Document ID: EPA-HQ-OPP-2006-0732-0008
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2008-01-02T05:00Z

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF           

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

MEMORANDUM

	Date:	August 22, 2007

	Subject:	Trifloxystrobin.  Section 3 Registration on Asparagus,
Vegetable, Root Except Sugar Beet, Subgroup 1B, Radish (Tops),and
Papaya, Black Sapote, Canistel, Mamey Sapote, Mango, Sapodilla, Star
Apple, Citrus Fruits, Crop Group 10, and Strawberry.  Summary of
Analytical Chemistry and Residue Data.  PP#: 6E7088, 6F7123 and 7F7171.

		DP Num: 332104 and 339752		Decision Number:  369020, 371443 and 371446

		PC Code:  129112		MRID Numbers:  46886201, 46886202, 

					46886203, 46960701, and 47021101

		40 CFR 180.555		Chemical Class:  Fungicide

	From:	Debra Rate, Ph.D., Biologist

		Alternative Risk Integration and Assessment (ARIA) Team

		Risk Integration and Minor Use Emergency Response Branch (RIMUERB) 

		Registration Division (RD) (7505P)

	Through:	William Cutchin, Acting Branch Senior Scientist

		ARIA

		RIMUERB/RD (7505P)

	

		And

		Leung Cheng, Ph.D., Chemist

		Registration Action Branch 3 (RAB3)

		Health Effects Division (HED) (7509P)

	To:	Debra Rate, Ph.D., Biologist

		ARIA

		RIMUERB/RD (7505P)



Executive Summary

Trifloxystrobin belongs to the MAEs (β-methoxyacryl esters) class of
fungicides, which are synthetic analogs of strobilurin A.  It is a
broad-spectrum preventative fungicide for control of many plant
diseases.  It works by interfering with the respiration of plant
pathogenic fungi, and it is a potent inhibitor of
spore朠牥業慮楴湯愠摮洠捹汥慩⁬牧睯桴മ

Permanent tolerances for residues of trifloxystrobin are listed in 40
CFR §180.555 and are expressed in terms of combined residues of
trifloxystrobin (benzeneacetic acid,
(E,E)-α-(methoxyimino)-2-[[[[1-[3-(trifluoromethyl)phenyl]ethylidene]am
ino]oxy]methyl]-, methyl ester) and the free form of its acid
metabolite,
(E,E)-alpha-(methoxyimino)-2-[[[[1-[3-(trifluoromethyl)phenyl]ethylidene
]amino]oxy] methyl]-benzeneacetic acid (CGA-321113), in/on a variety of
plant commodities at levels ranging from 0.04 ppm in/on several nut
crops to 30 ppm in citrus oil.  Tolerances have also been established on
livestock commodities from 0.02 ppm in milk to 0.05 ppm in fat, meat,
and meat-byproducts of livestock.  

Trifloxystrobin is currently registered in the U.S. under the name
Flint® Fungicide, which is a water dispersible granule (WG) with 50%
trifloxystrobin; Gem®, which is a flowable concentrate (FC) with 25%
trifloxystrobin; and Stratego® and Absolute® which are multiple active
ingredient (MAI) emulsifiable concentrate (EC) formulations containing
both trifloxystrobin and propiconazole or trifloxystrobin and
tebuconazole, respectively. 

The   SEQ CHAPTER \h \r 1 Interregional Research Project No. 4 (IR-4)
has submitted a request for an amended registration of the end-use
product, Flint® Fungicide (WG) (EPA Reg. No. 264-777) to include new
domestic uses of trifloxystrobin on asparagus, radish and papaya.  Bayer
has submitted data in support of a new use on strawberry.  Concurrently,
IR-4 and Bayer CropScience request the establishment of the following
permanent tolerances for residues of this fungicide, and Bayer
CropScience requests an increase in tolerances (citrus fruits, crop
group 10; citrus, oil; and citrus, dried pulp):

Proposed Tolerances

Asparagus	……………	0.07 ppm

Vegetable, root except sugar beet, subgroup 1B	……………	0.10 ppm

Radish (Tops)	……………	10 ppm

Papaya; black sapote; canistel; mamey sapote; mango; sapodilla; and star
apple	

……………	

0.70 ppm

Strawberry	……………	1.1 ppm

Revised Tolerances

Citrus Fruits, Crop Group 10	……………	0.4 ppm

Citrus, oil	……………	36.0 ppm

Citrus, dried pulp	……………	1.0 ppm

In petition PP#6E7088, IR-4 submitted data for the use of the WG
formulation of trifloxystrobin for up to 1) three broadcast foliar
applications to asparagus as needed at 0.125 lb ai/A, at 14 day
retreatment intervals (RTIs), for a maximum of 0.375 lb ai/A/season, 2)
two broadcast foliar applications to radish as needed at 0.125 lb ai/A,
at 7 day RTIs, for a maximum of 0.250 lb ai/A/season, and 3) four
broadcast foliar applications to papaya as needed at 0.125 lb ai/A, at 7
day RTIs, for a maximum of 0.50 lb ai/A/season.  

In petition PP#7F7171, Bayer CropScience submitted field trial data for
the use of the WG formulation of trifloxystrobin as six broadcast foliar
applications to strawberry at 0.10 lb ai/A at 7-14 day RTIs, for a
maximum of 0.60 lb ai/A/season, harvested with a 0 day preharvest
interval (PHI).

In petition PP#6F7123, Bayer CropScience submitted field trial data for
the use of the WG formulation of trifloxystrobin as four broadcast
foliar applications to citrus fruits during fruit development at
0.12-0.13 lb ai/A/application, at RTIs of 19-22 days, for a maximum of
0.49-0.51 lb ai/A/season.  The petitioner requests a change from the
currently labeled 30 day PHI to a 7 day PHI.

The qualitative nature of the residue in plants and livestock
commodities is understood based on adequate metabolism studies conducted
on apples, cucumbers, peanuts, sugar beets, wheat, goats, and laying
hens.  The HED Metabolism Assessment Review Committee (MARC) concluded
that both trifloxystrobin and CGA-321113 are of concern for both
regulatory and risk assessment purposes in both plant and livestock
commodities.  The MARC also determined that for livestock commodities,
the metabolite L7a (taurine conjugate of trifloxystrobin) in liver
should be included in the risk assessment.

There are no livestock feedstuffs associated with the proposed uses on
asparagus, papaya, strawberry or citrus fruit.  However, carrots and
turnips as a part of crop group 1B (vegetable, root, except sugar beet),
are cattle and swine feed items.  The addition of radish tolerances to
the already established tolerance for the vegetable, root, except sugar
beet, subgroup 1B, except radish and the increase of tolerances on
citrus, dried pulp, will have no impact on the established tolerances of
livestock commodities based on this addition to the respective dietary
burdens.  Accordingly, the current tolerances for livestock commodities
are adequate.  

Radish is a typically rotated commodity.  No rotational crop studies
were submitted with this petition.  The previously submitted field
rotational crop studies have been deemed adequate.  The plantback
restrictions for Flint( are adequate and no rotational crop tolerances
need to be proposed.  

An adequate gas chromatography with nitrogen phosphorus detector
(GC/NPD) method (Method AG-659A) is available for enforcing tolerances
for the combined residues of trifloxystrobin and CGA-321113 in plant
commodities.  Analytical method AG 659A, modified to utilize liquid
chromatography with tandem mass spectroscopy (LC/MS/MS), was used and
validated for the analysis of trifloxystrobin and the acid metabolite
CGA 321113 in oats and barley matrices.  These validated methods were
slightly modified to use gas chromatography/mass spectroscopy (GC/MS)
detection in the analysis of samples from the asparagus, radish, and
papaya field trials.  This method was adequately validated in
conjunction with these analyses.  Samples of strawberry and citrus
fruits were analyzed for residues of trifloxystrobin and its acid
metabolite using a LC/MS/MS method (Bayer Report No. 200177), which was
previously developed for the analysis of residues in tomatoes and
peppers.  The method uses the same extraction procedures as the GC/NPD
tolerance enforcement method (Method AG-659A), but uses different clean
up procedures and detection by LC/MS/MS.  The lowest limit of method
validation (LLMV) is 0.02 ppm for each analyte in radish, 0.05 ppm and
0.02 ppm for trifloxystrobin and CGA-321113, respectively, for
asparagus, for combined LLMVs of 0.04 ppm in/on all radish matrices and
0.07 ppm in/on all asparagus matrices.  The limits of quantitation (LOQ)
for papaya are 0.008 ppm and 0.20 ppm for trifloxystrobin and
CGA-321113, respectively.  The LOQs for oranges, lemons and grapefruit
are 0.01 ppm for both analytes in oranges and 0.02 ppm for both analytes
in lemons and grapefruit.  The LOQs for strawberry are 0.01 ppm for both
analytes.  The limits of detection (LOD) are 0.002 for each analyte in
each citrus fruit matrix and the calculated LODs for each analyte in
strawberry are 0.004 ppm.  An adequate number of field trials were
conducted in the appropriate regions for each of the current raw
agricultural commodities (RACs).  

Adequate field crop studies are available to support the requested
tolerance for asparagus.  The field crop database on vegetable, root,
except sugar beet, subgroup 1B with the addition of the submitted radish
field trial data support the requested tolerances on vegetable, root,
except sugar beet, subgroup 1B, and radish, tops.  Because papaya is a
representative crop for the subset of proposed tropical fruits, the
submission of adequate field trial can be translated to support
tolerances on the following requested tropical fruit RACs: papaya;
sapote, black; canistel; sapote, mamey; sapodilla; and star apple.  The
submitted field trial data for the proposed use on strawberry is
adequate to support the requested tolerance.  Finally, the submitted
field trial data on citrus fruit is adequate to support the requested
decreased PHI and corresponding increased tolerances for citrus fruits,
crop group 10, citrus, oil, and citrus, dried pulp.

Regulatory Recommendations and Residue Chemistry Deficiencies

A revised Section F must be submitted to the Agency correcting the
commodity definitions as shown in Table 9, and the proposed tolerance
levels of citrus fruits, crop group 10 from 0.4 ppm to 0.6 ppm and
citrus, oil from 36.0 ppm to 38.0 ppm.

The petitioner must submit revised labels to match the proposed use
rates from the Section Bs of each petition.

Pending the submission of the revised Section F, the revised labels, and
the forthcoming human health risk assessment, the Agency recommends
establishing permanent tolerances for the combined residues of
trifloxystrobin and CGA-321113 in/on asparagus at 0.07 ppm; vegetable,
root except sugar beet, subgroup 1B at 0.10 ppm; radish, tops at 10 ppm;
papaya, black sapote, canistel, mamey sapote, mango, sapodilla, and star
apple at 0.70 ppm; strawberry at 1.1 ppm; citrus fruits, crop group 10
at 0.6 ppm; citrus, oil at 38.0 ppm; and citrus, dried pulp at 1.0 ppm.

Background

trobin belongs to the MAEs (β-methoxyacryl esters) class of fungicides,
which are synthetic analogs of strobilurin A (FRAC Group 11).  It is a
broad-spectrum preventative fungicide for control of many plant
diseases.  It works by interfering with the respiration of plant
pathogenic fungi, and it is a potent inhibitor of spore germination and
mycelial growth. 

TABLE 1.	Test Compound Nomenclature

Compound	Chemical Structure

methyl
(E)-methoxyimino-{(E)-α-[1-(α,α,α-trifluoro-m-tolyl)ethylideneaminoo
xy]-o-tolyl}acetate

CAS name	

(E,E)-alpha-(methoxyimino)-2-[[[[1-[3-(trifluoromethyl)phenyl]ethylidene
]amino]oxy] methyl]-benzeneacetic acid methyl ester

CAS #	141517-21-7

End-use product/(EP)	Flint® Fungicide

Regulated Metabolite	

Company Code	

CGA-321113 (Trifloxystrobin acid)

Molecular  weight	

394

CAS name	

(alpha,E)-alpha-(methoxyimino)-2-[[[[1-[3-(trifluoromethyl)phenyl]ethyli
dene]amino]oxy]methyl]-benzeneacetic acid

CAS #	

not available

TABLE 2.	Physicochemical Properties of the Technical Grade Test
Compound.

Parameter	Value	Reference

Melting point/range	

72.9ºC	MRID No. 44502801

pH	

7.7 in 1% w/w aqueous dispersion at 25ºC

	Density	

1.36 g/cm2 at 21ºC

	Water solubility ( 25°C)	

not available

	Solvent solubility (mg/L at 25°C)	

methanol   76

acetone   >500

ethyl acetate   >500

n-hexane   11	

dichloromethane  >500

toluene  500

n-octanol  18

	Vapour pressure at 25°C	

3.4 x 10-6 Pa

	Dissociation constant (pKa)	

none at pH of 2-12

	Octanol/water partition coefficient Log(KOW)	

4.5

	UV/visible absorption spectrum	

17,500 at 250.7 µm (neutral)

17,300 at 250.2 µm (acidic)

15,900 at 252.3 µm (basic)

	

860.1200  Directions for Use

Sample labels including the requested uses were submitted with these
petitions.  The following use patterns for the requested crops were
taken from the Section Bs of the current petitions (PP#6E7088, PP#6F7123
and 7F7171).

TABLE 3.  Summary of Directions for Use of Trifloxystrobin.

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

Asparagus

Foliar Broadcast / Fern	Flint® Fungicide (WG) 

[264-777]	0.125	3	0.375	180 (All States excluding CA)

90 (CA)	Maintain a minimum of 14 day RTIs.

Radish

Foliar Broadcast / Early maturity, Vegetative	Flint® Fungicide (WG) 

[264-777]	0.125	2	0.250	6-8	Maintain a minimum of 7 day RTIs.

Papaya

Foliar Directed / Fruiting	Flint® Fungicide (WG) 

[264-777]	0.125	4	0.5	0	Maintain a minimum of 7 day RTIs.

Citrus Fruits, Crop Group 10

Foliar Broadcast	Flint® Fungicide (WG) 

[264-777]	0.125	4	0.5	7	Apply using ground or aerial equipment in a
minimum of 10 and 50 gal/A, respectively. 

Foliar Broadcast	Gem (FC)

[264-781]

	Foliar Broadcast	  HYPERLINK "javascript:viewRiName(468360)"  GEM 500
(SC) 

[264-826]

	Strawberry

Foliar Broadcast	Flint® Fungicide (WG) 

[264-777]	0.10	6	0.6	0	Repeat application as needed with a 7- to 14-day
interval.  Do not apply more than 2 sequential applications of Flint or
other strobilurin fungicides.

Foliar Broadcast

Not specified	USF 2014 (SC)

[264-RNET]	0.10

	3	0.6

	1	Repeat application as needed with a 7- to 14-day interval.  Do not
apply more than 2 sequential applications of USF 2014 or other
strobilurin-containing fungicides

The use patterns described in the Section Bs are adequate to allow
evaluation of the residue data and are supported by submitted field
trial data relative to the proposed uses for asparagus; vegetable, root
except sugar beet, subgroup 1B; radish tops; and papaya, black sapote,
canistel, mamey sapote, mango, sapodilla, star apple; strawberry; and
citrus fruits, crop group 10.  The labels must be revised to match the
proposed and study use rates.  

860.1300 Nature of the Residue - Plants

PP#8F4955, DP Num: 254208 and 257888, F. Ives, 22/JUL/1999

PP#0F06121, DP Num: 267787 and 272054, L. Cheng, 17/JAN/2002

DP Num: 287242, L. Cheng, 08/OCT/2003

MARC Memo: DP Num: 257835, 13/JUL/1999

The qualitative nature of the residue in plants is adequately understood
based on acceptable metabolism studies using the direct application of
trifloxystrobin to apples, cucumbers, and peanuts (PP#8F4955, DP Num:
254208 and 257888, F. Ives, 22/JUL/1999), sugar beets (PP#0F06121, DP
Num: 267787 and 272054, L. Cheng, 17/JAN/2002), and wheat (DP Num:
287242, L. Cheng, 08/OCT/2003).  The HED MARC (DP Num: 257835,
13/JUL/1999) concluded that both trifloxystrobin and the free form of
its acid metabolite CGA-321113 are of concern for both regulatory and
risk assessment purposes for plant commodities.  

860.1300 Nature of the Residue - Livestock

PP#8F4955, DP Num: 254208 and 257888, F. Ives, 22/JUL/1999

MARC Memo: DP Num: 257835, 13/JUL/1999

No livestock data were submitted with these petitions.  The qualitative
nature of the residue in livestock is adequately understood based on
acceptable goat and poultry metabolism studies (PP#8F4955, DP Num:
254208 and 257888, F. Ives, 22/JUL/1999).  The MARC (DP Num: 257835,
13/JUL/1999) determined that the total toxic residues for livestock,
both for regulatory and risk assessment purposes, is trifloxystrobin and
the free form of its acid metabolite CGA-321113.  Additionally,
metabolite L7a (taurine conjugate of trifloxystrobin) in the liver
should be included in risk assessment.

860.1340 Residue Analytical Methods

DP Num: 265003, L. Cheng, 13/APR/2000

46886201.der.com, D. Rate, 15/NOV/2006

46886202.der.com, D. Rate, 15/NOV/2006

46886203.der.com, D. Rate, 15/NOV/2006

46960701.der.com, D. Rate, 29/MAY/2007

47021101.der.com, D. Rate, 13/JUN/2007

An adequate GC/NPD method (Method AG-659A) is available for enforcing
tolerances for the combined residues of trifloxystrobin and the free
form of its acid metabolite (CGA-321113) in plant and livestock
commodities.  This method was validated by the Agency (DP Num: 265003,
L. Cheng, 13/APR/2000) and forwarded to FDA for inclusion in the
Pesticide Analytical Manual (PAM), Vol. II.  

Analytical method AG-659A, modified to utilize GC/MS detection, was used
for the analysis of trifloxystrobin and the acid metabolite CGA 321113
in each of the current commodities (asparagus, radish and papaya
matrices).  The method was adequately validated in conjunction with the
analysis of field trial samples.  The LLMV for trifloxystrobin and CGA
321113 was determined to be 0.05 ppm and 0.020 ppm, respectively for
asparagus.  The LLMV for each analyte, trifloxystrobin and CGA 321113,
was determined to be 0.02 ppm for radishes.  The LLMV for each analyte,
trifloxystrobin and CGA 321113, was determined to be 0.02 ppm for
papaya.  The LLMV for trifloxystrobin and CGA 321113 was not reported
for citrus fruit matrices or strawberry.  

860.1360 Multiresidue Methods

DP Nums: 257888 and 254208, F. Ives, 22/JUL/1999

The regulated residues were tested in accordance with the PAM, Volume I,
Appendix II.  Trifloxystrobin gave adequate responses through protocol
C, and was completely recovered from fortified apple samples when
analyzed through protocols D and E.  Acid metabolite CGA-321113 was
recoverable through protocol B and residues from apples fortified with
CGA-321113 were completely recovered through Section 402 E2/C1
(extraction with methylene chloride).  These data were forwarded to FDA.

860.1380 Storage Stability

DP Num: 254221, 254213, 254218, 254217; L. Cheng; 06/MAY/2000

46886201.der.com, D. Rate, 15/NOV/2006

46886202.der.com, D. Rate, 15/NOV/2006

46886203.der.com, D. Rate, 15/NOV/2006

46960701.der.com, D. Rate, 29/MAY/2007

47021101.der.com, D. Rate, 13/JUN/2007

Samples of asparagus were stored frozen up to 198 days prior to
analysis.  Samples of radish tops and roots were stored frozen up to 311
and 410 days, respectively, prior to analysis.  Samples of papaya were
stored frozen up to 504 days prior to analysis.  Samples of strawberry
were stored frozen up to 347 days prior to analysis.  In addition,
samples of oranges, lemons, and grapefruit were stored frozen 378, 451,
and 512 days, respectively prior to analysis.  Storage stability data
are available indicating that both trifloxystrobin and CGA-321113 are
stable at < -15ºC for at least 24 months in cucumber, potatoes, grapes,
and wheat (forage, grain, and straw) and for at least 18.6 months in
peanut nutmeats, hay, and oil (DP Num: 254221, 254213, 254218, 254217;
L. Cheng; 06/APR/2000).    SEQ CHAPTER \h \r 1 These data are adequate
to support the current petitions.

860.1400 Water, Fish, and Irrigated Crops

This guideline requirement is not relevant to the current petition as
the proposed use on asparagus, radish, papaya, strawberry and citrus
fruits are non-aquatic uses.

860.1460 Food Handling

This guideline requirement is not relevant to the current petition as
there is no food handling uses being proposed for trifloxystrobin.

860.1480 Meat, Milk, Poultry, and Eggs

There are no livestock feedstuffs associated with the proposed uses on
asparagus, papaya, strawberry, or citrus fruit commodities.  However,
carrots and turnips as a part of crop group 1B (vegetable, root, except
sugar beet), are cattle and swine feed items.  The addition of radish to
the already established tolerance for the vegetable, root, except sugar
beet, subgroup 1B, will have no impact on the established tolerances of
livestock commodities based on this addition to the respective dietary
burdens.  Accordingly, the current tolerances for livestock commodities
are adequate.  The leaves and foliage of vegetable, root commodities are
not significant feed items (B. Schneider, e-mail 08/AUG/2007).

860.1500 Crop Field Trials

46886201.der.com, D. Rate, 15/NOV/2006

46886202.der.com, D. Rate, 15/NOV/2006

46886203.der.com, D. Rate, 15/NOV/2006

46960701.der.com, D. Rate, 29/MAY/2007

47021101.der.com, D. Rate, 13/JUN/2007

Asparagus

To support the use of trifloxystrobin on asparagus, IR-4 has submitted
field trial data on using the WG formulation of Flint Fungicide with 50%
trifloxystrobin.  The results from these field trials are discussed
below and summarized in Table 4.

TABLE 4.	Summary of Residue Data from Crop Field Trials with
Trifloxystrobin.

Commodity	Analyte	Total Applic. Rate,

 lb ai/A

 (kg ai/ha)	PHI (days)	Residue Levels (ppm)

n	Min.	Max.	HAFT*	Mean

	Std. Dev.

Asparagus	Trifloxystrobin	0.37 – 0.39

(0.41 -0.44)	California

92 – 100

Rest of US

167 - 188	16	<0.05	<0.05	NA	NA	NA

	CGA321113 (Trifloxystrobin Acid)

<0.02	<0.02	NA	NA	NA

	Combined

<0.07	<0.07	NA	NA	NA

* HAFT = Highest Average Field Trial.

IR-4 has submitted field trial data for trifloxystrobin on asparagus. 
Seven trials were conducted on asparagus encompassing EPA growing
Regions 2 (NJ29 (Bridgeton, NJ)), 5 (MI25 (Holt, MI) and MI26 (East
Lansing, MI)), 10 (CA107 (Stockton, CA) and CA108 (San Ardo, CA)) and 11
(ID11(Caldwell) and WA*35 (Moxee, WA)) during the 2002 growing season. 
The number and locations of field trials are in accordance with OPPTS
Guideline 860.1500.

For the asparagus trials, at each test location, Flint® Fungicide was
applied three times at a target rate of 0.125 lb ai/A to vegetative or
senescing ferns, by foliar directed broadcast spray with a maximum
seasonal rate of 0.375 lb ai/A.  Applications were made at 14 day RTIs,
with a 92-188 day PHI.  No adjuvants were added to the spray mixture for
all applications.

The analytical method titled, “Residue Analysis of Trifloxystrobin
(CGA-279202 and CGA-321113) on Asparagus by GC/MS Detection,” was used
to analyze the collected asparagus samples.  This method was adapted
from the reference method, “Analytical Method for Determination of
Residues CGA-279202 and the Acid Metabolite CGA-321113 in Crops and
Animal substrate by Gas Chromatography” (Analytical Method No.
AG-659A).  Briefly, the RAC is blended with acetonitrile:water (80:20,
v:v).  After filtration, an aliquot is extracted with toluene and
hexane.  After separation and evaporation of the acetonitrile/toluene
mixture the sample is taken up in aqueous phosphoric acid and
partitioned with methyl-tert butyl ether:hexanes (1:1, v:v).  After
evaporation of the organic solvent mixture the sample is dissolved in
acetone.  The sample is then analyzed for trifloxystrobin and CGA-321112
by GC/MS.  This method is adequate for data collection based on
acceptable concurrent method recovery data for asparagus matrix.

The LOD and LOQ for asparagus matrices are the following:  

Matrix	LOD	LOQ

Asparagus:

     Trifloxystrobin

     CGA-321113	

0.025 ppm

0.006 ppm	

0.076 ppm

0.030 ppm

The LLMV for asparagus was reported at 0.05 ppm for trifloxystrobin and
0.02 ppm for CGA-321113.  The recoveries ranged from 112 to 124% for
trifloxystrobin at 0.05 ppm and from 60 to 90% for CGA-321113 at 0.02
ppm.

The parent (trifloxystrobin) and metabolite (CGA-321113) have been shown
to be stable for the duration of the storage period that occurred during
the course of these trials.  The results from these trials show that
maximum residues of trifloxystrobin and CGA-32113 recovered from
asparagus were <0.05 ppm and < 0.02 ppm, repectively, when treatment is
applied at a 1X target rate (0.375 lb ai/A seasonal rate) with a PHI of
92-108 days.  Residue decline data were not submitted for the use of
trifloxystrobin on asparagus matrices.  

Radish

To support the use of trifloxystrobin on radish, IR-4 has submitted
field trial data on using the WG formulation of Flint® Fungicide with
50% trifloxystrobin.  The results from these field trials are discussed
below and summarized in Table 5.

TABLE 5.	Summary of Residue Data from Crop Field Trials with
Trifloxystrobin.

Commodity	Analyte	Total Applic. Rate,

 lb ai/A

 (kg ai/ha)	PHI (days)	Residue Levels (ppm)

n	Min.	Max.	HAFT*	Mean

	Std. Dev.

Radish

Radish Tops	Trifloxystrobin	0.251–0.264

(0.281- 0.296)	6 - 8	12	0.068	7.00	6.80	2.49	2.80

	CGA321113 (Trifloxystrobin Acid)

0.047	0.42	0.38	0.16	0.13

	Combined

0.115	7.42	7.18	2.65	2.91

Radish Roots	Trifloxystrobin

	12	<0.02	0.06	0.05	0.03	0.01

	CGA321113 (Trifloxystrobin Acid)

<0.02	0.05	0.05	0.03	0.01

	Combined

<0.04	0.11	0.10	0.06	0.01

Radish Tops	Trifloxystrobin	0.494–0.527

(0.553-0.59)	6 - 8	12	0.12	17.00	14.5	5.38	5.78

	CGA321113 (Trifloxystrobin Acid)

0.066	0.53	0.50	0.23	0.16

	Combined

0.186	17.53	15.0	5.61	5.9

Radish Roots	Trifloxystrobin

	12	<0.02	0.12	0.11	0.06	0.03

	CGA321113 (Trifloxystrobin Acid)

<0.02	0.09	0.09	0.05	0.03

	Combined

<0.04	0.21	0.20	0.11	0.034

* HAFT = Highest Average Field Trial.

IR-4 has submitted field trial data for trifloxystrobin on radish (tops
and roots).  Six trials were conducted on radishes (tops and roots)
encompassing Regions 1 (NY19 (Freeville, NY)), 3 (FL48 (Citra, FL) and
FL49 (Citra, FL)), 5 (WI35 (Arlington, WI), 10 (CA106 (Holtville, CA)),
and 12 (OR22 (Aurora, OR)) during the 2002 growing season.  The number
and locations of field trials are in accordance with OPPTS Guideline
860.1500.

For the radish trials, at each test location, Flint® Fungicide was
applied two times at a 1X target rate of 0.125 lb ai/A or a 2X target
rate of 0.250 lb ai/A, to plants at 2 true leaves to early maturity, by
foliar directed spray with a maximum seasonal rate of 0.250 lb ai/A or
0.500 lb ai/A, respectively.  Applications were made with a 7-8 day RTI
with a 6-8 day PHI.  No adjuvants were added to the spray mixture for
all applications.  

The method used to analyze the radish samples is titled, “Residue
Analysis of Trifloxystrobin on Radish (Roots and Tops) by GC/MS
Detection, Version #3,” which was derived from the referenced method,
analytical method number AG 659A entitled, “Analytical Method for the
Determination of Residues CGA-279202 and the Acid Metabolite CGA-321113
in Crops and Animal Substrates by Gas Chromatography,” (14/JAN/1998). 
Briefly, the residues of trifloxystrobin and CGA-321113 are extracted
from radish tops and root samples by blending with acetonitrile:water
(80:20, v:v) and filtered.  An aliquot of the extract is taken and
partitioned with a salinized solution of toluene and hexane.  After
phase separation, the water layer is discarded and the
acetonitrile/toluene layer is concentrated, diluted in 0.085% aqueous
phosphoric acid:acetone (95:5, v:v), and cleaned up on a C18 solid phase
extraction (SPE) column eluted with 0.085% aqueous phosphoric
acid:acetone (70:30, v:v).  The eluate is concentrated and partitioned
with methyl-tert butyl ether:hexane (1:1, v:v).  Residues in the organic
solvent mixture are evaporated to dryness, dissolved in acetone, and
then analyzed for residues of trifloxystrobin and CGA-321113 by GC/MSD. 
This method is adequate for data collection based on acceptable
concurrent method recovery data for each matrix.

The LOD and LOQ for the respective RACs are the following:  

Matrix	LOD	LOQ

Radish:

      Tops:  Trifloxystrobin

                 CGA-321113

     Roots:  Trifloxystrobin

                  CGA-321113	

0.010 ppm

0.007 ppm

0.010 ppm

0.007 ppm	

0.030 ppm

0.021 ppm

0.029 ppm

0.021 ppm

The LLMV for radish matrices was 0.02 ppm for both analytes,
trifloxystrobin and CGA-321113.  Recoveries for tops ranged from 95 to
130% and 100 to 125%, respectively.  Recoveries for roots ranged from 95
to 120% and 10 to 100%, respectively.  The parent (trifloxystrobin) and
metabolite (CGA-321113) have been shown to be stable for the duration of
the storage period that occurred during the course of each of these
trials.  The results from these trials show that maximum residues of
trifloxystrobin were recovered from radish tops (7.0 ppm), followed by
radish roots (0.06 ppm), when treatment is applied at a 1X target rate
(0.250 lb ai/A seasonal rate) and that maximum residues of
trifloxystrobin were recovered from radish tops (17 ppm), followed by
radish roots (0.12 ppm), when treatment is applied at a 2X target rate
(0.500 lb ai/A seasonal rate) with PHIs of 6 to 8 days.  Residue decline
data were not submitted for the use of trifloxystrobin on radish
matrices.  

Papaya

To support the use of trifloxystrobin on papaya, IR-4 has submitted
field trial data on using the WG formulation of Flint® Fungicide with
50% trifloxystrobin.  The results from these field trials are discussed
below and summarized in Table 6.

TABLE 6.	Summary of Residue Data from Crop Field Trials with
Trifloxystrobin.

Commodity	Analyte	Total Applic. Rate,

 lb ai/A

 (kg ai/ha)	PHI (days)	Residue Levels (ppm)

n	Min.	Max.	HAFT*	Mean

	Std. Dev.

Papaya	Trifloxystrobin	0.506-0.521

(0.567-0.584)	0	8	0.07	0.28	0.27	0.18	0.08

	CGA321113 (Trifloxystrobin Acid)

<0.02	0.04**	0.04**	0.02**	0.01**

	Combined

0.09	0.32	0.31	0.20	0.09

* HAFT = Highest Average Field Trial.

** There may be uncertainty with these samples due to a dilution problem
with these samples (samples were diluted 10X versus 2X).  However since
the value of the residue was significantly less than the parent
(trifloxystrobin), the impact of the uncertainty should be negligible.

IR-4 has submitted field trial data for trifloxystrobin on papaya.  Four
trials were conducted on papaya encompassing Region 13 (FL37 (Homestead,
Florida), FL38 (Homestead, Florida), HI03 (Haleiwa, Hawaii) and HI04
(Keaau, Hawaii)) during the 2003 growing season.  The number and
locations of field trials are in accordance with OPPTS Guideline
860.1500.

For the papaya trials, at each test location, Flint® Fungicide was
applied four times at a 1X target rate of 0.125 lb ai/A, by foliar
directed spray to fruiting plants with a maximum seasonal rate of 0.500
lb ai/A.  Applications were made with a 7-8 day RTI with a 0 day PHI. 
Various non-ionic adjuvants were added to the spray mixture for all
applications.  

Analytical method AG 659A, entitled “Analytical Method for the
Determination of Residues CGA-279202 and the Acid Metabolite CGA-321113
in Crops and Animal Substrates by Gas Chromatography,” (14/JAN/1998),
was modified to utilize GC/MS detection in papaya matrices.  Briefly,
the samples were extracted with acetonitrile:water (80:20, v:v) and then
partitioned with toluene, a saturated NaCl solution, and hexane.  The
extract was then cleaned up using a solid phase extraction column
followed by partitioning with methyl tert-butyl ether:hexane and
concentrating to 1ml, prior to analysis.  This method is adequate for
data collection based on acceptable concurrent method recovery data for
the papaya matrix.

The LOD and LOQ of trifloxystrobin and CGA-321113 for papaya are the
following:

Matrix	LOD	LOQ

Papaya:

     Trifloxystrobin

     CGA-321113	

0.009 ppm

0.006 ppm	

0.008 ppm

0.019 ppm

The LLMV for papaya matrices was shown to be 0.02 for both the parent
(trifloxystrobin) and the acid metabolite (CGA-321113) with recovery
ranges from 90 to 109% and 76 to 101%, respectively.

The parent (trifloxystrobin) and metabolite (CGA-321113) have been shown
to be stable for the duration of the storage period that occurred during
the course of each of these trials.  The results from these trials show
that maximum residues of trifloxystrobin and CGA-321113 were 0.28 pm and
0.04 ppm, repsectively.  Residue decline data were not submitted for the
use of trifloxystrobin on papaya.  

Strawberry

To support the use of trifloxystrobin on strawberry, crop group 10,
Bayer CropScience has submitted field trial data using the WG
formulation of Flint® Fungicide with 50% trifloxystrobin.  The results
from these field trials are discussed below and summarized in Table 7.

TABLE 7.	Summary of Residue Data from Crop Field Trials with
Trifloxystrobin.

Commodity	Analyte	Total Applic. Rate,

 lb ai/A

 (kg ai/ha)	PHI (days)	Residue Levels (ppm)

n	Min.	Max.	HAFT*	Mean

	Std. Dev.

Strawberry	Trifloxystrobin	0.506-0.521

(0.567-0.584)	0	16	0.098	0.518	0.494	0.310	0.142

	CGA321113 (Trifloxystrobin Acid)

0.012	0.086	0.085	0.044	0.024

	Combined

0.111	0.591	0.563	0.355	0.150

* HAFT = Highest Average Field Trial.

Bayer CropScience has submitted field trial data for trifloxystrobin on
strawberry.  Eight field trials were conducted in the United States
during the 2005-2006 growing seasons in EPA growing Regions 1 (NY; 1
trial), 2 (GA; 1 trial), 3 (FL; 1 trial), 5 (MI; 1 trial), 10 (CA; 3
trials), and 12 (OR; 1 trial).  The number and locations of field trials
are in accordance with OPPTS Guideline 860.1500.

Each field trial consisted of one untreated plot and one treated plot. 
At each trial site, Flint® Fungicide (EPA Reg. No. 264-777), a 50%
water-dispersible granular (WDG or WG) formulation of trifloxystrobin,
was applied six times to strawberry plants as broadcast foliar
treatments, with 4- to 7-day retreatment intervals, at ~0.1 lb
ai/A/application for a total seasonal rate of ~0.6 lb ai/A. 
Applications were made using ground equipment in spray volumes of 55-69
gal/A without an adjuvant.

Mature samples of strawberries were collected immediately following the
final application (0-day preharvest interval).  Additionally, in one of
the trials (TF025-05D), strawberry samples were collected at PHIs of 3,
5, 7, and 10 days following the last application to generate residue
decline data.  One trial (TF026-05H) included an additional sample which
was processed into washed strawberries and cooked strawberries from
which residue reduction data were determined.

e determined by LC/MS/MS using electrospray ionization.  Parent and the
acid metabolite were quantified using the 409→186 and 395→186 ion
transitions, respectively.  Trifloxystrobin acid residues were not
converted to parent equivalents, but because the molecular weights are
similar for trifloxystrobin and trifloxystrobin acid (CGA-321113), the
sum reflects the total residue as parent equivalents.  

The LOD and LOQ of trifloxystrobin and CGA-321113 for strawberry are the
following:

Matrix	LOD	LOQ

Strawberry:

     Trifloxystrobin

     CGA-321113	

0.004 ppm

0.004 ppm	

0.01 ppm

0.01 ppm

The LLMV was not reported for strawberry.

The parent (trifloxystrobin) and metabolite (CGA-321113) have been shown
to be stable for the duration of the storage period that occurred during
the course of each of these trials.  The results from these trials show
that maximum residues of trifloxystrobin and CGA-321113 in strawberry
were 0.52 ppm and 0.086 ppm, respectively.  Data from the submitted
residue decline trial also showed that trifloxystrobin residues declined
from 0.24 ppm at the 0-day PHI to 0.10 ppm at the 10-day PHI.

Residue reduction data on strawberries from a single trial were also
provided to demonstrate the effect of washing and cooking on fruit
residues.  The data indicate that residues of trifloxystrobin and
CGA-321113 declined in/on strawberries after washing and cooking. 
Combined residues were 0.23 ppm in/on unwashed fruit (RAC), and declined
to 0.15 ppm in washed fruit (0.7x reduction factor) and 0.12 ppm in
cooked fruit (0.5x factor).  These data can be used for dietary risk
assessment.

Citrus Fruits, Crop Group 10

To support the use of trifloxystrobin on citrus fruits, crop group 10,
Bayer CropScience has submitted field trial data using the WG
formulation of Flint® Fungicide with 50% trifloxystrobin.  The results
from these field trials are discussed below and summarized in Table 8.

TABLE 8.	Summary of Residue Data from Crop Field Trials with
Trifloxystrobin.

Commodity	Analyte	Total Applic. Rate,

 lb ai/A

 (kg ai/ha)	PHI (days)	Residue Levels (ppm)1

n	Min.	Max.	HAFT2	Mean

	Std. Dev.

Orange	Trifloxystrobin	0.492-0.509

(0.552-0.570)	7	50	0.022	0.32	0.28	0.110	0.056

	CGA321113 (Trifloxystrobin Acid)

<0.01	<0.01	<0.01	0.01	--

	Combined

0.032	0.33	0.29	0.12	0.06

Lemon	Trifloxystrobin	0.497-0.502

(0.557-0.563)	6-7	20	0.046	0.35	0.30	0.17	0.090

	CGA321113 (Trifloxystrobin Acid)

<0.02	<0.02	<0.02	0.02	--

	Combined

0.066	0.37	0.32	0.19	0.09

Grapefruit	Trifloxystrobin	0.493-0.505

(0.553-0.566)	7	24	0.011	0.17	0.17	0.068	0.046

	CGA321113 (Trifloxystrobin Acid)

<0.02	<0.02	<0.02	0.02	--

	Combined

0.031	0.19	0.19	0.088	0.05

1  Residues are expressed in parent equivalents.  The LOQs are 0.01 ppm
for each analyte in oranges and 0.02 ppm for each analyte in lemons and
grapefruit.  Residues <LOQ were estimated to be at the LOQ for
calculation of mean and standard deviation.

2  HAFT = Highest Average Field Trial.

Bayer CropScience conducted 24 field trials on citrus fruits (13 orange,
5 lemon, 6 grapefruit) in EPA growing Regions 3, 6, and 10 during the
2004 and 2005 growing seasons.  The number and locations of field trials
are in accordance with OPPTS Guideline 860.1500.

At each test location, trifloxystrobin (50% WDG) was applied to citrus
trees as four broadcast foliar applications during fruit development at
0.119-0.130 lb ai/A/application, at RTIs of 19-22 days, for a total of
0.492-0.509 lb ai/A/season.  Applications were made using ground
equipment. With exception of one site in FL, each field trial had
side-by-side treated plots using either concentrated spray volumes of
35-65 GPA or dilute spray volumes of 204-385 GPA.  In all tests, citrus
fruits were harvested at 6-7 days after treatment (DAT).  A single
control and duplicate treated samples of citrus fruits (orange, lemon,
or grapefruit) were collected from each test at each interval.  

ified using the 409→186 and 395→186 ion transitions, respectively. 
Residues of both analytes are expressed in parent equivalents.  

The LOD and LOQ of trifloxystrobin and CGA-321113 for citrus fruits are
the following:

Matrix	LOD	LOQ

Orange:

     Trifloxystrobin

     CGA-321113	

0.002 ppm

0.002 ppm	

0.01 ppm

0.01 ppm

Lemon:

     Trifloxystrobin

     CGA-321113	

0.002 ppm

0.002 ppm	

0.02 ppm

0.02 ppm

Grapefruit:

     Trifloxystrobin

     CGA-321113	

0.002 ppm

0.002 ppm	

0.02 ppm

0.02 ppm

The LLMV was not reported for citrus fruits.

The parent (trifloxystrobin) and metabolite (CGA-321113) have been shown
to be stable for the duration of the storage period that occurred during
the course of each of these trials.  The results from these trials show
that maximum combined residues of trifloxystrobin and CGA-321113 in
orange, lemon and grapefruit were 0.33 ppm, 0.37 ppm, and 0.19 ppm,
respectively.  Data from four residue decline trials also showed that
trifloxystrobin residues declined steadily at longer post-treatment
intervals.  Between day 0 and 14, the residues declined by nearly 60% in
each trial.

Conclusions:  The database is adequate for asparagus and ARIA recommends
for the requested tolerance of 0.07 ppm.  Radish and papaya are
representative commodities for vegetable, root except sugar beet,
subgroup 1B; and the proposed tropical fruit group which includes
papaya; sapote, black; canistel; sapote, mamey; mango; sapodilla; and
star apple, respectively.  The data are adequate and ARIA recommends for
tolerances of 0.10 ppm for vegetable, root except sugar beet, subgroup
1B (based on rejected log normality (CA method and harmonization with
the Codex maximum residue limits (MRL) at 0.10 ppm in/on carrot), 10 ppm
for radish, tops (the calculated MRL was based on log normality in the
95th percentile); 0.70 ppm for papaya; sapote,black; canistel; sapote,
mamey; ,mango; sapodilla; and star apple (the calculated MRL of 0.70 ppm
was based on European Union (EU) log normality in the 99th percentile);
and 1.1 ppm for strawberry (the calculated MRL was based on European
Union (EU) log normality in the 99th percentile).  The data are adequate
to reduce the PHI for use on citrus and for setting revised tolerances
on citrus, fruit crop group 10, citrus, oil and citrus, dried pulp. 
ARIA recommends revising the current tolerances to 0.6 ppm for citrus
fruits, crop group 10; 38.0 ppm for citrus, oil; and 1.0 ppm for citrus,
dried pulp.  

A new Section F must be submitted to the Agency correcting the commodity
definitions as shown in Table 9 and revising the proposed tolerances to
match the recommended tolerances.  

860.1520 Processed Food and Feed

As there are no separately regulated processed commodities associated
with asparagus, radish, papaya and strawberry, a processing study is not
required to support the proposed uses.  

  SEQ CHAPTER \h \r 1 Orange processing studies were submitted in
conjunction with the original petition for use of trifloxystrobin on
citrus fruits (PP#0F06121, DP Num: 267787 and 272054, L. Cheng,
17/JAN/2002).  Oranges treated at 1.2x, 3.7x and 6.1x the proposed use
rate were processed into juice, oil, and dried pulp.  In these
processing studies, residues did not concentrate in juice, but
concentrated in oil (average 118x) and dried pulp (average 3x).

The HAFT residues for the combined trifloxystrobin residues from the
current field trials are 0.286 ppm for oranges, 0.324 ppm for lemons,
and 0.187 ppm for grapefruit.  Based on the HAFT for lemons and the
average concentration factors, the maximum expected combined residues
would be 38 ppm in oil and 0.97 ppm in dried pulp.

Conclusion.  These data support the proposed tolerance of 1.0 ppm for
dried citrus pulp; however, the proposed tolerance for citrus oil (36
ppm) should be increased to 38.0 ppm.  The revised Section F should
reflect this recommendation.

860.1650 Submittal of Analytical Reference Standards

The analytical reference standards for trifloxystrobin have been
submitted to the EPA National Pesticide Standards Repository.

860.1850 Confined Accumulation in Rotational Crops

860.1900 Field Accumulation in Rotational Crops

Of the submitted data for the requested crops, asparagus, radish,
papaya, strawberry, and citrus, only radish is a crop which is typically
rotated.  No rotational crop studies were submitted with this petition
(PP#6E7088).

However, a confined rotational crop study was submitted earlier.  The
study adequately characterized/identified the majority of radioactive
residues in/on all commodities harvested from all plantback intervals.  

860.1550 Proposed Tolerances

The MARC has concluded that trifloxystrobin and CGA-321113 are of
concern for both regulatory and risk assessment purposes in both plant
and livestock commodities.  Permanent tolerances are currently
established under 40 CFR §180.555 for the combined residues of
trifloxystrobin and CGA-321113 in or on a variety of plant commodities,
at levels ranging from 0.04 ppm on several nut crops to 30 ppm in citrus
oil.

Based on the submitted field trail data, IR-4 and Bayer CropScience have
proposed new tolerances in/on asparagus; Vegetable, root except sugar
beet, Subgroup 1B; radish (tops); papaya; black sapote; canistel; mamey
sapote; mango; sapodilla; and star apple; strawberry; and increased
tolerances for citrus fruits, Crop Group 10; citrus, oil; and citrus,
dried pulp (Table 9).  The available residue data support the proposed
permanent tolerances for asparagus; vegetable, root except sugar beet,
Subgroup 1B; radish, tops; papaya; black sapote; canistel; mamey sapote;
mango; sapodilla; and star apple; strawberry; citrus fruits, Crop Group
10; citrus, oil; and citrus, dried pulp.  ARIA recommends for the
tolerances as listed in Table 9.  

There are no established or proposed Canadian or Mexican MRLs for
trifloxystrobin on the requested commodities (See attached International
Residue Limit Status Sheet).  There are, however, Codex MRLs for carrot
at 0.1 ppm, strawberry at 0.2 ppm, citrus fruits at 0.5 ppm, and citrus,
dry pulp at 1.0 ppm.  There are no international harmonization issues
with petition PP# 6E7088 and based on ARIA’s analysis of the data (MRL
calculator), ARIA has recommended setting the tolerance of Vegetable,
root except sugar beet, Subgroup 1B to 0.10 ppm in order to harmonize
with the current Codex MRL for carrot.  However, due to submitted
residue data for strawberry (PP#7F7171) and citrus (PP#6F7123), the
Agency is unable to harmonize the recommended tolerances with Codex
MRLs.

TABLE 9.	Tolerance Summary for Trifloxystrobin.

Commodity	

Proposed Tolerance (ppm)	

Recommended Tolerance (ppm)	

Comments (correct commodity definition)

Asparagus	0.07	0.07

	Vegetable, root except sugar beet, Subgroup 1B	0.10	0.10

	Radish, tops	10	10

	Papaya

Sapote, black

Canistel

Sapote, mamey

Mango

Sapodilla

Star apple	0.70	0.70

	Strawberry	1.1	1.1

	Citrus Fruits, Crop Group 10	0.4	0.6

	Citrus, oil	36.0	38.0

	Citrus, dried pulp	1.0	1.0

	

APPENDICES:  Internation Residue Limit Status

		   MRL Tolerance Level Calculations

APPENDIX I:

INTERNATIONAL RESIDUE LIMIT STATUS

Methyl
(αE)-α-(mrthoxyimino)-2-[[[[(1E)-1-[3-(trifluoromethyl)phenyl]ethylide
ne]amino]oxy]methyl]benzeneacetate	

Common Name:  Trifloxystrobin	

X  Recommended tolerance

( Reevaluated tolerance

( Other	

Date: 07/12/07

Codex Status 

(Maximum Residue Limits)	

U. S. Tolerances

( No Codex proposal step 6 or above

( No Codex proposal step 6 or above for the crops requested	

Petition Numbers:  PP#6E7088, PP#6F7123 and 7F7171

DP Num:  332104, 334851, 334854 and 339495

Other Identifier:  

Residue definition (step 8/CXL): Trifloxystrobin (for compliance with
MRL)

	

Reviewer/Branch: D. Rate / RIMUER

	

Proposed Residue definition:  Combined residues of trifloxystrobin and
its free acid metabolite CGA-321113

Crop (s)	

MRL (mg/kg)	

Crop(s) 	

Tolerance (ppm)

Strawberry	0.2

Carrot	0.1	Asparagus	0.07

Potato	0.02 (*)

Citrus fruits	0.5

Citrus pulp, dry	1

	

	Vegetable, root except sugar beet, Subgroup 1B	0.1

	

	Radish, tops	10

Papaya; black sapote; canistel; mamey sapote; mango; sapodilla; and star
apple	0.7

Citrus Fruit, Crop Group 10	0.6

Citrus, oil	38.0

	

	Citrus, dried pulp	1.0

Strawberry	1.1

Limits for Canada	

Limits for Mexico

√  No Limits

(  No Limits for the crops requested	

(  No Limits

√  No Limits for the crops requested

Residue definition: N/A	

Residue definition:  trifloxystrobin

Crop(s)	

MRL (mg/kg)	

Crop(s)	

MRL (mg/kg)

S.Funk, 06/01/2007.  Revised 07/12/2007 for strawberry.

APPENDIX II.  Tolerance Assessment Calculations.

Radish, Tops:

The dataset used to establish a tolerance for trifloxystrobin on radish,
tops, consisted of field trial data representing application rates of
0.125 lb ai/A with a 6- to 8-day PHI.  As specified by the Guidance for
Setting Pesticide Tolerances Based on Field Trial Data SOP, the field
trial application rates and PHIs are within 25% of the maximum label
application rate and minimum label PHI, respectively.  The residue
values used to calculate the tolerance are provided in Table I-1.

All of the samples from the 6 field trials were above the LOQ.  Since
there were no values reported below the LOQ, maximum likelihood
estimation (MLE) procedures were not needed to impute censored values. 

The trifloxystrobin-radish (top) dataset was entered into the tolerance
spreadsheet.  Visual inspection of the lognormal probability plot
provided in the spreadsheet indicates that the dataset is reasonably
lognormal.  The result from the approximate Shapiro-Francia test
statistic (Figure I-1) confirmed that the assumption of lognormality
should not be rejected.

Since the field trial data for trifloxystrobin on radish, tops,
represent a small dataset (i.e., less than 15 samples) and are
reasonably lognormal, the upper bound estimate of the 95th percentile
based on the median residue value was compared to the minimum of the 95%
upper confidence limit (UCL) on the 95th percentile and the point
estimate of the 99th percentile, and the minimum value was selected as
the tolerance value.  Using the rounding procedure as outlined in the
Guidance for Setting Pesticide Tolerances Based on Field Trial Data SOP,
10 ppm is the recommended tolerance level for trifloxystrobin on radish,
tops.

Table I-1:

Figure I-1:

Papaya (papaya; black sapote; canistel; mamey sapote; mango; sapodilla;
and star apple):

The dataset used to establish a tolerance for trifloxystrobin on papaya,
consisted of field trial data representing application rates of 0.125 lb
ai/A with a 0 day PHI.  As specified by the Guidance for Setting
Pesticide Tolerances Based on Field Trial Data SOP, the field trial
application rates and PHIs are within 25% of the maximum label
application rate and minimum label PHI, respectively.  The residue
values used to calculate the tolerance are provided in Table I-2.

All 4 field trial samples were above the LOQ.  Since there were no
values reported below the LOQ, maximum likelihood estimation (MLE)
procedures were not needed to impute censored values. 

The trifloxystrobin-papaya dataset was entered into the tolerance
spreadsheet.  Visual inspection of the lognormal probability plot
provided in the spreadsheet indicates that the dataset is reasonably
lognormal.  The result from the approximate Shapiro-Francia test
statistic (Figure I-2) confirmed that the assumption of lognormality
should not be rejected.

Since the field trial data for trifloxystrobin on papaya, represent a
small dataset (i.e., less than 15 samples) and are reasonably lognormal,
the upper bound estimate of the 95th percentile based on the median
residue value was compared to the minimum of the 95% upper confidence
limit (UCL) on the 95th percentile and the point estimate of the 99th
percentile, and the minimum value was selected as the tolerance value. 
Using the rounding procedure as outlined in the Guidance for Setting
Pesticide Tolerances Based on Field Trial Data SOP, 0.70 ppm is the
recommended tolerance level for trifloxystrobin on papaya; black sapote;
canistel; mamey sapote; mango; sapodilla; and star apple.  

Table I-2:

Figure I-2:

Citrus Fruits, Crop Group 10:

The dataset used to assess tolerances for the combined residues of
trifloxystrobin and its acid metabolite (CGA-321113) on citrus fruits
consisted of field trial data representing four foliar applications of
trifloxystrobin (50% WDG) during fruit development at a rate of
0.119-0.130 lb ai/A/application and RTIs of 19-22 days, for a total of
0.49-0.51 lb ai/A/season (~1x rate).  Fruits were harvested at 6-7 DAT. 
As specified by the Guidance for Setting Pesticide Tolerances Based on
Field Trial Data SOP, the field trial application rates are within 25%
of the maximum label application rate and the PHIs are consistent with
the appropriate stage of maturity and the proposed PHI.  The values for
the combined residues used to calculate the tolerances are provided in
Tables I-3, I-4, I-5, possible tolerance values were calculated using
the orange, lemon, and grapefruit datasets separately and together.  

The datasets for each commodity were entered into the tolerance
spreadsheet and visual inspection of the lognormal probability plots
indicates that the each of the data sets is reasonably lognormal.  The
results from the approximate Shapiro-Francia test statistic confirmed
that the assumption of lognormality should not be rejected for any of
these representative crops.  The calculated tolerances were 0.3 ppm for
oranges, 0.6 ppm for lemons, and 0.3 ppm for grapefruit (Figures I-3,
I-4, and I-5).  As the data set for lemons resulted in the highest
tolerance (0.6 ppm), these data will be used to reassess the current
tolerance on citrus fruits from 0.3 ppm to 0.6 ppm.

Table I-3:

Regulator:	EPA 

Chemical:	Trifloxystrobin

Crop:	Orange

PHI:	7 days

App. Rate:

	Submitter:

Residues

	0.16

	0.1

	0.15

	0.21

	0.094

	0.089

	0.098

	0.13

	0.068

	0.071

	0.095

	0.13

	0.11

	0.11

	0.1

	0.12

	0.11

	0.11

	0.066

	0.08

	0.15

	0.11

	0.24

	0.33

	0.089

	0.12

	0.06

	0.089

	0.067

	0.064

	0.054

	0.032

	0.19

	0.21

	0.094

	0.083

	0.048

	0.061

	0.13

	0.13

	0.15

	0.14

	0.12

	0.17

	0.22

	0.17

	0.18

	0.14

	0.11

	0.074

Figure I-3:

Table I-4:

EPA

Trifloxystrobin

Lemon

7 Days

Residues

0.066

0.083

0.071

0.082

0.330

0.240

0.280

0.370

0.190

0.190

0.100

0.086

0.190

0.160

0.200

0.180

0.260

0.210

0.290

0.250

Figure I-4:

Table I-5:

EPA

Trifloxystrobin

Grapefruit

7 Days

Residues

0.101

0.057

0.066

0.068

0.098

0.097

0.110

0.130

0.056

0.041

0.048

0.050

0.055

0.068

0.071

0.053

0.031

0.035

0.088

0.120

0.180

0.120

0.180

0.190

Figure I-5:

Strawberry:

The dataset used to assess tolerances for the combined residues of
trifloxystrobin and its acid metabolite (CGA-321113) on strawberry
consisted of field trial data representing six foliar applications of
trifloxystrobin (50% WDG) during fruit development at a rate of 0.1 lb
ai/A/application and RTIs of 7-14 days, for a total of 0.6 lb
ai/A/season (~1x rate).  Samples were harvested at a 0 day PHI.  As
specified by the Guidance for Setting Pesticide Tolerances Based on
Field Trial Data SOP, the field trial application rates are within 25%
of the maximum label application rate and the PHIs are consistent with
the appropriate stage of maturity and the proposed PHI.  The values for
the combined residues used to calculate the tolerances are provided in
Table I-6.  

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ndicates that the data sets is reasonably lognormal.  The results from
the approximate Shapiro-Francia test statistic confirmed that the
assumption of lognormality should not be rejected.  The calculated
tolerance was 1.1 ppm for strawberry (Figures I-6).

Table I-6:

Regulator:	EPA 

Chemical:	Trifloxystrobin

Crop:	Strawberry

PHI:	0 Days

App. Rate:	0.6 lb ai/A/season

Submitter:	Bayer CropScience

	Residues

	0.260

	0.278

	0.435

	0.502

	0.534

	0.591

	0.111

	0.126

	0.265

	0.344

	0.204

	0.270

	0.469

	0.559

	0.325

	0.382

Figure I-6:

Radish, Roots:

The dataset used to establish a tolerance for trifloxystrobin on radish,
roots, consisted of field trial data representing application rates of
0.125 lb ai/A with a 6- to 8-day PHI.  As specified by the Guidance for
Setting Pesticide Tolerances Based on Field Trial Data SOP, the field
trial application rates and PHIs are within 25% of the maximum label
application rate and minimum label PHI, respectively.  The residue
values used to calculate the tolerance are provided in Table I-7.

All but 2 of the combined residues from the 6 field trial samples were
above the LOQ.  The trifloxystrobin-radish (root) dataset was entered
into the tolerance spreadsheet.  Visual inspection of the lognormal
probability plot provided in the spreadsheet indicates that the dataset
is reasonably lognormal.  The result from the approximate
Shapiro-Francia test statistic (Figure I-7) confirmed that the
assumption of lognormality should not be rejected.

σ) is used for the tolerance recommendation.  In this case the CA
method would set the tolerance level at 0.11 ppm (Figure I-8) or 0.15
ppm (Figure I-7) based on rounding guidelines.  However, based on
previously established tolerances from this subgroup and Codex MRLs on
carrot; and because no combined residue exceeded the previously
established group tolerance at 0.1 ppm, the tolerance of 0.1 ppm for the
trifloxystrobin in/on radish, root is recommended by ARIA as part of the
vegetable, root, except sugar beet, subgroup 1B.  

Table I-7:

Regulator:	EPA 

Chemical:	Trifloxystrobin

Crop:	Radish roots

PHI:	7 Days

App. Rate:

	Submitter:

Residues

	0.040

	0.040

	0.074

	0.060

	0.058

	0.080

	0.056

	0.068

	0.076

	0.068

	0.058

	0.074

Figure I-7:

Figure I-8:

EPA 

Trifloxystrobin

	Radish roots

	7 Days

Mean	Std. Dev.

	xbar	s	xbar + 3S

0.06	0.01	0.11

cc. Breann Hanson, Debra Rate

Trifloxystrobin	Summary of Analytical Chemistry and Residue Data	DP Num:
332104

  PAGE  2  of   NUMPAGES  31 

Trifloxystrobin	Summary of Analytical Chemistry and Residue Data	DP Num:
332104

  PAGE  3  of   NUMPAGES  31