropriate tolerance level; see Appendix I.  ARIA recommends for the
proposed tolerance of 2.5 ppm for the combined residues of triflumizole
and its metabolites containing the FA-1-1 moiety, calculated as parent,
in/on papaya.

According to the Reviewer’s Guide and Summary of HED ChemSAC Approvals
for Amending Crop Group/Subgroups [40 CFR 180.41] and Commodity
Definition [40 CFR 180.1(h)], dated 6/14/06, the submitted data for
papaya may be translated to support the proposed uses and tolerances on
black sapote, canistel, mamey sapote, mango, sapodilla, and star apple.

Pineapple

47224003.de1.doc

IR-4 has submitted residue data for triflumizole on pineapple from three
field trials conducted in Hawaii (Zone 13) during the 2004 growing
season.  A 50% WP formulation of triflumizole was applied to mature
pineapples as a postharvest dip treatment at a rate of 0.5 lb ai/100 gal
water (1x the proposed postharvest use rate).  Three different
postharvest treatments were examined:  one for which the treatment
solution contained only the 50% WP formulation; one for which fruit wax
was added; and one for which fruit oil was added.  Approximately 19-26
mL of solution was used per fruit.  Following dip treatment, pineapples
were allowed to dry and the crowns were removed.  

Samples of pineapple were analyzed for combined residues of triflumizole
and its aniline-containing metabolites using a GC/MSD working method
adapted with minor modifications from Morse Laboratories method
Meth-115, Revision #3, “Determination of Triflumizole in Crops.” 
The method converts triflumizole and all aniline-containing metabolites
to the metabolite FA-1-1 for determination, and combined residues are
reported in ppm triflumizole equivalents.  This method is adequate for
data collection based on acceptable method recoveries.  The LLMV was
0.010 ppm each for triflumizole and metabolites FM-6-1 and FA-1-1.  The
calculated LOQ and LOD for residues of triflumizole in/on pineapple
fruit were 0.01 ppm and 0.003 ppm, respectively.  The calculated LOQ and
LOD for residues of FM-6-1 in/on pineapple fruit were 0.004 ppm and
0.001 ppm, respectively, and the calculated LOQ and LOD for residues of
FA-1-1 in/on pineapple fruit were 0.006 ppm and 0.002 ppm, respectively.

The maximum storage duration of samples of treated pineapple fruit from
treatment to analysis was 803 days (26.4 months).  To support this
storage interval, a concurrent freezer storage stability study was
conducted using control samples of pineapple fortified separately with
triflumizole, FM-6-1, and FA-1-1 each at 5.0 ppm.  The fortified samples
were stored under the same conditions (<-15ºC) as the field trial
samples.  At 833-846 days, the stored samples were analyzed in
triplicate along with a control sample and control samples freshly
fortified with each analyte.  At the 833- to 846-day storage interval,
concurrent recovery samples had percent recoveries of 76, 78, and 76%
for triflumizole, FM-6-1, and FA-1-1, respectively.  The average
recovery from the stored samples (corrected for concurrent recoveries)
at 833-846 days was 100%, 96% and 36% for parent, FM-6-1, and FA-1-1,
respectively.  These recoveries correlate to declines of 0-64%, with an
overall average decline of 23% over 833-846 days (~27-28 months) of
storage.  Because the method converts parent and all metabolites to a
common moiety, corrections for the individual residue cannot be
determined.  Since the overall average decline is less than 30%, no
corrections for in-storage dissipation of residues have been made to
residue data at this time.

The results of the postharvest study (see Table 14 below) indicate that
the maximum combined residues of triflumizole and its aniline-containing
metabolites in/on pineapple fruit were 3.70 ppm (when treated with
triflumizole without fruit wax or oil), 2.28 ppm (treated with
triflumizole and a fruit wax), and 1.85 ppm (treated with triflumizole
and a fruit oil).

Table 14.  Summary of Residue Data from Pineapple Postharvest Trials
with Triflumizole.

Commodity	Total Applic. Rate

(lb ai/

100 gal)	PHI (days)	Adjuvant	Residue Levels (ppm)

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

Proposed use pattern = Postharvest fruit dip at 0.5 lb ai/100 gal

Pineapple fruit, without crown	0.5	N/A	None	6	2.52	3.70	3.11	2.70	2.82
0.444

	Wax	6	1.69	2.28	2.18	2.03	2.01	0.209

	Oil	6	1.45	1.85	1.81	1.72	1.69	0.161

Conclusion:  The submitted postharvest data for pineapple reflect the
proposed use pattern and are adequate to fulfill data requirements.  The
residue data for pineapple were entered into the Agency’s tolerance
spreadsheet as specified by the Guidance for Setting Pesticide
Tolerances Based on Field Trial Data to determine an appropriate
tolerance level; see Appendix I.  ARIA recommends for the proposed
tolerance of 4.0 ppm for the combined residues of triflumizole and its
metabolites containing the FA-1-1 moiety, calculated as parent, in/on
pineapple.

860.1520 Processed Food and Feed

Pineapple

47224003.de2.doc

IR-4 has submitted a pineapple processing study for triflumizole in
support of the proposed postharvest use.  A 50% WP formulation of
triflumizole was applied as a postharvest application to mature
pineapples at a rate of 0.5 lb ai/100 gal water (1x the proposed
postharvest use rate), with added fruit wax.  Following dip treatment,
pineapples were allowed to dry and then processed into pineapple process
residue and juice.

Samples of pineapple fruit raw agricultural commodity and processed
fractions were analyzed for combined residues of triflumizole and its
aniline-containing metabolites using a GC/MSD working method adapted
with minor modifications from Morse Laboratories method Meth-115,
Revision #3, “Determination of Triflumizole in Crops.”  The method
converts triflumizole and its aniline-containing metabolites to the
metabolite FA-1-1 for determination, and combined residues are reported
in ppm triflumizole equivalents.  This method is adequate for data
collection based on acceptable method recoveries.  The LLMV was 0.01 ppm
for pineapple fruit without crowns (RAC) and 0.025 ppm for pineapple
process residue and pineapple juice.

The calculated LOQs for residues of triflumizole and metabolites FM-6-1
and FA-1-1 in/on pineapple fruit were 0.01, 0.004, and 0.006 ppm,
respectively; in/on pineapple process residue the LOQs were 0.004,
0.019, and 0.022 ppm, respectively; in pineapple juice the LOQs were
0.027, 0.018, and 0.015 ppm, respectively.  The LODs for these analytes
in/on pineapple fruit were 0.003, 0.001, and 0.002 ppm, respectively;
in/on pineapple process residue the LODs were 0.001, 0.006, and 0.007
ppm, respectively; and in pineapple juice the LODs were 0.009, 0.006,
and 0.005 ppm, respectively.

Samples were processed within 2 days of harvest.  Pineapple RAC samples
were stored frozen for a maximum of 701 days (23.1 months), pineapple
process residue for up to 734 days (24.1 months), and pineapple juice
for 722 days (23.7 months), prior to analysis.  To support this storage
interval, a concurrent freezer storage stability study was conducted
using control samples of pineapple fruit, process residue, and juice
fortified separately with triflumizole, FM-6-1, and FA-1-1 each at 5.0
ppm.  The fortified samples were stored under the same conditions
(<-15ºC) as the field trial/processing samples.  At 833-846 days, the
stored samples of pineapple fruit (RAC) were analyzed in triplicate
along with a control sample and control samples freshly fortified with
each analyte.  At the 833- to 846-day storage interval, concurrent
recovery samples had percent recoveries of 76, 78, and 76% for
triflumizole, FM-6-1, and FA-1-1, respectively.  The average recovery
from the stored samples (corrected for concurrent recoveries) at 833-846
days was 100%, 96% and 36% for parent, FM-6-1, and FA-1-1, respectively.
 These recoveries correlate to declines of 0-64%, with an overall
average decline of 23% over 833-846 days (~27-28 months) of storage.

At 787-823 days, the stored samples of pineapple process residue were
analyzed in triplicate along with a control sample and control samples
freshly fortified with each analyte.  At the 787- to 823-storage
interval, concurrent recovery samples had average percent recoveries of
77, 75, and 85% for triflumizole, FM-6-1, and FA-1-1, respectively.  The
average recovery from the stored samples (corrected for concurrent
recoveries) at 787-823 days was 89%, 91% and 48% for parent, FM-6-1, and
FA-1-1, respectively.  These recoveries correlate to declines of 9 to
52%, with an overall average decline of 24% over 787-823 days (~26-27
months) of storage.

At 740-761 days, the stored samples of pineapple juice were analyzed in
triplicate along with a control sample and control samples freshly
fortified with each analyte.  At the 740- to 761-day storage interval,
concurrent recovery samples had percent recoveries of 81, 69, and 89%
for triflumizole, FM-6-1, and FA-1-1, respectively.  The average
recovery from the stored samples (corrected for concurrent recoveries)
at 740-761 days was 101%, 103% and 68% for parent, FM-6-1, and FA-1-1,
respectively.  These recoveries correlate to declines of -3 to 32%, with
an overall average decline of 9% over 740-761 days (~24-25 months) of
storage.

The method converts parent and all metabolites to a common moiety;
therefore, corrections for the individual residue cannot be determined. 
Since the overall average decline is less than 30%, no corrections for
in-storage dissipation of residues have been made to residue data at
this time.

The combined residues of triflumizole and its aniline-containing
metabolites, presented in ppm triflumizole parent equivalents, were 1.69
and 1.88 ppm in/on pineapple RAC from the HI01 trial (average 1.79 ppm).
 Following processing of pineapple fruit, combined triflumizole residues
were 1.51 ppm in pineapple process residue and 1.95 ppm in pineapple
juice.  Processing factors, based on the average field trial value as
described above, were 0.84x for pineapple process residue and 1.09x for
pineapple juice; see Table 15.  The observed processing factors are less
than the theoretical concentration factor of 3.8x for pineapple process
residue based on separation into components (OPPTS 860.1520, Table 3).

Table 15.  Residue Data from Pineapple Processing Study with
Triflumizole.

Trial: City, State; Year

(Trial ID#)	RAC	Processed Commodity	Total Rate

(lb ai/100 gal) 	PHI

(days)	Combined Residues (ppm)	Processing Factor3

Makawao, HI; 2004

(04-HI01)	Pineapple	Fruit (RAC)	0.5	N/A	1.69, 1.88 

[Average  =1.79]	--

Process residue	0.5	N/A	1.51	0.84x

Juice	0.5	N/A	1.95	1.09x

Conclusion:  The submitted pineapple processing study is adequate.  The
combined triflumizole residues did not concentrate in process residue
(processing factor of 0.84x) and marginally concentrated in juice
(1.09x) processed from pineapples bearing quantifiable residues.  These
data indicate that tolerances are not required for the processed
commodities of pineapple.

  SEQ "CHAPTER" \*Arabic  1 860.1650 Submittal of Analytical Reference
Standards

Analytical standards for triflumizole and its metabolites are currently
available in the EPA National Pesticide Standards Repository (personal
communication with Dallas Wright, ACB, 4/1/08).  Analytical reference
standards of the following compounds (and their expiration dates) are
available:  triflumizole (11/30/2008), metabolite FA-1-1 (3/31/2011),
metabolite FA-1-5 sulfate (9/30/2010), and metabolite FM-6-1
(8/31/2010).

860.1850 and 860.1900 Confined and Field Accumulation in Rotational
Crops

Adequate confined and limited field rotational crop studies were
submitted in conjunction with a tolerance petition for use of
triflumizole on strawberries (PP#1F06297, DP# 274589, 3/11/02, J. Tyler;
DP# 327173, 10/19/06, J. Tyler).  Based on the results of the confined
study, the MARC (meeting 2/26/02) concluded that the residues of concern
in rotational crops include triflumizole and all metabolites containing
the FA-1-1 moiety for purposes of risk assessment and the tolerance
expression.  Results from the limited rotational crop field trials also
indicated that the following plant-back intervals are appropriate for
rotated crops:  30 days for leafy and fruiting vegetables; 60 days for
root and tuber vegetables; and 1 year for cotton, small cereal grains,
and any other crops without registered uses for triflumizole.  As the
above plant-back intervals are specified on the current labels, no
additional rotational crop data or tolerances are needed.

860.1550 Proposed Tolerances

ARIA has determined that the residues of concern for plant commodities
include triflumizole and its metabolites containing the FA-1-1 moiety. 
The triflumizole tolerances for plant commodities established in 40 CFR
§180.476(a)(1) reflects the residues of concern.  The tolerance
expression proposed by the petitioner is consistent with the 40 CFR
§180.476(a)(1).

The Codex Alimentarius Commission has not established maximum residue
limits (MRLs) for residues of triflumizole in/on various raw
agricultural and processed commodities.  Canada and Mexico have
established MRLs for triflumizole but not for the crop commodities or
groups/subgroups requested in these petitions.  Canada’s MRL and U.S.
tolerance definitions are harmonized.  An International Residue Limit
Status sheet is appended to this document and follows this section.

The Agency’s Guidance for Setting Pesticide Tolerances Based on Field
Trial Data was utilized for determining appropriate tolerance levels.  A
summary of the tolerance assessment is presented in Table 16.

The spreadsheet recommends for the proposed tolerance of 35 ppm for the
combined residues of triflumizole and its metabolites containing the
FA-1-1 moiety, calculated as parent, in/on leafy greens (subgroup 4A)
except spinach based on the residue data for head and leaf lettuce.  In
addition, ARIA concludes that the data for the head and leaf lettuce are
adequate to support the requested tolerance of 35 ppm on cilantro
leaves.  The petitioner should submit a revised section F reflecting the
recommended commodity definition, coriander leaves.  The time-limited
tolerance for coriander leaves, dandelion leaves, and parsley leaves
each established at 20 ppm under Section 18 emergency exemptions [40 CFR
§180.476(b)], may be removed with the establishment of a permanent
tolerance for subgroup 4A except spinach.

The spreadsheet recommends for the proposed tolerance of 18 ppm for the
combined residues of triflumizole and its metabolites containing the
FA-1-1 moiety, calculated as parent, in/on Swiss chard.  The
time-limited tolerance for Swiss chard at 7.0 ppm, established under
Section 18 emergency exemptions [40 CFR §180.476(b)], may be removed
with the establishment of a permanent tolerance for Swiss chard.

The spreadsheet recommends individual tolerances of 8.0 ppm for broccoli
and 3.0 ppm for cabbage.  These recommended levels do not vary by more
than a factor of 5x.  Based on the residue data (corrected for storage
decline) for broccoli, ARIA recommends a tolerance of 8.0 ppm for the
combined residues of triflumizole and its metabolites containing the
FA-1-1 moiety, calculated as parent, in/on Brassica head and stem
(subgroup 5A).  The petitioner needs to submit a revised Section F to
amend the proposed tolerance level from 5.0 ppm to 8.0 ppm.  The
time-limited tolerances for broccoli at 1.0 ppm, Chinese napa cabbage at
20 ppm, and kohlrabi at 20 ppm, which are all established under Section
18 emergency exemptions [40 CFR §180.476(b)], may be removed with the
establishment of a permanent tolerance for Brassica head and stem
(subgroup 5A).

The spreadsheet recommends for the proposed tolerance of 50 ppm for the
combined residues of triflumizole and its metabolites containing the
FA-1-1 moiety, calculated as parent, in/on dried hop cones.  

The spreadsheet recommends for the proposed tolerance of 2.5 ppm for the
combined residues of triflumizole and its metabolites containing the
FA-1-1 moiety, calculated as parent, in/on papaya.  According to the
Reviewer’s Guide and Summary of HED ChemSAC Approvals for Amending
Crop Group/Subgroups [40 CFR 180.41] and Commodity Definition [40 CFR
180.1(h)], dated 6/14/06, the submitted data for papaya may be
translated to support the proposed uses and tolerances on black sapote,
canistel, mamey sapote, mango, sapodilla, and star apple.

The spreadsheet recommends for the proposed tolerance of 4.0 ppm for the
combined residues of triflumizole and its metabolites containing the
FA-1-1 moiety, calculated as parent, in/on pineapple.  No tolerances are
needed for the processed commodities of pineapple based on an acceptable
processing study.

Table 16.  Tolerance Summary for Triflumizole.

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

Brassica, head and stem, subgroup 5A	5.0	8.0

	Leafy greens subgroup 4A, except spinach	35	35

	Cilantro, leaves	35	35	The data for the head and leaf lettuce are
adequate to support the requested tolerance on cilantro leaves. 
Coriander leaves

Swiss chard	18	18

	Pineapple	4.0	4.0

	Papaya	2.5	2.5

	Sapote, black	2.5	2.5	

The submitted data for papaya may be translated to support the proposed
uses and tolerances on black sapote, canistel, mamey sapote, mango,
sapodilla, and star apple.

Canistel	2.5	2.5

	Sapote, mamey	2.5	2.5

	Mango	2.5	2.5

	Sapodilla	2.5	2.5

	Star apple	2.5	2.5

	Hop, dried cones	50	50

	Cattle, fat	0.5	0.10	All other tolerances for meat, milk, poultry, and
eggs should be deleted

Cattle, meat byproducts	0.5	0.20

	Goat, fat	0.5	0.10

	Goat, meat byproducts	0.5	0.20

	Horse, fat	0.5	0.10

	Horse meat byproducts	0.5	0.20

	Sheep, fat	0.5	0.10

	Sheep, meat byproducts	0.5	0.20

	References

DEB#:	4277 & 4278

Subject:	PP#6F3372/FAP#6H5497.  Triflumizole (Procure 50W) on Apples,
Pears, and Grapes.

From:	S. Malak

To:	L. Rossi

Dated:	3/16/90

MRIDs:	40752005-08

DEB#:	6410

Subject:	I.D. No. 400-UGA. Triflumizole.  Registration of A815
Technical.

From:	J. Smith

To:	B. Chambliss

Dated:	1/7/92

MRIDs:	45375403-06

DP#:	None

Subject:	PP #6F3372/FAP#6H5497.  Triflumizole (Procure 50W®) in or on
Various RACs and Animal Commodities.  (Request for Entry of the Proposed
Enforcement Methods into PAM II)

From:	G. Kramer

To:	A. Marcotte

Dated:	12/16/94

MRID(s):	None

DP#:	242429

Subject:	PP# 8F4938.  Triflumizole in/on Cherries.  Evaluation of
Residue Data and Analytical Methods.

From:	J. Tyler

To:	M. Waller/S. Gardner-Jenkins

Dated:	4/30/01

MRIDs:	44438401-02

DP#:	271003

Subject:	PP# 0F6077.  Triflumizole in/on Cucurbits.  Evaluation of
Residue Data and Analytical Methods.

From:	J. Tyler

To:	M. Waller/S. Gardner-Jenkins

Dated:	3/11/02

MRIDs:	44971301-03

DP#	274589

Subject:	PP# 1F06297.  Triflumizole in/on Strawberries.  Evaluation of
Residue Data and Analytical Methods.

From:	J. Tyler

To:	M. Waller/S. Gardner-Jenkins

Dated:	3/11/02

MRIDs:	45375403-06

DP#:	280869

Subject:	Briefing to MARC (for meeting on 2/26/02) 

From:	J. Tyler

To:	Y. Donovan

Dated:	3/13/02

MRIDs:	None

DP#	312293

Subject:	Triflumizole.  Section 3 Request for Use on Filberts.  Summary
of Analytical Chemistry and Residue Data.

From:	J. Tyler

To:	S. Jackson/R. Forrest

Dated:	5/18/05

MRID:	45810201

DP#	327173

Subject:	PP#s 1F06297 and 0F06077.  Triflumizole.  Label Amendment
Request and Review of Limited Field Rotational Study Submitted in
Response to HED-Memoranda Dated 3/11/02.

From:	J. Tyler

To:	T. Gibson/M. Waller

Dated:	10/19/06

MRID:	46728501

DP#s	338653 and 341963

Subject:	Triflumizole.  Petition for Registration of use on Brassica
Leafy Greens (Subgroup 5B).  Summary of Analytical Chemistry and Residue
Data.  Petition Number 7E7183

From:	J. Tomerlin

To:	B. Madden

Dated:	12/7/07

MRID:	47054101

Attachments:

International Residue Limit Status sheet

Appendix I - Tolerance Assessment Calculations

Template Version September 2005

INTERNATIONAL RESIDUE LIMIT STATUS

Chemical Name: 
1-[(1E)-1-[[4-chloro-2-(trifluoromethyl)phenyl]-imino]-2-propoxyethyl]-1
H-imidazole	Common Name:  Triflumizole	X Proposed tolerance

 Reevaluated tolerance

 Other	Date: 3/31/08

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

X No Codex proposal step 6 or above

 No Codex proposal step 6 or above for the crops requested	Petition
Numbers:  PP#s 7E7258 & 7E7286

DP#s:  344463 & 346779

Other Identifier:  Decision Nos. 383407 and 385797

Residue definition (step 8/CXL): N/A	Reviewer/Branch:  C. Swartz/RAB2

	Residue definition:  Combined residues of the fungicide triflumizole
and its metabolites containing the 4-chloro-2-trifluoromethylaniline
moiety, calculated as the parent compound

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

Brassica, head and stem, subgroup 5A	5.0

Leafy greens subgroup 4A, except spinach	35

Cilantro, leaves	35

Swiss chard	18

Pineapple	4.0

Papaya	2.5

Sapote, black	2.5

Canistel	2.5

Sapote, mamey	2.5

Mango	2.5

Sapodilla	2.5

Star apple	2.5

Hop, dried cones	50

Limits for Canada	Limits for Mexico

 No Limits

X No Limits for the crops requested	 No Limits

X No Limits for the crops requested

Residue definition:
1-[1-[[4-chloro-2-(trifluoromethyl)phenyl]imino]-2-propoxyethyl]-1Himida
zole, including metabolites containing the
4-chloro-2-trifluoromethylaniline moiety, expressed as triflumizole
Residue definition:  Triflumizole

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

	Notes/Special Instructions:  S.Funk, 04/09/2008.

Appendix I

Tolerance Assessment Calculations

normal.  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.

Brassica, Head and Stem (Subgroup 5A)

The dataset used to establish a tolerance for combined residues of
triflumizole and its aniline-containing metabolites on head and stem
Brassica consisted of field trial data for broccoli and cabbage (the
representative crops of head and stem Brassica), representing
application rates of 1.0 lb ai/A (4 applications at 0.25 lb
ai/A/application) with a 0-day PHI.  As specified by the SOP, the field
trial application rates and PHIs are within 25% of the maximum label
application rate and minimum label PHI, respectively.  Only corrected
(for storage decline) residue values that were entered into the
tolerance spreadsheet are provided in Table I-1.

All field trial sample results for broccoli and cabbage were above the
LLMV (LLMV = 0.050 ppm for each analyte).  The broccoli and cabbage
datasets were not small (18 samples each).  Data corrected for the
combined residues of triflumizole and its metabolites, determined as
FA-1-1, in/on broccoli and cabbage were entered into the tolerance
spreadsheet.  For broccoli, visual inspection of the lognormal
probability plot (Figure I-1) and the result from the approximate
Shapiro-Francia test statistic (Figure I-2) indicated that the
assumption of lognormality should be rejected.  For cabbage, visual
inspection of the lognormal probability plots (Figure I-3) and the
results from the approximate Shapiro-Francia test statistic (Figure I-4)
indicated that the dataset was reasonably lognormal.

Using the tolerance spreadsheet, the recommended tolerances are 8.0 ppm
for broccoli and 3.0 ppm for cabbage.  Because the minimum and maximum
recommended tolerances differ by less than 5x, a crop group tolerance is
appropriate for head and stem Brassica.  The recommended value is 8.0
ppm, the maximum of the recommended individual tolerances.

Table I-1.	Residue data used to calculate tolerance for combined
residues of triflumizole and its aniline-containing metabolites on head
and stem Brassica.

Regulator:	EPA	EPA

Chemical:	Triflumizole	Triflumizole

Crop:	Broccoli (corrected for storage decline)	Cabbage (corrected for
storage decline)

PHI:	0 days	0 Days

App. Rate:	1.0-1.517 lb ai/A	0.987-1.29 lb ai/A

Submitter:	IR-4	IR-4

MRID Citation:	MRID 47271302	MRID 47271301

	Combined Residues of Triflumizole and its Aniline-Containing
Metabolites (ppm)

	6.790	1.230

	6.450	0.522

	2.430	1.340

	1.180	0.750

	1.720	0.643

	0.489	0.483

	1.240	0.560

	0.614	0.208

	1.120	1.810

	0.511	1.600

	1.480	0.469

	1.180	0.215

	1.120	0.260

	0.976	0.223

	1.463	1.080

	1.187	0.522

	1.282	0.750

	1.012	0.710

Figure I-1.  Lognormal probability plot of triflumizole field trial data
for broccoli.

Figure I-2.   Tolerance spreadsheet summary of triflumizole field trial
data for broccoli.

Figure I-3.  Lognormal probability plot of triflumizole field trial data
for cabbage.

Figure I-4.   Tolerance spreadsheet summary of triflumizole field trial
data for cabbage.

Leafy Greens (Subgroup 4A), except spinach

The dataset used to establish a tolerance for combined residues of
triflumizole and its aniline-containing metabolites on leafy greens,
except spinach consisted of field trial data for head lettuce and field
and greenhouse trial data for leaf lettuce (the representative crops of
leafy greens, except spinach), representing application rates of 1.0 lb
ai/A (4 applications at 0.25 lb ai/A/application) with a 0-day PHI.  As
specified by the SOP, the field trial application rates and PHIs are
within 25% of the maximum label application rate and minimum label PHI,
respectively.  The residue values used to calculate the tolerance are
provided in Table I-2.

All field trial sample results for head and leaf lettuce were above the
LLMV (LLMV = 0.050 ppm for each analyte).  The head lettuce dataset was
small, but the leaf lettuce dataset including four greenhouse samples
was not small (14 and 18 samples, respectively).  The dataset for each
crop was entered into the tolerance spreadsheet.  Visual inspection of
the lognormal probability plots for head and leaf lettuce (Figures I-5
and I-7, respectively) provided in the spreadsheet indicated that the
head lettuce dataset was reasonably lognormal, but that the leaf lettuce
dataset was not.  The results from the approximate Shapiro-Francia test
statistic (Figures I-6 and I-8) confirmed that the assumption of
lognormality should not be rejected for head lettuce but should be
rejected for leaf lettuce.

Using the tolerance spreadsheet, the recommended tolerances are 12 ppm
for head lettuce and 35 ppm for leaf lettuce.  Because the minimum and
maximum recommended tolerances differ by less than 5x, a tolerance for
the requested subgroup is appropriate.  ARIA recommends a tolerance of
35 ppm leafy greens subgroup 4A except spinach.

Table I-2.	Residue data used to calculate tolerance for triflumizole and
its aniline-containing metabolites on head and leaf lettuce.

Regulator:	EPA	EPA

Chemical:	Triflumizole	Triflumizole

Crop:	Head Lettuce (field trials)	Leaf Lettuce (field and greenhouse
trials)

PHI:	0 days	0 days

App. Rate:	0.995-1.051 lb ai/A	0.990-1.009 lb ai/A

Submitter:	IR-4	IR-4

MRID Citation:	MRID 47224002	MRID 47224002

	Combined Residues of Triflumizole and its Aniline-Containing
Metabolites (ppm)

	3.000	11.000

	2.000	10.000

	3.700	17.000

	2.100	16.000

	1.400	1.400

	1.200	1.200

	1.200	24.000

	0.680	18.000

	8.300	18.000

	6.900	17.000

	1.000	4.800

	0.990	3.200

	4.600	6.300

	4.500	4.600

9.600

9.300

17.000

12.000

Figure I-5.  Lognormal probability plot of triflumizole field trial data
for head lettuce.

Figure I-6.   Tolerance spreadsheet summary of triflumizole field trial
data for head lettuce.

Figure I-7.  Lognormal probability plot of triflumizole field trial data
for leaf lettuce.

Figure I-8.   Tolerance spreadsheet summary of triflumizole field trial
data for leaf lettuce.

Hops

The dataset used to establish a tolerance for triflumizole on hops
consisted of field trial data representing application rates of 2.0 lb
ai/A (4 applications at 0.5 lb ai/A/application) with a 7-day PHI, using
the 50% WP or 4 lb/gal FC formulation.  Since minimal data points (three
samples) are available for the proposed 4 lb/gal FlC formulation, the
data set includes the data points representing the 50% WP formulation. 
The field trial application rates and PHIs are within 25% of the maximum
label application rate and minimum label PHI, respectively, for both
formulations.  The residue values that were entered into the tolerance
spreadsheet are provided in Table I-3.

All field trial sample results for triflumizole in/on hops were above
the LOQ (LOQ = 0.01/0.02 ppm for each analyte).  The hops dataset was
small (11 samples; 8 samples representing 50% WP and 3 samples
representing 4 lb/gal FlC).  Visual inspection of the lognormal
probability plot (Figure I-9) and the results from the approximate
Shapiro-Francia test statistic (Figure I-10) indicated that the hops
dataset was reasonably lognormal.  

Using the tolerance spreadsheet, the recommended tolerance is 50 ppm for
hops.

Table I-3.	Residue data used to calculate tolerance for combined
residues of triflumizole and its aniline-containing metabolites on hops.

Regulator:	EPA

Chemical:	Triflumizole

Crop:	Hops (50% WP and 4 lb/gal FlC)

PHI:	7 days

App. Rate:	2.020-2.037 lb ai/A

Submitter:	IR-4

MRID Citation:	MRIDs 47224005 & 47224006

	Combined Residues of Triflumizole and its Aniline-Containing
Metabolites (ppm)

	8.830

	8.460

	6.420

	16.600

	4.640

	25.900

	23.900

	17.100

	16.800

	15.300

	14.400

Figure I-9.  Lognormal probability plot of triflumizole field trial data
for hops.

Figure I-10.   Tolerance spreadsheet summary of triflumizole field trial
data for hops.

Papaya

The dataset used to establish a tolerance for combined residues of
triflumizole and its aniline-containing metabolites on papaya consisted
of field trial data representing application rates of 1.9 lb ai/A (5
applications at 0.375 lb ai/A/application) with a 0-day PHI.  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-4.

All field trial sample results for triflumizole and its
aniline-containing metabolites in/on papaya were above the LLMV (LLMV =
0.050 ppm for each analyte).  The papaya dataset was small (8 samples). 
Visual inspection of the lognormal probability plot (Figure I-11) and
the results from the approximate Shapiro-Francia test statistic (Figure
I-12) indicated that the papaya dataset was reasonably lognormal.  

Using the tolerance spreadsheet, the recommended tolerance is 2.5 ppm
for papaya.

Table I-4.	Residue data used to calculate tolerance for combined
residues of triflumizole and its aniline-containing metabolites on
papaya.

Regulator:	EPA

Chemical:	Triflumizole

Crop:	Papaya

PHI:	0 days

App. Rate:	1.863-1.920 lb ai/A

Submitter:	IR-4

MRID Citation:	MRID 47224004

	Combined Residues of Triflumizole and its Aniline-Containing
Metabolites (ppm)

	0.920

	0.852

	0.530

	0.525

	0.914

	0.846

	0.240

	0.200

Figure I-11.  Lognormal probability plot of triflumizole field trial
data for papaya.

Figure I-12.   Tolerance spreadsheet summary of triflumizole field trial
data for papaya.

	

 

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The dataset used to establish a tolerance for combined residues of
triflumizole and its aniline-containing metabolites on pineapple
consisted of field trial data representing a single postharvest
application of the 50% WP formulation (note that the proposed
formulation is a 4 lb/gal FlC) at a rate of 0.5 lb ai/100 gal.  The data
from all three treatment types (triflumizole alone, triflumizole plus
fruit wax, and triflumizole plus fruit oil) were used.  The postharvest
application rate is within 25% of the maximum label application rate. 
The residue values that were entered into the tolerance spreadsheet are
provided in Table I-5.

All field trial sample results for triflumizole and its
aniline-containing metabolites in/on pineapple were above the LLMV (LLMV
= 0.010 ppm for each analyte).  The pineapple dataset was large (18
samples).  Visual inspection of the lognormal probability plot (Figure
I-13) and the results from the approximate Shapiro-Francia test
statistic (Figure I-14) indicated that the pineapple dataset was
reasonably lognormal.  

Using the tolerance spreadsheet, the recommended tolerance is 4.0 ppm
for pineapple.

Table I-5.	Residue data used to calculate tolerance for combined
residues of triflumizole and its aniline-containing metabolites on
pineapple.

Regulator:	EPA

Chemical:	Triflumizole

Crop:	Pineapple, fruit (50% WP)

PHI:	Postharvest dip

App. Rate:	0.5 lb ai/100 gal

Submitter:	IR-4

MRID Citation:	MRID 47224003

	Combined Residues of Triflumizole and its Aniline-Containing
Metabolites (ppm)

	2.640

	2.540

	1.880

	1.690

	1.540

	1.450

	3.700

	2.520

	2.280

	2.070

	1.830

	1.680

	2.760

	2.750

	2.160

	1.990

	1.850

	1.760

Figure I-13.  Lognormal probability plot of triflumizole field trial
data for pineapple.

Figure I-14.   Tolerance spreadsheet summary of triflumizole field trial
data for pineapple.

Swiss chard

The dataset used to establish a tolerance for combined residues of
triflumizole and its aniline-containing metabolites on Swiss chard
consisted of field trial data representing application rates of 1.0 lb
ai/A (4 applications at 0.25 lb ai/A/application) with a 0-day PHI.  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-6.

All field trial sample results for triflumizole and its
aniline-containing metabolites in/on Swiss chard were above the LLMV
(LLMV = 0.050 ppm for each analyte).  The Swiss chard dataset was small
(6 samples).  Visual inspection of the lognormal probability plot
(Figure I-15) and the results from the approximate Shapiro-Francia test
statistic (Figure I-16) indicated that the Swiss chard dataset was
reasonably lognormal.  

Using the tolerance spreadsheet, the recommended tolerance is 18 ppm for
Swiss chard.

Table I-6.	Residue data used to calculate tolerance for combined
residues of triflumizole and its aniline-containing metabolites on Swiss
chard.

Regulator:	EPA

Chemical:	Triflumizole

Crop:	Swiss chard

PHI:	0 days

App. Rate:	0.997-1.028 lb ai/A

Submitter:	IR-4

MRID Citation:	MRID 47224001

	Combined Residues of Triflumizole and its Aniline-Containing
Metabolites (ppm)

	9.200

	7.700

	3.100

	2.200

	5.400

	5.300

Figure I-15.  Lognormal probability plot of triflumizole field trial
data for Swiss chard.

Figure I-16.   Tolerance spreadsheet summary of triflumizole field trial
data for Swiss chard.

Page   PAGE  1  of   NUMPAGE \*Arabic  50 

Triflumizole	Summary of Analytical Chemistry and Residue Data	DP#s: 
344463, 346779

Page   PAGE  50  of   NUMPAGE \*Arabic  50