Comment Info: =================

General Comment:hello I am a previous smoker for about 20 years. I can tell you now that it was a horrible experience trying to quit. It was so discouraging to try and fail.I was always sick with bronchitis, and lung infections. But it did not matter. I still smoked cigarettes. When cigarettes got to be to expensive. I switched to cigars. And then my health took a drastic turn for the worse. More lung infections. More severe bronchitis. One day I sat down and felt a sharp pain in my left lung. I couldn't breathe. I couldn't talk..After that ordeal and quite a scare to say the least. I decided to try once again to quit smoking. So after some research my husband  found out about some new e cigarettes that had came out. He did extensive research into what the liquid was made of, and all such things. My husband smoked heavier than I did. And his health was suffering also. He also smoked longer than I did. So he and I went on the ecigarette journey. At first we tried many different kinds of products. We also watched P. Busardo's video's on you tube in our research to be able to get good reviews and his videos helped us a great deal. So after a month or two we were strictly using ecigarettes. We quickly became more healthy. We also got our sense of smell back. What everyone else was smelling when we smoked. DEAR GOD it was horrible. So we cleaned EVERYTHING in our house, including the walls to get the chemical smell from when we smoked cigarettes out of our house.Now we actually feel better than we have in years. I can breathe better. We can go for walks without running out of breath. Now instead of a cigarette smell in our house. Its filled with good smells. Our food tastes better. We haven't smoked a cigarette nor cigar in over a year. And our lives are better for it. Its all been because of ecigarettes. My mother was a heavy smoker. She also has COPD. And congestive heart failure. We got her smoking ecigarettes. Her doctor praises them saying her lungs look better. She can do  her breathing exercises without struggle. There are so many health benefits to them I cant list them all. All I can speak of is from my own experience. And while I agree that they should be regulated. What I am hearing about is plain ridiculous. There is NO smoke that comes from them at all. And to ban them is in my opinion against our rights as U.S citizens.  The sale of Ecigs and ecig juice shouldnt be banned. And No its NOT toxic to the point that one drop of eliquid will kill someone, that statement is just silly. If the device is used properly then its perfectly safe. If its said that in order to buy them someone has to be over a certain age. Then that is alright as long as it goes no further than that. The sale of the products in my opinion has helped so many people get their lives back. And its sad to see the government try to take that away from people. We cant allow this to happen. The powers that be need to leave this alone. Let people be happy for a change instead of trying to govern every aspect of someone's existence. No the companies that give the people this service shouldnt be punished by a bunch of taxes that would make it near impossible for them to stay in business. Meaning if that happened the consumer would have to spend alot more just in order to pay the government its share. Thats NOT fair. So while im alright for putting an age requirement of the sale of the products.. I am NOT alright with regulating it to where the companies suffer for it. Which in turn makes the consumer suffers to. And by banning online sales of the products your hurting people rather than helping people. The government needs to fix things that are really an issue. And leave this alone. The government has had adequate time to make regulations on this matter. We the people need adequate time to have our voices heard. Please give the people at least 180 more days to have our voices  heard concerning this matter.


The average fluopyram residue found in/on unpeeled muskmelon (RAC) treated by drip line irrigation application was 0.0038 ppm.  The average fluopyram residue found in peeled muskmelons treated by drip line irrigation application was 0.0027 ppm.  The calculated processing factor was 0.71x for peeling.

Conclusions.  The submitted processing data are not needed to satisfy data requirements; however the data may be used for risk assessment purposes.

Peanut

A peanut processing trial was conducted to measure the magnitude of fluopyram residues in peanut and peanut processed commodities following exaggerated rate treatment.  At one site in GA, two broadcast foliar spray applications of the 4.16 lb/gal SC formulation were made to peanuts at a rate of 1.116 lb ai/A and 1.117 lb ai/A, respectively, for a total amount applied of 2.233 lb ai/A (2500 g ai/ha), which is 5x the proposed maximum seasonal rate.  The first application was made at growth stage of BBCH 88 (about 80% of pods developed to final size are ripe) with the second application occurring 13 days later at growth stage of BBCH 89 (nearly all pods developed to final size are ripe).  Each application was made at a spray volume of 15 GPA (138 to 144 L/ha).  Samples of peanuts were collected 6 days following the last application and processed into peanut meal, refined oil, dry roasted peanut, and peanut butter.

The resultant peanut nutmeat (RAC) sample and processed commodities were analyzed for residues of fluopyram using an adequate HPLC/MS/MS method, Method No. GM-001-P07-01.  The LOQ was 0.01 ppm in each matrix.  Sample storage conditions and durations are reported in Table 7; samples of peanut nutmeat and the peanut processed commodities were stored frozen for up to ~12 months prior to analysis.  The available storage stability data support the peanut processing study.

The average fluopyram residues in/on peanut nutmeat (RAC) were 0.094 ppm.  The average fluopyram residues for the required processed commodities were 0.018 ppm in meal and 0.023 ppm in refined oil, and the average residues for the additional risk assessment samples were 0.024 ppm in dry roasted peanuts and 0.021 ppm in peanut butter.  Fluopyram residues did not concentrate in the processed commodities of meal (0.2x processing factor), refined oil (0.2x), dry roasted peanuts (processing factor = 0.3x), and peanut butter (0.2x).

The processing factors determined for fluopyram residues in this study are less than the theoretical processing factors of 2.2x for peanut meal and 2.8x for peanut oil (based on separation into components; OPPTS 860.1520, Table 3).

Conclusions.  The submitted peanut processing data are adequate to satisfy data requirements.  The data indicate that no tolerances are needed for peanut processed commodities.

Plum

A plum processing trial was conducted to measure the magnitude of fluopyram residues in plums and plum processed commodities following exaggerated rate treatment.  At one site in CA, two airblast applications of the 4.16 lb/gal SC formulation were made to plum trees at a rate of 1.116 lb ai/A and 1.117 lb ai/A, respectively, for a total amount applied of 2.23 lb ai/A (2503 g ai/ha) which is >5x the proposed maximum seasonal rate.  The applications were made at spray volumes of 50 GPA (469-470 L/ha).  The first application was made to the plums at fruit ripe for picking (BBCH 87), with a 7-day interval between the two applications.  Samples of plum fruit were collected on the day of the last application and processed into prunes and washed fruit.

The resultant plum samples and processed commodities were analyzed for residues of fluopyram using an adequate HPLC/MS/MS method, Method No. GM-001-P07-01.  The LOQ was 0.01 ppm in each matrix.  Sample storage conditions and durations are reported in Table 7; samples of plum fresh fruit and the plum processed commodities were stored frozen for ~10 months prior to analysis.  The available storage stability data support the plum processing study.

The average fluopyram residues in/on plum (RAC) were 0.18 ppm.  The average fluopyram residues for the required processed commodity were 0.21 ppm in/on prune.  The average fluopyram residue data for additional risk assessment samples were 0.09 ppm in/on washed fruit.  The fluopyram residue was found to concentrate in prunes (1.1x).  No concentration (<1x) of fluopyram residue was found in washed fruit (0.5x).

The processing factors determined for fluopyram residue in this study are less than the maximum theoretical concentration factor (based on loss of water) of 3.4x for prunes (OPPTS 860.1520, Table 2).

Conclusions.  The submitted plum processing data are adequate to satisfy data requirements.

The data indicate that fluopyram residues concentrate in prunes.  Using the HAFT of 0.283 ppm and the 1.1x processing factor, the expected residues in prunes following treatment at 1x would be 0.31 ppm, which is less than the recommended tolerance of 0.35 ppm for plum.  No tolerance is needed for prunes.

Potato

A potato processing trial was conducted to measure the magnitude of fluopyram residues in potato and potato processed commodities following exaggerated rate treatment.  At one site in MN, two broadcast foliar spray applications of the 4.16 lb/gal SC formulation were made to potatoes at a rate of 1.123 lb ai/A and 1.124 lb ai/A, respectively, for a total amount applied of 2.25 lb ai/A (2545 g ai/ha) which is >5x the proposed maximum seasonal rate.  The applications were made at spray volumes of 17 GPA (161 L/ha).  The first application was made at the end of flowering in the first inflorescence (BBCH 69) and the second application, 4 days later, berries in the fructification ochre-colored (BBCH 85).  Samples of potato were collected 6 days following the last application and processed into the required processed commodities of wet peel, potato chips, and potato flakes.  In addition, samples of washed potatoes, tuber without peel, and cooked potatoes were generated for use in the dietary risk assessment for fluopyram.

The resultant potato samples and processed commodities were analyzed for residues of fluopyram using an adequate HPLC/MS/MS method, Method No. GM-001-P07-01.  The LOQ was 0.01 ppm in each matrix.  Sample storage conditions and durations are reported in Table 7; samples of potato tuber and the potato processed commodities were stored frozen for ~10 months prior to analysis.  The available storage stability data support the potato processing study.

The average fluopyram residues in/on potato tubers (RAC) were 0.016 ppm.  The average fluopyram residues for the required processed commodities were 0.069 ppm in potato wet peel, <0.01 ppm in potato chips and 0.02 ppm in potato flakes.  The average fluopyram residue data for additional risk assessment samples were 0.01 ppm in washed tubers, and <0.01 ppm in both peeled and cooked tubers.  The fluopyram residue did not concentrate in the required processed commodities of potato chips (0.3x processing factor) and potato flakes (1x).  However, the residue did concentrate in potato wet peel (4.3x).  In the additional samples generated for dietary risk assessment, fluopyram residue did not concentrate in washed tubers (0.7x), and peeled and cooked tubers (0.2x).

The processing factors determined for fluopyram residues in this study are less than the maximum theoretical concentration (processing) factor of 5.0x for potatoes (OPPTS 860.1520, Table 1).

Conclusions.  The submitted potato processing data are adequate to satisfy data requirements.

The processing data indicate that fluopyram residues concentrate in wet peel.  Using the HAFT of 0.017 ppm and the 4.3x processing factor, the expected residues in potato wet peel following treatment at 1x would be 0.073 ppm.  These data support a tolerance of 0.08 ppm for processed potato waste.

Soybean (proposed label revised as rotated)

A soybean processing trial was conducted to measure the magnitude of fluopyram residues in soybean seed, AGF, and soybean processed commodities following exaggerated rate treatment.  At one site in KS, two broadcast foliar applications of the 4.16 lb/gal SC formulation were made to soybean at a rate of 1.11 lb ai/A/application (1250 g ai/ha/application), for a total amount applied of 2.23 lb ai/A (2500 g ai/ha).  The first application was made at growth stage BBCH 79 (all pods reached final length) with the second application occurring 7 days later at growth stage BBCH 81 (10% pods ripe, beans final color, dry and hard).  Each application was made at a spray volume of 15 GPA (138 L/ha).  Samples of soybean seed were collected 13 days after the last application and processed into AGF, and the required processed commodities of meal, hulls, and oil (refined, bleached and deodorized).  In addition, defatted flour and soymilk were generated for risk assessment purposes.

The resultant soybean RAC samples and processed commodities were analyzed for residues of fluopyram using an adequate HPLC/MS/MS method, Method No. GM-001-P07-01.  The LOQ was 0.01 ppm in soybean seed and all processed commodities except AGF.  The LOQ was 0.10 ppm in AGF.  Sample storage conditions and durations are reported in Table 7; samples of soybean seed (RAC), AGF, and the soybean processed commodities analyzed in this study were held in frozen storage for a maximum of ~12 months, ~13 months, and ~2 months, respectively, prior to analysis.  The available storage stability data support the soybean processing study.

The average fluopyram residues in/on soybean seed were 0.49 ppm.  The average fluopyram residues in/on soybean AGF were 110 ppm.  The average fluopyram residues for the required processed commodities were 0.02 ppm in soybean meal, 0.64 ppm in soybean hulls, and 0.01 ppm in soybean refined oil.  The average fluopyram residue data for additional risk assessment samples were 0.02 ppm in soybean flour and <0.01 ppm in soybean milk.  Fluopyram residues did not concentrate (processing factor <1x) in the processed commodities of soybean meal (0.05x), soybean refined oil (0.02x), soybean flour (0.04x) or soybean soymilk (0.01x).  However, the residue did concentrate in soybean hulls (1.3x) and in soybean AGF (222x).

The processing factors determined for fluopyram residue in this study are less than the maximum theoretical concentration factors based on separation into components of 11.3x for soybean hulls, 2.2x for soybean meal, and 12.0x for soybean oil (OPPTS 860.1520, Table 3).

Conclusions.  The submitted soybean processing data are adequate for estimating residue levels in potential livestock feedstuffs and for dietary exposure analysis.

Strawberry

EPA does not require residue data for any processed commodities of strawberry.  However, the petitioner collected additional strawberry samples in the field trials to determine possible residue reduction from washing strawberries and from cooking strawberries.

From the decline trial plot receiving two foliar broadcast applications, subsamples of strawberries, collected at a 0-day PHI, were processed by washing and by washing and cooking, and these subsamples were evaluated for residues of fluopyram.  From the decline trial plot receiving two drip irrigation applications, subsamples of strawberries, collected at a 7-day PHI, were processed by washing and cooking, and these subsamples were evaluated for residues of fluopyram.  The washing and cooking procedures were performed in a manner similar to normal household practice.

The washed and cooked strawberry samples were analyzed for residues of the parent compound, fluopyram using an adequate HPLC/MS/MS method, Method No. GM-001-P07-01.  The LOQ was 0.01 ppm in each matrix.  Sample storage conditions and durations are reported in Table 7; samples of strawberries and strawberry processed commodities were stored frozen for up to ~7 months prior to analysis.  The available storage stability data support the strawberry processing study.

The average fluopyram residues in/on strawberries treated by foliar broadcast application were reduced from an average of 0.445 ppm in/on the RAC to an average of 0.327 ppm in washed fruit and 0.328 ppm in washed and cooked fruit.  The average fluopyram residues in/on strawberries treated by drip line irrigation application were the same in/on the strawberry RAC (0.014 ppm) as in the washed and cooked strawberries (0.014 ppm).  The average processing factor for washed and cooked fruit was 0.9x.

Conclusions.  The submitted processing data are not needed to satisfy data requirements; however the data may be used for risk assessment purposes.

Summer squash

EPA does not require residue data for any processed commodities of summer squash.  However, the petitioner collected additional summer squash samples in the North American field trials to determine possible residue reduction from washing or cooking summer squash.

From the summer squash decline trial plot receiving two foliar broadcast or drip line irrigation applications, residue reduction subsamples of summer squash, collected at 0- or 7-day PHI, were processed by washing or cooking, and these subsamples were evaluated for residues of fluopyram.

The samples of summer squash before and after washing or cooking were analyzed for residues of fluopyram using an adequate HPLC/MS/MS method, Method No. GM-001-P07-01.  The LOQ was 0.01 ppm in summer squash.  Sample storage conditions and durations are reported in Table 7; samples of summer squash were stored frozen for up to ~9 months prior to analysis.  The available storage stability data for lettuce are adequate to support the summer squash processing study.

The average fluopyram residue found in/on summer squash (RAC) treated by broadcast foliar application was 0.0684 ppm.  The average fluopyram residue found in washed and cooked summer squash treated by broadcast foliar application were 0.0388ppm and 0.0317 ppm, respectively.  The calculated processing factors were 0.57x for washing and 0.46x for cooking.

The average fluopyram residue found in/on summer squash (RAC) treated by drip line irrigation application was 0.0112 ppm.  The average fluopyram residue found in washed and cooked summer squash treated by drip line irrigation application was 0.011 ppm.  The calculated processing factor was 0.97x for cooking.

Conclusions.  The submitted processing data are not needed to satisfy data requirements; however the data may be used for risk assessment purposes.

Sugar beet

A sugar beet processing trial was conducted to measure the magnitude of fluopyram residues in sugar beet roots and sugar beet processed commodities following exaggerated rate treatment.  At one site in MN, two broadcast foliar spray applications of the 4.16 lb/gal SC formulation were made to sugar beet plants at a rate of 1.155 lb ai/A and 1.048 lb ai/A, respectively, for a total amount applied of 2.20 lb ai/A (2494 g ai/ha), which is >5x the proposed maximum seasonal rate.  The applications were made at spray volumes of 18 GPA (170 L/ha) and 17 GPA (161 L/ha), respectively.  The first application was made when the beet-root had reached harvestable size (BBCH 49) and the second application 6 days later (BBCH 49).  A single composite sample of sugar beet roots was dug at a 7-day PHI (BBCH 49) and processed into sugar beet dried pulp, molasses, and refined sugar.

The resultant sugar beet root samples and processed commodities were analyzed for residues of fluopyram using an adequate HPLC/MS/MS method, Method No. GM-001-P07-01.  The LOQ was 0.01 ppm in each matrix.  Sample storage conditions and durations are reported in Table 7; samples of sugar beet root and the sugar beet processed commodities were stored frozen for ~13 months and ~3 months, respectively, prior to analysis.  The available storage stability data support the sugar beet processing study.

The average fluopyram residues in/on sugar beet root (RAC) were 0.26 ppm.  The average fluopyram residues for the processed commodities were 0.33 ppm in dried pulp, 0.33 ppm in refined sugar, and 0.25 ppm in molasses.  The fluopyram residue did not concentrate in the processed commodity of molasses (0.9x processing factor).  However, the residue did concentrate slightly in dried pulp and refined sugar (1.3x).

The processing factors determined for fluopyram residue in this study are less than the maximum observed (theoretical) concentration factor of 20x for sugar beet dry pulp and the theoretical concentration factor (based on separation into components) of 12.5x for sugar (OPPTS 860.1520, Tables 3 and 4).

Conclusions.  The submitted sugar beet processing data are adequate to satisfy data requirements.

The processing data indicate that fluopyram residues concentrate in sugar beet dried pulp and refined sugar.  Using the HAFT of 0.02 ppm and the 1.3x processing factor, the expected residues in dried pulp and refined sugar following treatment at 1x would be <0.03 ppm.  Because these values are less than the recommended tolerance of 0.04 ppm for sugar beet root, no tolerances are needed for sugar beet dried pulp or refined sugar.

Wheat (proposed label revised as rotated)

A wheat processing trial was conducted to measure the magnitude of fluopyram residues in wheat grain, aspirated wheat grain fractions, and wheat processed commodities following exaggerated rate treatment.  At one site in MN, two broadcast foliar spray applications of the 4.16 lb/gal SC formulation were made to wheat at a rate of 1.16 lb ai/A and 1.17 lb ai/A, respectively, for a total amount applied of 2.33 lb ai/A (2610 g ai/ha).  Each application was made at a spray volume of 18 GPA (164-167 L/ha).  The first application was made at growth stage of BBCH 77 (late milk) with the second application occurring 13 days later at growth stage of BBCH 89 (fully ripe).  Samples of wheat grain were collected 14 days after the last application and processed into AGF and the required processed commodities of bran, flour, shorts, middlings, and germ.

The resultant wheat samples and processed commodities were analyzed for residues of fluopyram using an adequate HPLC/MS/MS method, Method No. GM-001-P07-01.  The LOQ was 0.01 ppm in wheat grain, 0.10 ppm in wheat bran, flour, middlings, shorts, and germ, and 0.20 ppm in AGF.  Sample storage conditions and durations are reported in Table 7; samples of wheat grain (RAC), AGF, and the wheat processed commodities analyzed in this study were held in frozen storage for a maximum of ~11 months, ~11 months, and <1 month, respectively, prior to analysis.  The available storage stability data for wheat grain support wheat grain and aspirated grain sample storage durations and conditions.  Storage stability data are not needed for wheat processed fractions since processed samples were stored less than 30 days.

The average fluopyram residues in/on wheat grain were 1.57 ppm.  The average fluopyram residues in/on wheat AGF were 109 ppm.  The average fluopyram residues for the required processed commodities were 4.23 ppm in wheat bran, 0.19 ppm in wheat flour, 3.80 ppm in wheat germ, 0.53 ppm in wheat middlings, and 1.18 ppm in wheat shorts.  Fluopyram residues did not concentrate (processing factor <1x) in the processed commodities of wheat flour (0.1x), wheat middlings (0.3x), and wheat shorts (0.8x).  However, the residue did concentrate in wheat AGF (69.7x), wheat bran (2.7x), and wheat germ (2.4x).

The processing factors determined for fluopyram residue in this study are less than the maximum theoretical concentration factors of 7.7x for wheat bran, 1.4x for wheat flour, and 8.3x for wheat shorts (OPPTS 860.1520, Table 3; based on separation into components).

Conclusions.  The submitted wheat processing data are adequate for estimating residue levels in potential livestock feedstuffs and for dietary exposure analysis.

860.1650 Submittal of Analytical Reference Standards

Analytical standard for fluopyram is currently available in the EPA National Pesticide Standards Repository (personal communication with Charles Stafford, ACB, 6/14/11).  However, no standard is available for AE C656948-benzamide.  The registrant is required to submit a reasonable amount of the analytical reference standard for the benzamide.  The reference standard should be sent to the Analytical Chemistry Lab, which is located at Fort Meade, Maryland, to the attention of either Theresa Cole or Thuy Nguyen at the following address:

	USEPA
	National Pesticide Standards Repository/Analytical Chemistry Branch/OPP
	701 Mapes Road
	Fort George G. Meade, MD  20755-5350

(Note that the mail will be returned if the extended zip code is not used.)

860.1850 Confined Accumulation in Rotational Crops

First Entry Monograph for Fluopyram, Section B.7.9.1 (MRIDs 47372631 and 47372632)

Bayer submitted confined rotational crops studies with fluopyram labeled in the phenyl and the pyridyl rings.

MRID 47372631:  The metabolism of the fungicide fluopyram was investigated in the rotational crops wheat, Swiss chard, and turnips from three consecutive rotations.  [phenyl-UL-[14]C]Fluopyram was applied uniformly onto to bare soil in a planting container (area approx. 1 m[2]) by spray application.  The application rate amounted to 534 g ai/ha (0.476 lb ai/A) which is ~1.1x the proposed maximum seasonal rate.  Crops of the 1st, 2nd and 3rd rotation were sown 30 days, 139 days, and 280 days after soil application.  See Table 27 below for summary results.

Table 27.           Total Radioactive Residues (TRRs) in crops at different PBI
TRR (ppm)
                                     Wheat
                                  Swiss chard
                                    Turnip

                                    Forage
                                      Hay
                                     Straw
                                     Grain

                                     Tops
                                     Root
First rotation (30 days)
                                     0.100
                                     1.783
                                     6.156
                                     0.167
                                     0.540
                                     0.884
                                     0.065
Second rotation (139 days)
                                     0.785
                                     1.120
                                     3.450
                                     0.054
                                     0.377
                                     0.113
                                     0.013
Third rotation (280 days)
                                     0.197
                                     1.527
                                     1.032
                                     0.023
                                     0.164
                                     0.103
                                     0.009

TRR accumulated at >=0.01 ppm in all rotated crop matrices from all PBIs, except turnip roots from the 280-day PBI.  TRR ranged from 0.009 ppm in turnip roots planted 280 days after soil application to 6.156 ppm in mature wheat straw planted 30 days after soil application.  TRR generally declined with the later PBIs, except in wheat forage in which residues increased at the 139-day PBI, but decreased at the 280-day PBI, to approximately 2x the initial value.

Conventional extraction of the RACs using ACN/water released >96% of the radioactive residues in Swiss chard and turnip leaves and roots, 87-95% of the radioactive residues in wheat forage, hay, and straw, and 77-85% of the radioactive residues in wheat grain.  Turnip roots from the 280-day PBI were not subjected to extraction procedures due to low TRR.  The post extraction solids of wheat hay (all rotations) and wheat straw (1st and 2nd rotation) were exhaustively extracted using ACN/water in a microwave with increased temperature.  Microwave extraction released a further 3-5% TRR in wheat hay and straw.  Conventional and microwave extracts of wheat hay and straw showed similar metabolite patterns.  Diastase treatment of the post extraction solids of wheat grain released a further 9% TRR from the solids of the 1st rotation, and 15% TRR from the solids of the 2nd rotation.  The solutions after diastase treatment were further characterized as polar and probably natural compounds by partitioning (1st rotation).  Nonextractable residues remaining after all extractions were <10% TRR in all rotated crop RACs from all PBIs, except 280-day PBI wheat grain in which the nonextractable residues were 21.9% TRR, but represented 0.005 ppm.

Parent fluopyram and 28 metabolites were detected in the various samples of the three rotations.  Of these, the active substance and 12 metabolites were identified by HPLC/MS and HPLC/MS/MS.  The other 16 metabolites (unknowns) were characterized by their extraction and retention in radio-HPLC; each of them were <0.04 ppm.  Additionally, a very polar region was characterized in wheat grain, accounting for up to 21.3% TRR (0.01 ppm) in the second rotation, which the petitioner concluded could be due to assimilated [14]CO2 which was incorporated in the starch matrix.

Parent fluopyram accounted for the major part of the residues in all RACs of all rotations, at 56-84% TRR in the RACs of the 1st rotation, 33-78% TRR in the RACs of the 2nd rotation, and 28-59% TRR in the RACs in the 3rd rotation.  Fluopyram was found at levels >=0.01 ppm in all rotational crop commodities from the 30- and 139-day PBIs and in all commodities except wheat grain and turnip root from the 280-day PBI.  In general, the levels of the parent compound decreased with subsequent PBIs.  AE C656948-7-hydroxy and its various conjugates with glucose, malonic acid (2 isomers), and sulfuric acid were important metabolites mainly in Swiss chard, where AE C656948-7-hydroxy accounted for 21% TRR in the 1st rotation, increasing to about 35% TRR in the following rotations.  In the other RACs, levels of AE C656948-7-hydroxy were lower, at <10% TRR, except in wheat hay and straw from the 3rd rotation in which AE C656948-7-hydroxy accounted for 12.3-12.6% TRR.  The sulfuric acid conjugate of AE C656948-7-hydroxy, AE C656948-7-OH-SA, was also a prominent metabolite in Swiss chard, increasing from 7% TRR in the 1st rotation to 16% and 12% TRR in the 2nd and 3rd rotations, respectively.  AE C656948-7-OH-SA was also detected at low levels in turnip leaves (0.7-1.0% TRR; 30- and 139-day PBIs), but not in the other rotated crop RACs.

Two label-specific metabolites were identified:  AE C656948-benzamide and AE C656948-benzoic acid.  AE C656948-benzoic acid accounted for 0.6-6.9% TRR in wheat forage, hay, and grain, and turnip leaves and roots from the 30-day PBI; 0.3-0.4% TRR in wheat forage and hay, and 13.6% TRR in wheat grain from the 139-day PBI; and 13% TRR in wheat grain from the 280-day PBI.  AE C656948-benzamide accounted for 2.8-9.7% TRR in wheat forage, hay, straw, and grain, and turnip leaves and roots, and 11.1% TRR in Swiss chard from the 30-day PBI; 3.2-7.4% TRR in all RACs from the 139-day PBI; and 5.9-8.0% TRR in wheat forage, hay, straw, and grain, and 10.3-11.7% TRR in Swiss chard and turnip leaves from the 280-day PBI.

AE C656948-8-hydroxy and its conjugate were only of minor importance.  Both or at least one of them were detected in all RACs but at very low levels (<2.7% TRR in total).  AE C656948-phenol-glc was detected in turnip leaves only, where it amounted to 10%, 16%, and 10% TRR in the 1st, 2nd, and 3rd rotations, respectively.

MRID 47372632:  The metabolism of the fluopyram was investigated in the rotational crops wheat, Swiss chard, and turnips from three consecutive rotations.  [pyridyl-2,6-[14]C]Fluopyram was applied uniformly onto bare soil in a planting container (area approx. 1 m[2]) by spray application.  The application rate amounted to 514 g ai/ha (0.459 lb ai/A), which is 1x the proposed maximum seasonal rate.  Crops of the 1st, 2[nd], and 3rd rotation were sown 30 days, 139 days and 280 days after soil application, respectively.  See Table 28 below for summary results.

Table 28.      Total Radioactive Residues (TRRs) in crops at different PBI
TRR (ppm)
                                     Wheat
                                  Swiss chard
                                    Turnip

                                    Forage
                                      Hay
                                     Straw
                                     Grain

                                     Tops
                                     Root
First rotation (30 days)
                                     0.157
                                     1.802
                                     6.663
                                     0.412
                                     0.570
                                     0.565
                                     0.036
Second rotation (139 days)
                                     0.568
                                     0.971
                                     2.562
                                     0.072
                                     0.343
                                     0.103
                                     0.010
Third rotation (280 days)
                                     0.167
                                     0.709
                                     1.622
                                     0.037
                                     0.211
                                     0.095
                                     0.012

TRR accumulated at >=0.01 ppm in all rotated crop matrices from all PBIs.  TRR ranged from 0.010 ppm in turnip roots planted 139 days after soil application to 6.663 ppm in mature wheat straw planted 30 days after soil application.  TRR generally declined with the later PBIs, except in wheat forage in which residues increased at the 139-day PBI, but returned to the initial levels at the 280-day PBI.

Conventional extraction of the RACs using ACN/water released >97% of the radioactive residues in Swiss chard and turnip leaves and roots, 85-96% of the radioactive residues in wheat forage, hay, and straw, and 82-92% of the radioactive residues in wheat grain.  The post extraction solids of wheat hay (2nd and 3rd rotation) and wheat straw (1st and 2nd rotation) were exhaustively extracted using ACN/water in a microwave with increased temperature.  Microwave extraction released a further 3-6% TRR in wheat hay and straw.  Conventional and microwave extracts of wheat hay and straw showed similar metabolite patterns.  Diastase treatment of the post extraction solids of wheat grain released a further 4% TRR from solids of the 1st rotation, and 9% TRR from the solids of the 2nd rotation.  The solutions after diastase treatment were further characterized as polar and probably natural compounds by partitioning (1st rotation only).  Nonextractable residues remaining after all extractions were <10% TRR in all rotated crop RACs from all PBIs, except 280-day PBI wheat grain in which the nonextractable residues were 17.8% TRR, but represented 0.007 ppm.

Parent fluopyram and 29 metabolites were detected in the various rotated crop samples of the three rotations.  Of these, the active substance and 12 metabolites were identified by HPLC/MS, HPLC/MS/MS, and co-chromatography.  The other 17 metabolites (unknowns) were characterized by their extraction and retention in radio-HPLC; each were <=0.011 ppm representing 0.1-2.0% TRR, except the unknown metabolites in wheat straw, each of which were in the range of 0.4-1.3% TRR and equivalent to 0.011-0.042 ppm.

Apart from wheat grain, the parent compound was the main compound in all RACs of all rotations and accounted for 57-86% TRR in the RACs of the 1st rotation, 37-95% TRR in the RACs of the 2nd rotation, and 39-92% TRR in the RACs of the 3rd rotation.  Fluopyram was found at levels >=0.01 ppm in all rotational crop commodities from all three PBIs.  In wheat grain, the parent accounted for 20.4 - 33.4% TRR in the three rotations.  AE C656948-7-hydroxy and its various conjugates with glucose, malonic acid (two isomers) and sulfuric acid were important metabolites mainly in Swiss chard, where the AE C656948-7-hydroxy accounted for 28% TRR in the 1st rotation increasing to 37-39% TRR in the following rotations.  In the other RACs, the amount of AE C656948-7-hydroxy was lower (<=10% TRR).  The sulfuric acid conjugate of AE C656948-7-hydroxy, AE C656948-7-OH-SA, was also a prominent metabolite in Swiss chard, increasing from 8% TRR in the 1st rotation to 17% and 14% TRR in the 2nd and 3rd rotations, respectively; AE C656948-7-OH-SA was also found at low levels (<1% TRR) in turnip leaves from all PBIs.  AE C656948-7-hydroxy-glc, and AE C656948-7-hydroxy-glc-MA (isomers 1 and 2) were minor metabolites (<10% TRR) in wheat forage, hay, and straw, Swiss chard, and/or turnip leaves.

Two label-specific metabolites were identified:  AE C656948-PCA and AE C656948-methyl-sulfoxide.  They formed the major part of the residues in wheat grain (totaling 48.9 - 65.4% TRR in the three rotations); AE C656948-PCA amounted to 56%, 16% and 29% TRR in the 1st, 2nd and 3rd rotation, respectively, and AE C656948-methyl-sulfoxide amounted to 1.2%, 49% and 20% TRR in the 1st, 2nd and 3rd rotation, respectively. AE C656948-PCA and AE C656948-methyl sulfoxide were also detected in other rotated crop RACs.  AE C656948-PCA accounted for 17% TRR in 30-day PBI wheat forage and <10% TRR in wheat forage from subsequent PBIs, as well as in wheat hay, wheat straw (found in 1st rotation only), Swiss chard, turnip leaves, and turnip roots (1st rotation only).  AE C656948-methyl-sulfoxide was identified in wheat forage, hay, and straw, and Swiss chard at low levels (<5% TRR).

AE C656948-8-hydroxy and its conjugate were only of minor importance.  Both or at least one of them were detected in all RACs but at very low levels (<2.9% TRR in total).  AE C656948-phenol-glc was detected in turnip leaves only, where it amounted to 12%, 18% and 15% TRR in the 1st, 2nd and 3rd rotation, respectively.

Conclusions.  The submitted studies are adequate to satisfy data requirements.

Based on the results of the studies, metabolism of fluopyram in rotated crops appears to occur via:
   *	hydroxylation of the ethylene linking group of the parent compound forming AE C656948-7-hydroxy and -8-hydroxy metabolites;
   *	hydroxylation of the phenyl ring and subsequent conjugation with glucose;
   *	conjugation of the hydroxylated metabolites with glucose, malonic acid, and sulfuric acid;
   *	hydrolytic cleavage and subsequent oxidation to AE C656948-benzamide, AE C656948-benzoic acid, AE C656948-pyridyl carboxylic acid, and AE C656948-methyl sulfoxide; and
   *	formation of polar, probably natural compounds which were incorporated into the starch matrix of grains.
The petitioner stated that AE C656948-pyridyl carboxylic acid and AE C656948-methyl sulfoxide were possibly formed at low proportions in the soil or by enzymes located in the roots of the plants, and selectively translocated into grains following phloem transport.

The proposed metabolic pathway is very similar to that for primary crops.  In rotational Swiss chard and turnip leaves, a sulfate conjugate (AE C656948-7-OH-SA) was found which was not found in primary crops.  In rotational turnip leaves, hydroxylation of the ethylene linkage and hydroxylation in the phenyl-ring and subsequent conjugation with glucose was observed, leading to AE C656948-phenol-glc which was not found in primary crops.  The metabolites AE C656948-benzoic acid and conjugates of AE C656948-8-hydroxy were also found in rotational crops and not in primary crops.

The residue of concern in rotational crops for tolerance enforcement is fluopyram; the residue of concern in rotated crops except in legumes and oilseed crops for risk assessment is fluopyram, and in rotated legumes and oilseed crops is fluopyram plus C656948-benzamide (ROCKS decision memo, 7/16/2009).  Based on the results of the confined rotational crop studies, field rotational crop studies are needed for fluopyram.

860.1900 Field Accumulation in Rotational Crops

Second Entry Monograph for Fluopyram, Section B.7.9.2 (MRIDs 47567123-47567125)

Bayer submitted field rotational crop data from three studies.  Two extensive field rotational crop studies were conducted with alfalfa and cotton with a target PBI of 14 days.  In addition, a limited rotational crop study was conducted with wheat, turnip, and mustard greens with a PBI of approximately 240 days.  The results of the field rotational crop studies are summarized in Table 29 and discussed below.

Table 29.	Summary of Results of Field Rotational Studies.
Commodity
Total Application Rate (lb ai/A) [kg ai/ha]
PBI (days)
Fluopyram Residue Levels (ppm)

n
Min.
Max.
HAFT
Median
Mean
Std. Dev.
ROTATED ALFALFA ((proposed use = 0.450 lb ai/A maximum seasonal rate to annual crops, 14-day PBI)
Alfalfa forage; 1[st] cutting
0.444-0.459 (0.497-0.514)
12-14
24
<0.01
0.39
0.33
0.04
0.07
0.09
Alfalfa forage; 2[nd] cutting

22
<0.01
0.10
0.1
0.04
0.05
0.03
Alfalfa forage; 3[rd] cutting

22
0.01
0.19
0.17
0.03
0.05
0.05
Alfalfa hay; 1[st] cutting
0.444-0.459  (0.497-0.514)
12-14
24
0.02
0.93
0.93
0.09
0.21
0.28
Alfalfa hay; 2[nd] cutting

22
0.01
0.36
0.35
0.11
0.13
0.11
Alfalfa hay; 3[rd] cutting

22
0.01
0.46
0.42
0.06
0.13
0.13
ROTATED COTTON (proposed use = 0.450 lb ai/A maximum seasonal rate to annual crops, 14-day PBI)
Undelinted cottonseed
0.442-0.456 (0.495-0.511)
12-14
22
<0.01
<0.01
<0.01
0.01
0.01
NA
Cotton gin byproducts

10
<0.01
0.02
0.02
0.01
0.01
0.01
OTHER ROTATED CROPS (proposed use = 0.450 lb ai/A maximum seasonal rate to annual crops, other than alfalfa and cottonl)
Turnip roots
0.440 - 0.456
(0.493 - 0.511)
228-236
6
<0.01
<0.01
<0.01
<0.01
<0.01
NA
Turnip tops

6
<0.01
0.0408
0.0344
0.0180
0.0189
0.0014
Mustard greens
0.440  -  0.445 (0.493  -  0.499)
228-236
6
<LOQ
0.0363
0.0348
0.0131
0.0176
0.0138
Wheat forage
0.450 - 0.467 (0.505 - 0.525)
236-248
6
<0.01
0.0481
0.0412
0.0104
0.0195
0.0174
Wheat hay

6
0.0177
0.0892
0.0819
0.0322
0.0442
0.0302
Wheat grain

6
<0.01
<0.01
<0.01
<0.01
<0.01
NA
Wheat straw

6
0.0112
0.124
0.124
0.0314
0.0558
0.0536

Alfalfa (MRID 47567124):  A total of 12 field trials were conducted during the 2007 growing season to measure the magnitude of fluopyram residues in alfalfa forage and hay planted as a rotational crop following crops treated with fluopyram.  Trials were conducted in Zone 1 (PA), 2 (GA), 5 (IA, OH, NE, IN, ND, MN), 7 (ND), 9 (ID), 10 (CA), and 11 (ID).  Two foliar spray applications of the 4.16 lb/gal SC formulation (AE C656948 500 SC) were made to a cover crop or bare soil at a target rate of 0.223 lb ai/A/application (0.215 to 0.232 lb ai/A/application) for a total target application rate of 0.446 lb ai/A (0.444 to 0.459 lb ai/A or 0.497 to 0.514 kg ai/ha; 1x the proposed maximum seasonal rate to annual crops).  The interval between applications was 5-6 days.  Alfalfa was planted at a target PBI of 14 days at each site; the actual PBI ranged from 12 to 14 days.  All applications were made using ground-based equipment.

At each trial, duplicate treated samples of rotated alfalfa forage and hay were collected at each cutting.  A single composite control sample of alfalfa forage and hay was also taken from an untreated plot at the time of the first cutting.  Hay was allowed to air dry in the field at each cutting.  In eleven of the field trials, three cuttings were performed; in one trial, alfalfa forage and hay were only collected from a single cutting.

The alfalfa forage and hay samples were analyzed for residues of the parent compound using an adequate HPLC/MS/MS method, Method No. GM-001-P07-01.  The LOQ was 0.01 ppm in alfalfa forage and hay.  Sample storage conditions and durations are reported in Table 7; samples were stored frozen for up to ~11 months prior to analysis.  The available storage stability data support the field rotational crop study.

The results of the field rotational crop studies are summarized in Table 29.  Quantifiable residues of fluopyram were found in/on alfalfa forage and hay from all three cuttings.  Maximum fluopyram residues in/on alfalfa forage were 0.39 ppm at the first cutting, 0.10 ppm at the second cutting, and 0.19 ppm at the third cutting.  Maximum fluopyram residues in/on alfalfa hay were 0.93 ppm at the first cutting, 0.36 ppm at the second cutting, and 0.46 ppm at the third cutting.

Conclusions - Alfalfa.  The extensive alfalfa field rotational crop study is adequate to satisfy data requirements.  Geographic representation of data is adequate; the location and number of field trials are in compliance with EPA geographic representation requirements for use on alfalfa.  The data indicate that rotational crop tolerances for alfalfa forage and hay are needed to support the proposed 14-day PBI for alfalfa.  The appropriate tolerance levels were calculated using the data from the first cutting; the data support tolerances of 0.45 ppm for rotated alfalfa forage and 1.1 ppm for rotated alfalfa hay (see Appendix II).

Cotton (MRID 47567125):  A total of 11 field trials were conducted during the 2007 growing season to measure the magnitude of fluopyram residues in cotton seed and gin byproducts planted as a rotational crop following crops treated with fluopyram.  Trials were conducted in Zone 2 (NC), 4 [AR (2), LA], 6 (TX), 8 [KS, TX(2)], and 10 [CA(3)].  The petitioner noted that a twelfth trial was initiated but then cancelled due to crop failure; it is due to be repeated.

Two foliar spray applications of the 4.16 lb/gal SC formulation (AE C656948 500 SC) were made to a cover crop or bare soil at a target rate of 0.223 lb ai/A/application (0.218 to 0.230 lb ai/A/application) for a total target application rate of 0.446 lb ai/A (0.442 to 0.456 lb ai/A or 0.495 to 0.511 kg ai/ha; 1x the proposed maximum seasonal rate to annual crops).  The interval between applications was 1-5 days.  Cotton was planted at each site at a target PBI of 14 days; the actual PBI ranged from 12 to 14 days.  All applications were made using ground-based equipment.

At each trial, single untreated and duplicate treated samples of rotated seed cotton were collected at the normal harvest time (growth stage BBCH 89/99).  The petitioner stated that cotton was harvested using either a mechanical picker (three trials), mechanical stripper (two trials), or by hand (six trials).  Samples were ginned at the trial site (one trial) or at a ginning facility.

Samples of undelinted cotton seed and gin byproducts were analyzed for residues of the parent compound using an adequate HPLC/MS/MS method, Method No. GM-001-P07-01.  The LOQ was 0.01 ppm in alfalfa forage and hay.  Sample storage conditions and durations are reported in Table 7; samples were stored frozen for up to ~7 months prior to analysis.  The available storage stability data support the field rotational crop study.

The results of the field rotational crop studies are summarized in Table 29.  Residues of fluopyram were below the LOQ in/on all undelinted cotton seed samples.  Quantifiable residues were found in/on cotton gin byproducts, at 0.02 ppm in/on four out of ten samples.

Conclusions - Cotton.  The extensive cotton field rotational crop study is adequate to satisfy data requirements pending submission of the repeat field study.  Geographic representation of data is adequate for cottonseed; the location and number of field trials are in compliance with HED requirements for a use on cotton since the pesticidal use resulted in no quantifiable residues.  The data indicate that rotational crop tolerances for cotton undelinted seed and gin byproducts are needed to support the proposed 14-day PBI for cotton.  The data support an interim inadvertent  tolerance of 0.01 ppm for cotton undelined seed and 0.05 ppm for gin byproducts (see Appendix II).

Limited field rotational crop study (MRID 47567123):  A limited rotational crop study with an 8-month PBI was conducted to measure the magnitude of fluopyram residues in wheat, turnip, and mustard green planted as rotational crops following cover crops treated with fluopyram.  A total of 3 field trials were conducted in Zone 3 (FL), 4 (MS), and 10 (CA) during the 2007 growing season.  Two foliar spray applications of the 4.16 lb/gal SC formulation (AE C656948 500 SC) were made to cover crops at a target rate of 0.223 lb ai/A/application (0.216 to 0.229 lb ai/A/application) for a total target application rate of 0.446 lb ai/A (0.440 to 0.467 lb ai/A or 0.493 to 0.525 kg ai/ha); 1x the proposed maximum seasonal rate to annual crops.  The interval between applications was 5-7 days.  Rotational crops of mustard greens, turnips, and wheat were planted at each site at a target PBI of 240 days; the actual PBI ranged from 228 to 248 days.  At each trial, a single control and duplicate treated samples of rotated turnip (tops and roots), mustard greens (leaves), and wheat (forage, hay, grain, and straw) were collected at normal commercial maturity.  Wheat hay was allowed to dry in the field or under shelter according to local practice.

The samples were analyzed for residues of the parent compound using an adequate HPLC/MS/MS method, Method No. GM-001-P07-01.  The LOQ was 0.01 ppm for each rotated crop commodity.  Sample storage conditions and durations are reported in Table 7; samples were stored frozen for up to ~13 months prior to analysis.  The available storage stability data support the field rotational crop study.

The results of the limited field rotational crop studies are summarized in Table 29.  Quantifiable residues of fluopyram were found in/on turnip tops (up to 0.04 ppm), mustard greens (up to 0.04 ppm), wheat forage (up to 0.05 ppm), wheat hay (up to 0.09 ppm), and wheat straw (up to 0.12 ppm).  Residues were below the LOQ in/on all samples of rotated turnip root and wheat grain.

In addition, limited EU field rotational studies were conducted on carrot or turnip, head lettuce, and wheat in Germany, France, Italy and Spain with PBI's ranging from 28-49 days.  The wheat field rotational crop trials showed maximum fluopyram levels of 0.01 ppm in wheat grain, 0.12 ppm in wheat forage, and 0.28 ppm in wheat straw when sampled at 30 day PBI (MRID 47372633).

Conclusions - Limited field rotational crop study.  The submitted limited rotational crop study indicates the potential for quantifiable fluopyram residues in/on crops rotated 8 months following fluopyram application.  Other than alfalfa and cotton (PBI of 14 days), and those crops on the label, extensive field rotational crop studies and rotational crop tolerances are required to support the rotation to canola, cereal grains except rice, corn, and soybean following application of fluopyram to potato and dry beans.

In the submission of January 24, 2011 (Revised Portfolio for Fluopyram), the registrant acknowledged that additional rotational crop data are needed to set rotational crop tolerances.  In the absence of sufficient rotational crop data, the registrant suggested to use the highly conservative target crop residue data for setting rotational crops tolerances.  The issue was submitted to ChemSAC for advice and the option was to examine the confined accumulation data, limited field rotational crop data, and primary crop data for the target rotated crops, and select an intermediate level so as to discourage potential misuse (i.e., direct foliar application) and provide adequate maximum residue levels for legal uses according to label instructions (ChemSAC minutes, 2/9/2011).

The residue data in canola, soybean and cereal grains except rice resulting from foliar applications for setting tolerances are described in Appendix III.  Wheat is the only crop among the cereal grains that contains foliar, limited field rotational, and confined accumulation data.  When compared to the confined accumulation and limited field rotational crop data, the foliar residues in wheat commodities range from 2.7x (wheat straw) to 76x (wheat grain).  Thus, HED recommends rotational crop tolerances be set at half of the calculated primary crop tolerances with a PBI of 30 days: canola seed at 1.8 ppm, soybean seed at 0.10 ppm, soybean forage at 4.0 ppm, soybean hay at 15 ppm, cereal grains group 15 (except rice), at 1.5 ppm, and forage at 4.0 ppm, hay at 6.5 ppm, and straw and stover at 7.0 ppm of cereal grains group 16 (except rice).  These tolerance levels may be revised upon review of extensive field rotational crop data.

In addition, since the confined accumulation data reflect a maximum PBI of 280 days when TRR's in some crop matrices still exceeded 0.01 ppm, rotation to crops other than those discussed above is not supported.

860.1550 Proposed Tolerances

Bayer CropScience has proposed that the residue of concern for tolerance expression in crop commodities is fluopyram, and that the residues of concern for tolerance expression in livestock commodities are fluopyram and its metabolite AE C656948-benzamide, expressed as parent equivalents.  HED has concluded that the proposed tolerance expressions are appropriate.

Codex MRLs are established for residues of fluopyram in cucumber (0.5 ppm), grapes (2 ppm), dried grapes (5 ppm), milks (0.07 ppm), and edible offal (0.7 ppm).

The tolerances proposed by Bayer CropScience are listed in Table 30, along with the tolerance levels recommended by HED.  As indicated at the beginning of the document, the registrant has withdrawn the following crops or crop groups from the petition: CG 1B Root veg and 1C Tuberous and corm veg (except potatoes and sugarbeet), CG2 Leaves of root and tuberous veg
CG3-07A&B Bulb veg, CG4 Leafy veg, CG5 Brassica, CG6A Edible legumes, CG6B Succulent beans and peas, CG6C (part) Dried peas (and some dried beans), CG7 Foliage of legume veg, CCG8 Fruiting veg, CG9 Cucurbit veg (except watermelon), CG10 Citrus, CG11 Pome fruit (except apple), CG12 Stone fruit (except cherry), CG13-07A&B Caneberries and Bushberries, CG13-07F Vine fruit (except wine grapes), CG13-07G Low growing berries (except strawberry), CG15 Cereal Grains (except for rotational purposes), CG16 Forage Cereals (except for rotational purposes), CG17 Grasses grown for forage or seed, CG18 Non grass animal feeds, CG19 Herbs and Spices, CG20 Oilseeds (except canola), Hops, Globe artichoke, Christmas Trees, Turf and Ornamentals.  The Agency's Guidance for Setting Pesticide Tolerances Based on Field Trial Data was utilized for determining appropriate tolerance levels for raw agricultural crop commodities; see Appendix II for tolerance calculations.

Adequate field trial data are available to support the proposed uses on apple, cucurbit vegetables (including watermelon), dried beans, peanut, potato, stone fruit (including cherry), strawberry, sugar beet, tree nuts, and wine grapes.  The proposed tolerances are appropriate for:  almond, hulls; tree nuts; peanut hay; and cucurbit vegetables.  The proposed tolerances are too high for sugar beet root, cotton undelinted seed, peanut, and stone fruit group 12, and HED recommends that tolerances at 0.04 ppm, 0.01 ppm, 0.02 ppm, and 0.70 ppm, respectively, be established.  No tolerances have been proposed for apple; beet, sugar, tops; dried beans; grape, wine; potato; and strawberry, and tolerances for these commodities are needed.  HED recommends that tolerances at 0.30 ppm, 15 ppm, 0.09 ppm, 1.4 ppm, 0.02 ppm, and 1.5 ppm, respectively, be established for apple; beet, sugar, tops; dried beans; grape, wine; potato; and strawberry.

The petitioner proposed a tolerance for "nut, tree, group 14 (including pistachio)" at 0.05 ppm.  Separate tolerances must be proposed for the tree nut crop group and pistachio.  The available data indicate that 0.05 ppm is an appropriate level for these tolerances.

Pending submission of information confirming that the proposed use of fluopyram on bananas to be imported into the U.S. conforms to the use patterns of the submitted banana field trial data, adequate data are available to support the proposed tolerance on banana.

The available processing data indicate that the proposed tolerance is appropriate for cotton gin byproducts.  Tolerances for fluopyram residues are needed for wet apple pomace and processed potato waste.  The available data indicate that the proposed tolerances are too high and that lower tolerances are needed, at 0.60 ppm for apple wet pomace and 0.08 ppm for processed potato waste.  No tolerances are needed for the remaining processed commodities.

Pending submission of one additional/repeat study with rotated cotton, adequate field rotational crop data are available for rotated alfalfa and cotton commodities.  The proposed tolerance for cotton gin byproducts is adequate.  However, the proposed tolerances for alfalfa forage and hay are too low and the proposed tolerance for undelinted cotton seed is too high; tolerances of 0.45 ppm, 1.1 ppm, and 0.01 ppm would be appropriate for alfalfa forage, alfalfa hay, and undelinted cotton seed, respectively.  In addition, the tolerances for alfalfa and cotton commodities must be revised to be specified in terms of indirect or inadvertent residues of fluopyram.

The revised label also permits crop rotation to canola, cereal grains (except rice) and soybean after treating dried beans and potato.  However, extensive field rotational crop data for these crops are not available.  In the absence of sufficient rotational crop data, the registrant suggested to use the highly conservative target crop residue data for setting rotational crops tolerances.  The preference would be to select an intermediate level between the confined accumulation/ limited field rotational crop data and primary crop data for the target rotated crops so as to discourage potential misuse (i.e., direct foliar application) and provide adequate maximum residue levels for legal uses according to label instructions.  Thus, HED recommends rotational crop tolerances be set at half of the calculated primary crop tolerances with a PBI of 30 days: canola seed at 1.8 ppm, soybean seed at 0.10 ppm, soybean forage at 4.0 ppm, soybean hay at 15 ppm, cereal grains group 15 (except rice) at 1.5 ppm, and forage at 4.0 ppm, hay at 6.5 ppm, and straw and stover at 7.0 ppm of cereal grains group 16 (except rice).  These tolerances may be revised upon review of extensive field rotational crop data.

The petitioner has proposed tolerances for combined residues of fluopyram and AE C656948-benzamide in egg; milk; the fat, meat, and meat byproducts of poultry; and the fat, liver, meat, and meat byproducts (except liver) of cattle, goat, hog, horse, and sheep.  The estimated livestock dietary burden and available feeding study data indicate that most of the proposed tolerances for livestock commodities are too low.  In addition, HED no longer establishes separate tolerances for liver.

The recommended tolerances for plant and livestock commodities are presented in Table 30.

Table 30.		Tolerance Summary for Fluopyram.
Commodity
                           Proposed Tolerance (ppm)
                    Recommended/ Harmonized Tolerance (ppm)
Comments; Correct Commodity Definition
(a)(1) It is recommended that tolerances be established for residues of the fungicide fluopyram (N-[2-[3-chloro-5-(trifluoromethyl)-2-pyridinyl]ethyl]-2-(trifluoromethyl)benzamide), including its metabolites and degradates, in or on the commodities below.  Compliance with the tolerance levels specified below is to be determined by measuring only fluopyram in or on the commodity.
Almond, hulls
                                      8.0
                                      8.0
Almond, hull
Apple
                                      0.5
                                     0.30

Apple, wet pomace
                                      2.5
                                     0.60

Banana (Import)
                                      1.0
                                      1.0
Tolerance must include a footnote stating "No U.S. registrations as of [date of FR notice]."
Beet, sugar, roots
                                     0.10
                                     0.04
Beet, sugar, root
Beet, sugar, tops
                                      30
                                    Remove
Tolerance is not required.
Cherry
                                      1.5
                                     0.60

Grape, wine
                                      2.0
                                      2.0

Nut, tree, group 14 and pistachio
                                     0.05
                                     0.05
Nut, tree, group 14
A separate tolerance is needed for pistachio; see below
Peanut
                                     0.05
                                     0.02

Pistachio

                                     0.05
A separate tolerance is needed for pistachio.
Potato
                                     0.05
                                     0.02

Potato, processed potato waste
                                     0.15
                                     0.08

Strawberry
                                      2.0
                                      1.5

Watermelon
                                      1.0
                                      1.0

Vegetable, bean, dried, shelled (except soybean)
                                     0.50
                                     0.09
Bean, dry
(a)(2) It is recommended that tolerances be established for residues of the fungicide fluopyram (N-[2-[3-chloro-5-(trifluoromethyl)-2-pyridinyl]ethyl]-2-(trifluoromethyl)benzamide), including its metabolites and degradates, in or on the commodities below.  Compliance with the tolerance levels specified below is to be determined by measuring only the sum of fluopyram and its metabolite 2-(trifluoromethyl)benzamide, calculated as the stoichiometric equivalent of fluopyram, in or on the commodity.
Cattle, fat
                                     0.10
                                     0.11

Cattle, meat
                                     0.10
                                     0.15

Cattle, meat byproducts, except liver
                                     0.10
                                      1.1
Cattle, meat byproducts
Cattle, liver
                                      1.2

Eggs
                                     0.10
                                     0.25
Egg
Goat, fat
                                     0.10
                                     0.11

Goat, meat
                                     0.10
                                     0.15

Goat, meat byproducts, except liver
                                     0.10
                                      1.1
Goat, meat byproducts
Goat, liver
                                      1.2

Hog, fat
                                     0.01
                                     0.05

Hog, meat
                                     0.01
                                     0.05

Hog, meat byproducts, except liver
                                     0.01
                                     0.70
Hog, meat byproducts
Hog, liver
                                     0.15

Horse, fat
                                     0.10
                                     0.11

Horse, meat
                                     0.10
                                     0.15

Horse, meat byproducts, except liver
                                     0.10
                                      1.1
Horse, meat byproducts
Horse, liver
                                      1.2

Milk
                                      1.2
                                     0.07

Poultry, fat
                                     0.05
                                     0.20

Poultry, meat
                                     0.03
                                     0.15

Poultry, meat byproducts
                                     0.20
                                     0.60

Sheep, fat
                                     0.10
                                     0.11

Sheep, meat
                                     0.10
                                     0.15

Sheep, meat byproducts, except liver
                                     0.10
                                      1.1
Sheep, meat byproducts
Sheep, liver
                                      1.2

(d) It is recommended that tolerances be established for indirect or inadvertent residues of fungicide fluopyram (N-[2-[3-chloro-5-(trifluoromethyl)-2-pyridinyl]ethyl]-2-(trifluoromethyl)benzamide), including its metabolites and degradates, in or on the commodities below.  Compliance with the tolerance levels specified below is to be determined by measuring only fluopyram in or on the commodity.
Alfalfa, forage
                                     0.25
                                     0.45

Alfalfa, hay
                                     0.80
                                      1.1

Canola, seed
                                      5.0
                                      1.8

Corn, sweet, kernel plus cob with husk removed
                                     0.10
                                    Remove
Tolerance is covered under Grain, cereal, group 15, except rice; see below
Cotton, gin byproducts
                                     0.05
                                     0.05

Cotton, undelinted seed
                                     0.10
                                     0.01

Grain, cereal, forage, fodder and straw, group 16, except rice; forage
                                      8.0
                                      4.0

Grain, cereal, forage, fodder and straw, group 16, except rice; hay, straw and stover
                                      14
                                      7.0

Grain, cereal, forage, fodder and straw, group 16, except rice; aspirated fractions
                                      50
                                    Remove
Tolerance is not applicable.
Grain, cereal, group 15, except rice and sweet corn
                                      3.0
                                      1.5
Grain, cereal, group 15, except rice
Soybean, forage
                                      8.0
                                      4.0

Soybean, hay
                                      30
                                      15

Soybean, hulls
                                     0.40
                                    Remove
Tolerance is not applicable.
Soybean, seed
                                     0.30
                                     0.10

References

Attachments:
International Residue Limits
Appendix I  -  Summary of Fluopyram and Metabolites
Appendix II - Tolerance Assessment Calculations
Appendix III - Tolerance Assessment Calculations (for "rotated crops" except alfalfa and cotton)

Template Version September 2005

International Residue Limits

                        Fluopyram (080302; 06/06/2011)
Summary of US and International Tolerances and Maximum Residue Limits
Residue Definition:
US
Canada
Mexico[2]
Codex[3]
40 CFR 180.XXX:
Plants: fluopyram (N-[2-[3-chloro-5-(trifluoromethyl)-2-pyridinyl]ethyl]-2-(trifluoromethyl)benzamide).

Livestock: sum of fluopyram (N-[2-[3-chloro-5-(trifluoromethyl)-2-pyridinyl]ethyl]-2-(trifluoromethyl)benzamide) and its benzamide metabolite [2-(trifluoromethyl)-benzamide], calculated as the stoichiometric equivalent of fluopyram

Identical to US

Plants:  fluopyram.
Animal commodities: Sum of fluopyram and 2-(trifluoromethyl)benzamide, expressed as fluopyram.

Commodity[1]
Tolerance (ppm) /Maximum Residue Limit (mg/kg)

                                      US
Canada
Mexico[2]
Codex[3]
Almond hull
8.0

Apple
0.30

Apple wet pomace
0.60

Banana (import)
1.0

Bean, dry
0.09

Cherry
0.60

Nut, tree, group 14
0.05

Peanut
0.02

Pistachio
0.05

Potato
0.02

Potato processed waste
0.08

Strawberry
1.5

Sugar beet
0.04

Watermelon
1.0

Wine Grapes
2.0

 5 Dried grapes (=currants, raisins and sultanas) ; 2 Grapes

Alfalfa forage
0.45

Alfalfa hay
1.1

Canola seed
1.8

Cotton gin byproducts
0.05

Cotton undelinted seed
0.01

Grain, cereal, group 15, except rice
1.5

Grain, cereal, forage, fodder and straw, group 15, except rice; forage
4.0

Grain, cereal, forage, fodder and straw, group 15, except rice; hay, straw and stover
7.0

Soybean forage
4.0

Soybean hay
15

Soybean seed
0.10

Cattle, fat
0.11

Cattle, meat
0.15

0.1 Meat (from mammals other than marine mammals)
Cattle, meat byproducts
1.1

0.7 Edible offal (mammalian)
Eggs
0.25

Goat, fat
0.11

Goat, meat
0.15

Goat, meat byproducts
1.1

Hog, fat
0.05

Hog, meat
0.05

Hog, meat byproducts
0.70

Horse, fat
0.11

Horse, meat
0.15

Horse, meat byproducts
1.1

Milk
0.07

Milks 0.07
Poultry, fat
0.20

Poultry, meat
0.15

Poultry, meat byproducts
0.60

Sheep, fat
0.11

Sheep, meat
0.15

Sheep, meat byproducts
1.1

[1] Includes only commodities of interest for this action.  Tolerance values should be the HED recommendations and not those proposed by the applicant.
2 Mexico adopts US tolerances and/or Codex MRLs for its export purposes.

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