CC
                                      75
                                      10
                                     0.026
                                    0.0035
Canola, meal
                                      PC
                                      88
                                      10
                                     0.075
                                     0.085
TOTAL BURDEN
                                      --
                                      --
                                      100
                                      --
                                     3.39
Poultry: 75% CC, 25% PC
Sorghum, grain, grain
                                      CC
                                      86
                                      75
                                     1.62
                                     1.22
Canola, meal
                                      PC
                                      88
                                      15
                                     0.075
                                     0.011
Alfalfa, meal
                                      PC
                                      89
                                       5
                                     0.16
                                     0.008
Untreated
                                      PC
                                      --
                                       5
                                      --
                                      --
TOTAL BURDEN
                                      --
                                      --
                                      100
                                      --
                                     1.24
Swine: 85% CC, 15% PC
Sorghum, grain, grain
                                      CC
                                      86
                                      80
                                     1.62
                                     1.30
Wheat, milled byproducts
                                      CC
                                      88
                                       5
                                     0.30
                                     0.015
Canola, meal
                                      PC
                                      88
                                      15
                                     0.075
                                     0.011
TOTAL BURDEN
                                      --
                                      --
                                      100
                                      --
                                     1.33
[1]  R:  Roughage; CC:  Carbohydrate concentrate; PC:  Protein concentrate.
[2]  OPPTS 860.1000 Table 1 Feedstuffs (June 2008).
[3]  Contribution = ([residue /% DM] X % diet) for beef and dairy cattle; contribution = ([residue] X % diet) for poultry and swine.

Cattle:  Four treatment groups of three dairy cows each were dosed orally for 29 consecutive days with fluopyram at nominal dose levels of 23 mg/capsule, 232 mg/capsule, 696 mg/capsule and 2323 mg/capsule; the actual dosing rates (based on feed consumption) were 1.5 ppm dry feed (dose group B), 14.4 ppm dry feed (dose group C), 44.1 ppm dry feed (dose group D), and 133.1 ppm dry feed (dose group E).  Additionally, three dairy cows (dose group F) were fed at 145.9 ppm dry feed for 29 consecutive days, followed by untreated feed for another 7 days (one cow), 14 days (one cow), and 21 days (one cow) in order to investigate the depuration of fluopyram and its metabolites in milk and tissues.  One cow was not dosed to serve as a control (dose group A).  The dosing levels of the groups identified by the petitioner as B, C, D, E, and F represent 0.79x, 7.6x, 23x, 70x, and 77x, respectively, the dietary burden to beef cattle and 0.44x, 4.2x, 13x, 39x, and 43x, respectively, the dietary burden to dairy cattle.

Cows were milked twice daily.  Duplicate milk samples from the animals of the groups A, B, C, D, and E were taken on Day 1, 2, 4, 8, 10, 13, 17, 21, 24, 26 and 29 after the first administered dose.  Milk was additionally collected from the animals of dose group F on Day 21, 24, 26, 29, 31, 34, 36, 38, 41, 43, 45, 47, and 50.  Cows were sacrificed less than 24 hours after the final dose; cows from the depuration study were sacrificed 7, 14, and 21 days after the last dosing.  Samples of liver, muscle, kidney, and fat (perirenal, subcutaneous, and mesenteric) were taken for analysis.  Samples of cream (milk fat) and skim milk were generated from milk samples collected on study Day 21 (high dose group only).

Samples of cattle matrices were analyzed for residues of fluopyram and its metabolites AE C656948-benzamide, and AE C656948-olefine (E- and Z-isomers) using HPLC/MS/MS Method 01061.  This method was adequate for data collection based on acceptable method recoveries.  The validated LOQs in each matrix were 0.01 ppm for fluopyram and AE C656948-benzamide (expressed in parent equivalents) and 0.02 ppm for combined residues of the E and Z isomers of AE C656948-olefine (expressed in parent equivalents).

Milk and tissue samples were stored frozen (<=-18 ºC) prior to analysis, and all analyses were completed within 30 days of collection; therefore, no supporting storage stability data are required.

The results of the cattle feeding study are summarized in Table 9.  In milk, residues of fluopyram appeared to reach a plateau by Day 4; residues of AE C656948-benzamide and AE C656948-olefines appeared to reach a plateau by Day 8.  Residues of fluopyram and AE C656948-benzamide were highest in liver, and residues of AE C656948-olefines were highest in fat.  Residues of each analyte showed a clear dose-response for all tissues.

Milk taken from dose group E (133.1 ppm) was separated by centrifugation into skim milk and milk fat.  The fat content of each of the milk fat samples was determined; the average fat content was 73.8%.  Residues of fluopyram in skim milk and milk fat were 0.02 ppm and 1.1-1.4 ppm, respectively, and residues of AE C656948-benzamide in skim milk and milk fat were 1.4-1.5 ppm and 0.72-0.98 ppm, respectively; combined residues of fluopyram and AE C656948-benzamide were 1.42-1.52 ppm and 2.08-2.12 ppm in milk fat.  The total residues of AE C656948-olefines in skim milk and milk fat were below the LOD and 0.78-1.3 ppm, respectively.

The data indicate that quantifiable residues of AE C656948-benzamide occur in all cattle matrices at all dosing levels; quantifiable residues of fluopyram were observed in liver at all dosing levels, in milk and fat at dosing levels of >=14.4 ppm, and in muscle and kidney at dosing levels of >=44.1 ppm.

Transfer factors for fluopyram and AE C656948-benzamide were calculated for each matrix at each feeding level, using the maximum observed residue level for tissues and the average residue level for milk (the average residues were used for milk because milk is a commodity that is typically blended).  The calculated transfer factors are presented in Table 10.

Table 9.	Maximum Residues of Fluopyram, AE C656948-Benzamide[1], and AE C656948-Olefines[1] in Cattle Commodities by Feeding Level.
Cattle Matrix
                                    1.5 ppm
                                   14.4 ppm
                                   44.1 ppm
                                   133.1 ppm
Fluopyram
Milk (Day 4 to end)[2]
                                   <0.01
                                 <0.01-0.02
                               (average = 0.01)
                                   0.02-0.09
                               (average = 0.03)
                                   0.06-0.17
                               (average = 0.10)
Fat[3]
                                   <0.01
                                     0.07
                                     0.33
                                     0.71
Kidney
                                   <0.01
                                   <0.01
                                     0.05
                                     0.08
Liver
                                     0.26
                                     0.98
                                      2.8
                                      4.0
Muscle
                                   <0.01
                                   <0.01
                                     0.04
                                     0.03
AE C656948-Benzamide
Milk (Day 8 to end)[2]
                                   0.01-0.09
                               (average = 0.02)
                                   0.15-0.37
                               (average = 0.22)
                                   0.40-0.77
                               (average = 0.54)
                                    1.1-1.9
                                (average = 1.5)
Fat[3]
                                     0.01
                                     0.33
                                     0.45
                                      1.1
Kidney
                                     0.03
                                     0.38
                                     0.88
                                      1.6
Liver
                                     0.10
                                      1.9
                                      3.2
                                      7.0
Muscle
                                     0.02
                                     0.44
                                     0.79
                                      1.5
Combined Residues of Fluopyram and AE C656948-Benzamide
Milk (Day 8 to end)[2]
                               <0.02-<0.10
                               (average = 0.03)
                                 <0.16-0.39
                               (average = 0.23)
                                   0.42-0.80
                               (average = 0.57)
                                    1.2-2.0
                                (average = 1.6)
Fat[3]
                                   <0.02
                                     0.37
                                     0.78
                                      1.6
Kidney
                                   <0.04
                                   <0.39
                                     0.93
                                      1.7
Liver
                                     0.36
                                      2.3
                                      5.3
                                     10.9
Muscle
                                   <0.03
                                   <0.45
                                     0.83
                                      1.5
AE C656948-Olefines
Milk (Day 8 to end)[2]
                                   <0.02
                                    <=0.02
                                 <0.02-0.05
                               (average = 0.02)
                                   0.07-0.14
                               (average = 0.10)
Fat[3]
                                   <0.02
                                     0.12
                                     0.32
                                     0.94
Kidney
                                   <0.02
                                   <0.02
                                     0.04
                                     0.15
Liver
                                   <0.02
                                     0.06
                                     0.13
                                     0.58
Muscle
                                   <0.02
                                   <0.02
                                     0.03
                                     0.04
[1]  Residues expressed in parent equivalents.
2  Range of residues over plateau period.
[3]  Includes perirenal, mesenteric, and subcutaneous fat.

Table 10.	Calculated transfer factors in cattle.[1]
Commodity
                                    1.5 ppm
                                   14.4 ppm
                                   44.1 ppm
                                   133.1 ppm
                                   145.9 ppm
Fluopyram[2]
Milk  (Day 8 to end)
                                      nd
                                    0.0007
                                    0.0007
                                    0.00075
                                    0.0069
Fat
                                      nd
                                     0.005
                                    0.0075
                                    0.0053
                                      --
Liver
                                     0.173
                                     0.068
                                     0.064
                                     0.030
                                      --
Muscle
                                      nd
                                      nd
                                    0.0009
                                    0.0002
                                      --
Kidney
                                      nd
                                      nd
                                     0.001
                                    0.0006
                                      --
AE C656948-benzamide[2]
Milk  (Day 8 to end)
                                     0.01
                                     0.015
                                     0.012
                                     0.011
                                     0.017
Fat
                                     0.007
                                     0.023
                                     0.010
                                     0.008
                                      --
Liver
                                     0.067
                                     0.13
                                     0.073
                                     0.053
                                      --
Muscle
                                     0.01
                                     0.030
                                     0.018
                                     0.011
                                      --
Kidney
                                     0.02
                                     0.026
                                     0.020
                                     0.012
                                      --
[1]  Transfer factor calculated by dividing residue value by feeding level.  nd = not determined; residues were below the LOQ.
[2]  For milk, the transfer factor was calculated using the average residue value over the plateau period (day 8 through study end for the 1.5-, 14.4-, 44.1-, and 133.1-ppm feeding levels, and day 24 through day 29 for the 145.9-ppm feeding level).  For all tissues, the transfer factor was calculated using the maximum residue value observed at the specified feeding level.

In the depuration study, the mean residues of fluopyram in milk were 0.11 ppm at the end of the dosing period (Day 29); residues decreased to values below the LOQ for all animals on Day 31 and remained below the LOQ until the end of the study.  The mean residues of AE C656948-benzamide in milk were 2.7 ppm at the end of the dosing period (Day 29); mean residues decreased to 0.02 ppm on Day 43 and values below the LOQ were measured from Day 47 until the end of the study.  The mean total residues of AE C656948-olefines in milk were 0.13 ppm at the end of the dosing period (Day 29); mean residues decreased to values between 0.03 and 0.04 ppm from Day 36 until sacrifice on Day 43, and then values below the LOQ were measured from Day 47 until the end of the study.

Residues in tissues from the depuration study were determined at sacrifice, on Day 36, 43 and 50.  Residues of fluopyram were below the LOD in all samples, with the exception of the liver sample collected on Day 36, where a residue of 0.06 ppm was measured.  Residues of AE C656948-benzamide in tissues were quantifiable in all tissues on Day 36 and then decreased on Day 43 and Day 50.  In muscle, kidney, and liver, AE C656948-benzamide residues remained at quantifiable levels on Day 50; in fat, residues decreased to levels <LOQ on Day 43 and Day 50.

The total residues of olefines in subcutaneous fat increased from 0.04 ppm on Day 36 to 0.28 ppm on Day 50.  Total residues of olefines measured on Day 36 in perirenal and mesenteric fat (0.12 and 0.13 ppm, respectively) increased to 0.21 and 0.26 ppm on Day 43 and reached a total residue level of 0.11 ppm on Day 50.  In liver and kidney, the total residues of olefines were quantifiable on Day 36 and decreased on Day 43 and Day 50.

Poultry:  Four treatment groups each consisting of 12 laying hens were dosed orally, via feed, for 28 consecutive days with fluopyram at target dose rates of 0, 0.05, 0.50, 1.5, or 5.0 ppm feed.  Each treatment group was divided into three subgroups of four hens each.  The dosing levels were based on preliminary field residue data and were designated by the petitioner 0.1X (dose group B), 1X (dose group C), 3X (dose group D), and 10X (dose group E) based on the anticipated maximum dietary burden arising from the use of fluopyram in U.S. [the 0.1X group should represent the 1X dose for Europe].  The actual dose levels were 0.05 ppm feed (group B), 0.49 ppm feed (C), 1.6 ppm feed (D) and 4.8 ppm feed (E).  Additionally, three groups of laying hens (5 hens/group) were fed at the 10X feeding level (dose group F) for 28 consecutive days in order to investigate the depuration of fluopyram and its metabolites in eggs and tissues thereafter.  One control group (9 hens; dose group A) was not dosed.  The dosing levels of the groups identified by the petitioner as B, C, D, and E represent 0.04x, 0.40x, 1.2x, and 4.0x, respectively, the dietary burden to poultry.

Eggs were collected from each dose subgroup daily during the dosing period.  Eggs were collected for analysis on study days 0, 1, 2, 5, 7, 9, 12, 14, 16, 21, 23, 26, and 28; for the depuration group, eggs were collected for analysis on study days 21, 23, 26, 28, 30, 33, 36, 37, 40, 41, 44, 48, and 49.  Hens were sacrificed 3-7 hours after the final dose; for the depuration group, hens were sacrificed on Day 36, Day 41, and Day 49.  Samples of liver (entire organ), muscle, and overlaying skin together with any associated fat (and abdominal fat) were collected for analysis.

Samples of hen matrices were analyzed for residues of fluopyram and its metabolites AE C656948-benzamide, and AE C656948-olefine (E- and Z-isomers) using HPLC/MS/MS Method 01061.  This method was adequate for data collection based on acceptable method recoveries.  The validated LOQs in each matrix were 0.01 ppm for fluopyram and AE C656948-benzamide and 0.02 ppm for combined residues of the E and Z isomers of AE C656948-olefine.

Egg and tissue samples were stored frozen (<=-18 ºC) prior to analysis, and all analyses were completed within 30 days of collection; therefore, no supporting storage stability data are required.

The results of the poultry feeding study are summarized in Table 11.  Residues of fluopyram in eggs were below the LOQ of 0.01 ppm in all samples from all dosing groups.  Residues of the AE C656948-olefines were below the LOQ of 0.02 ppm in all egg samples from the B, C, and D dose groups; the maximum residues of AE C656948-olefines in eggs from the E dose group were 0.02 ppm.  Residues of AE C656948-benzamide in eggs reached a plateau by Day 21 after the first dose.  The maximum residues of AE C656948-benzamide in eggs, expressed as parent equivalents, were 0.76 ppm for the E dose group, 0.23 ppm for the D dose group, 0.09 ppm for the C dose group, and below the LOQ of 0.01 ppm for the B dose group.

Residues of fluopyram in tissues were below the LOQ level of 0.01 ppm in all samples.  In skin with fat and muscle samples from the B group, AE C656948-benzamide residues were below the LOQ of 0.01 ppm; quantifiable residues of AE C656948-benzamide were found in skin with fat and muscle samples from the higher dose groups.  Residues of AE C656948-benzamide were highest in liver, with maximum residues ranging from 0.02 ppm in the B group to 1.6 ppm in the E group.  The benzamide residues showed a clear dose-response for tissues.

Residues of AE C656948-olefines in tissues were below the LOQ in all tissues from the B and C dose groups, and were below the LOQ in liver and muscle from the D dose group.  Maximum residues of AE C656948-olefines in skin with fat at the D dose group were 0.03 ppm.  For the E dose group, maximum residues of AE C656948-olefines were 0.08 ppm for skin with fat, 0.02 ppm for liver, and 0.06 ppm for muscle.

The data indicate that quantifiable residues of AE C656948-benzamide occur in liver at all dosing levels and in egg, skin with fat, and muscle at dosing levels >=0.49 ppm; no quantifiable residues of fluopyram were observed in poultry matrices at any dosing level.

Transfer factors for fluopyram and AE C656948-benzamide were calculated for each matrix at each feeding level, using the maximum observed residue level for eggs and tissue.  The calculated transfer factors are presented in Table 12.

Table 11.	Maximum Residues of Fluopyram, AE C656948-Benzamide[1], and AE C656948-Olefines[1] in Hen Commodities by Feeding Level.
Hen Matrix
                                   0.05 ppm
                                   0.49 ppm
                                    1.6 ppm
                                    4.8 ppm
Fluopyram
Egg (Day 21 to end)[2]
                                   <0.01
                                   <0.01
                                   <0.01
                                   <0.01
Skin with fat
                                   <0.01
                                   <0.01
                                   <0.01
                                   <0.01
Liver
                                   <0.01
                                   <0.01
                                   <0.01
                                   <0.01
Muscle
                                   <0.01
                                   <0.01
                                   <0.01
                                   <0.01
AE C656948-Benzamide
Egg (Day 21 to end)[2]
                                   <0.01
                                   0.07-0.09
                               (average = 0.08)
                                   0.20-0.23
                               (average = 0.21)
                                   0.64-0.76
                               (average = 0.71)
Skin with fat
                                   <0.01
                                     0.04
                                     0.11
                                     0.63
Liver
                                     0.02
                                     0.16
                                     0.43
                                      1.6
Muscle
                                   <0.01
                                     0.04
                                     0.10
                                     0.33
Combined Residues of Fluopyram and AE C656948-Benzamide
Egg (Day 21 to end)[2]
                                   <0.02
                               <0.08-<0.10
                               (average = 0.09)
                               <0.21-<0.24
                               (average = 0.22)
                               <0.65-<0.77
                               (average = 0.72)
Skin with fat
                                   <0.02
                                   <0.05
                                   <0.12
                                   <0.64
Liver
                                   <0.03
                                   <0.17
                                   <0.44
                                    <1.6
Muscle
                                   <0.02
                                   <0.05
                                   <0.11
                                   <0.34
AE C656948-Olefines
Egg (Day 21 to end)[2]
                                   <0.02
                                   <0.02
                                   <0.02
                                 <0.02-0.02
Skin with fat
                                   <0.02
                                   <0.02
                                     0.03
                                     0.08
Liver
                                   <0.02
                                   <0.02
                                   <0.02
                                     0.02
Muscle
                                   <0.02
                                   <0.02
                                   <0.02
                                     0.06
[1]  Residues expressed in parent equivalents.
[2]  Range of residues over plateau period.

Table 12.	Calculated transfer factors in poultry.[1]
Commodity
                                   0.05 ppm
                                   0.49 ppm
                                    1.6 ppm
                                    4.8 ppm
AE C656948
Egg (Day 21 to end)
                                      nd
                                      nd
                                      nd
                                      nd
Skin with Fat
                                      nd
                                      nd
                                      nd
                                      nd
Liver
                                      nd
                                      nd
                                      nd
                                      nd
Muscle
                                      nd
                                      nd
                                      nd
                                      nd
AE C656948-benzamide
Egg (Day 21 to end)
                                      nd
                                     0.18
                                     0.14
                                     0.16
Skin with Fat
                                      nd
                                     0.08
                                     0.07
                                     0.13
Liver
                                     0.40
                                     0.33
                                     0.27
                                     0.33
Muscle
                                      nd
                                     0.08
                                     0.06
                                     0.07
[1]  Transfer factor calculated by dividing residue value by feeding level.  nd = not determined; residues were below the LOQ.

In samples from the depuration study, residues of AE C656948-benzamide and AE C656948-olefine decreased steadily with time in eggs and tissues after the treated feed (F) was withdrawn from the hens.  In eggs, average residue of benzamide amounted to 0.83 ppm on Day 28 and decreased steadily to 0.03 ppm on Day 49.  The total olefines residues amounted to 0.03 ppm on Day 28 and decreased steadily to < LOQ on Day 49.  In skin with fat, liver, and muscle samples from the F dose group, benzamide residues were 0.41 ppm, 1.4 ppm, and 0.29 ppm on Day 28, respectively, and decreased to 0.05 ppm in liver, 0.02 ppm (skin with fat) and 0.01 ppm (muscle) on Day 49.  No residues of fluopyram were found in any samples from the depuration study.

Conclusions.  The submitted studies are adequate to satisfy data requirements.  The data indicate that tolerances for fluopyram residues of concern are needed for egg, milk, and the meat, fat, and meat byproducts of cattle, goat, hog, horse, poultry, and sheep.

The maximum anticipated residues of fluopyram and AE C656948-benzamide were calculated using the estimated dietary burdens for fluopyram and the transfer factors reported in Table 10 (cattle and swine commodities) and Table 12 (poultry commodities).  The maximum anticipated residues are presented in Table 13.

Table 13.	Maximum Anticipated Residues of Fluopyram and AE C656948-Benzamide in Livestock Commodities Following Dosing at 1x the Dietary Burden.
Livestock
                           Estimated Dietary Burden
                                     (ppm)
Matrix
                                Fluopyram (ppm)
                         AE C656948-Benzamide (ppm) 1
        Combined residues of Fluopyram and AE C656948-Benzamide  (ppm)
Cattle
                                   3.39 [2]
Fat
                                     0.025
                                     0.078
                                     0.10

Muscle
                                     0.031
                                     0.10
                                     0.13

Kidney
                                    0.0034
                                     0.088
                                     0.091

Liver
                                     0.586
                                     0.44
                                     1.03

Milk
                                    0.0025
                                     0.051
                                     0.054
Poultry
                                     1.24
Fat
                                   <0.01
                                     0.161
                                     0.17

Muscle
                                   <0.01
                                     0.100
                                     0.11

Liver
                                   <0.01
                                     0.500
                                     0.51

Egg
                                   <0.01
                                     0.223
                                     0.23
Swine
                                     1.33
Fat
                                     0.010
                                     0.031
                                     0.041

Muscle
                                    0.0012
                                     0.040
                                     0.041

Kidney
                                    0.0013
                                     0.035
                                     0.036

Liver
                                     0.23
                                     0.173
                                     0.40
[1]  Expressed as parent equivalents.
[2]  Maximum estimated dietary burden for dairy cattle, used to calculate maximum anticipated ruminant residues.

Based on the maximum anticipated residues, HED concludes that the following tolerances are appropriate for the combined residues of fluopyram and AE C656948-benzamide in livestock commodities:  0.11 ppm for the fat, 0.10 ppm for kidney, and 0.15 ppm for meat of cattle, goat, horse, and sheep; 1.1 ppm for the meat byproducts of cattle, goat, horse, and sheep; 0.06 ppm for milk; 0.04 ppm for kidney of hog; 0.05 ppm for the fat and meat of hog; 0.45 ppm for the meat byproducts of hog; 0.20 ppm for the fat of poultry; 0.15 ppm for the meat of poultry; 0.60 ppm for the meat byproducts of poultry; and 0.25  ppm for egg.

860.1500 Crop Field Trials

First Entry Monograph for Fluopyram, Sections B.<IP_ADDRESS> through B.<IP_ADDRESS> (MRIDs 47372603-47372605, 47372608, 47372610, and 47372615)
Second Entry Monograph for Fluopyram, Sections B.<IP_ADDRESS> through <IP_ADDRESS> (MRIDs 47372603, 47372606, 47567010-47567037, and 47567101)

Bayer submitted crop field trial data from field trials conducted in North America with a variety of crops, as well as data from field trials conducted in Latin America for banana.  The relevant studies are described below, and the results are summarized in Table 14 through Table 25.  The petitioner additionally submitted data from field trials conducted in Europe with a variety of crops, which included data from studies conducted in greenhouses.  For cucumber, melon, and strawberry, the European greenhouse data are discussed below because the data will be used to support greenhouse uses in North America.  No other European field trial data are discussed herein.

For the North American field trials, the petitioner collected residue data for fluopyram only.

The Agency's Guidance for Setting Pesticide Tolerances Based on Field Trial Data was utilized for determining appropriate tolerance levels based on the submitted crop field trial data for raw agricultural crop commodities.  All tolerance calculations are presented in Appendix II and III.

HED notes that for the European greenhouse trials, samples were collected at three or four intervals in addition to the proposed PHI.  In each trial, if residues of fluopyram at intervals greater than the proposed PHI exceeded the residue level at the PHI, the higher values were used in data summaries to cover the worst case residue; the higher values were also used for tolerance calculations.  HAFT stands for highest averge field trial value.

      Also, with the exception of the banana field trials and one grape field trial, no spray adjuvants were used in any of the crop field trials.  However, HED has recently reviewed bridging field trials conducted on strawberry, grape, cucumber, bulb onion, potato, lettuce, tomato, peach, apple and almond with and without addition of 0.125% v/v of a non-ionic surfactant (Induce(R)) and concluded that the addition of the NIS had no significant effect on the residue level concentration on these crops (D384287, S. Funk, 6/8/2011).  Therefore, the product label must be amended to specify that non-ionic surfactants at 0.125% v/v may be added to spray mixtures.

Apple

Bayer has submitted magnitude of the residue studies for apple and pear, the representative crops of pome fruit, group 11.  The results from the apple field trials are discussed below and summarized in Table 14.

Table 14.	Summary of Residue Data from Apple Field Trials with Fluopyram.
Crop matrix
                   Total Applic. Rate  (lb ai/A) [kg ai/ha]
                                  PHI (days)
                        Fluopyram Residue Levels (ppm)

                                       n
                                     Min.
                                     Max.
                                     HAFT
                                    Median
                                     Mean
                                   Std. Dev.
POME FRUIT (proposed use = 0.445 lb ai/A total application rate, 0-day PHI; 7-day revised PHI)
Two Applications; Concentrate Spray
Apple
                       0.440  -  0.461 (0.493  -  0.517)
                                       7
                                      34
                                     0.040
                                     0.247
                                     0.242
                                     0.109
                                     0.120
                                     0.063
Two Applications; Dilute Spray
Apple
0.440  -  0.461 (0.493  -  0.517)
                                       7
                                      24
                                     0.057
                                     0.262
                                     0.255
                                     0.086
                                     0.105
                                     0.055
Four Applications; Concentrate Spray
Apple
0.477  -  0.479 (0.535  -  0.536)
                                       7
                                       4
                                     0.061
                                     0.107
                                     0.101
                                     0.083
                                     0.084
                                     0.021

Seventeen apple trials were conducted in North America in 2006 and 2007.  Seventeen apple trials, representing twelve harvest trials and five decline trials, were conducted in Zones 1 (NY, PA, and VA, 3 trials), 2 (GA, 1 trial), 5 (IL, MI, ON, and WI, 7 trials), 9 (UT, 1 trial), 10 (CA, 1 trial), and 11 (ID, OR, and WA, 4 trials).

Two foliar spray applications of the 4.16 lb/gal SC formulation at a rate of 0.214-0.231 lb ai/A (240-259 g ai/ha) were made to apples with a 5- to 7-day application interval, for total application rates of 0.440-0.461 lb ai/A (493-517 g ai/ha).  The foliar spray application rates represent ~1x the proposed maximum seasonal rate.  For all trials, foliar spray applications were made in concentrate spray volumes, at 39-72 GPA (368-671 L/ha).  For 12 of the trials, there was an additional plot in which applications were made with dilute spray volumes, at 208-306 GPA (1941-2860 L/ha).  For two of the apple trials, there was an additional plot in which a total of four foliar spray applications, at rates ranging from 0.115 to 0.124 lb ai/A/application (129 to 139 g ai/ha/application) for a total rate ranging from 0.477 to 0.479 lb ai/A (535 to 536 g ai/ha).  For these trials, all plots were treated with a low volume spray solution, ranging 51-61 GPA (480-570 L/ha).  Duplicate treated samples of apple were harvested on the day of last application (0-day PHI) and 7 days following the last application in the harvest trials and 0, 3, 7, 10, and 14 days following the last application in the decline trials.

The apple samples 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 each in/on apple fruit.  Sample storage conditions and durations are reported in Table 6; samples were stored frozen for up to ~16 months prior to analysis.  The available storage stability data support the apple field trial study.

The results of the apple field trials are summarized in Table 14 (7-day data only).  Residues of fluopyram in/on apple fruit at a 7-day PHI for the plots with two applications and concentrate spray volumes ranged from 0.040-0.25 ppm.  The mean and HAFT were 0.12 ppm and 0.24 ppm, respectively.

Residues of fluopyram in/on apple fruit at a 7-day PHI for the plots with two applications and dilute spray volumes ranged from 0.057-0.26 ppm.  The mean and HAFT were 0.11 ppm and 0.26 ppm, respectively.

Residues of fluopyram in/on apple fruit at a 7-day PHI for the plots with four applications ranged from 0.061-0.11 ppm.  The mean and HAFT were 0.084 ppm and 0.10 ppm, respectively.

For all the decline trials, fluopyram residues decreased from the 0-day PHI to the 14-day PHI.

Conclusions.  The submitted residue data for apple are adequate to fulfill data requirements.  The number and locations of the field trials are in accordance with OPPTS Guideline 860.1500 for apple.  Field trials were conducted at ~1x the proposed maximum seasonal rate and samples were harvested at the revised PHI.

Based on the available data and the NAFTA tolerance calculator (see Appendix II), a tolerance of 0.30 ppm for residues of fluopyram in/on apple is appropriate.

Dried beans

Bayer has submitted magnitude of the residue studies for dried bean and dried pea seed, representative crops of dried shelled pea and bean, subgroup 6C.  The results from the dry bean field trials are discussed below and summarized in Table 15.

Table 15.	Summary of Residue Data from Dry Bean Field Trials with Fluopyram.
Crop matrix
                   Total Applic. Rate  (lb ai/A) [kg ai/ha]
                                  PHI (days)
                        Fluopyram Residue Levels (ppm)

                                       n
                                     Min.
                                     Max.
                                     HAFT
                                    Median
                                     Mean
                                   Std. Dev.
DRIED BEANS (proposed use = 0.445 lb ai/A total application rate, 0-day PHI; revised use = 0.268 lb ai/A total application rate, 14-day PHI)
Dried bean seed
                           0.441-0.452 (0.494-0.507)
                                 0[1], 13-14
                                      18
                                   <0.01
                                    0.076
                                    0.068
                                    0.012
                                    0.024
                                    0.021
[1]  At one trial (n=2), the bean plants were cut from the ground at a 0-day PHI and the seed was sampled 14 days later, after drying in the field.  Sample residues from this trial were not the maximum residue or HAFT for the study.

Nine trials, representing eight harvest trials and one decline trial, were conducted in Zones 5 (IA, IL, MN, and NE, 4 trials), 7 (ND, 1 trial), 8 (TX, 1 trial), 9 (ID, 1 trial), 10 (CA, 1 trial), and 11 (ID, 1 trial) on dried beans during the 2006-2007 growing seasons.

Two foliar spray applications of the 4.16 lb/gal SC formulation at a rate of 0.218-0.229 lb ai/A/application (244-257 g ai/ha) were made to dried beans with 5- to 7-day RTIs, for total application rates of 0.441-0.452 lb ai/A (494-507 g ai/ha).  The application rates represent ~1.7x the proposed maximum seasonal rate.  Applications were made in spray volumes of 10-20 GPA (91-183 L/ha).  For all trials except one, duplicate treated samples of dried bean were harvested 13-14 days after the final application in the harvest trials and 0, 7, 14, 17, and 21 days following last application in the decline trial.  At one harvest trial, the bean plants were cut from the ground at a 0-day PHI and seed was sampled 14 days later, after drying in the field.  There are no feed items involved with the proposed dried beans.

The dried bean seed samples 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 dried bean seed.  Sample storage conditions and durations are reported in Table 7; samples were stored frozen for up to ~14 months prior to analysis.  The available storage stability data support the dried bean seed field trial study.

The results of the dried bean field trials are summarized in Table 15.  Residues of fluopyram in/on dried bean seed at a 13- to 14-day PHI ranged from <0.01-0.076 ppm.  The mean and HAFT were 0.024 ppm and 0.068 ppm, respectively.  In the decline trial, average residues in/on dried bean seeds declined from the 0-day PHI to the 22-day PHI.

Conclusions.  The submitted residue data for dried bean are adequate to fulfill data requirements.  The number and locations of the field trials are in accordance with OPPTS Guideline 860.1500 for dried bean.  Field trials were conducted at ~1.7x the revised maximum seasonal rate for dried seed.

The residue data have been adjusted for rate differential and based on the NAFTA tolerance calculator (see Appendix II), a tolerance of 0.09 ppm for residues of fluopyram in/on dried bean is appropriate.

Grape

Bayer has submitted magnitude of the residue studies for grape.  The results from these field trials are discussed below and summarized in Table 16.

Table 16.	Summary of Residue Data from Grape Field Trials with Fluopyram.
Crop matrix
                   Total Applic. Rate  (lb ai/A) [kg ai/ha]
                                  PHI (days)
                        Fluopyram Residue Levels (ppm)

                                       n
                                     Min.
                                     Max.
                                     HAFT
                                    Median
                                     Mean
                                   Std. Dev.
GRAPE (proposed use = 0.445 lb ai/A total application rate, 7-day PHI; revised to wine grapes only )
Grape
                                  0.439-0.458
                                 [0.492-0.513]
                                      6-7
                                      32
                                     0.096
                                     0.950
                                     0.948
                                     0.372
                                     0.401
                                     0.229

Sixteen trials, representing fifteen harvest trials and one decline trial, were conducted in Zones 1 (NY and PA, 2 trials), 5 (IL, 1 trial; MI, 1 trial; and ON, 2 trials), 10 (CA, 8 trials), and 11 (OR and WA, 2 trials) during the 2006 and 2007 growing seasons.

Two foliar spray applications of the 4.16 lb/gal SC formulation at a rate of 0.217-0.230 lb ai/A/application (243-258 g ai/ha) were made to grapes with 12- to 14-day RTIs, for total application rates of 0.439-0.458 lb ai/A (492-513 g ai/ha).  The application rates represent ~1x the proposed maximum seasonal rate.  Applications were made in spray volumes of 47-67 GPA (438-627 L/ha).  Duplicate treated samples were harvested 3 and 7 days following last application in the harvest trials, and 0, 3, 7, 10, and 14 days following last application in the decline trial.

The grape samples 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 grapes.  Sample storage conditions and durations are reported in Table 6; samples were stored frozen for up to ~13 months prior to analysis.  The available storage stability data support the grape field trial study.

The results of the grape field trials are summarized in Table 16.  Residues of fluopyram ranged from 0.096-0.950 ppm in/on grapes harvested at a 7-day PHI.  The mean and HAFT values were 0.401 ppm and 0.948 ppm for the 7-day PHI, respectively.  In the decline trial, the mean residue level decreased from the 0-day PHI to the 14-day PHI.

Conclusions.  The submitted crop field trial data for grape are adequate to satisfy data requirements.  The number and locations of the field trials are in accordance with OPPTS Guideline 860.1500 for grape.  Field trials were conducted at ~1x the proposed maximum seasonal rate and samples were harvested at the proposed PHI.

Based on the available data and the NAFTA tolerance calculator (see Appendix II), a tolerance of 1.4 ppm for residues of fluopyram in/on grape, wine is appropriate.

Peanut

Bayer has submitted magnitude of the residue studies for peanut.  The results from these field trials are discussed below and summarized in Table 17.

Table 17.	Summary of Residue Data from Peanut Field Trials with Fluopyram.
Crop matrix
                   Total Applic. Rate  (lb ai/A) [kg ai/ha]
                                  PHI (days)
                        Fluopyram Residue Levels (ppm)

                                       n
                                     Min.
                                     Max.
                                     HAFT
                                    Median
                                     Mean
                                   Std. Dev.
    PEANUT (proposed use = 0.445 lb ai/A total application rate, 7-day PHI)
Peanut
                      0.438 to 0.455  (0.491 to 0.510)
                                      6-7
                                      24
                                   <0.01
                                     0.018
                                     0.017
                                   <0.01
                                     0.011
                                   <0.01
Peanut, hay
                      0.438 to 0.455  (0.491 to 0.510)
                                      6-7
                                      24
                                     1.08
                                     21.88
                                     20.66
                                     6.19
                                     8.72
                                     6.78

Twelve trials, representing eleven harvest trials and one decline trial, were conducted in Zones 2 (FL, GA, NC, and VA, 7 trials), 3 (FL, 2 trials), 6 (TX, 2 trials), and 8 (TX, 1 trial) during the 2007-2008 growing seasons.  One FL trial, conducted in Zone 3, was used to fulfill the requirements for Zone 2 since the trial site was close to the border of Zones 2 and 3.

Two foliar spray applications of the 4.16 lb/gal SC formulation at a rate of 0.216-0.229 lb ai/A/application (242-256 g ai/ha) were made to peanuts with 12- to 14-day RTIs, for total application rates of 0.438-0.455 lb ai/A (491-510 g ai/ha).  The application rates represent ~1x the proposed maximum seasonal rate.  Applications were made in spray volumes of 10-20 GPA (92-184 L/ha).  Duplicate treated samples of peanut nutmeat and hay were harvested 6-7 days after the last application in the harvest trials, and 0, 2, 6, 9, and 13 days following last application in the decline trial.  Both commodities were allowed to dry in the field or under shelter for 2 to 17 days, until commercial dryness was obtained.

The peanut RAC samples 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/on peanut nutmeat and 1.0 ppm in peanut hay.  Sample storage conditions and durations are reported in Table 7; samples were stored frozen for up to ~19 months prior to analysis.  The available storage stability data support the peanut field trial study.

The results of the peanut field trials are summarized in Table 17.  Residues of fluopyram in/on peanut at a 6- to 7-day PHI ranged from <0.01-0.018 ppm.  The mean and HAFT were 0.011 ppm and 0.017 ppm, respectively.  Residues of fluopyram in/on peanut hay at a 6- to 7-day PHI ranged 1.08-21.88 ppm.  The mean and HAFT were 8.72 ppm and 20.7 ppm, respectively.  Since residues were low in the nutmeat, residue decline could not be assessed; however, the residues declined from the 0- to the 13-day PHI in the peanut hay decline trial samples.

Conclusions.  The submitted peanut crop field trial data are adequate to fulfill data requirements.  The number and locations of the field trials are in accordance with OPPTS Guideline 860.1500 for use on peanut.  Field trials were conducted at ~1x the proposed maximum seasonal rate and samples were harvested at the proposed PHI.

Based on the available data and the NAFTA tolerance calculator (see Appendix II), a tolerance of 0.02 ppm for residues of fluopyram in/on peanut is appropriate.  Since the proposed includes a feeding restriction on peanut hay, a tolerance in/on peanut hay is not needed and the proposed peanut hay tolerance should be removed.

Pistachio  -  see Tree nut, group 14

The proposed use on pistachio is identical to the proposed use on the tree nut crop group.  HED has concluded that pistachios are to be a member of the tree nuts crop group [see memo entitled "Reviewer's Guide and Summary of HED ChemSAC Approvals for Amending Crop Group/Subgroups [40 CFR 180.411 and Commodity Definitions [40 CFR 180.1 (h)]" from B. Schneider to B. Madden dated 6/14/06], with almonds and pecans remaining as the representative commodities.  Until 40 CFR §180.41 is updated, tolerances for pistachios will be listed separately from the crop group tolerance, but the tolerance will be established at the same level as the crop group.  Thus, the available data support a tolerance of 0.05 ppm for fluopyram residues in/on pistachio.

Potato

Bayer has submitted magnitude of the residue studies for potato.  The results from these field trials are discussed below and summarized in Table 18.

Table 18.	Summary of Residue Data from Potato Field Trials with Fluopyram.
Crop matrix
                   Total Applic. Rate  (lb ai/A) [kg ai/ha]
                                  PHI (days)
                        Fluopyram Residue Levels (ppm)

                                       n
                                     Min.
                                     Max.
                                     HAFT
                                    Median
                                     Mean
                                   Std. Dev.
POTATO (proposed use = 0.445 lb ai/A total application rate, 7-day PHI; revised to 0.356 lb ai/A for ground applications and 0.275 lb ai/A for aerial applications)
Potato, tuber
                         0.437 - 0.454 (0.489 - 0.509)
                                      6-7
                                      32
                                   <0.01
                                     0.017
                                     0.017
                                     0.01
                                     0.01
                                     0.002

Sixteen trials, representing fourteen harvest trials and two decline trials, were conducted in Zones 1 (NY and PA, 2 trials), 2 (VA, 1 trial), 3 (FL, 1 trial), 5 (IL, KS, MN, and NE, 4 trials), 10 (CA, 1 trial), and 11 (ID, OR, and WA, 7 trials) during the 2006 growing season.  One ID trial in Zone 11 was used to fulfill the requirements for Zone 9 since the trial was conducted at a site close to the border between Zones 9 and 11.

Two foliar spray applications of the 4.16 lb/gal SC formulation at a rate of 0.211-0.234 lb ai/A/application (236-263 g ai/ha) were made to potato with 3- to 5-day RTIs, for total application rates of 0.437-0.454 lb ai/A (489-509 g ai/ha).  The application rates represent ~1.3-1.6x the proposed maximum seasonal rate.  Applications were made in spray volumes of 10-19 GPA (93-175 L/ha).  Duplicate treated samples were harvested 6-7 days following the last application in the harvest trials, and 0, 3, 7, 14, and 21 days following last application in the decline trials.

The potato samples 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 potato tuber.  Sample storage conditions and durations are reported in Table 7; samples were stored frozen for up to ~20 months prior to analysis.  The available storage stability data support the potato field trial study.

The results of the potato field trials are summarized in Table 18.  Residues of fluopyram in/on potato tubers at a 6- to 7-day PHI ranged from <0.01-0.02 ppm.  The mean and HAFT were 0.01 ppm and 0.017 ppm, respectively.  In the decline trials, the residue levels were at or below the LOQ at all sampling intervals.

Conclusions.  The submitted potato crop field trial data are adequate to fulfill data requirements.  The number and locations of the field trials are in accordance with OPPTS Guideline 860.1500 for tuberous and corm vegetables subgroup 1C.  Field trials were conducted at ~1.3-1.6x the proposed maximum seasonal rate and samples were harvested at the proposed PHI.

Since >60% of the samples resulted in residues <0.01 ppm the NAFTA tolerance calculator was not used.  Based on the maximum field trial residue, HED concludes that a tolerance of 0.02 ppm for residues of fluopyram in/on potato is appropriate.

Strawberry

Bayer has submitted magnitude of the residue studies for strawberry.  The results from these field trials are discussed below and summarized in Table 19.

Table 19.	Summary of Residue Data from Strawberry Field Trials with Fluopyram.
Crop matrix
                   Total Applic. Rate  (lb ai/A) [kg ai/ha]
                                  PHI (days)
                        Fluopyram Residue Levels (ppm)

                                       n
                                     Min.
                                     Max.
                                     HAFT
                                    Median
                                     Mean
                                   Std. Dev.
STRAWBERRY (proposed use = 0.445 lb ai/A total application rate, 0-day PHI for spray uses and drip application and 1-day PHI greenhouse uses; revised to delete field spray use)
Strawberry - drip irrigation field
                                  0.442-0.468
                                 [0.495-0.525]
                                       0
                                      20
                                   <0.01
                                     0.112
                                     0.10
                                     0.010
                                     0.026
                                     0.028
Strawberry - greenhouse spray (European data)
                                     0.446
                                    [0.500]
                                       1
                                       8
                                     0.12
                                     0.79
                                     0.79
                                     0.27
                                     0.35
                                     0.26

Ten trials, representing nine harvest trials and one decline trial, were conducted in Zones 1 (PA, 1 trial), 2 (GA, 1 trial), 3 (FL, 1 trial), 5 (IA, MI, and MN, 3 trials), 10 (CA, 3 trials), and 12 (OR, 1 trial) during the 2007 growing season.

Each trial consisted of two treatment plots, a spray treated plot and a drip irrigation plot.  For the spray treated plot, two foliar spray applications of the 4.16 lb/gal SC formulation at a rate of 0.217-0.235 lb ai/A/application (243-263 g ai/ha) were made to strawberry plants with 5- to 6-day RTIs, for total application rates of 0.438-0.463 lb ai/A (491-525 g ai/ha).  A second treated plot received two drip irrigation applications of the 4.16 lb/gal SC formulation at a rate of 0.221-0.234 lb ai/A/application (248-262 g ai/ha) with 5- to 6-day RTIs, for total application rates of 0.442-0.468 lb ai/A (495-525 g ai/ha).  The application rates represent ~1x the proposed maximum seasonal rate.  Spray applications were made in spray volumes of 5-20 GPA (47-189 L/ha).  For drip irrigation, there was a minimum of one emitter per plant with all plants having an equal number of emitters; application volumes were 0.27-0.57 gal/hr/emitter (1.0-2.2 L/hr/emitter).  Duplicate treated samples were harvested on the day of last application for both treatment plots; samples were additionally harvested 7 days after last application from the drip irrigation plots.  At one site, duplicate samples were collected at intervals of 0, 3, 7, 10, and 14 days following the last application in both plots to evaluate residue decline.

The strawberry samples 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 strawberries.  Sample storage conditions and durations are reported in Table 7; samples were stored frozen for up to ~8 months prior to analysis.  The available storage stability data support the strawberry field trial study.

The results of the strawberry field trials are summarized in Table 19.  For the drip irrigation trials, fluopyram in/on strawberry at the 0-day PHI ranged from <0.01 to 0.11 ppm.  The mean and HAFT values were 0.026 ppm and 0.10 ppm for the 0-day PHI, respectively.  In the decline trial, the residue level at the 0-day PHI was <0.01 ppm, and residues increased to about 0.03 ppm at 10 and 14 days after last treatment.  The residue levels in the drip irrigation trials were 5 to 10 times lower than those observed in the broadcast application trials.

Europe:  Eight greenhouse trials on strawberry were conducted during the 2006 and 2007 growing seasons according to the critical European GAP.  The greenhouse trials were located in Spain, Italy, Germany (2), Netherlands, northern France, United Kingdom, and Belgium.

In the greenhouse trials, the 4.16 lb/gal SC formulation was applied as sprays twice with an application rate of 0.5 L/ha and 300-1000 L water per ha, corresponding to a spray concentration of 0.05-0.17% and a rate of 0.25 kg ai/ha/application.  The applications were carried out with 6- to 7-day RTIs with the last application approximately 1 day prior to the expected date of harvest.  Total application rates were 0.50-0.54 kg ai/ha (0.446-0.482 lb ai/A), corresponding to 1x the proposed maximum seasonal rate.  At each trial, single samples of strawberry were harvested just before last treatment and at 0, 1, 3/4, 5/6, and 7/8 days after the last treatment.

The strawberry samples were analyzed for residues of the parent compound fluopyram and its metabolites AE C656948-benzamide, AE C656948-PAA, and AE C656948-PCA using an adequate HPLC/MS/MS method, Method No. 00984-M001.  The LOQ (expressed as parent equivalents) was 0.01 ppm for all analytes.  Sample storage conditions and durations are reported in Table 7; samples were stored frozen for up to ~9 months prior to analysis.  The available storage stability data support the strawberry study.

The results of the Europe strawberry greenhouse trials are summarized in Table 19; only data for residues of fluopyram are included.  In greenhouse trials, residues of fluopyram at the 1-day PHI ranged from 0.12-0.79 ppm in strawberry fruit (median 0.27 ppm).  Residues of the metabolite AE C656948-PAA were <LOQ in/on all samples at all sampling events.  Residues of the metabolite AE C656948-PCA were <LOQ in/on all samples at the 1-day PHI.  Residues of the metabolite AE C656948-benzamide were <LOQ in/on all samples at all sampling intervals, except for one trial where quantifiable residues were observed at all sampling intervals, and residues at 0.02 ppm at the 1-day PHI were obtained.

Analysis of the data for the different PHIs indicated decline of fluopyram residue levels in/on strawberry fruits with time.  The decline in fluopyram residues between first and last sampling days averaged 36% for the trials conducted in greenhouse (excepted in one trial where no decline was observed).

Conclusions.  The submitted crop field trial data for strawberry are adequate to satisfy data.  The number and locations of the North American field trials are in accordance with OPPTS Guideline 860.1500 for strawberry as a representative crop of subgroup 13-07G.  Field trials were conducted at ~1x the proposed maximum seasonal rate and samples were harvested at the proposed PHI.  The European greenhouse data may be translated to support greenhouse use on strawberries in North America.

Based on the available data and the NAFTA tolerance calculator (see Appendix II), a tolerance of 1.5 ppm for residues of fluopyram in/on strawberry is appropriate.

Sugar beet root

Bayer has submitted magnitude of the residue studies for sugar beet; the results for roots from the sugar beet field trials are discussed below and summarized in Table 20.

Table 20.	Summary of Residue Data from Sugar Beet Field Trials with Fluopyram.
Crop matrix
                   Total Applic. Rate  (lb ai/A) [kg ai/ha]
                                  PHI (days)
                        Fluopyram Residue Levels (ppm)

                                       n
                                     Min.
                                     Max.
                                     HAFT
                                    Median
                                     Mean
                                   Std. Dev.
SUGAR BEET  (proposed use = 0.445 lb ai/A total application rate, 7-day PHI; revised to 0.222 lb ai/A)
Sugar beet, root
                       0.439  -  0.456 (0.492  -  0.511)
                                      5-7
                                      24
                                     0.013
                                     0.050
                                     0.040
                                     0.026
                                     0.029
                                     0.011

Twelve trials, representing eleven harvest trials and one decline trial, were conducted in Zones 5 (IL, MN, ND, NE, and WI, 5 trials), 7 (ND, 1 trial), 8 (TX, 1 trial), 9 (ID, 1 trial), 10 (CA, 2 trials), and 11 (ID and OR, 2 trials) during the 2006 growing season.

Two foliar spray applications of the 4.16 lb/gal SC formulation at a rate of 0.216-0.230 lb ai/A/application (242-258 g ai/ha) were made to sugar beet with 5- to 7-day RTIs, for total application rates of 0.439-0.456 lb ai/A (492-511 g ai/ha).  The application rates represent ~2x the proposed maximum seasonal rate.  Applications were made in spray volumes of 9-22 GPA (80-201 L/ha).  Duplicate treated samples of roots were harvested 5-7 days following the last application in the harvest trials, and 0, 6, 13, 19, and 27 days following last application in the decline trial.  Samples of sugar beet tops were also collected; these data are discussed below under sugar beet tops.

The sugar beet root samples 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 sugar beet root.  Sample storage conditions and durations are reported in Table 7; samples were stored frozen for up to ~19 months prior to analysis.  The available storage stability data support the sugar beet field trial study.

The results for roots from the sugar beet field trials are summarized in Table 20.  Residues of fluopyram in/on sugar beet roots at a 5- to 7-day PHI ranged from 0.013-0.050 ppm.  The mean and HAFT were 0.029 ppm and 0.040 ppm, respectively.  In the decline trial, the average residues decreased in/on sugar beet roots from the 0-day PHI to the 27-day PHI.

Conclusions.  The submitted sugar beet crop field trial data are adequate to fulfill data requirements.  The number and locations of the field trials are in accordance with OPPTS Guideline 860.1500 for sugar beets.  Field trials were conducted at ~2x the proposed maximum seasonal rate and samples were harvested at the proposed PHI.

The residue data have been adjusted for rate differential and based on the NAFTA tolerance calculator (see Appendix II), a tolerance of 0.04 ppm for residues of fluopyram in/on sugar beet root is appropriate.

Sugar beet tops

Bayer has submitted magnitude of the residue studies for sugar beet and turnip tops, the representative crops of leaves of root and tuber vegetables, group 2, as well as for radish tops.  The results from the sugar beet tops field trials are discussed below and summarized in Table 21.

Table 21.	Summary of Residue Data from Sugar Beet Top Field Trials with Fluopyram.
Crop matrix
                   Total Applic. Rate  (lb ai/A) [kg ai/ha]
                                  PHI (days)
                        Fluopyram Residue Levels (ppm)

                                       n
                                     Min.
                                     Max.
                                     HAFT
                                    Median
                                     Mean
                                   Std. Dev.
SUGAR BEET (proposed use = 0.445 lb ai/A total application rate, 7-day PHI; revised to 0.222 lb ai/A)
Sugar beet, tops
                       0.439  -  0.456 (0.492  -  0.511)
                                      5-7
                                      24
                                     0.273
                                     18.7
                                     16.5
                                     0.803
                                     3.30
                                     4.89

Twelve trials, representing eleven harvest trials and one decline trial, were conducted in Zones 5 (IL, MN, ND, NE, and WI, 5 trials), 7 (ND, 1 trial), 8 (TX, 1 trial), 9 (ID, 1 trial), 10 (CA, 2 trials), and 11 (ID and OR, 2 trials) during the 2006 growing season.

Two foliar spray applications of the 4.16 lb/gal SC formulation at a rate of 0.216-0.230 lb ai/A/application (242-258 g ai/ha) were made to sugar beet with 5- to 7-day RTIs, for total application rates of 0.439-0.456 lb ai/A (492-511 g ai/ha).  The application rates represent ~2x the proposed maximum seasonal rate.  Applications were made in spray volumes of 9-22 GPA (80-201 L/ha).  Duplicate treated samples of tops were harvested 5-7 days following the last application in the harvest trials, and 0, 6, 13, 19, and 27 days following last application in the decline trial.

The sugar beet top samples 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 sugar beet tops.  Sample storage conditions and durations are reported in Table 7; samples were stored frozen for up to ~19 months prior to analysis.  The available storage stability data support the sugar beet field trial study.

The results for tops from the sugar beet field trials are summarized in Table 21.  Residues of fluopyram in/on sugar beet tops at a 5- to 7-day PHI ranged from 0.27-18.7 ppm.  The mean and HAFT were 3.30 ppm and 16.5 ppm, respectively.  In the decline trial, the average residues decreased in/on sugar beet tops from the 0-day PHI to the 27-day PHI.

Conclusions.  The submitted sugar beet crop field trial data are adequate to fulfill data requirements.  The number and locations of the field trials are in accordance with OPPTS Guideline 860.1500 for leaves of sugar beet.  Field trials for sugar beet were conducted at ~2x the proposed maximum seasonal rate and samples were harvested at the proposed PHI.

Sugar beet tops are no longer considered a livestock feed item.  Therefore, a tolerance for residues of fluopyram in/on leaves of sugar beet is not needed.

Cucurbit vegetable, group 9

Bayer has submitted magnitude of the residue studies for cucumber, melon, and summer squash, the representative crops of cucurbit vegetable, group 9.  The results from these field trials are discussed below and summarized in Table 22.  Per letter of 8 August 2011, the registrant withdrew use on the cucurbit crop group and instead proposed use on watermelon only.

Table 22.	Summary of Residue Data from Crop Group 9 Field Trials with Fluopyram.
Crop matrix
                   Total Applic. Rate  (lb ai/A) [kg ai/ha]
                                  PHI (days)
                        Fluopyram Residue Levels (ppm)

                                       n
                                     Min.
                                     Max.
                                     HAFT
                                    Median
                                     Mean
                                   Std. Dev.
CUCURBIT VEGETABLES (proposed use = 0.445 lb ai/A total application rate, 0-day PHI spray uses, 3-day PHI greenhouse uses, and 7-day PHI drip applications)
Foliar Spray Applications
Cucumber
                           0.432-0.454 (0.485-0.508)
                                       0
                                      12
                                     0.037
                                     0.189
                                     0.144
                                     0.092
                                     0.094
                                     0.045
Muskmelon
                           0.445-0.469 (0.499-0.526)
                                       0
                                      12
                                     0.069
                                     0.529
                                     0.439
                                     0.192
                                     0.217
                                     0.156
Summer squash
0.443-0.445 (0.497-0.510)
                                       0
                                      10
                                    0.0468
                                     0.179
                                     0.173
                                     0.083
                                     0.099
                                     0.047
Drip Line Irrigation
Cucumber
0.446-0.456 (0.500-0.511)
                                       7
                                      12
                                   <0.01
                                     0.058
                                     0.057
                                     0.016
                                     0.022
                                     0.017
Muskmelon
0.446-0.455 (0.500-0.510)
                                      5-7
                                      12
                                   <0.01
                                     0.029
                                     0.027
                                   <0.01
                                     0.015
                                     0.008
Summer squash
0.446 (0.500)
                                      6-7
                                      10
                                   <0.01
                                     0.017
                                     0.015
                                     0.013
                                     0.012
                                     0.002
Greenhouse Applications
Cucumber (European data)
0.535 (0.600)
                                      2-4
                                       8
                                     0.04
                                     0.29
                                     0.29
                                     0.12
                                     0.15
                                     0.09
Muskmelon (European data)
0.535 (0.600)
                                      31
                                       7
                                     0.04
                                     0.19
                                     0.19
                                     0.11
                                     0.12
                                     0.05
[1]  The data include results from one trial with a PHI of 1 day (no sample collected at 3-day PHI) and one trial with a PHI of 7 days (residues were higher than those at the 3-day PHI).

Cucumber

Six cucumber trials, representing five harvest trials and one decline trial, were conducted in Zones 2 (GA and NC, 2 trials), 3 (FL, 1 trial), 5 (IA and OH, 2 trials), and 6 (TX, 1 trial) during the 2007 growing season.

At each trial site there was one untreated plot and two treated plots.  At one treated plot, two foliar spray applications of the 4.16 lb/gal SC formulation at a rate of 0.210-0.229 lb ai/A (235-257 g ai/ha) were made to cucumber with a 5- to 6-day application interval, for total application rates of 0.432-0.454 lb ai/A (485-508 g ai/ha).  The foliar spray application rates represent ~1x the proposed maximum seasonal rate.  Foliar spray applications were made in spray volumes of 16-19 GPA (146-182 L/ha).  Duplicate treated samples were harvested on the day of last application in the foliar spray harvest trials, and 0, 1, 3, 7, and 10 days following the final application in the foliar spray decline trial.

At the other treated plot, two drip line irrigation applications of the 4.16 lb/gal SC formulation at a rate of 0.223-0.233 lb ai/A (250-261 g ai/ha) were made to cucumber with a 5- to 6-day application interval, for total application rates of 0.446-0.456 lb ai/A (500-511 g ai/ha).  The drip line irrigation application rates represent ~1x the proposed maximum seasonal rate.  Drip line irrigation applications were made in spray volumes of 0.12-0.57 gal/hr (0.47-2.2 L/hr).  Duplicate samples of cucumber were harvested at a 7-day PHI in the drip line irrigation harvest trials, and 0, 3, 7, 10, and 14 days following the final application for the drip line irrigation decline trial.

The cucumber samples 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 cucumber fruit.  Sample storage conditions and durations are reported in Table 7; samples were stored frozen for up to ~9 months prior to analysis.  The available storage stability data support the cucumber field trial study.

The results of the cucumber field trials are summarized in Table 22.  Residues of fluopyram in/on cucumber fruit at a 0-day PHI for the plots with foliar spray applications ranged from 0.037-0.19 ppm.  The mean and HAFT were 0.094 ppm and 0.14 ppm, respectively.  Residues of fluopyram in/on cucumber fruit at a 7-day PHI for the plots with drip line irrigation applications ranged from <0.01-0.058 ppm.  The mean and HAFT were 0.02 ppm and 0.057 ppm, respectively.  In the decline trial with foliar spray applications, a more than 50% reduction of residue levels was observed from the 0-day to the 10-day PHI.  In the decline trial with drip line irrigation, no major increase or decrease of residues was observed from the 0-day PHI to the 14-day PHI for cucumber fruit samples.

Europe:  Eight greenhouse trials on cucumber were conducted during the 2006 growing season according to the critical European GAP.  The greenhouse trials were located in southern France (2), Spain, Italy, Germany (2), Netherlands, and Greece.  The results reported herein were obtained from "Tier 2 Summary of the Metabolism and Residues Data for Fluopyram (AE C656948)," which was prepared by Bayer CropScience (MRID 47567126).

In the greenhouse trials, the 4.16 lb/gal SC formulation was applied as sprays twice with an application rate of 0.6 L/ha and 750-1500 L water per ha, corresponding to a spray concentration of 0.04 to 0.08% and a rate of 0.30 kg ai/ha/application.  All applications were made at the specified rates.  Total application rates were 0.600 kg ai/ha (0.535 lb ai/A) for the greenhouse trials, representing ~1.2x the proposed maximum seasonal rate.

The applications were carried out with 6- to 7-day RTIs with the last application approximately 1 day prior to the expected date of harvest.  At each trial, single samples of cucumber were harvested just before last treatment and at 0, 1, 2/3/4, 5, and 7 days after the last treatment.

The cucumber samples were analyzed for residues of the parent compound fluopyram and its metabolites AE C656948-benzamide, AE C656948-PAA, and AE C656948-PCA using an adequate HPLC/MS/MS method, Method No. 00984.  The LOQ (expressed as parent equivalents) was 0.01 ppm for all analytes.  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 cucumber field trial study.

The results of the Europe cucumber greenhouse trials are summarized in Table 22, reflecting residues of fluopyram only and the desired 3-day PHI.  In greenhouse, the residues of fluopyram at a 2- to 4-day PHI ranged from 0.04-0.29 ppm in cucumber fruit (median 0.12 ppm).  Residues of the three metabolites AE C656948-PAA, AE C656948-benzamide, and AE C656948-PCA were <LOQ in/on all samples at all sampling events.

Analysis of the data for the different PHIs indicated decline of fluopyram residue levels in/on cucumber fruits with time.  The decline in fluopyram residues between first and last sampling day averaged 46%.

Melon

Six muskmelon trials, representing five harvest trials and one decline trial, were conducted in Zones 2 (GA, 1 trial), 5 (ND, 1 trial), 6 (TX, 1 trial), and 10 (CA, 3 trials) during the 2007 growing season.

At each trial site there was one untreated plot and two treated plots.  At one treated plot, two foliar spray applications of the 4.16 lb/gal SC formulation at a rate of 0.220-0.235 lb ai/A (246-263 g ai/ha) were made to melon with a 5-day application interval, for total application rates of 0.445-0.469 lb ai/A (499-526 g ai/ha).  The foliar spray application rates represent ~1x the proposed maximum seasonal rate.  Foliar spray applications were made in spray volumes of 15-18 GPA (139-172 L/ha).  Duplicate treated samples were harvested on the day of last application in the foliar spray harvest trials, and 0, 1, 3, 7, and 10 days following the final application in the foliar spray decline trial.

At the other treated plot, two drip line irrigation applications of the 4.16 lb/gal SC formulation at a rate of 0.223-0.228 lb ai/A (250-255 g ai/ha) were made to muskmelon with a 5-day application interval, for total application rates of 0.446-0.455 lb ai/A (500-510 g ai/ha).  The drip line irrigation application rates represent ~1x the proposed maximum seasonal rate.  Drip line irrigation applications were made in spray volumes of 0.23-0.43 gal/hr (0.88-1.6 L/hr).  Duplicate samples of muskmelon were harvested at a 5- to 7-day PHI in the drip line irrigation harvest trials, and 0, 3, 7, 10, and 14 days following the final application for the drip line irrigation decline trial.

The muskmelon samples 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 muskmelon fruit. 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 muskmelon field trial study.

The results of the muskmelon field trials are summarized in Table 22.  Residues of fluopyram in/on muskmelon fruit at a 0-day PHI for the plots with foliar spray applications ranged from 0.069-0.53 ppm.  The mean and HAFT were 0.22 ppm and 0.44 ppm, respectively.  Residues of fluopyram in/on muskmelon fruit at a 5- to 7-day PHI for the plots with drip line irrigation applications ranged from <0.01-0.029 ppm.  The mean and HAFT were 0.015 ppm and 0.027 ppm, respectively.  In the decline trial with foliar spray applications, residues increased from the 0-day PHI to the 1-day PHI, and then did not increase from the 3- to the 10-day PHI.  Residues were <0.01 ppm in/on all samples from the decline trial for drip line irrigation treatment.

Europe:  Seven greenhouse trials on melon/watermelon were conducted during the 2006 and 2007 growing seasons according to the critical European GAP.  The greenhouse trials were located in southern France (2), Spain (2), Italy, Germany, and Portugal.  The results reported herein were obtained from "Tier 2 Summary of the Metabolism and Residues Data for Fluopyram (AE C656948)," which was prepared by Bayer CropScience (MRID 47567126).
In the greenhouse trials, the 4.16 lb/gal SC formulation was applied as sprays twice with an application rate of 0.6 L/ha and 600-1000 L water per ha, corresponding to a spray concentration of 0.06-0.1% and 0.30 kg ai/ha/application.  All applications were made at the specified rates.  Total application rates were 0.600 kg ai/ha (0.535 lb ai/A) for the greenhouse trials, representing ~1.2x the proposed maximum seasonal rate.

The applications were carried out with 7-day RTIs with the last application approximately 3 days prior to the expected date of harvest.  At each trial, single samples of melon were harvested just before last treatment and at 0, 1, 3, and 7 days after the last treatment.

The melon samples were analyzed for residues of the parent compound fluopyram and its metabolites AE C656948-benzamide, AE C656948-PAA, and AE C656948-PCA using an adequate HPLC/MS/MS method, Method No. 00984.  The LOQ (expressed as parent equivalents) was 0.01 ppm for all analytes.  Sample storage conditions and durations are reported in Table 7; samples were stored frozen for up to ~10 months prior to analysis.  The available storage stability data support the melon field trial study.

The results of the Europe melon greenhouse trials are summarized in Table 22, reflecting residues of fluopyram only and the desired 3-day PHI.  In greenhouse, the residues of fluopyram at a 3-day PHI ranged from 0.04 and 0.19 ppm (which includes one trial at 0.04 ppm at day 7 and one trial at 0.09 ppm at day 1) in melon fruit (median 0.11 ppm).  Residues of the three metabolites AE C656948-PAA, AE C656948-benzamide, and AE C656948-PCA were <LOQ in/on all samples at all sampling events.

Analysis of the data for the different PHIs indicated decline of fluopyram residue levels in/on melon/watermelon fruits with time.  The decline in fluopyram residues between first and last sampling days averaged 52% for 6 greenhouse trials; for one other greenhouse trial, no decline was observed.

Squash

Five summer squash trials, representing four harvest trials and one decline trial, were conducted in Zones 1 (PA, 1 trial), 2 (GA, 1 trial), 3 (FL, 1 trial), 5 (WI, 1 trial), and 10 (CA, 1 trial) during the 2007 growing season.

At each trial site there was one untreated plot and two treated plots.  At one treated plot, two foliar spray applications of the 4.16 lb/gal SC formulation at a rate of 0.221-0.229 lb ai/A (248-257 g ai/ha) were made to summer squash with a 5-day application interval, for total application rates of 0.443-0.455 lb ai/A (497-510 g ai/ha).  The foliar spray application rates represent ~1x the proposed maximum seasonal rate.  Foliar spray applications were made in spray volumes of 14-20 GPA (131-187 L/ha).  Duplicate treated samples were harvested on the day of last application in the foliar spray harvest trials, and 0, 1, 3, 7, and 10 days following the final application for the foliar spray decline trial.

At the other treated plot, two drip line irrigation applications of the 4.16 lb/gal SC formulation at a rate of 0.223 lb ai/A (250 g ai/ha) were made to summer squash with a 5-day application interval, for total application rates of 0.446 lb ai/A (500 g ai/ha).  The drip line irrigation application rates represent ~1x the proposed maximum seasonal rate.  Drip line irrigation applications were made in spray volumes of 0.16-0.47 gal/hr (0.61-1.8 L/hr).  Duplicate samples of summer squash were harvested at a 6- to 7-day PHI in the drip line irrigation harvest trials, and 0, 3, 7, 10, and 14 days following the final application in the drip line irrigation decline trial.

The squash samples 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 fruit.  Sample storage conditions and durations are reported in Table 7; samples were stored frozen for up to ~9 months prior to analysis.  The available storage stability data support the summer squash field trial study.

The results of the summer squash field trials are summarized in Table 22.  Residues of fluopyram in/on summer squash fruit at a 0-day PHI for the plots with foliar spray applications ranged from 0.047-0.18 ppm.  The mean and HAFT were 0.10 ppm and 0.17 ppm, respectively.  Residues of fluopyram in/on summer squash fruit at a 6- to 7-day PHI for the plots with drip line irrigation applications ranged from <0.01-0.017 ppm.  The mean and HAFT were 0.012 ppm and 0.015 ppm, respectively.  In the decline trial with foliar spray applications, residues increased from the 0-day PHI to the 1-day PHI, and then decreased to <0.01 ppm at the 10-day PHI.  For the drip line irrigation decline trial, residues increased from <0.01 ppm at the 0-day PHI to 0.017 ppm at the 14-day PHI.

Conclusions.  The submitted residue data for cucumber, muskmelon, and summer squash are adequate to fulfill data requirements.  The number and locations of the field trials are in accordance with OPPTS Guideline 860.1500 for cucurbit vegetables, group 9.  Field trials were conducted at ~1x the proposed maximum seasonal rate and samples were harvested at the proposed PHIs for each application type.  The residue data for muskmelon are applicable to watermelon.

Based on the available data and the NAFTA tolerance calculator (see Appendix II), a tolerance of 1.0 ppm for residues of fluopyram in/on watermelon is appropriate.

Stone fruit, group 12

Bayer has submitted magnitude of the residue studies for peach, cherry, and plum, the representative crops of stone fruit, group 12.  The results from these field trials are discussed below and summarized in Table 23.  Per letter of 8 August 2011, the registrant withdrew uses on stone fruit group 12 and instead petitioned use on cherry only.

Table 23.	Summary of Residue Data from Crop Group 12 Field Trials with Fluopyram.
Crop matrix
                   Total Applic. Rate  (lb ai/A) [kg ai/ha]
                                  PHI (days)
                        Fluopyram Residue Levels (ppm)

                                       n
                                     Min.
                                     Max.
                                     HAFT
                                    Median
                                     Mean
                                   Std. Dev.
STONE FRUIT (proposed use = 0.445 lb ai/A total application rate, 0-day PHI; revised cherry use = 0.183 lb ai/A, revised stone fruit use other than cherry = 0.367 lb ai/A)
Concentrate Spray
Cherry
                                0.447  -  0.460
                               (0.501  -  0.516)
                                       0
                                      12
                                     0.066
                                     0.641
                                     0.639
                                     0.505
                                     0.425
                                     0.223
Peach
                                0.436  -  0.456
                               (0.489  -  0.511)
                                       0
                                      18
                                     0.126
                                     0.457
                                     0.44
                                     0.306
                                     0.29
                                     0.105
Plum
                                0.429  -  0.445
(0.481  -  0.499)
                                       0
                                      12
                                     0.022
                                     0.286
                                     0.257
                                     0.052
                                     0.082
                                     0.085
Dilute Spray
Cherry
                                0.444  -  0.457
(0.498  -  0.512)
                                       0
                                      12
                                     0.147
                                     1.229
                                     1.174
                                     0.396
                                     0.516
                                     0.349
Peach
                                0.441  -  0.457
(0.494  -  0.512)
                                       0
                                      18
                                     0.175
                                     0.588
                                     0.548
                                     0.318
                                     0.34
                                     0.121
Plum
                                0.442  -  0.454
(0.495  -  0.509)
                                       0
                                      12
                                     0.021
                                     0.292
                                     0.283
                                     0.044
                                     0.083
                                     0.095

Cherry

Six cherry (sweet and tart) trials, representing five harvest trials and one decline trial, were conducted during the 2006 growing season.  Four sweet cherry trials were conducted in Zones 5 (MI, 1 trial), 10 (CA, 1 trial), and 11 (OR and WA, 2 trials).  Two tart cherry trials were conducted in Zones 1 (PA, 1 trial) and 5 (MI, 1 trial).

At each trial site there was one untreated plot and two treated plots.  At each treated plot, two foliar spray applications of the 4.16 lb/gal SC formulation at a rate of 0.219-0.231 lb ai/A (245-259 g ai/ha) were made to cherries with a 5- to 8-day application interval, for total application rates of 0.444-0.460 lb ai/A (498-516 g ai/ha).  The foliar spray application rates represent ~2.4x the proposed maximum seasonal rate.  Foliar spray applications were made in concentrate spray volumes, 45-67 GPA (419-624 L/ha), at one treated plot and in dilute spray volumes, 204-309 GPA (1905-2889 L/ha), at the other treated plot.  Duplicate treated samples were harvested on the day of the last application in the harvest trials and 0, 3, 7, 10, and 14 days following the last application in the decline trial.

The cherry fruit samples 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 cherries.  Sample storage conditions and durations are reported in Table 7; samples were stored frozen for up to ~18 months prior to analysis.  The available storage stability data support the cherry field trial study.

The results of the cherry field trials are summarized in Table 23.  Residues of fluopyram in/on cherry fruit at a 0-day PHI for the plots with concentrate spray volumes ranged from 0.066-0.64 ppm.  The mean and HAFT were 0.43 ppm and 0.64 ppm, respectively.  Residues of fluopyram in/on cherry fruit at a 0-day PHI for the plots with dilute spray volumes ranged from 0.15-1.23 ppm.  The mean and HAFT were 0.52 ppm and 1.17 ppm, respectively.  In the decline trial, average residues decreased between the 0- and the 14-day PHI.

Peach

Nine peach trials, representing eight harvest trials and one decline trial, were conducted in Zones 1 (PA, 1 trial), 2 (GA, 3 trials), 5 (MI, 1 trial), 6 (TX, 1 trial), and 10 (CA, 3 trials) during the 2006 and 2007 growing seasons.

At each trial site there was one untreated plot and two treated plots.  At each treated plot, two foliar spray applications of the 4.16 lb/gal SC formulation at a rate of 0.213-0.233 lb ai/A (239-261 g ai/ha) were made to peaches with a 5- to 7-day application interval, for total application rates of 0.436-0.457 lb ai/A (489-512 g ai/ha).  The foliar spray application rates represent ~1.2x the proposed maximum seasonal rate.  Foliar spray applications were made in concentrate spray volumes, 40-62 GPA (371-577 L/ha), at one treated plot and in dilute spray volumes, 210-358 GPA (1962-3350 L/ha), at the other treated plot.  Duplicate treated samples were harvested on the day of the last application in the harvest trials and 0, 3, 7, 10, and 14 days following the last application in the decline trial.

The peach fruit samples 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 peaches.  Sample storage conditions and durations are reported in Table 7; samples were stored frozen for up to ~18 months prior to analysis.  The available storage stability data support the peach field trial study.

The results of the peach field trials are summarized in Table 23.  Residues of fluopyram in/on peach fruit at a 0-day PHI for the plots with concentrate spray volumes ranged from 0.13-0.46 ppm.  The mean and HAFT were 0.29 ppm and 0.44 ppm, respectively.  Residues of fluopyram in/on peach fruit at a 0-day PHI for the plots with dilute spray volumes ranged from 0.18-0.59 ppm.  The mean and HAFT were 0.34 ppm and 0.55 ppm, respectively.  In the decline trial, average residues remained approximately the same from the 0-day PHI to the 14-day PHI.

Plum

Six plum trials, representing five harvest trials and one decline trial, were conducted in Zones 5 (MI, 1 trial), 10 (CA, 4 trials), and 12 (OR, 1 trial) during the 2006 growing season.

At each trial site there was one untreated plot and two treated plots.  At each treated plot, two foliar spray applications of the 4.16 lb/gal SC formulation at a rate of 0.213-0.227 lb ai/A (239-254 g ai/ha) were made to plums with a 6- to 7-day application interval, for total application rates of 0.429-0.454 lb ai/A (481-509 g ai/ha).  The foliar spray application rates represent ~1.2x the proposed maximum seasonal rate.  Foliar spray applications were made in concentrate spray volumes, 43-61 GPA (405-574 L/ha), at one treated plot and in dilute spray volumes, 206-303 GPA (1923-2853 L/ha), at the other treated plot.  Duplicate treated samples were harvested on the day of the last application in the harvest trials and 0, 3, 7, 10, and 14 days following the last application in the decline trial.

The plum fruit samples 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 plums.  Sample storage conditions and durations are reported in Table 7; samples were stored frozen for up to ~18 months prior to analysis.  The available storage stability data support the plum field trial study.

The results of the plum field trials are summarized in Table 23.  Residues of fluopyram in/on plum fruit at a 0-day PHI for the plots with concentrate spray volumes ranged from 0.02-0.29 ppm.  The mean and HAFT were 0.082 ppm and 0.26 ppm, respectively.  Residues of fluopyram in/on plum fruit at a 0-day PHI for the plots with dilute spray volumes ranged from 0.021-0.29 ppm.  The mean and HAFT were 0.083 ppm and 0.28 ppm, respectively.  In the decline trial, average residues increased from the 0-day to 7-day PHI and then decreased from the 7-day to the 14-day PHI.

Conclusions.  The submitted residue data for peach and plum are adequate to fulfill data requirements.  The number and locations of the field trials are in accordance with OPPTS Guideline 860.1500 for stone fruit, group 12.  Field trials were conducted at ~1.2x (within 25% of) the proposed maximum seasonal rate and samples were harvested at the proposed PHI.  The available data support tolerances of 0.70 ppm for residues of fluopyram in/on peach and 0.35 ppm in/on plum.

For cherry, the residue data have been adjusted for rate differential.  Based on the available data and the NAFTA tolerance calculator (see Appendix II), a tolerance of 0.60 ppm for residues of fluopyram in/on cherry is appropriate.

Tree nut, group 14

Bayer has submitted magnitude of the residue studies for almond and pecan, the representative crops of tree nuts, group 14.  The results from these field trials are discussed below and summarized in Table 24.  The results for almond and pecan are also intended to support use on pistachio.

Table 24.	Summary of Residue Data from Crop Group 14 Field Trials with Fluopyram.
Crop matrix
                   Total Applic. Rate  (lb ai/A) [kg ai/ha]
                                  PHI (days)
                        Fluopyram Residue Levels (ppm)

                                       n
                                     Min.
                                     Max.
                                     HAFT
                                    Median
                                     Mean
                                   Std. Dev.
  TREE NUT (proposed use = 0.445 lb ai/A total application rate, 14-day PHI)
Concentrate Spray
Almond
                           0.437-0.449 (0.490-0.503)
                                      14
                                      10
                                   <0.01
                                     0.019
                                     0.018
                                   <0.01
                                     0.01
                                     0.01
Almond, hulls
                           0.437-0.449 (0.490-0.503)
                                      14
                                      10
                                     1.93
                                     4.45
                                     4.25
                                     3.26
                                     3.18
                                     1.09
Pecan
                                  0.445-0.455
(0.499-0.510)
                                     12-14
                                      10
                                   <0.01
                                     0.021
                                     0.018
                                   <0.01
                                     0.01
                                     0.01
Dilute Spray
Almond
                                 0.439- 0.462
(0.492-0.518)
                                      14
                                      10
                                   <0.01
                                     0.016
                                     0.015
                                   <0.01
                                     0.01
                                     0.01
Almond, hulls
                                 0.439- 0.462
(0.492-0.518)
                                      14
                                      10
                                     1.22
                                     6.12
                                     5.43
                                     2.44
                                     2.97
                                     1.57
Pecan
                                  0.448-.458
(0.502-0.513)
                                     12-14
                                      10
                                   <0.01
                                     0.045
                                     0.031
                                   <0.01
                                     0.01
                                     0.014

Almond

Five almond trials, representing four harvest trials and one decline trial, were conducted in Zone 10 (CA) during the 2006 growing season.

At each trial site there was one untreated plot and two treated plots.  At each treated plot, two foliar spray applications of the 4.16 lb/gal SC formulation at a rate of 0.218-0.231 lb ai/A (244-259 g ai/ha) were made to almonds with a 6- to 7-day application interval, for total application rates of 0.437-0.462 lb ai/A (490-518 g ai/ha).  The foliar spray application rates represent ~1x the proposed maximum seasonal rate.  Foliar spray applications were made in concentrate spray volumes, 50-60 GPA (468-561 L/ha), at one treated plot and in dilute spray volumes, 209-299 GPA (1956-2799 L/ha), at the other treated plot.  Duplicate treated samples (nutmeat and hulls) were harvested 14 days after the last application in the harvest trials.  Additionally, samples were collected from one plot at 0, 7, 14, 21, and 28 days following the final application in the decline trial.

The almond samples (nutmeat and hulls) 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 almond hulls and nutmeat.  Sample storage conditions and durations are reported in Table 7; samples were stored frozen for up to ~22 months prior to analysis.  The available storage stability data support the almond field trial study.

The results of the almond field trials are summarized in Table 24.  Residues of fluopyram in/on almond hulls at a 14-day PHI for the plots with concentrate spray volumes ranged from 1.93-4.45 ppm.  The mean and HAFT were 3.18 ppm and 4.25 ppm, respectively.  Residues of fluopyram in/on almond hulls at a 14-day PHI for the plots with dilute spray volumes ranged from 1.22-6.12 ppm.  The mean and HAFT were 2.97 ppm and 5.43 ppm, respectively.  In the decline trial, average residues in the almond hulls decreased from the 0-day PHI to the 7-day PHI, then increased from the 7-day PHI to the 28-day PHI (noted dry matter content also increased in longer PHI samples).

Residues of fluopyram in/on almond nutmeat at a 14-day PHI for the plots with concentrate spray volumes ranged from <0.01-0.019 ppm.  The mean and HAFT were 0.01 ppm and 0.018 ppm, respectively.  Residues of fluopyram in/on almond nutmeat at a 14-day PHI for the plots with dilute spray volumes ranged from <0.01-0.016 ppm.  The mean and HAFT were 0.01 ppm and 0.015 ppm, respectively.  In the decline trial, average residues in the almond nutmeat increased from the 0-day PHI to the 14-day PHI, and then declined from the 21-day PHI to the 28-day PHI.

Pecan

Five pecan trials, representing four harvest trials and one decline trial, were conducted in Zones 2 (GA, 2 trials), 4 (AR, 1 trial), 6 (TX, 1 trial), and 8 (TX, 1 trial) during the 2006 growing season.

At each trial site there was one untreated plot and two treated plots.  At each treated plot, two foliar spray applications of the 4.16 lb/gal SC formulation at a rate of 0.219-0.232 lb ai/A (246-260 g ai/ha) were made to pecans with a 13- to 14-day application interval, for total application rates of 0.445-0.458 lb ai/A (499-513 g ai/ha).  The foliar spray application rates represent ~1x the proposed maximum seasonal rate.  Foliar spray applications were made in concentrate spray volumes, 41-69 GPA (385-647 L/ha), at one treated plot and in dilute spray volumes, 205-308 GPA (1914-2879 L/ha), at the other treated plot.  Duplicate treated samples (nutmeat) were harvested 12-14 days after the last application in the harvest trials and 0, 7, 14, 21, and 28 days following the last application in the decline trial.

The pecan samples (nutmeat) 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 pecan nutmeat.  Sample storage conditions and durations are reported in Table 7; samples were stored frozen for up to ~19 months prior to analysis.  The available storage stability data support the pecan field trial study.

The results of the pecan field trials are summarized in Table 24.  Residues of fluopyram in/on pecan nutmeat at a 12- to 14-day PHI for the plots with concentrate spray volumes ranged from <0.01-0.021 ppm.  The mean and HAFT were 0.01 ppm and 0.018 ppm, respectively.  Residues of fluopyram in/on pecan nutmeat at a 12- to 14-day PHI for the plots with dilute spray volumes ranged from <0.01-0.045 ppm.  The mean and HAFT were 0.01 ppm and 0.031 ppm, respectively.  In the decline trial, average residues in the pecan nutmeat decreased from the 0-day PHI to <0.01 ppm at the 14-day PHI and remained <LOQ to the 28-day PHI.

Conclusions.  The submitted residue data for almond and pecan are adequate to fulfill data requirements.  The number and locations of the field trials are in accordance with OPPTS Guideline 860.1500 for tree nut, group 14.  Field trials were conducted at ~1x the proposed maximum seasonal rate and samples were harvested at the proposed PHI.

Based on the available data and the NAFTA tolerance calculator (see Appendix II), a tolerance of 0.05 ppm for residues of fluopyram in/on tree nut, group 14 and a tolerance of 8.0 ppm for residues of fluopyram in/on almond hulls are appropriate.

Banana

Bayer has submitted magnitude of the residue studies for banana.  The results from these field trials are discussed below and summarized in Table 25.

Table 25.	Summary of Residue Data from Banana Field Trials with Fluopyram.
Crop matrix
                         Total Applic. Rate [kg ai/ha]
                                  PHI (days)
                        Fluopyram Residue Levels (ppm)

                                       n
                                     Min.
                                     Max.
                                     HAFT
                                    Median
                                     Mean
                                   Std. Dev.
 BANANA - Latin America (no proposed use information was provided for banana)
Banana, whole fruit, bagged
                                  0.587-0624
                                       0
                                      28
                                   <0.01
                                     0.040
                                     0.038
                                     0.015
                                     0.018
                                     0.009
Banana, whole fruit, unbagged
                                  0.587-0624
                                       0
                                      28
                                     0.018
                                     0.526
                                     0.510
                                     0.144
                                     0.164
                                     0.140

Fourteen banana trials, representing twelve harvest trials and two decline trials, were conducted in Costa Rica (4 trials), Ecuador (4 trials), Guatemala (2 trials), Honduras (1 trial), Mexico (1 trial), and Colombia (2 trials) during the 2007 growing season.

Six foliar spray applications of the 4.16 lb/gal SC formulation at a rate of 0.0803-0.0999 lb ai/A/application (90-112 g ai/ha) were made to bananas with 5- to 11-day RTIs, for total application rates of 0.524 to 0.557 lb ai/A (587 to 624 g ai/ha).  Applications were made to unbagged and bagged bananas; bagged bananas had a perforated plastic bag placed over the fruit at the normal time the bagging operation is commercially performed, approximately one week after flowering begins.  The target application pattern was six application at 0.0892 lb ai/A/application (0.100 kg ai/ha/application) with a 7-day RTI.  The petitioner did not provide any information pertaining to the proposed use of fluopyram on bananas.  Applications were made in spray volumes of 2.25-6.73 GPA (21-63 L/ha).  Duplicate treated samples of banana (bagged and unbagged) were harvested on the day of last application in the harvest trials, and 0, 2/3, 5, and 6/7 days following last application in the decline trials (unbagged bananas only).

The banana samples 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/on banana.  For residues of the metabolites AE C656948-benzamide, AE C656948-PAA, and AE C656948-PCA, extracts were diluted with appropriate solvents and analyzed by HPLC/MS/MS.  The method was adequate for data collection based on acceptable concurrent method recoveries.  The LOQ was 0.01 ppm for each analyte in banana.  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 banana field trial study.

The results of the Latin American banana field trials are summarized in Table 25.  Residues of fluopyram in/on bagged whole banana at a 0-day PHI ranged from <0.01-0.040 ppm.  The mean and HAFT were 0.018 ppm and 0.038 ppm, respectively.  Residues of fluopyram in/on unbagged whole banana at a 0-day PHI ranged from 0.018-0.526 ppm.  The mean and HAFT were 0.164 ppm and 0.51 ppm, respectively.  No residues of AE C656948-benzamide, AE C656948-PCA or AE C656948-PAA greater than the LOQ of 0.01 ppm were observed in/on whole banana samples treated with fluopyram.

Fluopyram residues declined moderately from the 0- to the 6- to 7-day PHI in unbagged bananas.  Placing a perforated plastic bag over the bananas prior to making the fluopyram applications reduced the fluopyram residue significantly, from a mean of 0.164 ppm to a mean of 0.018 ppm.

Conclusions.  The submitted banana crop field trial data are adequate to fulfill data requirements pending submission of the proposed use directions for banana.

The number and locations of banana field trials conducted in Latin America satisfies the HED geographic representation requirements for an import tolerance on banana.  As specified in the "NAFTA Guidance Document on Data Requirements for Tolerances on Imported Commodities in the United States and Canada," a total of 12 field trials are required to support an import tolerance on bananas (amount available for consumption that is imported is >75%, and the maximum percent of diet for banana is between 0.2 and 1.0%).  Based on import data from 2003-2007, the major banana importing countries are Guatemala (29.0% of imports), Ecuador (27.4%), Costa Rica (26.9%), Honduras (13.3%), and Colombia (13.3%; data from "Fruit and Tree Nuts Situation and Outlook Yearbook," USDA, 2008).

Based on the available data and the NAFTA tolerance calculator (see Appendix II), a tolerance of 1.0 ppm for residues of fluopyram in/on banana is appropriate.

860.1520 Processed Food and Feed

First Entry Monograph for Fluopyram, Sections B.<IP_ADDRESS> through B<IP_ADDRESS> (MRIDs 47372605, 47372622 through 47372630)
Second Entry Monograph for Fluopyram, Sections B.<IP_ADDRESS> through <IP_ADDRESS> (MRIDs 47567023, 47567025, 47567026, 47567030, and 47567111-47567122)

The residue program in North America included studies to determine levels of fluopyram in processed commodities of apples, canola, corn (field), cotton (rotated), grapes, oranges, peanuts, plums, potatoes, soybeans, sugar beets, sunflowers, tomatoes, and wheat.  In addition, the effects of common industrial processes, such as washing, cooking, peeling, canning, and drying, on the reduction of residue levels in many commodities were also investigated.

Bayer submitted processing study data from various processing and residue reduction studies conducted in North America and Europe.  Only the North American studies are summarized below.  A summary of the average processing factors found for the processed commodities of apple, canola, field corn, cotton (rotated), grape, melon, peanut, plum, potato, soybean, strawberry, sugar beet, and wheat is presented in Table 26.

Table 26.	Summary of Processing Factors for Fluopyram.
RAC
Processed Commodity
                           Average Processing Factor
Apple
Wet pomace
                                      2.3

Juice
                                      0.4

Washed fruit
                                      0.7

Peeled fruit
                                     0.03

Applesauce
                                     0.01

Dried fruit
                                     0.03
Canola
Meal
                                      0.3

Refined oil
                                     0.01
Corn, field
Aspirated grain fractions
                                      161

Starch
                                      0.2

Refined/bleached/deodorized oil (wet milled)
                                      0.6

Grits
                                      0.5

Flour
                                      0.9

Meal
                                      0.8

Bran
                                      2.6

Refined/bleached/deodorized oil (dry milled)
                                      0.1
Cotton (rotated)
Meal
                                     NC[1]

Hulls
                                      NC

Refined oil
                                      NC
Melon
Peeled (foliar treatment)
                                     0.044

Peeled (drip irrigation)
                                     0.71
Peanut
Meal
                                      0.2

Refined oil
                                      0.2

Dry roasted peanuts
                                      0.3

Peanut butter
                                      0.2
Plum
Prune
                                      1.1

Washed fruit
                                      0.5
Potato
Chips
                                      0.3

Flakes
                                      1.0

Wet peel
                                      4.3

Washed tubers
                                      0.7

Peeled tubers
                                      0.2

Cooked tubers
                                      0.2
Soybean
Aspirated grain fractions
                                      222

Meal
                                     0.05

Refined oil
                                     0.02

Hulls
                                      1.3

Flour
                                     0.04

Soymilk
                                     0.01
Strawberry
Washed and cooked (foliar treatment)
                                      0.9

Washing and cooking did not reduce the residue of fluopyram on strawberries treated by drip irrigation application
Sugar beet
Dried pulp
                                      1.3

Refined sugar
                                      1.3

Molasses
                                      0.9
Summer squash
Washed (foliar treatment)
                                     0.57

Washed and cooked (foliar treatment)
                                     0.46

Washed and cooked (drip irrigation)
                                     0.97
Wheat
Aspirated grain fractions
                                     69.7

Flour
                                      0.1

Middlings
                                      0.3

Shorts
                                      0.8

Bran
                                      2.7

Germ
                                      2.4
[1]  NC = not calculated.  A processing factor could not be calculated because residues were below the LOQ in both the RAC and the processed commodity.

The available processing data indicate that tolerances are needed for fluopyram residues in apple wet pomace and processed potato waste (wet peel).  The tolerances proposed by the petitioner for these commodities are too high; reduced tolerances of 0.60 ppm for apple wet pomace, 0.08 ppm for processed potato waste, are supported by the processing data.  Although the available processing data indicate that fluopyram residues concentrate (1.3x or less) in prune, sugar beet dried pulp, sugar beet refined sugar, no tolerances are needed for these commodities as residues are not expected at levels exceeding the recommended RAC tolerance.

Apple

An apple processing trial was conducted to measure the magnitude of fluopyram residues in apples and apple processed commodities following exaggerated rate treatment.  At one site in NY, two airblast applications of the 4.16 lb/gal SC formulation were made to apple trees at a rate of 1.125 lb ai/A and 1.115 lb ai/A, respectively, for a total amount applied of 2.24 lb ai/A (2511 g ai/ha), which is 5x the proposed maximum seasonal rate.  The applications were made at spray volumes of 65 GPA (610 L/ha).  The first application was made to the apples at the beginning of ripening (BBCH 81), with a 6-day interval between the two applications.  Samples of apple fruit were collected 5 days following the last application and processed into apple wet pomace, juice, washed fruit, peeled fruit, applesauce, and dried fruit.

The apple 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 fresh fruit and the processed commodities were stored frozen for up to ~9 months prior to analysis.  The available storage stability data support the apple processing study.

The average fluopyram residues in/on apple RAC were 0.93 ppm.  The average fluopyram residues for the required processed commodities were 2.14 ppm in apple wet pomace and 0.41 ppm in apple juice, and the average residues for the additional risk assessment samples were 0.65 ppm in washed fruit, 0.03 ppm in peeled fruit, 0.01 ppm in applesauce, and 0.03 ppm in dried fruit.  Fluopyram residues were found to concentrate in apple wet pomace (2.3x processing factor) but did not concentrate in apple juice (0.4x), washed fruit (0.7x), peeled fruit (0.03x), applesauce (0.01x), or dried fruit (0.03x).

The processing factor for apple pomace is lower than the theoretical concentration factor of 14x for apple pomace (OPPTS 860.1520, Table 4).

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

The processing data indicate that fluopyram residues concentrate in apple wet pomace.  Based on the HAFT residues for fluopyram residues in/on apple from the North American field trials (0.255 ppm), and the processing factor from the North American processing study (2.3x), expected fluopyram residues in wet pomace would be 0.59 ppm.  Therefore, a tolerance of 0.60 ppm would be appropriate for residues of fluopyram in wet apple pomace.

Canola (proposed label revised as rotated)

A canola processing trial was conducted to measure the magnitude of fluopyram residues in canola and canola 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 canola plants at a rate of 1.166 lb ai/A and 1.116 lb ai/A, respectively, for a total amount applied of 2.28 lb ai/A (2.58 kg ai/ha).  The applications were made at spray volumes of 17 GPA (161 L/ha) and 19 GPA (180 L/ha), respectively.  The first application was made when 50% of pods ripe and thirteen days later the second application was made when 60% of pods ripe.  Samples of canola were collected 14 days following the last application and processed into canola meal and oil.

The resultant canola 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 canola seed and the canola processed commodities were stored frozen for up to ~12 months prior to analysis.  The available storage stability data support the canola processing study.

The average fluopyram residues in/on canola seed were 0.83 ppm.  The average fluopyram residues for the processed commodities were 0.28 ppm in canola meal and 0.01 ppm in canola oil.  Fluopyram residues did not concentrate in canola meal (0.3x) or canola refined oil (refined, bleached and deodorized; 0.01x).

The processing factors for canola meal and canola oil are lower than the theoretical concentration factors of 1.9x for canola meal and 3.0x for canola oil (OPPTS 860.1520, Table 3).

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

Corn (proposed label revised as rotated)

A field corn processing trial was conducted to measure the magnitude of fluopyram residues in field corn, aspirated corn grain fractions, and corn processed commodities following exaggerated rate treatment.  At one site in IL, two broadcast foliar applications of the 4.16 lb/gal SC formulation were made to field corn at a rate of 1.09 lb ai/A and 1.10 lb ai/A, respectively, for a total amount applied of 2.19 lb ai/A (2460 g ai/ha).  The applications were made at spray volumes of 18 GPA (167-170 L/ha).  Both applications were made at growth stage 87 (physiological maturity) with the second application occurring 7 days after the first.  Samples of corn grain were collected 12 days after the last application and processed into AGF, starch, and refined/bleached/deodorized oil from wet milling, and grits, flour, meal, bran, and refined/bleached/deodorized oil from dry milling.

The resultant corn 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 field corn grain and all processed commodities except AGF.  The LOQ was 2.00 ppm in AGF.

Sample storage conditions and durations are reported in Table 7; samples of field corn grain (RAC), AGF, and the corn processed commodities analyzed in this study were held in frozen storage for a maximum of ~13 months, 15 months, and 2 months, respectively, prior to analysis.  The available storage stability data support the field corn processing study.

The average fluopyram residues in/on field corn grain were 0.028 ppm.  The average fluopyram residues in/on field corn AGF were 4.48 ppm.  The average fluopyram residues for the required processed commodities were <LOQ in field corn wet milled starch, 0.017 ppm in refined/bleached/deodorized oil (wet milled), 0.014 ppm in field corn grits, 0.024 ppm in field corn flour, 0.023 ppm in field corn meal, 0.074 ppm in field corn bran, and <LOQ in refined/bleached/deodorized oil (dry milled).

Fluopyram residues did not concentrate in field corn starch (0.2x), refined/bleached/deodorized oil (wet milled; 0.6x), field corn grits (0.5x), field corn flour (0.9x), field corn meal (0.8x), and refined/bleached/deodorized oil (dry milled; 0.1x).  However, the residue did concentrate in field corn AGF (161x), and field corn bran (2.6x).

The processing factors determined for fluopyram residues in this study are less than the maximum theoretical concentration factor of 25x for corn oil (based on separation into components; OPPTS 860.1520, Table 3).

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

Cotton (Rotated)

A cotton processing trial was conducted to measure the magnitude of fluopyram residues in cotton undelinted seed and cottonseed processed commodities following exaggerated rate treatment.  At one site in AR, two broadcast applications of the 4.16 lb/gal SC formulation were made to bare ground at a rate of 1.11 lb ai/A and 1.12 lb ai/A, for a total amount applied of 2.23 lb ai/A (2500 g ai/ha), which is 5x the proposed maximum seasonal rate.  Each application was made at a spray volume of 10 GPA (93-94 L/ha).  Cotton was planted with a PBI of 12 days.  Samples of seed cotton were harvested at the normal growth stage for commercial harvest and processed into cottonseed meal, hulls, and refined oil (bleached and deodorized).

The resultant cotton seed 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 cottonseed and cottonseed processed commodities were stored frozen for up to ~7 months and <1 month, respectively, prior to analysis.  The available storage stability data for rape seed are adequate and may be translated to support the cottonseed processing study.  Storage stability data are not needed for cotton processed fractions since processed samples were stored less than 30 days.

The fluopyram residues in/on cottonseed and the processed commodities were less than the LOQ of 0.01 ppm following a 5x exaggerated rate of application of fluopyram.  Therefore, processing factors could not be determined.

The maximum theoretical concentration factors based on separation into components are 3.8x for cotton hulls, 2.2x for cotton meal, and 6.3x for cotton oil (OPPTS 860.1520, Table 3).

Conclusions.  The submitted cotton processing data are adequate to satisfy data requirements.  No tolerances for cotton processed commodities are needed.

Melon

EPA does not require residue data for any processed commodities of muskmelons.  However, the petitioner collected additional muskmelon samples in the North American field trials to determine possible residue reduction from peeling muskmelons.

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

The samples of muskmelon before and after peeling 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 muskmelons.  Sample storage conditions and durations are reported in Table 7; samples of muskmelon were stored frozen for up to ~7 months prior to analysis.  The available storage stability data for lettuce are adequate to support the muskmelon processing study.

The average fluopyram residue found in/on unpeeled muskmelons (RAC) treated by broadcast foliar application was 0.151 ppm.  The average fluopyram residue found in peeled muskmelons treated by broadcast foliar application was 0.0067 ppm.  The calculated processing factor was 0.044x for peeling.