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

Pg 1 of 21 **860. 18590 UNITED STA** 

**TES ENVIRONMENTA L PROTECTION A** **GENCY WA** **SHINGTON, D.C. 20460 OFFICE OF**  **CHEMICAL SAFETY AND**  **PO L**  **LUTION PREVENTION** 
**MEMORANDUM Date**  **:** 0 4 /1 4 /14 **SUBJECT:** Trifloxy strobin. Application for Section 3 Registration for Use s on Dry Pea s , Chickpea s , and L entils. Summary of Analy tical Chemistry

and Residue Data. **PC Code:** 129112 **DP Barcode:** D 4 13711 **Decision No.:** 478982 **Registration No. :**  264 - 1055 **Petition No.:** 3F8180 **Regulatory Action:** Section 3 Registration **Risk Assessment Type:** NA **Case No.:** NA **T XR No.:**  NA **CAS No.:** 141517 - 21 - 7 **MRID No.:** See MRID Summary Table **40 CFR:** 180.555 **FROM:** Meheret Negussie , Chemist

Ris k A ssessment Branch III (RAB 3 ) 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

Pg 2 of 21 Summary of Submitted Residue Chemistry Studies OCSPP 860 Seri es 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Dry Bean (Phaseolus spp) Following Treatment with SP102000010777 (Pr othioconazole/Trifloxystrobin) Study No.: RAJAN003 Unpublished study prepared by Bayer CropScience. 456 pages. 860.1500 4907280 2 49072802/PMRA# 2306696 Milo, J. and A. Harbin (2013) Study title: FOX 325 SC Foliar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 Study No.: RAJAN004 Unpublished study prepared by Bayer CropScience. 555 pages.Trifloxystrobin Summary of Analytical Chemistry and Residue Data DP# : 413711

Pg 3 of 21 **Executive Summary** Trifloxy strobin belo ngs to the MAEs (β - methoxyacryl esters) class of fungicides, which are sy nthetic 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 fr uit, nut, vegetable, and field crops. Under PP# 3F8180 , Bayer CropScience (Bayer) is proposing the establishment of permanent tolerances for residues of the fungicide trifloxy strobin [ 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 ) - ethylideneaminooxy methyl] - phenyl]acetic acid] in/on the follow ing raw agricultural commodities :

Pea, dry , seed ................................ .............................. 0.0 6 ppm Pea, dry , hay ................................ ................................ ... 15 ppm Pea, dry , vines ................................ ................................ . 4 ppm Chickpea, seed ................................ ............................ 0.06 ppm Chickpea, hay ................................ ................................ . 1 5 ppm Chickpea, vines ................................ ............................... 4 ppm Lentils ................................ ................................ ........ 0.06 ppm Inconjunction with this petition, Bayer is requesting registration of USF 0728 325 SC , a 1.2 7 lb ai / gal suspension concentrate (SC) formulation [EPA File Sy mbol No. 264 - 1055]. The product is a multiple active ingredient (MAI) prod uct that also contains prothioconazole at 1.49 lb ai /gal. The subject review only

addresses the adequacy

of the available d ata to support the proposed uses of trifloxy strobin only . T he proposed use s 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 trifloxy strobin and max imum seasonal rates of 0.24 lb ai/A. R etreatment int ervals (RTI s) of 10 - 14 day s, and preharvest intervals (PHI s) of 0 - day s for forage/vines and hay and 30 - day s for seed are proposed . Tolerances are currently

established for the combined residues of tri floxy strobin and the free form of its acid metabolite CGA

– 321113 in/on various crop and livestock commodities ranging from 0.0 1 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 - 3 21113 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 L 7a (taurine conjugate of trifloxy strobin) in liver should be included in th e risk assessment.Trifloxystrobin Summary of Analytical Chemistry and Residue Data DP# : 413711

Pg 4 of 21 An adequate gas chromatography method with nitrogen phosphorus detection ( GC/NPD ), Method AG - 659A , is available for enforcing tolerances for the combined residues of trifloxy strobin and CGA - 321113 in plant and livestock commodities. Samples from the submitted crop field trials on dry peas (see d, forage, and hay ) and chickpeas were analy zed for residues of triflox ys trobin and CGA - 321113 using a high performance liquid chromatography method with tandem mass spectrometry detection (L C/MS/M S) . 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 (LLM V) is equivalent to the limit of quantitation ( LOQ ) which was 0.010 ppm for each analy

te 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 propos ed use on dry

peas does not result in an increased dietary burden for livestock. T he existing tolerances on livestock commodities are adequate. Adequate crop field trial data have been submitted to support the requested use s 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 vine s 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 0.0 6 ppm for pea, dry, seed ; 15 p pm for pea, field

, hay ; 4 ppm for pea, field , vines ; and 0.04 ppm for chickpea, seed . The recommended tolerance for chick pea seed at 0.04 ppm is increased to 0.06 ppm for harmonization purposes. The pea results are translated to cover lentils. The propose d 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 M RL s. A revised Section F needs to be submitted to reflect the correct commodity definition s . There are no processed commodities associated with the proposed new uses ; therefore, no new processing studies were submitted or reviewed for this petition. Ad equate 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 liste d on the label for direct use. Codex MRL s are expressed in terms of trifloxy strobin for plants ; thus , harmonization of MRL s is not possible. The Codex residue definition for l ivestock is the same as the US. The Canadian residue definition s for plants and livestock are the same as the US. There are no Codex MRL s established on the proposed crops. Canadian MRL s exist for dry chickpeas, dry

lentils, and dry field peas at 0.02 ppm. This petition is reviewed as a workshare with Canada ; tol erances for the proposed crops are harmonized.Trifloxystrobin Summary of Analytical Chemistry and Residue Data DP# : 413711

Pg 5 of 21 **Regulatory Recommendations and Residue Chemistry Deficiencies** HED has examined the residue chemistry database for trifloxy strobin . Pending submission of a revised Section F (see requirements under Proposed Tolerances ; Ta ble 7 ), there are no residue chemistry issues that would preclude granting a Section 3 registration and establishment of tolerances for combined residues of trifloxy strobin and its acid metabolite CGA - 321113 , as follow s : Pea, dry , seed ................................ .............................. 0.0 6 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 c hemical structure and nomenclature of trifloxy strobin and its regulated metabolite are presented in Table 1 , and the physicochemical properties of the technical grade of trifloxy strobin are presented in Table 2. **Table 1**  **. Trifloxystrobin Nom**  **enclature**
. Ch emical structure O N C F 3 N O O

CH 3 O C H 3 CH 3

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] - o tolyl}acetate CAS name methyl (α E) - α - (methoxyimino) - 2 - [[[[(1 E) - 1 - [3 - (trifluoromethyl)phenyl]ethylidene]amino]oxy]methyl]benzeneacetate CAS registry number 141517 - 21 - 7 End - use product (EP) Prothioconazole/Trifloxystrobin USF 0728 325 SC 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 C F 3 N O H O O C H 3 C H 3

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

Pg 6 of 21 **Table 1**  **. Trifloxystrobin Nom**  **enclature**
. Company Code CGA - 321113 CAS name ( α E) - α – (methoxyimino - [2 - [[ [ (E) - 1 - [ 3 - ( trifluoromethyl ) phenyl ] - ethylidene ] amino ] oxy] methyl] benzene acetic acid CAS # 252913 - 85 - 2 **Table 2. Physicochem** **ical Properties of Trifloxystrobin.** Parameter Value Reference 1 Melting point 72.9oC MRID 44502801 pH 7 .7 in 1% w/w aqueous dispersion at 25oC Density 1.36 g/cm2 at 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

tolue ne 500 n - octanol 18 Vapor pressure 3.4 x 10 - 6 Pa at 25oC Dissociation constant, pKa none at pH of 2 - 12 Octanol/water partition coefficient Log(P OW) 4.5 at 25oC UV/visible absorption spectrum (molecular absorption c oefficients) 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 Trifloxy strobin USF 0728 325 SC ; EPA File Sy mbol 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 t olerances are being proposed including dry peas, chick

peas, 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; Ty pe ; and Equip ment Formulation

[EPA Fi le Symbol No.] Applic.

Rate (lb ai/A) Max. No.

Applic. per Season Max.

Seasonal Applic. Rate (lb ai/A) PHI

(days) Use Directions and

Limitations 1 **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.Trifloxystrobin Summary of Analytical Chemistry and Residue Data DP# : 413711

Pg 7 of 21 **Table 3**  **. Summary of Directions for Use of**  **Trifloxystrobin .**  Applic. Timing; Ty pe ; and Equip ment Formulation

[EPA Fi le Symbol No.] Applic.

Rate (lb ai/A) Max. No.

Applic. per Season Max.

Seasonal Applic. Rate (lb ai/A) PHI

(days) Use Directions and

Limitations 1 **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 (w hen multiple applications are permitted). T o 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 use s . The proposed maximum seasonal rate, minimum PHI s, and minimum RTI s are supported by

the submitted field trial data . **860.1300 Nature of the Residue -**  **Plants** DP#287242 , L. Cheng , 10/ 0 8/20 03 DP#s 267787 and 272054 , L. Cheng , 0 1/17/20 02 DP#s 254208 and 257888 , F. Ives , 0 7/22/ 19 99 DP#257835 , F. Ives and B. Greear , 0 7/13/ 19 99 The qualitative nature of the resid ue 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 trifloxy strobin and the free form of its aci d 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 trifloxy strobin and the free form of its acid metabolite CGA - 321113. Additionally , metabolite L 7a (taurine conjugate of trifloxy strobin) in the liver is to be included in risk assessment. **860.1340 Residue Analytical Meth ods**  DP#265003 , L. Cheng , 0 4/13/20 00 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 vali dated by the Agency

and forwarded to FDA for inclusion in the Pesticide Analytical Manual (PAM), Vol. I I.Trifloxystrobin Summary of Analytical Chemistry and Residue Data DP# : 413711

Pg 8 of 21 Data collection method: Samples from the submitted crop field trials on dry peas and chickpeas were anal yz ed for residues of trifloxystrobin and CGA - 321113 using an LC/MS/M S method . Briefly , subsample s 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 analy zed using high performance liquid chromatography with tandem mass spectrometry ( HP LC - MS/MS ) in the positive ion mode under multiple reaction monitoring (MRM) conditions, using ion transitions m/z 409  1 86 for trifloxy strobin 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 L OQ was reported as 0.01 ppm for each analy te. The LC/MS/MS meth od was adequately validated in conjunction with the analysis of field trial samples using control samples fortified separately with trifloxy strobin and CGA - 321113 at levels ranging from 0.01, 0.05, and 0.2 p pm. 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 analy tical 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 chi ckpeas were determined using an acceptable data collection method. **860.1360 Multiresidue Methods** DP#s 254208 and 257888 , F. Ives , 0 7/22/ 19 99 The regulated residues were tested in accordance with the Pesticide Analytical Method ( PAM ) , Volume I , Appendix I I. Trifloxy strobin gave adequate responses through protocol C, and was completely

recovered from fortified apple samples when analy zed through protocols D and E. Acid metabolite CGA - 321113 was recoverable through protocol B and residues from apples forti fied 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 254 221, L. Cheng , 04/06/2000 ( PP#9F5070 ) Storage sta

bility 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 b oth analy tes were demonstrated to be stable in/on the following RAC s : 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 commoditi es, residues of both analy tes 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 avai lable data are adequate to support storage stability requireme nts for fruit or fruiting vegetables, non - oily grains, oily

crops, and potatoes. ForTrifloxystrobin Summary of Analytical Chemistry and Residue Data DP# : 413711

Pg 9 of 21 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 ty pes and will be translated to beans and peas. The storage duration s 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**  **Duration s of**  **Sam ples from**  **Crop Field Trial Studies.** Matrix Storage

Tem perature (°C) Actual Storage Duration (days) Interval of Demonstrated Storage Stability Chickpea seed - 21 to - 13 83 - 116 Residues of trifloxystrobin and CGA 321113 are reasonably stable under f rozen storage condit ions in/on cucumber, grape, potato , and w heat grain for up to ~2 years, and in/on apple and peanut nutmeat for up to 18.6 mo nths. 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 duratio ns and conditions of samples of dry pea and chickpeas f

ro m the submitted crop field trial studies. **860.1400 Water, Fish, and Irrigated Crops** There are no proposed uses that are relevant t o 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 P ea field seeds , hay , and vines are the livestock feedstuffs associated with the proposed use s . The dietary

burden for beef cattle is not affected since these commodities are not fe d 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 fo r poultry and swine. The livestock maximum reasonably balanced diets (MRBD) of trifloxy strobin were recalculated using the highest average field trial (HAFT)/median residues for pea commodities and tolerance level resid

ues for existing uses. For cattle, corn forage contributes the entire roughageTrifloxystrobin Summary of Analytical Chemistry and Residue Data DP# : 413711

Pg 10 of 21 component at a higher dietary contribution of trifloxy strobin than pea hay . A similar situation exists for the protein concentrate fraction of the poultry and swine diets. Soy

bean meal contributes the entire p rotein concentrate component at a higher dietary contribution of trifloxy strobin 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 use s on dry

peas and chickpeas ; therefore, the established tolerances for livestock c ommodities will not be affected. **860.1500 Crop Field Trials Dry Beans**  **(Chickpeas)** 49072801.der.doc Bayer has s ubmitted field trial data for trifloxystrobin on dry bean s ( 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 l ocation, two foliar applications of a 1.2 lb ai /gal suspension concentrate (SC) formulati on; (USF 0728 325SC , EPA File Sy mbol 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 a i /ha) . An adjuvant was not added to the spray mixture. Dry bean seed was harvested at PHI s of 28 to 32 days. Dry b ean seed was collected from one site at PHI s 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 HP LC - 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 analy te. All recoveries were in the acceptable range of 70 - 120%, thus validating the method. The lim it of quantitation (L OQ) was reported as 0.01 ppm for each analy te. 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 fo r at least 1 8.6 months, thus demonstrating the acceptability of storage intervals and conditions in the study . The results from these trials show that residue s found in/ on dry bean seed samples were less than LOQ (<0.01 ppm) for trifloxystrobin , ≤ 0. 0 13 ppm for the metabolite CGA321113 , and ≤0.023 ppm for the combined residues (trifloxystrobin and CGA 321113) at PHI s 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 trifloxy strobin. Averag e r esidues of trifloxy strobin were observed to decline from 0.0145 ppm to levels below L OQ (<0.01 ppm) within a 4 - day span (PHI s of 21 - 25 days). Average r esidues of the metabolite CGA321113 were also observed to decline from 0.016 ppm to 0.011 ppm over a period of 19 days (PHI s of 21 - 40 days).Trifloxystrobin Summary of Analytical Chemistry and Residue Data DP# : 413711

Pg 11 of 21 **Table 5**  **. Summary of Residue Data from** **Crop Field Trials with Trifloxystrobin.**  Analyte Total Rate 1

lb ai/A (g ai /ha) PHI

(days) N Residue Levels 2 (ppm)

Min. Max. LAFT HAFT Median Mean Std. Dev. **Dry Bea ns**  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 th e 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 trifloxy strobin on dry pea s ( 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 formulati on; (USF 0728 325SC , EPA File Sy

mbol No. 264 - 1055 ) were applied in a spray volume of approximately 15 GPA ( 140 L/ha) with a RTIof 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 t o the spray mixture. Dry

pea vines (forage) and hay were collected at PHI s of 6 to 8 days and dry pea seed was collected at PHI s of 29 to 31 days . Samples were collected from one site at PHI s of 0, 3, 7 and 13 days (forage and hay ), and 20, 25, 31, 34 an d 40 day s (seed) to determine residue decline. Residues of trifloxystrobin and the metabolite CGA 321113 in dry pea seeds were quantified using HP LC - 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 analy te. All recoveries were in the acceptable range of 70 - 120%, thus validating the method. The L OQ was reported as 0.01 ppm for each analy te. Samples were stored frozen for a maximum of 203 day s 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 fo r 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 trifloxy strobin , the maximum resid u es found on dry

pea commodities were <LOQ (<0.01 ppm), 8.20 ppm , and 2.30 ppm for trifloxy strobin 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 vin es (forage) , respectively . Inthe decline trial , average combined residues of trifloxy strobin and CGA 321113 were seen to decrease with increasing PHI s from 0.022 ppm at 20 days to 0.02 ppm at 40 days in seed, fromTrifloxystrobin 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 Rate 1

lb ai/ha (g ai /ha) PHI

(days) n Residue Levels 2 (ppm)

Min. Max. LAFT HAFT Median Mean Std. Dev. **Dry Pea, Seed** Trifloxystrobin 0.23 - 0.24

(26 0 - 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, Ha y**  Trifloxystrobin 0.23 - 0.24 (260 - 265 6 - 8 9 2.10 8.20 2.10 6.75 4.20 4.49 1.74 3 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 3 25 SC application 2 Except for Min/Max, va lues 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 use s. 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 O ECD tolerance calculation spreadsheet, the recommended tolerances are 0.0 6 ppm for pea, dry, seed ; 15 ppm for pea, field, hay ; 4 ppm for pea, field, vines ; and 0.04 ppm for chickpea, seed . T he recommended tolerance for chick pea seed at 0.04 ppm is increased to 0.06 ppm for harmonization purposes. The pea results are translated to cover lentils. T he proposed tolerances on chickpea seed and lentil seed are not needed since pea dry

seed includes these commodities (40 CFR 180.1 (g)). H ED is recommending to establish a tolerance on pea, dry , seed at 0.06 ppm in order to harmonize with the Canadian recommended MRL s. 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**  Analy tical standards for trifloxy strobin (expiration 0 7/13/20 16) and CGA - 321 1 13 [trifloxystrobin acid (E,E); expiration 0 9/24/20 15] are currently available in the EPA National Pesticide Standards Repositor y (communication with Theresa Cole , ACB , 0 6 /1 8 /20 14).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 , 0 4/ 0 6/20 00, L. Cheng (PP#9F5070) DP#s 254208 and 257888, 0 7/22/ 19 99, F. Ives (PP#8F04955) An adequate confined rotational c rop study is available ( PP#8F04955 ) reflecting the application of 14 C - trifloxy strobin at 2.0 lb ai/A (~ 8 X 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 residue s 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 appl ication 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 ( ~ 4 X the maximum proposed seasonal application rate for the requested uses ). In these tw o field trials, rotational crops of lettuce, turnips, and wheat were planted at 30 - and 120 - day PBI s , and samples of the appropriate RACs were collected and analy zed for residues of trifloxystrobin and CGA - 321113. At both test locations, residues o f trifl oxy strobin and CGA - 32111 3 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 PBIsamples. The available field rotational crop data support a 30 - day PBIfor all crops not listed on the label for direct use. **860.1550 Proposed Tolerances** The Agency

has determined that the tolerance express i on for primary and rotational crops should include parent trifloxystrobin and its free acid metabolite CGA - 321113. Perm anent t olerances are currently

established for the combined residues of trifloxystrobin and CGA

– 321113 in/on various plant and animal commodities ranging from 0.0 1 ppm to 38 ppm [40 CFR §180.555(a)]. The tolerance expression proposed under the current pet ition is appropriate. Insupport of registration of the 1.27 lb ai /gal SC formulation of tri fl oxy strobin , the petitioner is proposing tolerances for the following commodities : chickpeas, dry peas, and lentils. T he proposed and established tolerances, al ong with the recommendations of HED , are presented in Table 7 . Insupport of the proposed tolerances, a dequate field trial reflecting the proposed use pattern s 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. T he OECD statistical calculation procedure was utilized for determining appropriate tolerance levels (refer to Appendix I I). The available data will support the proposed tole rances 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 chick pea 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 isTrifloxystrobin 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 t o harmonize with the Canadian recommended MRL s. A revised Section F needs to be submitted to reflect the correct commodity

definitions. Refer to Appendix I for the tolerance calculations. Codex M RL s are expressed in terms of trifloxy strobin for plants ; thus harmonization of MRL s is not possible. The Codex residue definition for l ivestock is the same as the US. The Canadian residue definition s for plants and livestock are the same as the US. The re are no Codex MRL s established on the proposed crops. Canadian MRL s 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 Sum**  **ma ry for**  **Trifloxyst r**  **obin.** Commodity Pr oposed 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/Harmo nization 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: 0 4/23/ 19 99 MRIDs: 44496601 and 44502801 DP #: 257835 Subject: Trifloxy strobin. Results of HED Metabolism Assessment Review Committee

Meeting held 6/15/99. From: F. Ives and B. Greear To: G. Kramer Dated: 0 7/13/ 19 99 MRIDs: NoneTrifloxystrobin Summary of Analytical Chemistry and Residue Data DP# : 413711

Pg 15 of 21 DP # s : 254208 and 257888 Subjec t: PP#8F04955 . Request for Uses and Tolerances for Trifloxystrobin (proposed I SO

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: 0 7/22 / 19 99 M RIDs: 44502801, 44496822 - 44966845, 44527505, 44496601 - 44496602, 44496812,

44496847 - 44496848, 44496817 - 44496820 DP#s : 254213, 254217, 254218, and 254221 Subject: PP#9F5070. Trifloxy strobin on Almond, Fruiting Vegetables, Hops, Sugar Beet,

Potato, and Wheat. Review of Analy tical Methods and Residue Data. From: L. Cheng To: C. Giles - Parker/J. Whitehurst Date: 0 4/ 0 6/2 00 MRIDs: 44757207, 44757208, 44757209, 44757210, 44757211, 44757212, 44757213,

44757214, 44757215, 44757216, 44757217, 44757218, and 44757219 DP # : 265003 Subject: PP#8F04955 . Trifloxy strobin on Apples, Apple Pomace, Grapes, Summer

Squash, Peanut Hay , Peanuts, Cow L iver, Cow Milk, and Raisin. Evaluation of Tolerance Method Validation Report dated January 18, 2000. From: L. Cheng To: C . Giles - Parker/J . Whitehurst Dated: 0 4/13/20 00 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 Analy tica l Methods and Residue Data. From: L. Cheng To: C. Giles - Parker Dated: 0 1/17/20 02 MRIDs: 45080800, 45080806, 45080808, 45080809, 45080810, 45080811, 45126200,

45269400, 45269401, 45269402, 45276400, 45276401 DP#: 286639 Subject: Trifloxy strobin. Summary o f Analy tical Chemistry

and Carrot and Celery Residue Data. PP# 3E06522 From: L. Cheng To: J. Whitehurst/C. Giles - Parker Date: 0 1/23/20 03 MRIDs: 45784901 and 45784902Trifloxystrobin Summary of Analytical Chemistry and Residue Data DP# : 413711

Pg 16 of 21 DP # : 287242 Subject: Trifloxy strobin. Summary of Wheat Metabolism Data. Conditional Data. From: L. Cheng To: J. Whitehurst/C. Giles - Parker Dated: 10/ 0 8/20 03 MRIDs: 45721803, 45721804 DP#: 338207 Subject: Trifloxy strobin. Petition for Tolerances on Grasses Grown for Seed. Summary of Analy tical Chemistry

and Residue Data. Petition Number: 6F7024. From: D. Rate To: D. Rate Dated: 0 4/10/20 07 MRID: 46727801 DP# s : 357865 and 362063 Subject: Trifloxy strobin. Application for Section 3 Registration for Use of Suspension

Concentrate Formulation s on Soy bean. Summary

of Analy tical Chemistry

and Re sidue Data. From: S. Funk To: T. Kish/B. Crowe Dated: 0 6/23/20 09 MRID: 47496202 DP#s: 363108 Subject: Trifloxy strobin. Application for Section 3 Registration for Use on Field, Sweet,

and Pop Corn. Summary of Analy tical Chemistry

and Residue Data. From: W. Cutchin To: T. Kish/J. Bauzin Dated: 01/25/2010 MRID: 47521902 Attachments: International Residue L imit Status sheet Appendix I - Tolerance Assessment CalculationsTrifloxystrobin Summary of Analytical Chemistry and Residue Data DP# : 413711

Pg 17 of 21 

### Trifloxystrobin ( 129112 , Requested 2/25/14 ) Summary of US and International Toleran ces and Maximum Residue Limits Residue Definition : US Canada Mexico 2 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 aci d , 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: T rifloxystrobin 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. Commodity 1 Tolerance (ppm) /Maxim um Residue Limit (mg/kg) US Canada Mexico 2 Codex Pea, dry , seed 0.0 6 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 trifloxy strobin and CGA 321113. T he LOQ for each analy te in each commodity

was 0.01 ppm, for a combined L OQ of 0.02 ppm. For the c rops 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 trifloxy strobin 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

PHI s for seed and 6 - 8 - day PHI s 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 PHI s are within 25% of the maximum label application rate. The average residue values that were entered into the tolerance spre adsheet are provided in Table I - 1 and Table I - 2 (below). Using the OECD tolerance calculation spreadsheet, the recommended tolerances are 0.0 6 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 incr ease the tolerance for chickpea, s eed 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 tole rance on pea, dry , seed at 0.06 ppm in order to harmonize with the Canadian recommended MRL s. A revised Section F needs to be submitted to reflect the correct commodity definitions. **Table I -**  **1. Residue Data Used to Calculate Tolerance for T**  **rifloxystrobin on**  **Chickpea. Regulator:**  EPA **Chem ical:**  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 **Com bined Residues of Trifloxystrobin and CGA**  **- 321113 (ppm** **)** 0.02 1 0.02 0.021 0.023 0.02 0.02 0.02 0.022 0.02Trifloxystrobin Summary of Analytical Chemistry and Residue Data DP# : 413711

Pg 19 of 21 **Table I -**  **2 .**  **Residue Data Used to Calculate Tolerance for T rifloxystrobin on**  **Dry Peas. Regulator:**  EPA EPA EPA **Chem ical:**  Trifloxystrobin Trifloxystrobin Trifloxystrobin **Crop:** Pea, field, see d Pea, field, hay Pea, field, forage (vines) **PHI:** 29 - 31 Day s 6 - 8 Day s 6 - 8 Day s **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 **Com bined 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 Sum ma**  **ry of Trifloxystrobin Field Trial Data f**  **or 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 -**  **c ensored 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 Spreadshee t Sum**  **ma ry of Trifloxystrobin Field Trial Data**  **f or**  **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 Sum ma**  **ry of Trifloxystrobin Field Trial Data f**  **or Pea**  **Field H ay.**  **Triflox ystrobin**  **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** 4.737Trifloxystrobin 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 Sum ma**  **ry of Trifloxystrobin Field Trial Data f**  **or 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 **Correct ion 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**