Trifloxystrobin Summary of Analytical Chemistry and Residue Data DP#: 413711

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860. 18590

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

OFFICE OF CHEMICAL SAFETY

AND POLLUTION PREVENTION

MEMORANDUM

Date: 04/14/14

SUBJECT: Trifloxystrobin. Application for Section 3 Registration for Uses on Dry Peas, 

Chickpeas, and Lentils. Summary of Analytical Chemistry and Residue Data.

PC Code: 129112 DP Barcode: D413711

Decision No.: 478982 Registration No.: 264-1055

Petition No.: 3F8180 Regulatory Action: Section 3 Registration

Risk Assessment Type: NA Case No.: NA

TXR No.: NA CAS No.: 141517-21-7

MRID No.: See MRID Summary Table 40 CFR: 180.555

FROM: Meheret Negussie, Chemist

Risk Assessment Branch III (RAB3)

Health Effects Division (HED), 7509P

THRU: Steve Funk, Senior Chemist

Christine Olinger, Branch Chief

RAB3/HED (7509P)

TO: Nancy Tsaur, Chemist/Risk Assessor

RAB3/HED (7509P)

and

Tony Kish, RM 22

Fungicide Branch/RD (7505P)
Trifloxystrobin Summary of Analytical Chemistry and Residue Data DP#: 413711

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Summary of Submitted Residue Chemistry Studies

OCSPP 860 

Series 

Guideline

MRID 

Number

Title

860.1500 49072801 49072801/PMRA# 2306694 Milo, J. and A. Harbin (2013) Study title: FOX 325 SC 

Foliar Fungicide: Magnitude of Trifloxystrobin Residue In/On Dry Bean (Phaseolus 

spp) Following Treatment with SP102000010777 (Prothioconazole/Trifloxystrobin) 

Study No.: RAJAN003 Unpublished study prepared by Bayer CropScience. 456 

pages. 

860.1500 49072802 49072802/PMRA# 2306696 Milo, J. and A. Harbin (2013) Study title: FOX 325 SC 

Foliar Fungicide: Magnitude of Trifloxystrobin Residue In/On Dry Pea (Pisum spp) 

Following Treatment with SP102000010777 (Prothioconazole/Trifloxystrobin). 

Study No.: RAJAN004 Unpublished study prepared by Bayer CropScience. 555 

pages. 
Trifloxystrobin Summary of Analytical Chemistry and Residue Data DP#: 413711

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Executive Summary

Trifloxystrobin belongs to the MAEs (β-methoxyacryl esters) class of fungicides, which are 

synthetic analogs of strobilurin A (Fungicide Resistance Action Committee Group 11). It is a

broad-spectrum preventative fungicide used for control of many plant diseases in various fruit, 

nut, vegetable, and field crops.

Under PP# 3F8180, Bayer CropScience (Bayer) is proposing the establishment of permanent 

tolerances for residues of the fungicide trifloxystrobin [benzeneacetic acid, (E,E)-α-

(methoxyimino)-2-[[[[1-[3-(trifluoromethyl)phenyl]ethylidene]amino]oxy]methyl]-, methyl 

ester] and the free form of its acid metabolite CGA-321113 [(E,E)-(methoxyimino)-[2-[1-(3-

(trifluoromethylphenyl)-ethylideneaminooxymethyl]-phenyl]acetic acid] in/on the following raw 

agricultural commodities:

Pea, dry, seed ..............................................................0.06 ppm

Pea, dry, hay...................................................................15 ppm

Pea, dry, vines .................................................................4 ppm

Chickpea, seed ............................................................0.06 ppm

Chickpea, hay.................................................................15 ppm

Chickpea, vines ...............................................................4 ppm

Lentils ........................................................................0.06 ppm

In conjunction with this petition, Bayer is requesting registration of USF 0728 325 SC, a 1.27 lb

ai/gal suspension concentrate (SC) formulation [EPA File Symbol No. 264-1055]. The product 

is a multiple active ingredient (MAI) product that also contains prothioconazole at 1.49 lb ai/gal.

The subject review only addresses the adequacy of the available data to support the proposed 

uses of trifloxystrobin only. 

The proposed uses are dry peas, chickpeas, and lentils. The product is proposed for multiple 

foliar applications at single application rates of 0.12 lb ai/A/application of trifloxystrobin and 

maximum seasonal rates of 0.24 lb ai/A. Retreatment intervals (RTIs) of 10- 14 days, and 

preharvest intervals (PHIs) of 0-days for forage/vines and hay and 30-days for seed are proposed.

Tolerances are currently established for the combined residues of trifloxystrobin and the free 

form of its acid metabolite CGA–321113 in/on various crop and livestock commodities ranging 

from 0.01 ppm to 38 ppm [40 CFR §180.555(a)]. 

The qualitative nature of the residue in plants and livestock commodities is adequately

understood based on acceptable metabolism studies reflecting direct application of trifloxystrobin 

to apples, cucumbers, peanuts, sugar beets, and wheat, and metabolism studies on goats and 

laying hens. HED has concluded that both trifloxystrobin and CGA-321113 are of concern for 

both regulatory and risk assessment purposes for both plant and livestock commodities. HED 

also determined that for livestock commodities, the metabolite L7a (taurine conjugate of 

trifloxystrobin) in liver should be included in the risk assessment.
Trifloxystrobin Summary of Analytical Chemistry and Residue Data DP#: 413711

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An adequate gas chromatography method with nitrogen phosphorus detection (GC/NPD), 

Method AG-659A, is available for enforcing tolerances for the combined residues of 

trifloxystrobin and CGA-321113 in plant and livestock commodities. Samples from the 

submitted crop field trials on dry peas (seed, forage, and hay) and chickpeas were analyzed for 

residues of trifloxystrobin and CGA-321113 using a high performance liquid chromatography

method with tandem mass spectrometry detection (LC/MS/MS). Residues of CGA-321113 were 

converted to parent equivalents using a molecular weight conversion factor. The method was 

adequately validated in conjunction with the analysis of crop field trial samples. The lowest level

of method validation (LLMV) is equivalent to the limit of quantitation (LOQ) which was 0.010

ppm for each analyte in/on all matrices.

Adequate storage stability data are available to support the storage durations and conditions of 

samples of dry pea commodities, chickpeas, and lentils from the submitted crop field trial 

studies. 

The proposed use on dry peas does not result in an increased dietary burden for livestock. The 

existing tolerances on livestock commodities are adequate. 

Adequate crop field trial data have been submitted to support the requested uses on dry peas, 

chickpeas, and lentils. The trials reflect the proposed use pattern and the number and locations of 

the trials are acceptable based on the ChemSAC minutes of 20 March, 2013. Tolerances for 

chickpea hay and vines are not needed since both commodities are not significant livestock feed 

items. Based on the Organization for Economic Cooperation and Development (OECD) 

tolerance calculation spreadsheet, the recommended tolerances are 0.06 ppm for pea, dry, seed; 

15 ppm for pea, field, hay; 4 ppm for pea, field, vines; and 0.04 ppm for chickpea, seed. The 

recommended tolerance for chickpea seed at 0.04 ppm is increased to 0.06 ppm for 

harmonization purposes. The pea results are translated to cover lentils. The proposed tolerances 

on chickpea seed and lentil seed are not needed since pea dry seed includes these commodities

(40 CFR 180.1 (g)). HED is recommending to establish a tolerance on pea, dry, seed at 0.06 

ppm in order to harmonize with the Canadian recommended MRLs. A revised Section F needs 

to be submitted to reflect the correct commodity definitions.

There are no processed commodities associated with the proposed new uses; therefore, no new 

processing studies were submitted or reviewed for this petition. 

Adequate confined and field rotational crop data are available. HED previously concluded that 

the residues of concern in rotated crops are trifloxystrobin and CGA-321113. The available data 

support a 30-day plant-back interval (PBI) for all crops not listed on the label for direct use. 

Codex MRLs are expressed in terms of trifloxystrobin for plants; thus, harmonization of MRLs is 

not possible. The Codex residue definition for livestock is the same as the US. The Canadian 

residue definitions for plants and livestock are the same as the US. There are no Codex MRLs 

established on the proposed crops. Canadian MRLs exist for dry chickpeas, dry lentils, and dry

field peas at 0.02 ppm. This petition is reviewed as a workshare with Canada; tolerances for the 

proposed crops are harmonized. 
Trifloxystrobin Summary of Analytical Chemistry and Residue Data DP#: 413711

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Regulatory Recommendations and Residue Chemistry Deficiencies

HED has examined the residue chemistry database for trifloxystrobin. Pending submission of a 

revised Section F (see requirements under Proposed Tolerances; Table 7), there are no residue 

chemistry issues that would preclude granting a Section 3 registration and establishment of 

tolerances for combined residues of trifloxystrobin and its acid metabolite CGA-321113, as 

follows:

Pea, dry, seed ..............................................................0.06 ppm

Pea, field, hay.................................................................15 ppm

Pea, field, vines ...............................................................4 ppm

A human health risk assessment is forthcoming.

860.1550 Proposed Tolerances

 The petitioner needs to submit a revised Section F to reflect the correct commodity

definitions as presented in Table 7.

Background

The chemical structure and nomenclature of trifloxystrobin and its regulated metabolite are 

presented in Table 1, and the physicochemical properties of the technical grade of trifloxystrobin

are presented in Table 2.

Table 1. Trifloxystrobin Nomenclature.

Chemical structure

O

N

CF3

N

O

O

CH3

O

H C3

CH3

Common name Trifloxystrobin

Company experimental name BO17211 or CGA-279202

IUPAC name methyl (E)-methoxyimino-{(E)-α-[1-(α,α,α,-trifluoro-m-tolyl)ethylideneaminooxy]-otolyl}acetate

CAS name methyl (αE)-α-(methoxyimino)-2-[[[[(1E)-1-[3-

(trifluoromethyl)phenyl]ethylidene]amino]oxy]methyl]benzeneacetate

CAS registry number 141517-21-7

End-use product (EP) Prothioconazole/Trifloxystrobin USF 0728 325SC Fungicide; 1.49 lb ai/gal 

prothioconazole and 1.27 lb ai/gal trifloxystrobin; EPA File Symbol No. 264-1055

Chemical structure of metabolite 

CGA-321113 

O

N

CF3

N

OH

O O

H3C

CH3

Common Name trifloxystrobin acid
Trifloxystrobin Summary of Analytical Chemistry and Residue Data DP#: 413711

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Table 1. Trifloxystrobin Nomenclature.

Company Code CGA-321113

CAS name (α E)- α –(methoxyimino-[2-[[[(E)-1-[3-(trifluoromethyl)phenyl]-

ethylidene]amino]oxy]methyl]benzeneacetic acid

CAS # 252913-85-2

Table 2. Physicochemical Properties of Trifloxystrobin.

Parameter Value Reference1

Melting point 72.9oC MRID 44502801

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

Density 1.36 g/cm2at 21oC

Water solubility 0.00061 g/L at 20oC

Solvent solubility (g/L at 25oC) methanol 76

acetone >500

ethyl acetate >500

n-hexane 11

dichloromethane >500

toluene 500

n-octanol 18

Vapor pressure 3.4 x 10-6Pa at 25oC

Dissociation constant, pKa none at pH of 2-12

Octanol/water partition coefficient 

Log(POW)

4.5 at 25oC

UV/visible absorption spectrum

(molecular absorption coefficients)

17,500 at 250.7 μm (neutral)

17,300 at 250.2 μm (acidic)

15,900 at 252.3 μm (basic)

1 RD Memo, DP# 254920, 4/23/99, A. Smith.

860.1200 Directions for Use

The petitioner has submitted a Section B along with a draft specimen label for the 1.27 lb ai/gal 

SC formulation of Trifloxystrobin USF 0728 325 SC; EPA File Symbol No. 264-1055. The 

product is a multiple active ingredient (MAI) product that also contains prothioconazole at 1.49

lb ai/gal. The Section B is limited to the crops for which tolerances are being proposed including 

dry peas, chickpeas, and lentils.

A summary of the proposed use patterns is presented in Table 3. 

Table 3. Summary of Directions for Use of Trifloxystrobin.

Applic. Timing;

Type; and 

Equipment

Formulation

[EPA File 

Symbol No.]

Applic. 

Rate 

(lb ai/A)

Max. No. 

Applic. per 

Season

Max. 

Seasonal 

Applic. 

Rate

(lb ai/A)

PHI

(days)

Use Directions and 

Limitations1

Chickpeas

Foliar spray;

Ground, aerial, or 

chemigation

1.27 lb ai/gal

SC

[264-1055]

12 fl 

oz/A

(0.12)

2

24 fl oz/A

(0.24)

7-Forage

30-Seed

The proposed RTI is 

10-14 days.

Dry peas

Foliar spray;

Ground, aerial, or 

chemigation

1.27 lb ai/gal

SC

[264-1055]

12 fl 

oz/A

(0.12)

2

24 fl oz/A

(0.24)

7-Forage

30-Seed

The proposed RTI is 

10-14 days.
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Table 3. Summary of Directions for Use of Trifloxystrobin.

Applic. Timing;

Type; and 

Equipment

Formulation

[EPA File 

Symbol No.]

Applic. 

Rate 

(lb ai/A)

Max. No. 

Applic. per 

Season

Max. 

Seasonal 

Applic. 

Rate

(lb ai/A)

PHI

(days)

Use Directions and 

Limitations1

Lentils

Foliar spray;

Ground, aerial, or 

chemigation

1.27 lb ai/gal

SC

[264-1055]

12 fl 

oz/A

(0.12)

2 24 fl oz/A

(0.24)

7-Forage

30-Seed

The proposed RTI is 

10-14 days.

1 RTI = Retreatment interval. All applications are to begin preventatively and continue as needed (when multiple 

applications are permitted).

To limit the potential for development of disease resistance, no more than two sequential 

applications of the product or any Group 11- or Group 3-containing fungicide may be made 

before rotating with a fungicide from a different group.

Conclusions. The use directions are adequate to allow evaluation of the residue data relative to 

the proposed uses. The proposed maximum seasonal rate, minimum PHIs, and minimum RTIs 

are supported by the submitted field trial data.

860.1300 Nature of the Residue - Plants

DP#287242, L. Cheng, 10/08/2003

DP#s 267787 and 272054, L. Cheng, 01/17/2002

DP#s 254208 and 257888, F. Ives, 07/22/1999

DP#257835, F. Ives and B. Greear, 07/13/1999

The qualitative nature of the residue in plants is adequately understood based on acceptable 

metabolism studies reflecting direct application of trifloxystrobin to apples, cucumbers, peanuts, 

sugar beets, and wheat. HED previously concluded that 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

Residue Chemistry Memo DP#s 254208 and 257888, F. Ives, 7/22/99

Residue Chemistry Memo DP# 257835, F. Ives and B. Greear, 7/13/99

The qualitative nature of the residue in livestock is adequately understood based on acceptable 

goat and poultry metabolism studies. HED previously determined that the residues of concern 

for livestock, both for regulatory and risk assessment purposes, are trifloxystrobin and the free 

form of its acid metabolite CGA-321113. Additionally, metabolite L7a (taurine conjugate of 

trifloxystrobin) in the liver is to be included in risk assessment.

860.1340 Residue Analytical Methods

DP#265003, L. Cheng, 04/13/2000

Enforcement method: An adequate GC/NPD method (Method AG-659A) is available for 

enforcing tolerances for the combined residues of trifloxystrobin and CGA-321113 in plant and 

livestock commodities. This method was validated by the Agency and forwarded to FDA for 

inclusion in the Pesticide Analytical Manual (PAM), Vol. II.
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Data collection method: Samples from the submitted crop field trials on dry peas and chickpeas 

were analyzed for residues of trifloxystrobin and CGA-321113 using an LC/MS/MS method. 

Briefly, subsamples of the ground bean samples were extracted twice with acetonitrile/water (4/1, 

v/v) using homogenization with a tissuemizer and shaking, and brought to final volume. An 

aliquot of sample was measured into a vial and further diluted. Samples were analyzed using 

high performance liquid chromatography with tandem mass spectrometry (HPLC-MS/MS) in the 

positive ion mode under multiple reaction monitoring (MRM) conditions, using ion transitions 

m/z 409  186 for trifloxystrobin and m/z 395  186 for CGA 321113. Quantification with 

internal standards was performed based on a linear regression curve of trifloxystrobin and CGA 

321113. The method LOQ was reported as 0.01 ppm for each analyte.

The LC/MS/MS method was adequately validated in conjunction with the analysis of field trial 

samples using control samples fortified separately with trifloxystrobin and CGA-321113 at levels 

ranging from 0.01, 0.05, and 0.2 ppm. Concurrent method recoveries were generally within the 

acceptable range of 70-120% for all samples tested. The fortification levels used in concurrent

method validation were adequate to bracket residues found in treated samples of all commodities.

Conclusions. The residue analytical methods data are adequate to satisfy data requirements for 

the subject action. Acceptable enforcement methodology is available for tolerance enforcement 

purposes for residues in/on crop commodities, and residues of trifloxystrobin and CGA-321113 

in/on dry peas and chickpeas were determined using an acceptable data collection method.

860.1360 Multiresidue Methods

DP#s 254208 and 257888, F. Ives, 07/22/1999

The regulated residues were tested in accordance with the Pesticide Analytical Method (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# 286639, L. Cheng, 01/23/2003 (PP#3E06522)

DP#s 254213, 254217, 254218, and 254221, L. Cheng, 04/06/2000 (PP#9F5070)

Storage stability data are available indicating that residues of trifloxystrobin and its metabolite 

CGA-321113 are stable during frozen storage in a number of raw agricultural and processed 

commodities. Residues of both analytes were demonstrated to be stable in/on the following 

RACs: cucumbers, grapes, potato tubers, and wheat whole plant, grain, and straw for up to 24 

months; and apples, peanut nutmeats, and peanut hay for up to 18.6 months. In processed 

commodities, residues of both analytes were demonstrated to be stable in apple pomace, grape 

juice, peanut oil, and potato granules/flakes for up to 18.6 months. 

HED previously concluded that the available data are adequate to support storage stability

requirements for fruit or fruiting vegetables, non-oily grains, oily crops, and potatoes. For 
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processed commodities, the available data are representative of oilseeds and fruits/fruiting 

vegetables. No storage stability data are available for high protein content commodities, such as 

beans and peas. However, the available storage stability data on high water content 

commodities, high starch content commodities, high acid content commodities, and high oil 

content commodities indicate stability across a broad range of commodity types and will be 

translated to beans and peas.

The storage durations and conditions of samples from the crop field trials submitted to support 

this petition are presented in Table 4.

Table 4. Summary of Storage Conditions and Durations of Samples from Crop Field Trial Studies. 

Matrix Storage 

Temperature

(°C)

Actual Storage Duration

(days)

Interval of Demonstrated Storage 

Stability

Chickpea seed -21 to -13 83-116 Residues of trifloxystrobin and CGA321113 are reasonably stable under 

frozen storage conditions in/on 

cucumber, grape, potato, and wheat 

grain for up to ~2 years, and in/on apple

and peanut nutmeat for up to 18.6 

months.

Dry Pea, Seed 108-131 

Dry Pea, Vine 184-202

Dry Pea, Hay 185-203

Conclusions. The available storage stability data are adequate to support the storage durations 

and conditions of samples of dry pea and chickpeas from the submitted crop field trial studies. 

860.1400 Water, Fish, and Irrigated Crops

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

860.1460 Food Handling

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

860.1480 Meat, Milk, Poultry, and Eggs

Residue Chemistry Memo DP# 363108, W. Cutchin, 1/25/10

Residue Chemistry Memo DP# 338207, D. Rate, 4/10/07

Residue Chemistry Memo DP# 254208 and 257888, F. Ives, 7/22/99

Pea field seeds, hay, and vines are the livestock feedstuffs associated with the proposed uses. 

The dietary burden for beef cattle is not affected since these commodities are not fed to beef 

cattle. 

Dietary burdens based on reasonably balanced diets (RBDs) for livestock were most recently

calculated (DP# 363108). The calculated dietary burdens for livestock were 3.40 ppm for beef 

cattle, 9.90 ppm for dairy cattle, and 0.80 ppm for poultry and swine.

The livestock maximum reasonably balanced diets (MRBD) of trifloxystrobin were recalculated 

using the highest average field trial (HAFT)/median residues for pea commodities and tolerancelevel residues for existing uses. For cattle, corn forage contributes the entire roughage 
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component at a higher dietary contribution of trifloxystrobin than pea hay. A similar situation 

exists for the protein concentrate fraction of the poultry and swine diets. Soybean meal 

contributes the entire protein concentrate component at a higher dietary contribution of 

trifloxystrobin than pea seed. The livestock dietary burden remains unchanged. Therefore, the 

established livestock tolerances are sufficient.

Conclusions. The dietary burdens for cattle, poultry and swine are unaffected by the proposed 

amended uses on dry peas and chickpeas; therefore, the established tolerances for livestock 

commodities will not be affected.

860.1500 Crop Field Trials

Dry Beans (Chickpeas)

49072801.der.doc

Bayer has submitted field trial data for trifloxystrobin on dry beans (Phaseolus spp). Nine trials 

were conducted in Canada encompassing Zones 5 (ON; 3 trials), 7 (SK; 3 trials), 7A (AB; 1 

trial), and 14 (SK; 2 trials) during the 2012 growing season.

At each test location, two foliar applications of a 1.2 lb ai/gal suspension concentrate (SC) 

formulation; (USF 0728 325SC, EPA File Symbol No. 264-1055) were applied in a spray

volume of approximately 15 gallons per acre (GPA) (140 L/ha) with a RTI of 10-14 days. The 

corresponding target rate for trifloxystrobin was 0.12 lb ai/A (132 g ai/ha/application) for a target 

seasonal rate of 0.24 lb ai/A (264 g ai/ha). An adjuvant was not added to the spray mixture. Dry

bean seed was harvested at PHIs of 28 to 32 days. Dry bean seed was collected from one site at 

PHIs of 21, 25, 29, 36, and 40 days to determine residue decline. Forage samples were not 

collected.

Residues of trifloxystrobin and the metabolite CGA 321113 in dry bean seeds were quantified

using HPLC-MS/MS with stable-labeled internal standards. Validation and concurrent 

recoveries were generated by spiking at levels of 0.01 ppm, 0.05 ppm, and 0.2 ppm for each 

analyte. All recoveries were in the acceptable range of 70-120%, thus validating the method.

The limit of quantitation (LOQ) was reported as 0.01 ppm for each analyte. 

Samples were stored for a maximum of 116 days before analysis. Storage stability data are 

available showing that residues of trifloxystrobin and the metabolite CGA 321113 were stable 

in/on various raw agricultural and processed commodities stored under frozen storage conditions 

for at least 18.6 months, thus demonstrating the acceptability of storage intervals and conditions 

in the study. 

The results from these trials show that residues found in/on dry bean seed samples were less than 

LOQ (<0.01 ppm) for trifloxystrobin, ≤ 0.013 ppm for the metabolite CGA321113, and ≤0.023 

ppm for the combined residues (trifloxystrobin and CGA 321113) at PHIs of 28-32 days after 

two treatments at a total application rate of 0.23-0.24 lb ai/A (258 to 271 g ai/ha) of 

trifloxystrobin. Average residues of trifloxystrobin were observed to decline from 0.0145 ppm to 

levels below LOQ (<0.01 ppm) within a 4-day span (PHIs of 21-25 days). Average residues of 

the metabolite CGA321113 were also observed to decline from 0.016 ppm to 0.011 ppm over a 

period of 19 days (PHIs of 21-40 days).
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Table 5. Summary of Residue Data from Crop Field Trials with Trifloxystrobin.

Analyte Total Rate1

lb ai/A

(g ai/ha)

PHI 

(days)

N Residue Levels2(ppm)

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

Dry Beans

Trifloxystrobin (0.23-0.24)

258-271 28-32 9

<0.01 <0.01 <0.01 <0.01 <0.01 <0.01 NA

CGA 321113 <0.01 0.013 <0.01 0.013 0.01 0.01 0.001

Combined Residues <0.02 <0.023 <0.02 <0.023 0.02 0.02 0.001

1 Total rate refers only to trifloxystrobin in the USF 0728 325 SC application.

2 Except for Min/Max, values reflect per trial averages based on the combined residues trifloxystrobin and CGA 321113 

calculated as parent equivalents. A value of 0.01 ppm was used in any calculations involving residues less than LOQ.

n = number of field trials; LAFT = Lowest Average Field Trial; HAFT = Highest Average Field Trial

Dry Peas

49072802.der.doc

Bayer has submitted field trial data for trifloxystrobin on dry peas (Pisum spp). Nine trials were 

conducted in Canada and the US encompassing Zones 7 (SK, ND; 4 trials), and 14 (AB, SK; 5

trials) during the 2012 growing season.

At each test location, two foliar applications of a 1.2 lb ai/gal SC formulation; (USF 0728 

325SC, EPA File Symbol No. 264-1055) were applied in a spray volume of approximately 15 

GPA (140 L/ha) with a RTI of 11-14 days. The corresponding target rate for trifloxystrobin was 

0.12 lb ai/A (132 g ai/ha/application) for a target seasonal rate of 0.24 lb ai/A (264 g ai/ha). An 

adjuvant was not added to the spray mixture. Dry pea vines (forage) and hay were collected at 

PHIs of 6 to 8 days and dry pea seed was collected at PHIs of 29 to 31 days. Samples were 

collected from one site at PHIs of 0, 3, 7 and 13 days (forage and hay), and 20, 25, 31, 34 and 40 

days (seed) to determine residue decline. 

Residues of trifloxystrobin and the metabolite CGA 321113 in dry pea seeds were quantified 

using HPLC-MS/MS with stable-labeled internal standards. Validation and concurrent recoveries 

were generated by spiking at levels of 0.01 ppm, 0.05 ppm, and 0.2 ppm for each analyte. All 

recoveries were in the acceptable range of 70-120%, thus validating the method. The LOQ was 

reported as 0.01 ppm for each analyte. 

Samples were stored frozen for a maximum of 203 days before analysis. Storage stability data 

are available showing that residues of trifloxystrobin and the metabolite CGA 321113 were 

stable in/on various raw agricultural and processed commodities stored under frozen storage 

conditions for at least 18.6 months, thus demonstrating the acceptability of storage intervals and 

conditions in the study. 

The results from these trials show that after applications at a total rate of 0.23 to 0.24 lb ai/A 

(260 to 265 g ai/ha) for trifloxystrobin, the maximum residues found on dry pea commodities 

were <LOQ (<0.01 ppm), 8.20 ppm, and 2.30 ppm for trifloxystrobin and 0.023 ppm, 0.49 ppm, 

and 0.055 ppm for CGA 321113, and 0.033, 8.43, 2.34 ppm for the combined residues

(trifloxystrobin and CGA 321113) on seed, hay, and vines (forage), respectively.

In the decline trial, average combined residues of trifloxystrobin and CGA 321113 were seen to 

decrease with increasing PHIs from 0.022 ppm at 20 days to 0.02 ppm at 40 days in seed, from 
Trifloxystrobin Summary of Analytical Chemistry and Residue Data DP#: 413711

Pg 12 of 21

14.4 ppm at 0 day to 2.6 ppm at 13 days in hay, and from 2.8 ppm at 0 day to 0.7 ppm at 13 days 

in vines (forage).

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

Analyte Total Rate1

lb ai/ha 

(g ai/ha)

PHI 

(days)

n Residue Levels2(ppm)

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

Dry Pea, Seed

Trifloxystrobin 0.23-0.24

(260-265)

29-31 9

<0.01 <0.01 <0.01 <0.01 <0.01 <0.01 NA

CGA 321113 <0.01 0.023 <0.01 0.022 0.011 0.013 0.004

Combined Residues <0.02 <0.033 <0.02 <0.032 0.021 0.023 0.004

Dry Pea, Hay

Trifloxystrobin 0.23-0.24

(260-265 6-8 9

2.10 8.20 2.10 6.75 4.20 4.49 1.743

CGA 321113 0.04 0.49 0.09 0.40 0.25 0.24 0.097

Combined Residues 2.14 8.43 2.19 7.10 4.51 4.73 1.808

Dry Pea, Vines (Forage)

Trifloxystrobin 0.23-0.24

(260-265)

6-8 9

0.55 2.30 0.61 1.95 1.05 1.12 0.408

CGA 321113 0.023 0.055 0.026 0.052 0.039 0.038 0.008

Combined Residues 0.58 2.34 0.64 1.98 1.09 1.16 0.410

1 Total rate refers only to trifloxystrobin in the USF 0728 325 SC application

2 Except for Min/Max, values reflect per trial averages based on the combined residues trifloxystrobin and CGA 321113 

calculated as parent equivalents. A value of 0.01 was used in any calculations involving residues less than LOQ.

n = number of field trials; LAFT = Lowest Average Field Trial; HAFT = Highest Average Field Trial.

Conclusions. Pending submission of a revised Section F, the submitted dry peas and chickpeas 

field trial data are adequate to fulfill data requirements in support of the proposed uses. The trials 

reflect the proposed use pattern and the number and locations of the trials are acceptable based 

on the ChemSAC minutes of 20 March, 2013.

The proposed tolerances for chickpea hay and vines are not needed since both commodities are 

not significant livestock feed items. Based on the OECD tolerance calculation spreadsheet, the 

recommended tolerances are 0.06 ppm for pea, dry, seed; 15 ppm for pea, field, hay; 4 ppm for 

pea, field, vines; and 0.04 ppm for chickpea, seed. The recommended tolerance for chickpea 

seed at 0.04 ppm is increased to 0.06 ppm for harmonization purposes. The pea results are 

translated to cover lentils. The proposed tolerances on chickpea seed and lentil seed are not 

needed since pea dry seed includes these commodities (40 CFR 180.1 (g)). HED is 

recommending to establish a tolerance on pea, dry, seed at 0.06 ppm in order to harmonize with 

the Canadian recommended MRLs. A revised Section F needs to be submitted to reflect the 

correct commodity definitions. Refer to Appendix I for the tolerance calculations. 

860.1520 Processed Food and Feed

There are no processed commodities associated with the proposed new uses; therefore, no new 

processing studies were submitted or reviewed for this petition. 

860.1650 Submittal of Analytical Reference Standards

Analytical standards for trifloxystrobin (expiration 07/13/2016) and CGA-321113 

[trifloxystrobin acid (E,E); expiration 09/24/2015] are currently available in the EPA National 

Pesticide Standards Repository (communication with Theresa Cole, ACB, 06/18/2014).
Trifloxystrobin Summary of Analytical Chemistry and Residue Data DP#: 413711

Pg 13 of 21

860.1850 and 860.1900 Confined and Field Accumulation in Rotational Crops

DP#s 254213, 254217, 254218, and 254221, 04/06/2000, L. Cheng (PP#9F5070)

DP#s 254208 and 257888, 07/22/1999, F. Ives (PP#8F04955)

An adequate confined rotational crop study is available (PP#8F04955) reflecting the application 

of 14C-trifloxystrobin at 2.0 lb ai/A (~8X the maximum proposed seasonal application rate for the 

requested uses). Based on the data from the primary plant metabolism studies and the confined 

rotational crop study, HED concluded that the residues of concern in plants, including rotational 

crops, are parent and its free acid metabolite CGA-321113.

Adequate limited field rotational crop studies are also available (PP#9F5070) reflecting the 

application of trifloxystrobin (water granular (WG) formulation) to primary crops of squash or 

cucumbers as four foliar applications at rates totaling 1.0 lb ai/A/ season (~4X the maximum 

proposed seasonal application rate for the requested uses). In these two field trials, rotational 

crops of lettuce, turnips, and wheat were planted at 30- and 120-day PBIs, and samples of the 

appropriate RACs were collected and analyzed for residues of trifloxystrobin and CGA-321113. 

At both test locations, residues of trifloxystrobin and CGA-321113 were <0.02 ppm (<LOQ) in 

all RAC samples from crops planted 30 days after the last application; therefore, no analysis was 

conducted on the 120-day PBI samples. 

The available field rotational crop data support a 30-day PBI for all crops not listed on the label 

for direct use. 

860.1550 Proposed Tolerances

The Agency has determined that the tolerance expression for primary and rotational crops should 

include parent trifloxystrobin and its free acid metabolite CGA-321113. Permanent tolerances 

are currently established for the combined residues of trifloxystrobin and CGA–321113 in/on 

various plant and animal commodities ranging from 0.01 ppm to 38 ppm [40 CFR §180.555(a)]. 

The tolerance expression proposed under the current petition is appropriate.

In support of registration of the 1.27 lb ai/gal SC formulation of trifloxystrobin, the petitioner is 

proposing tolerances for the following commodities: chickpeas, dry peas, and lentils. The 

proposed and established tolerances, along with the recommendations of HED, are presented in 

Table 7.

In support of the proposed tolerances, adequate field trial reflecting the proposed use patterns

were submitted for chickpeas and dry peas.

The proposed tolerances for chickpea hay and vines are not needed since both commodities are 

not significant livestock feed items. The OECD statistical calculation procedure was utilized for

determining appropriate tolerance levels (refer to Appendix II). The available data will support 

the proposed tolerances of 0.06 ppm for pea, dry, seed; 15 ppm for pea, field, hay; 4 ppm for 

pea, field, vines; and 0.04 ppm for chickpea, seed. The recommended tolerance for chickpea 

seed at 0.04 ppm is increased to 0.06 ppm for harmonization purposes. The pea results are 

translated to cover lentils. The proposed tolerances on chickpea seed and lentil seed are not 

needed since pea dry seed includes these commodities (40 CFR 180.1 (g)). HED is 
Trifloxystrobin Summary of Analytical Chemistry and Residue Data DP#: 413711

Pg 14 of 21

recommending to establish a tolerance on pea, dry, seed at 0.06 ppm in order to harmonize with 

the Canadian recommended MRLs. A revised Section F needs to be submitted to reflect the 

correct commodity definitions. Refer to Appendix I for the tolerance calculations. 

Codex MRLs are expressed in terms of trifloxystrobin for plants; thus harmonization of MRLs is 

not possible. The Codex residue definition for livestock is the same as the US. The Canadian 

residue definitions for plants and livestock are the same as the US. There are no Codex MRLs 

established on the proposed crops. Canadian MRLs exist for dry chickpeas, dry lentils, and dry

field peas at 0.02 ppm. This petition is reviewed as a work share with Canada; tolerances for the 

proposed crops are harmonized. 

Table 7. Tolerance Summary for Trifloxystrobin. 

Commodity Proposed Tolerance 

(ppm)

Recommended 

Tolerance (ppm)

Comments; Correct Commodity 

Definition

Pea, dry, seed 0.06 0.06

Pea, dry, hay 15 15 Pea, field, hay

Pea, dry, vines 4 4 Pea, field, vines

Chickpea, seed 0.06 Not Needed Covered by pea, dry, 

seed/Harmonization

Chickpea, hay 15 Not Needed

Chickpea, vines 4 Not Needed

Lentil, seed 0.06 Not Needed Covered by pea, dry, seed.

References

DP#: 254920

Subject: Product Chemistry Review of CGA-279202 Technical.

From: A. Smith

To: J. Whitehurst 

Date: 04/23/1999

MRIDs: 44496601 and 44502801

DP#: 257835

Subject: Trifloxystrobin. Results of HED Metabolism Assessment Review Committee 

Meeting held 6/15/99.

From: F. Ives and B. Greear

To: G. Kramer

Dated: 07/13/1999

MRIDs: None
Trifloxystrobin Summary of Analytical Chemistry and Residue Data DP#: 413711

Pg 15 of 21

DP#s: 254208 and 257888

Subject: PP#8F04955. Request for Uses and Tolerances for Trifloxystrobin (proposed ISO 

common name) on Cucurbit Vegetables, Grapes, Peanuts, and Pome Fruit and a 

Tolerance for Imported Bananas.

From: F. Ives

To: C. Giles-Parker/J. Whitehurst

Dated: 07/22/1999

MRIDs: 44502801, 44496822-44966845, 44527505, 44496601-44496602, 44496812, 

44496847-44496848, 44496817-44496820

DP#s: 254213, 254217, 254218, and 254221

Subject: PP#9F5070. Trifloxystrobin on Almond, Fruiting Vegetables, Hops, Sugar Beet, 

Potato, and Wheat. Review of Analytical Methods and Residue Data.

From: L. Cheng

To: C. Giles-Parker/J. Whitehurst 

Date: 04/06/200

MRIDs: 44757207, 44757208, 44757209, 44757210, 44757211, 44757212, 44757213, 

44757214, 44757215, 44757216, 44757217, 44757218, and 44757219

DP#: 265003

Subject: PP#8F04955. Trifloxystrobin on Apples, Apple Pomace, Grapes, Summer 

Squash, Peanut Hay, Peanuts, Cow Liver, Cow Milk, and Raisin. Evaluation of 

Tolerance Method Validation Report dated January 18, 2000.

From: L. Cheng

To: C. Giles-Parker/J. Whitehurst

Dated: 04/13/2000

MRID: 44496836

DP#s: 267787 and 272054

Subject: PP#0F06121. PC Code 129112. CAS # 141517-21-7. Trifloxystrobin on Barley, 

Citrus, Corn (Field and Pop), Pecan, Pistachio, Rice, and Stone Fruit. Review of 

Analytical Methods and Residue Data.

From: L. Cheng

To: C. Giles-Parker

Dated: 01/17/2002

MRIDs: 45080800, 45080806, 45080808, 45080809, 45080810, 45080811, 45126200, 

45269400, 45269401, 45269402, 45276400, 45276401

DP#: 286639

Subject: Trifloxystrobin. Summary of Analytical Chemistry and Carrot and Celery

Residue Data. PP#3E06522

From: L. Cheng

To: J. Whitehurst/C. Giles-Parker 

Date: 01/23/2003

MRIDs: 45784901 and 45784902
Trifloxystrobin Summary of Analytical Chemistry and Residue Data DP#: 413711

Pg 16 of 21

DP#: 287242

Subject: Trifloxystrobin. Summary of Wheat Metabolism Data. Conditional Data.

From: L. Cheng

To: J. Whitehurst/C. Giles-Parker

Dated: 10/08/2003

MRIDs: 45721803, 45721804

DP#: 338207

Subject: Trifloxystrobin. Petition for Tolerances on Grasses Grown for Seed. Summary of 

Analytical Chemistry and Residue Data. Petition Number: 6F7024.

From: D. Rate

To: D. Rate

Dated: 04/10/2007

MRID: 46727801

DP#s: 357865 and 362063

Subject: Trifloxystrobin. Application for Section 3 Registration for Use of Suspension 

Concentrate Formulations on Soybean. Summary of Analytical Chemistry and 

Residue Data.

From: S. Funk

To: T. Kish/B. Crowe

Dated: 06/23/2009

MRID: 47496202

DP#s: 363108

Subject: Trifloxystrobin. Application for Section 3 Registration for Use on Field, Sweet, 

and Pop Corn. Summary of Analytical Chemistry and Residue Data.

From: W. Cutchin

To: T. Kish/J. Bauzin

Dated: 01/25/2010

MRID: 47521902

Attachments: 

International Residue Limit Status sheet

Appendix I - Tolerance Assessment Calculations
Trifloxystrobin Summary of Analytical Chemistry and Residue Data DP#: 413711

Pg 17 of 21

Trifloxystrobin (129112, Requested 2/25/14)

Summary of US and International Tolerances and Maximum Residue Limits 

Residue Definition:

US Canada Mexico2 Codex

40 CFR 180.555:

Plants and Livestock: sum of 

trifloxystrobin, benzeneacetic acid, 

(E,E)-α-(methoxyimino)-2-[[[[1-[3-

(trifluoromethyl) 

phenyl]ethylidene] 

amino]oxy]methyl]-, methyl ester, 

and the free form of its acid 

metabolite CGA–321113, 

(E,E)-methoxyimino-[2-[1-(3-

trifluoromethyl-phenyl)-

ethylideneaminooxymethyl]-

phenyl]acetic acid, calculated as 

the stoichiometric equivalent of 

trifloxystrobin

Methyl (α,E)-α-

(methoxyimino)-2-[[[(E)-

[1-[3-

(trifluoromethyl)phenyl]

ethylidene]amino]oxy]m

ethyl]benzeneacetate, 

including the metabolite 

(α,E)-α-

(methyoxyimino)-2-

[[[(E)-[1-[3-

(trifluromethyl)phenyl]et

hylidene]amino]oxy]met

hyl]benzeneacetic acid, 

expressed as 

trifloxystrobin

Plant: Trifloxystrobin

Livestock: sum of 

trifloxystrobin and 

[(E,E)-methoxyimino-{2-

[1-(3-

trifluoromethylphenyl)et

hylideneaminooxymethyl

]

phenyl}acetic acid] 

(CGA 321113), 

expressed as 

trifloxystrobin. The 

residue is fat-soluble.

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

US Canada Mexico2 Codex

Pea, dry, seed 0.06 0.06

(proposed) 

(pea field, 

pea pigeon, 

chickpea, 

lentil) seed

0.02 dry 

(field peas, 

chickpeas, 

lentils)

Pea, field, hay 15

Pea, field, vines 4

Completed: M. Negussie; 02/25/14

1

Includes only commodities of interest for this action. Tolerance values should be the HED recommendations and 

not those proposed by the applicant.

2 Mexico adopts US tolerances and/or Codex MRLs for its export purposes.
Trifloxystrobin Summary of Analytical Chemistry and Residue Data DP#: 413711

Pg 18 of 21

Appendix I. Tolerance Assessment Calculations.

The tolerance expression for trifloxystrobin is combined residues of trifloxystrobin and CGA321113. The LOQ for each analyte in each commodity was 0.01 ppm, for a combined LOQ of 

0.02 ppm.

For the crops listed below, the OECD statistical calculation spreadsheet was used for calculating 

recommended tolerances. As specified in the OECD document, the average residue value was 

used. 

The dataset used to establish tolerances for trifloxystrobin on dry pea (seed, forage, hay) and 

chickpeas consisted of field trial data representing application rates of 0.23-0.24 lb ai/A with a 

28-32-day PHIs for seed and 6-8-day PHIs for field pea forage (vines) and hay. As specified by

the Guidance for Setting Pesticide Tolerances Based on Field Trial Data (SOP), the field trial 

application rates and minimum label PHIs are within 25% of the maximum label application rate. 

The average residue values that were entered into the tolerance spreadsheet are provided in Table 

I-1 and Table I-2 (below). Using the OECD tolerance calculation spreadsheet, the recommended

tolerances are 0.06 ppm for pea, dry, seed, 15 ppm for pea, field, hay; 4 ppm for pea, field, vines; 

and 0.04 ppm for chickpea, seed. HED is recommending to increase the tolerance for chickpea, 

seed to 0.06 ppm for harmonization purposes. The proposed tolerances on chickpea seed and 

lentil seed are not needed since pea dry seed includes these commodities (40 CFR 180.1 (g)). 

HED is recommending to establish a tolerance on pea, dry, seed at 0.06 ppm in order to 

harmonize with the Canadian recommended MRLs. A revised Section F needs to be submitted 

to reflect the correct commodity definitions.

Table I-1. Residue Data Used to Calculate Tolerance for Trifloxystrobin on 

Chickpea.

Regulator: EPA

Chemical: Trifloxystrobin

Crop: Chickpea (Dry beans)

PHI: 28-32 Day

App. Rate: 0.23-0.24 lb ai/A

Submitter: Bayer CropScience

MRID Citation: MRID 49072801

Combined Residues of Trifloxystrobin and CGA-321113 (ppm)

0.021

0.02

0.021

0.023

0.02

0.02

0.02

0.022

0.02
Trifloxystrobin Summary of Analytical Chemistry and Residue Data DP#: 413711

Pg 19 of 21

Table I-2. Residue Data Used to Calculate Tolerance for Trifloxystrobin on Dry Peas.

Regulator: EPA EPA EPA

Chemical: Trifloxystrobin Trifloxystrobin Trifloxystrobin

Crop: Pea, field, seed Pea, field, hay Pea, field, forage (vines)

PHI: 29-31 Days 6-8 Days 6-8 Days

App. Rate: 0.23-0.24 lb ai/A 0.23-0.24 lb ai/A 0.23-0.24 lb ai/A

Submitter: Bayer CropScience Bayer CropScience Bayer CropScience

MRID Citation: MRID 49072802 MRID 49072802 MRID 49072802

Combined Residues of Trifloxystrobin and CGA-321113 (ppm)

0.032 4.51 0.94

0.023 6.32 1.09

0.026 2.19 1.35

0.020 3.27 0.636

0.020 3.58 0.812

0.021 7.10 1.54

0.022 5.55 0.95

0.021 6.94 1.15

0.020 3.17 1.98

Figure I-1. Tolerance Spreadsheet Summary of Trifloxystrobin Field Trial Data for Chickpeas.

Trifloxystrobin

Chickpeas

EPA

0.23-0.24 lb ai/A

Total number of data (n) 9

Percentage of censored data 56%

Number of non-censored data 4

Lowest residue 0.020

Highest residue 0.023

Median residue 0.020

Mean 0.021

Standard deviation (SD) 0.001

Correction factor for censoring (CF) 0.630

Proposed MRL estimate

- Highest residue 0.023

- Mean + 4 SD 0.025

- CF x 3 Mean 0.039

Unrounded MRL 0.039

Rounded MRL 0.04
Trifloxystrobin Summary of Analytical Chemistry and Residue Data DP#: 413711

Pg 20 of 21

High uncertainty of MRL estimate.

[High level of censoring]

Figure I-2. Tolerance Spreadsheet Summary of Trifloxystrobin Field Trial Data for Dry Pea Seed.

Trifloxystrobin

Dry Pea, Seed

EPA

0.23-0.24 lb ai/A

Total number of data (n) 9

Percentage of censored data 33%

Number of non-censored data 6

Lowest residue 0.020

Highest residue 0.032

Median residue 0.021

Mean 0.023

Standard deviation (SD) 0.004

Correction factor for censoring (CF) 0.778

Proposed MRL estimate

- Highest residue 0.032

- Mean + 4 SD 0.039

- CF x 3 Mean 0.053

Unrounded MRL 0.053

Rounded MRL 0.06

Figure I-3. Tolerance Spreadsheet Summary of Trifloxystrobin Field Trial Data for Pea Field Hay.

Trifloxystrobin

Dry Pea, Hay

EPA

0.23 - 0.24 lb ai/A

Total number of data (n) 9

Percentage of censored data 0%

Number of non-censored data 9

Lowest residue 2.190

Highest residue 7.100

Median residue 4.510

Mean 4.737
Trifloxystrobin Summary of Analytical Chemistry and Residue Data DP#: 413711

Pg 21 of 21

Standard deviation (SD) 1.806

Correction factor for censoring (CF) 1.000

Proposed MRL estimate

- Highest residue 7.100

- Mean + 4 SD 11.960

- CF x 3 Mean 14.210

Unrounded MRL 14.210

Rounded MRL 15

Figure I-4. Tolerance Spreadsheet Summary of Trifloxystrobin Field Trial Data for Pea Field Forage

(Vines).

Trifloxystrobin

Dry Pea, Forage (Vines)

EPA

0.23 - 0.24 lb ai/A

Total number of data (n) 9

Percentage of censored data 0%

Number of non-censored data 9

Lowest residue 0.636

Highest residue 1.980

Median residue 1.090

Mean 1.161

Standard deviation (SD) 0.410

Correction factor for censoring (CF) 1.000

Proposed MRL estimate

- Highest residue 1.980

- Mean + 4 SD 2.802

- CF x 3 Mean 3.483

Unrounded MRL 3.483

Rounded MRL 4