Each test location included one treated and one untreated plot.  At each site, the treated plot received three broadcast or directed foliar applications (except as noted below for the trial located in AZ) of metrafenone (2.5 lb ai/gal SC, BASF formulation code BAS 560 03 F) targeting 0.30 lb ai/A/application (0.336 kg ai/ha/application), with a nominal 7-day RTI, resulting in a total rate of 0.90 lb ai/A (1.0 kg ai/ha/season).  The actual application rate was 0.29-0.33 lb ai/A/application, with a 6- to 8-day RTI, for a total rate of 0.89-0.95 lb ai/A (0.999-1.066 kg ai/ha/season).  At the trial in AZ, in order to allow the fruit to develop further and provide adequate samples for residue analysis, four foliar sprays of metrafenone at 0.30-0.32 lb ai/A/application were made, with a 7- or 8-day RTI, totalling 1.23 lb ai/A (1.38 kg ai/ha/season).  All applications were made in approximately 31-90 GPA of water (286-841 L/ha) using ground equipment.  An adjuvant was included in the spray mixture for each application.  At all test sites tomato RAC samples (fruit) were harvested at normal crop maturity, at a 0 day PHI, after the spray had dried on the fruit, and again at a 6-8 day PHI.  At two test sites (Trial CA124 and FL38), additional treated samples were collected 1, 3, 9-10 and 12-14 day PHI to examine residue decline.

The residues of parent metrafenone in tomato RAC samples were quantitated using an LC/MS/MS multi-residue QuEChERS method (BASF Study #398340).  Sample analysis was conducted by Pyxant Labs (Colorado Springs, CO).  The method was successfully validated on tomato in conjunction with this study prior to analysis of the field samples.  Acceptable concurrent method recovery data for tomato RAC samples were also obtained for metrafenone.  The validated LOQ for residues of metrafenone in tomato RAC samples was 0.01 ppm.  The estimated method LOD was reported as 0.001 ppm, or approximately 10% of the LOQ.  The calculated LOD and LOQ for metrafenone in tomato fruit were 0.001 and 0.004 ppm, respectively.

The tomato RAC samples were stored frozen for 303-730 days (approximately 10-24 months) from collection to extraction for analysis.  Adequate storage stability data for metrafenone are available to support the storage conditions and durations incurred by the tomato residue samples in this study.

As summarized in Table <IP_ADDRESS>, below, the results from these trials show that following the last of three or four foliar applications of metrafenone at roughly 0.3 lb ai/A/application, with 6- to 8-day RTIs, residues of metrafenone (and per trial averages) were 0.041-0.452 (0.069-0.427) ppm in 38 treated tomato samples harvested at a 0-day PHI and <0.01-0.188 (<0.011-0.163) ppm in 38 treated tomato samples harvested at a 6-8 day PHI.  Data from the residue decline sites indicate that metrafenone residues in tomato generally declined with increasing PHIs.

TABLE <IP_ADDRESS>	Summary of Residue Data from Tomato Field Trials with Metrafenone
                                   Commodity
                                Total Use Rate
                               lb ai/A (g ai/ha)
                                 PHI (Days)[2]
                            Residue Levels (ppm)[1]

                                     n[3]
                                     Min.
                                     Max.
                                    LAFT[4]
                                    HAFT[4]
                                    Median
                                     Mean
                                   Std. Dev.
                                    Tomato
                                    (Fruit)
                                  0.891-1.234
                                  (999-1383)
                                       0
                                      18
                                    0.0409
                                     0.452
                                    0.0694
                                     0.427
                                     0.110
                                     0.164
                                     0.094

                                  0.910-0.922
                                (1020-1033)[5]
                                       1
                                       2
                                    0.0427
                                    0.0865
                                    0.0541
                                    0.0721
                                    0.0631
                                    0.0631
                                     NA[6]

                                       3
                                       2
                                    0.0512
                                    0.0830
                                    0.0572
                                    0.0748
                                    0.0660
                                    0.0660
                                      NA

                                  0.891-1.234
                                  (999-1383)
                                      6-8
                                      18
                                   <0.01
                                     0.188
                                  <0.0107
                                     0.163
                                    0.0860
                                    0.0770
                                    0.0446

                                  0.910-0.922
                                (1020-1033)[5]
                                     9, 10
                                       2
                                    0.0149
                                    0.0719
                                    0.0187
                                    0.0536
                                    0.0362
                                    0.0362
                                      NA

                                    12, 14
                                       2
                                    0.0138
                                    0.0327
                                    0.0166
                                    0.0247
                                    0.0207
                                    0.0207
                                      NA
      1. Except for sample min/max, values reflect per trial averages.
2. The first harvest was on the day of the last application (0-day PHI) at all trials.  The second harvest was 6 to 8 days after the last application (6- to 8-day PHI) at all trials, except field trials  - CA124 and  - FL38.  At field trial  - CA124, a decline study was conducted with the last application 0, 1, 3, 6, 10 and 12 days before harvest (0- to 12-day PHI). At field trial  - FL38, a decline study was conducted with the last application 0, 1, 3, 7, 9 and 14 days before harvest (0- to 14-day PHI).
3. n = number of field trials.
      4. LAFT = Lowest Average Field Trial value; HAFT = Highest Average Field Trial value.
      5. Data from the two residue decline trials.
      6. NA = Not Applicable.

Fruiting Vegetables, Pepper (MRID #49119107):  BASF has submitted field trial data for metrafenone (BAS 560 F) on pepper from a total of eight trials conducted during the 2010 growing season:  five on bell pepper varieties in NAFTA Growing Zones 2 (GA, one trial), 3 (FL, one trial), 5 (IL, one trial), 6 (OK, one trial) and 10 (CA, one trial) and three on non-bell pepper varieties in NAFTA Growing Zones 2 (GA, one trial), 8 (KS, one trial) and 10 (CA, one trial).  HED has determined that one trial pair (R100014 and R100019) should be considered replicates; the above field trial distribution incorporates this conclusion.

Each test location included one treated and one untreated plot.  At each site, the treated plot received three broadcast foliar applications of metrafenone as an SC formulation, targeting 0.30 lb ai/A/application (0.336 kg ai/ha/application), with a nominal 7-day RTI, resulting in a total rate of 0.90 lb ai/A (1.0 kg ai/ha/season).  The actual application rate was 0.29-0.31 lb ai/A/application, with a 7-day RTI, for a total rate of 0.88-0.91 lb ai/A (0.991-1.017 kg ai/ha/season).  The applications were made in approximately 21-31 GPA of water (200-286 L/ha) using ground equipment.  A nonionic surfactant (NIS) adjuvant was included in the spray mixture for each application.

Pepper RAC samples (fruit) were harvested at normal crop maturity, at a 0-day PHI at all test sites, after the spray had dried on the fruit, and again at a 7 day PHI.  At one test site (Trial R100014, CA), additional treated samples were collected at 3, 10 and 14 day PHIs to examine residue decline.

The residues of parent metrafenone in pepper RAC samples were quantitated using an LC/MS/MS multi-residue QuEChERS method (BASF Study #398340, reported as Method #R00033).  Sample analysis was conducted by Pyxant Labs (Colorado Springs, CO).  The method was successfully validated on pepper in conjunction with this study prior to analysis of the field samples.  Acceptable concurrent method recovery data for pepper RAC samples were also obtained for metrafenone.  The validated LOQ for residues of metrafenone in pepper RAC samples was 0.01 ppm.  The method LOD was reported as 0.001 ppm, or 10% of the LOQ.

The pepper RAC samples were stored frozen for 671-764 days (approximately 22-25 months) from collection to extraction for analysis, and were analyzed within 16 days of extraction.  Adequate storage stability data for metrafenone are available to support the storage conditions and durations incurred by the pepper residue samples in this study.

As summarized in Table <IP_ADDRESS>, below, the results from these trials show that following the last of three foliar applications of metrafenone at roughly 0.3 lb ai/A/application, with 7-day RTIs, residues of metrafenone (and per trial averages) were 0.067-0.667 (0.081-0.498) ppm in 18 treated pepper samples harvested at a 0-day PHI and were 0.062-0.296 (0.065-0.295) ppm in 18 treated pepper samples harvested at a 7-day PHI.

The maximum residues were observed in the non-bell pepper cultivars, but were at relatively similar levels to those observed in the bell-pepper cultivars:  Maximum metrafenone residues (and maximum per trial averages) for bell pepper varieties were 0.508 (0.417) ppm at the 0-day PHI and 0.271 (0.221) ppm at the 7-day PHI, and for non-bell pepper varieties, 0.667 (0.498) ppm at the 0-day PHI and 0.296 (0.295) ppm at the 7-day PHI.  Data from the residue decline site indicate that metrafenone residues in pepper declined with increasing pre-harvest intervals (results not shown here; see the DER for MRID #49119107 for further details).

TABLE <IP_ADDRESS>	Summary of Residue Data from Pepper Field Trials with Metrafenone
                                   Commodity
                               Total Appl. Rate
                               lb ai/A (g ai/ha)
                                  PHI (days)
                            Residue Levels (ppm)[1]

                                       n
                                     Min.
                                     Max.
                                    LAFT[2]
                                    HAFT[2]
                                    Median
                                     Mean
                                   Std. Dev.
                                  Bell Pepper
                                    (Fruit)
                                  0.884-0.907
                                  (991-1017)
                                       0
                                       5
                                     0.112
                                     0.508
                                     0.148
                                     0.417
                                     0.270
                                     0.297
                                     0.113

                                       7
                                       5
                                    0.0828
                                     0.271
                                    0.0991
                                     0.221
                                     0.163
                                     0.158
                                    0.0506
                            Non-bell Pepper (Fruit)

                                       0
                                       3
                                    0.0665
                                     0.667
                                    0.0813
                                     0.498
                                     0.353
                                     0.311
                                     0.212

                                       7
                                       3
                                    0.0622
                                     0.296
                                    0.0649
                                     0.295
                                     0.144
                                     0.168
                                     0.117
                            Combined Pepper (Fruit)

                                       0
                                       8
                                    0.0665
                                     0.667
                                    0.0813
                                     0.498
                                     0.312
                                     0.302
                                     0.142

                                       7
                                       8
                                    0.0622
                                     0.296
                                    0.0649
                                     0.295
                                     0.154
                                     0.162
                                    0.0734
      1. Except for sample min/max, values reflect per trial averages; n = number of field trials
      2. LAFT = Lowest Average Field Trial Value; HAFT = Highest Average Field Trial value.

Fruiting Vegetables Conclusions:  The results have shown that the maximum residues of metrafenone in fruiting vegetables (tomato and pepper RAC samples) following three foliar broadcast applications of the 2.5 lb ai/gal SC formulation totaling roughly 0.9 lb ai/A/season were 0.667 ppm at a 0-day PHI.  Data from the residue decline tests indicated that metrafenone residues in fruiting vegetables declined with increasing PHIs.  The maximum metrafenone residues in fruiting vegetables are within a factor of 5 of each other (0.452 and 0.667 ppm for tomato and pepper, respectively, at the targeted 0-day PHI); therefore, the residues are within the EPA guidelines for the establishment of a group tolerance in crop group 8-10 (fruiting vegetables).

An acceptable method was used for residue quantitation, and adequate storage stability data are available to support the sample storage conditions and durations.

Cherry (MRID #49145402):  IR-4 submitted field trial residue data for metrafenone on cherry.  Fourteen cherry field trials (9 sweet cherry trials, and 5 tart cherry trials) were conducted in the United States and Canada during the 2010 growing season in NAFTA Growing Zones 1 (NY; 1 trial), 5A (MI; 2 trials), 5 (ON; 3 trials), 9 (CO; 1 trial), 10 (CA; 2 trials) and 11 (ID, WA, and BC; 5 trials).  HED has concluded that three trials conducted in Zone 5 should be considered replicates for purposes of OCSPP Residue Chemistry Test Guideline 860.1500 data requirements.  The above field trial distribution incorporates this conclusion.

Each trial consisted of one untreated and one treated plot.  At each trial location, the treated plot received two foliar directed applications of a 2.5 lb ai/gal SC formulation of metrafenone (BAS560 03 F SC) at 0.286-0.314 lb ai/A/application (321-352 g ai/ha/application) for a total seasonal rate of 0.575-0.626 lb ai/A (645-702 g ai/ha).  Applications were made at 6- to 9-day RTIs using ground equipment (airblast sprayer) in spray volumes of 105-189 GPA (984-1767 L/ha), except at the NY trial, where higher than normal temperatures accelerated maturation, and required that applications be initiated earlier than anticipated; the first application at this trial was made in a spray volume of 60.7 GPA (568 L/ha).  An NIS, methylated seed oil (MSO), crop oil concentrate (COC), or organo-silicone surfactant (OSS) was added to the spray mixtures for all applications.  Samples of cherries were harvested from all trial sites at PHIs of 6-8 and 13-15 days.  Additional cherry samples were collected from two trials at PHIs of 0, 3, 17 and 21 days to generate residue decline data.

Samples of cherries were analyzed for residues of metrafenone using an LC/MS/MS method derived from QuEChERS Method #R00033.  The LOQ, determined as the LLMV, was 0.01 ppm.  The method was adequate for data collection, based on acceptable method validation and concurrent recovery data.  The fortification levels used in concurrent method recovery were adequate to bracket expected residue levels.  Concurrent recoveries were corrected for apparent residues in controls; residues in treated samples were not corrected for residues in controls.

Samples of cherries were transferred to a sample preparation facility for homogenization prior to shipment to the analytical laboratory.  Samples were stored frozen (-31 to -3°C at the field sites, <=-5°C at the sample preparation facility, and temperature unspecified at the analytical laboratory) from collection to analysis for 676-784 days (22.2-25.8 months).  Samples were analyzed within 2-9 days of extraction.  Adequate storage stability data are available to support the sample storage conditions and durations.

The results from these trials are summarized in Table <IP_ADDRESS>, below.  Following two foliar directed applications of a 2.5 lb ai/gal SC formulation of metrafenone at a total rate of 0.575-0.626 lb ai/A (645-702 g ai/ha), residues (and per trial averages) of metrafenone in cherries harvested at PHIs of 6-8 days and 13-15 days, respectively, were 0.280-1.17 (0.317-1.16) and 0.117-0.704 (0.144-0.608) ppm.  It was noted that the highest residues in cherries harvested at the 6- to 8-day PHI were observed in samples from the NY trial, where the first application was made in a lower than targeted spray volume, and the highest residues in cherries harvested at the 13- to 15-day PHI were observed in samples from one of the replicate MI trials, where adjuvant rates were lower than expected.  At the residue decline trials, residues of metrafenone generally declined with increasing PHI in cherries (results not shown here; see the DER for MRID #49145402 for further details).

TABLE <IP_ADDRESS>	Summary of Residue Data from Cherry Field Trials with Metrafenone.
                                   Commodity
                                  Total Rate
                                    lb ai/A
                                   (g ai/ha)
                                  PHI (days)
                           Residue Levels  (ppm)[1]

                                       n
                                     Min.
                                     Max.
                                    LAFT[2]
                                    HAFT[2]
                                    Median
                                     Mean
                                   Std. Dev.
Cherry
                                  0.575-0.626
                                   (645-702)
                                      6-8
                                      14
                                     0.280
                                     1.17
                                     0.317
                                     1.16
                                     0.493
                                     0.547
                                     0.221

                                     13-15
                                      14
                                     0.117
                                     0.704
                                     0.144
                                     0.608
                                     0.340
                                     0.370
                                     0.146
1. Except for sample min/max, values reflect per trial averages; n = number of distinct field trials.
2. LAFT = Lowest Average Field Trial; HAFT = Highest Average Field Trial.

Cherry Conclusions:  The submitted cherry field trial data are scientifically acceptable.  Following two foliar directed applications of a 2.5 lb ai/gal SC formulation of metrafenone at a total rate of 0.575-0.626 lb ai/A (645-702 g ai/ha), residues (and per trial averages) of metrafenone in cherries harvested at PHIs of 6-8 days and 13-15 days, respectively, were 0.280-1.17 (0.317-1.16) and 0.117-0.704 (0.144-0.608) ppm.  At the residue decline trials, residues of metrafenone generally decreased with increasing PHIs in cherries.

An acceptable method was used for residue quantitation, and adequate storage stability data are available to support the sample storage conditions and durations.

Hops (MRID #49145403):  IR-4 submitted field trial data for metrafenone on hops.  Five hops field trials were conducted in the United States and Canada during the 2010 growing season in NAFTA Growing Zones 5 (ON 1 trial), 5B (QC; 1 trial), 11 (ID and WA; 2 trials) and 12 (OR; 1 trial).  Examination of the field trial records indicates that there were sufficient differences between the trials that each trial constitutes a separate trial for purposes of OCSPP Residue Chemistry Test Guideline 860.1500 data requirements.

Each trial consisted of one untreated plot and one treated plot.  At each trial location, the treated plot received two foliar directed applications of a 2.5 lb ai/gal SC formulation of metrafenone (BAS560 03 F SC) at 0.304-0.319 lb ai/A/application (341-358 g ai/ha/application) for a total seasonal rate of 0.609-0.635 lb ai/A (683-712 g ai/ha).  Applications were made at 6- to 8-day RTIs, except at the ON trial, where the second application was delayed due to a hurricane (10-day RTI).  Applications were made using ground equipment in spray volumes of 84.6-173.8 GPA (791-1626 L/ha).  An NIS, MSO, COC or OSS was added to the spray mixtures for all applications.  Samples of fresh hops cones were harvested by hand at maturity from all trials at a PHI of 1-4 days.  Samples designated for dried hops cones were dried per normal cultural practices at or near the field sites.  To assess residue decline in dried hops cones, additional samples were collected at PHIs of 0, 4, 7 and 14 days from the WA trial.  Additional samples were also collected at the ON trial at 0- and 1-day PHIs for a residue decline study that was terminated due to low yields.

Samples were analyzed for residues of metrafenone using an LC/MS/MS method derived from QuEChERS Method #R00033.  The LOQ, determined as the LLMV, was 0.01 ppm in dried and fresh hops cones.  The analytical method was adequate for data collection, based on acceptable method validation and concurrent recovery data.  The fortification levels used in method validation and concurrent method recovery were adequate to bracket expected residue levels.  Concurrent recoveries were corrected for apparent residues in controls; residues in treated samples were not corrected for residues in controls.

Samples were transferred to a sample preparation facility for homogenization prior to shipment to the analytical laboratory.  Samples were stored frozen (-42 to 4.2°F at the field sites, <=5°C at the preparation facility, and -29 to - 17°C at the analytical laboratory) from harvest to analysis for 754-819 days (24.8-26.9 months) for dried hops cones, and 752-778 days (24.7-25.6 months) for fresh hops cones.  Samples were analyzed within 1-7 days of extraction.  Adequate storage stability data are available to support the sample storage conditions and durations for residues of metrafenone.

The results from these trials are summarized in Table <IP_ADDRESS>, below.  Following two foliar directed applications of the 2.5 lb ai/gal SC formulation of metrafenone at 0.609-0.635 lb ai/A (683-712 g ai/ha), residues (and per trial averages) of metrafenone in dried hops cones and fresh hops cones, respectively, harvested at 1- to 4-day PHIs were 15.72-158.8 (16.87-131.9) and 5.51-31.36 ppm.  It was noted that the highest residues in dried hops cones were observed in samples from the ON trial where the second application was delayed due to a hurricane and where, according to the petitioner, half of the crop was destroyed by insects between applications.  Excluding results for the ON trial (because the hops cones were not of commercial quality), the highest average residues observed were 23.52 ppm.  At the WA residue decline trial, residues of metrafenone in dried hops cones decreased with increasing PHI.  At the ON decline trial, residues decreased from the 0- to 1-day PHI, but the highest residues were observed in samples from the 2-day PHI (results not shown here; see the DER for MRID #49145403 for further details).

It was noted that the highest residues in dried hops cones were observed in samples from the ON trial, where the second application was delayed due to a hurricane and where, according to the petitioner, half of the crop was destroyed by insects between applications.  There were several communications with the petitioner (IR-4) regarding the ON trial, and an outlier analysis (Grubbs test) was submitted by IR-4.  The outlier analysis was evaluated by HED (D421923; Bayazid Sarkar; 21 August 2014).  HED used a different approach for analyzing the data (the Grubbs test was conducted on transformed data because there was sufficient evidence to reject the assumption of normality), and ultimately concurred that the residue value obtained from the ON field trial constituted an outlier.  The results of the HED analysis were shared with the PMRA reviewers, who then agreed to exclude that residue value from the dataset input to the OECD tolerance calculation procedure.  Excluding results for the ON trial (the outlier), the highest average residue observed was 23.52 ppm.  On a final note regarding hops, HED's recommended tolerance includes the results from European field trials, even though the North American field trial data were adequate.  Using the combined data sets results in a greater likelihood that any future European and Canadian MRLs, and US tolerances will all be harmonized.

TABLE <IP_ADDRESS>	Summary of Residue Data from Hops Field Trials with Metrafenone (MRID #49145403).
                                   Commodity
                                  Total Rate
                               lb ai/A (g ai/ha)
                                  PHI (days)
                      Metrafenone Residue Levels (ppm)[1]

                                       n
                                     Min.
                                     Max.
                                    LAFT[2]
                                    HAFT[2]
                                    Median
                                     Mean
                                  Std.  Dev.
Hops cones, dried
                                  0.609-0.635
                                   (683-712)
                                      1-2
                                       5
                                     15.72
                                     158.8
                                     16.87
                                     131.9
                                     21.50
                                     43.07
                                     48.59
Hops cones, fresh
                                  0.609-0.635
                                   (683-712)
                                      2-4
                                       5
                                    5.51[3]
                                   31.36[3]
                                    5.51[3]
                                   31.36[3]
                                    6.17[3]
                                   11.76[3]
                                   11.08[3]
1. Except for sample min/max, values reflect per trial averages; n = number of field trials.
2. LAFT = Lowest Average Field Trial; HAFT = Highest Average Field Trial.
3. Only one sample per trial was analyzed; therefore sample min = LAFT, and sample max = HAFT. Statistical data are therefore reflective of individual sample residues rather than per trial mean residue values.

Hops (MRID #49145403) Conclusions:  The submitted hops field trial data are scientifically acceptable.  Following two foliar directed applications of the 2.5 lb ai/gal SC formulation of metrafenone at 0.609-0.635 lb ai/A (683-712 g ai/ha), residues (and per trial averages) of metrafenone in dried hops cones and fresh hops cones, respectively, harvested at 1- to 4-day PHIs were 15.72-158.8 (16.87-131.9) and 5.51-31.36 ppm.  It was noted that the highest residues in dried hops cones were observed in samples from the ON trial, where the second application was delayed due to a hurricane and where, according to the petitioner, half of the crop was destroyed by insects between applications.  Excluding results for the ON trial (because the hops cones were not of commercial quality, and the average residue from the trial was deemed an outlier via the Grubbs test), the highest average residues observed were 23.52 ppm.  At the WA residue decline trial, residues of metrafenone in dried hops cones decreased with increasing PHI.  At the ON decline trial, residues decreased from the 0- to 1-day PHI, but the highest residues were observed in samples from the 2-day PHI.

An acceptable method was used for residue quantitation, and the study is supported by adequate storage stability data.

Hops (MRIDs #49145407 & -08):  IR-4 submitted crop field trial and processing study data for metrafenone on hops.  Six field trials were conducted in Germany during the 2009 (four trials; MRID #49145407) and 2010 (two trials; MRID #49145408) growing seasons.  Both studies reflected collection of fresh (green) and dried hops cones.  In the 2009 study dried hops cones from three trials were processed to yield the following processed commodities:  beer, brewer's yeast, extracted hops, and hops draff.  Because the processed commodities of hops are not considered significant food/feed commodities in the US, the results of the processing study are presented herein but are not discussed in detail.

Each trial consisted of one untreated plot and one treated plot.  At each trial location, the treated plot received two foliar directed applications of a 4 lb ai/gal (500 g ai/L) SC formulation of metrafenone (BAS 560 02 F) at 0.279-0.321 lb ai/A/application (313-360 g ai/ha/application) for a total seasonal rate of 0.580-0.633 lb ai/A (650-710 g ai/ha).  Applications were made at 6- to 8-day RTIs using ground equipment in spray volumes of 335-388 GPA (3133-3625 L/ha) without an adjuvant.  Samples of fresh (green) hops cones were harvested at PHIs of 0, 1, 2-4, and 7-8 days.  Additional samples of green hops cones designated for dried hops cones were collected from the 2- to 4-day PHIs at each site and were dried in hops kilns.

Samples were analyzed for residues of metrafenone using LC/MS/MS via BASF methods #535/1 (L0076/01) and #535/3 (L0076/03).  The methods are essentially identical.  The LOQ, determined as the LLMV, was 0.01 ppm in all sample matrices.  The analytical methods were adequate for data collection, based on acceptable method validation and concurrent recovery data.  The fortification levels used in method validation and concurrent method recovery were adequate to bracket expected residue levels.  Recoveries were corrected for apparent residues in controls; residues in treated samples were not corrected for residues in controls.

Samples were stored frozen (<=-18°C at the field sites, preparation facility, and analytical laboratories) from harvest to analysis for 147-242 days (4.8-8.0 months) for green hops cones and 151-236 days (5.0-7.8 months) for dried hops cones.  Samples were analyzed within 1-2 days of extraction.  Adequate storage stability data are available to support the sample storage durations and conditions for residues of metrafenone.

The results from these trials are summarized in Table <IP_ADDRESS>, below.  Following two foliar directed applications of the 4 lb ai/gal (500 g ai/L) SC formulation of metrafenone at 0.580-0.633 lb ai/A (650-710 g ai/ha), residues (and per trial averages) of metrafenone in green hops cones and dried hops cones, respectively, harvested at a 2- to 4-day PHI were 1.78-8.50 (1.78-8.50) and 13.3-34.4 (13.3-34.4) ppm.  At the residue decline trials, residues of metrafenone in green hops cones generally declined with increasing PHI in four of the six trials, but remained relatively stable in two trials from the 0-day PHI to 7-day PHI (results not shown here; see the DER for MRIDs #49145407 and -08 for further details).

TABLE <IP_ADDRESS>	Summary of Residue Data from Hops Field Trials with Metrafenone (MRIDs #49145407 & 49145408).
                                   Commodity
                                  Total Rate
                                    lb ai/A
                                   (g ai/ha)
                                  PHI (days)
                      Metrafenone Residue Levels (ppm)[1]

                                       n
                                     Min.
                                     Max.
                                    LAFT[2]
                                    HAFT[2]
                                    Median
                                     Mean
                                  Std.  Dev.
Hops cones, green
                                  0.580-0.633
                                   (650-710)
                                      2-4
                                       6
                                     1.78
                                     8.50
                                     1.78
                                     8.50
                                     3.57
                                     4.16
                                     2.31
Hops cones, dried

                                      2-4
                                       6
                                     13.3
                                     34.4
                                     13.3
                                     34.4
                                     22.8
                                     24.7
                                     8.98
1. Except for sample min/max, values reflect per trial averages; n = number of field trials.
2. LAFT = Lowest Average Field Trial; HAFT = Highest Average Field Trial.

Hops (MRID #49145407 & -08) Conclusions:  Following two foliar directed applications of the 4 lb ai/gal (500 g ai/L) SC formulation of metrafenone at 0.580-0.633 lb ai/A (650-710 g ai/ha), residues (and per trial averages) of metrafenone in green hops cones and dried hops cones, respectively, harvested at a 2- to 4-day PHI were 1.78-8.50 (1.78-8.50) and 13.3-34.4 (13.3-34.4) ppm.  In the residue decline trials, residues of metrafenone in green hops cones generally declined with increasing PHI in four of the six trials, but remained relatively stable in two trials from the 0-day PHI to 7-day PHI.

Acceptable methods were used for quantitation of residues, and the study is supported by adequate storage stability data.

Peach (MRID #49145401):  IR-4 submitted field trial residue data for metrafenone on peach.  Fourteen peach field trials were conducted in the United States and Canada during the 2011 growing season in NAFTA Growing Zones 1 (NY; 1 trial), 2 (NJ and NC; 4 trials), 4 (AR; 1 trial), 5A (MI; 1 trial), 5 (ON; 2 trials), 6 (TX; 1 trial), 10 (CA; 3 trials) and 11 (BC; 1 trial). HED has determined that two Zone 10 and two Zone 5 peach trials should be considered replicates for purposes of OCSPP Residue Chemistry Test Guideline 860.1500 data requirements.  The above field trial distribution incorporates this conclusion.

Each trial consisted of one untreated plot and one treated plot. At each trial location, the treated plot received two foliar directed applications of a 2.5 lb ai/gal SC formulation of metrafenone (BAS560 03 F SC) at 0.291-0.307 lb ai/A/application (326.2-344.2 g ai/ha/application) for a total seasonal rate of 0.583-0.610 lb ai/A (653.6-683.9 g ai/ha).  Applications were made at 6- to 8-day RTIs using ground equipment in spray volumes of 104-182 GPA (973-1701 L/ha).  An NIS, COC or OSS was added to the spray mixtures for all applications.  Samples of peaches were harvested at PHIs of 6-8 days and 13-15 days at all trial sites.  Additional samples of peaches were collected from two trials at PHIs of 0, 3, 15/17 and 17/21 days to generate residue decline data.

Samples of peaches were analyzed for residues of metrafenone using an LC/MS/MS method derived from a QuEChERS Method #R00033. The LOQ, determined as the LLMV, was 0.01 ppm.  The method was adequate for data collection, based on acceptable method validation and concurrent recovery data.  The fortification levels used in method validation and concurrent method recovery were adequate to bracket expected residue levels.  Concurrent recoveries and residues in the treated samples were not corrected for residues in controls.

Samples were transferred to a sample preparation facility for homogenization prior to shipment to the analytical laboratory.  Samples were stored frozen (frozen at the field sites, <=-5°C at the sample preparation facility, and temperature unspecified at the analytical laboratory) from collection to analysis for 297-397 days (9.8-13.1 months).  Samples were analyzed within 0-15 days of extraction.  Adequate storage stability data are available to support the sample storage conditions and durations.

The results from these trials are summarized in Table <IP_ADDRESS>, below.  Following two foliar directed applications of the 2.5 lb ai/gal SC formulation of metrafenone at 0.583-0.610 lb ai/A (653.6-683.9 g ai/ha), residues (and per trial averages) of metrafenone in peaches harvested at PHIs of 6-8 days and 13-15 days, respectively, were 0.041-0.520 (0.051-0.489) and 0.029-0.394 (0.035-0.355) ppm.  At the residue decline trials, residues of metrafenone in peaches declined with increasing PHI in peaches (results not shown here; see the DER for MRID #49145401 for further details).

TABLE <IP_ADDRESS>	Summary of Residue Data from Peach Field Trials with Metrafenone.
                                   Commodity
                                  Total Rate
                               lb ai/A (g ai/ha)
                                  PHI (days)
                            Residue Levels (ppm)[1]

                                       n
                                     Min.
                                     Max.
                                    LAFT[2]
                                    HAFT[2]
                                    Median
                                     Mean
                                  Std.  Dev.
Peach
                                  0.583-0.610
                                 (653.6-683.9)
                                      6-8
                                      14
                                     0.041
                                     0.520
                                     0.051
                                     0.489
                                     0.208
                                     0.211
                                     0.098

                                     13-15
                                      14
                                     0.029
                                     0.394
                                     0.035
                                     0.355
                                     0.142
                                     0.143
                                     0.075
1. Except for sample min/max, values reflect per trial averages; n = number of distinct field trials.
2. LAFT = Lowest Average Field Trial; HAFT = Highest Average Field Trial.

Peach Conclusions:  Following two foliar directed applications of the 2.5 lb ai/gal SC formulation of metrafenone at 0.583-0.610 lb ai/A (653.6-683.9 g ai/ha), residues (and per trial averages) of metrafenone in peaches harvested at PHIs of 6-8 days and 13-15 days, respectively, were 0.041-0.520 (0.051-0.489) and 0.029-0.394 (0.035-0.355) ppm.  At the residue decline trials, residues of metrafenone in peaches declined with increasing PHI in peaches.

An acceptable method was used for residue quantitation, and adequate storage stability data are available to support the sample storage conditions and durations.

Cucurbits (MRIDs #49145404, -05 & -06):  IR-4 has submitted field trial residue data for metrafenone on cantaloupe, cucumber and summer squash, the representative commodities of the cucurbit vegetable group 9, from 32 crop field trials conducted in the United States and Canada during the 2010 growing season.  Twelve cantaloupe trials were conducted in NAFTA Growing Zones 2 (GA and MD; 2 trials), 5 (OH and ON; 2 trials); 5B (QC; 1 trial), 6 (TX; 2 trials) and 10 (AZ, CA, and NM; 5 trials); six cucumber trials were conducted in Zones 2 (GA; 2 trials), 3 (FL, 1 trial), 5 (IA and MN; 2 trials) and 6 (OK; 1 trial); and fourteen squash trials were conducted in Zones 1 (NY; 1 trial), 2 (MD, NC, and SC; 3 trials), 3 (FL; 1 trial), 5 (ON; 2 trials), 5B (QC; 1 trial), 6 (TX; 2 trials), 10 (AZ and CA; 2 trials), 11 (WA; 1 trial) and 12 (BC; 1 trial).  Examination of the field trial records indicates that there were sufficient differences between the trials that each trial constitutes a separate trial for purposes of OCSPP Residue Chemistry Test Guideline 860.1500 data requirements.

Each trial consisted of one untreated and one treated plot.  At each trial location, the treated plot received three foliar broadcast or directed applications of a 2.5 lb ai/gal SC formulation of metrafenone (BAS560 03 F SC) at 0.286-0.316 lb ai/A/application (0.321-0.354 kg ai/ha/application) for a total seasonal rate of 0.884-0.936 lb ai/A (0.993-1.049 kg ai/ha).  Applications were made at 6-to 9-day RTIs using ground equipment in spray volumes of 29.2-74.2 GPA (273-693 L/ha).  At one ON squash trial, the first application was made in error at half the target application rate (0.124 lb ai/A; 0.139 kg ai/ha); therefore, the test substance was re-applied 3 days later at 0.312 lb ai/A (0.350 kg ai/ha), and the remaining two applications were made according to the study protocol.  This trial received a total of four applications for a total rate of 1.042 lb ai/A (1.168 kg ai/ha).  An NIS, MSO, COC or OSS was added to the spray mixtures for all applications.  Samples of cantaloupe, cucumber and summer squash were harvested at a PHI of 0 days.  Additional samples were collected from two trials for cantaloupe at PHIs of 1, 3, 7, 10/11 and 13/15 days, one trial for cucumber at PHIs of 1, 3, 7 and 10 days, and one trial for summer squash at PHIs of 1, 4, 6, 9 and 13 days to generate residue decline data.

Samples were analyzed for residues of metrafenone using an LC/MS/MS method derived from QuEChERS Method #R00033.  The LOQ, determined as the LLMV, was 0.01 ppm for metrafenone in all crop matrices.  The method was adequate for data collection, based on acceptable method validation and concurrent recovery data.  The fortification levels used in method validation and concurrent method recovery were adequate to bracket expected residue levels.  Concurrent recoveries were corrected for apparent residues in controls for cantaloupe and summer squash, but recoveries were not corrected for apparent residues in controls for cucumber.  Residues in treated samples were not corrected for residues in controls.

Samples of cucurbit vegetables were transferred to a sample preparation facility for homogenization prior to shipment to the analytical laboratory.  Samples of cucurbit vegetables were stored frozen (frozen at the field sites, <-10 or -5°C at the sample preparation facility, and -29 to -10°C at the analytical laboratories) from collection to analysis for 450-842 days (14.8-27.7 months).  Samples were analyzed within 0-2 days of extraction.  Adequate storage stability data are available to support the sample storage conditions and durations.

The results from these trials are summarized in Table <IP_ADDRESS>, below.  Following three (or four) foliar broadcast or directed applications of a 2.5 lb ai/gal SC formulation of metrafenone (BAS560 03 F SC) at a total seasonal rate of 0.884-1.042 lb ai/A (0.993-1.168 kg ai/ha), residues (and per trial averages) of metrafenone in cantaloupe, cucumber and summer squash harvested at a 0-day PHI, were 0.038-0.332 (0.038-0.282), 0.046-0.168 (0.053-0.157), and 0.067-0.357 (0.072-0.305) ppm, respectively.  It was noted that at the one summer squash trial in which four applications were made for a total seasonal rate of 1.042 lb ai/A, residues were consistent with those observed at other trials, and are included in the values reported above.  At the residue decline studies, residues of metrafenone generally declined with increasing PHI in cantaloupe, cucumbers and summer squash (results not shown here; see the DER for MRIDs #4914540, -05 and -06 for further details).

TABLE <IP_ADDRESS>	Summary of Residue Data from Cuburbit Field Trials with Metrafenone.
                                   Commodity
                                  Total Rate,
                                    lb ai/A
                                  (kg ai/ha)
                                  PHI (days)
                               Residues (ppm)[1]

                                       n
                                     Min.
                                     Max.
                                    LAFT[2]
                                    HAFT[2]
                                    Median
                                     Mean
                                   Std. Dev.
Cantaloupe
                                  0.886-0.936
                                 (0.993-1.049)
                                       0
                                      12
                                     0.038
                                     0.332
                                     0.038
                                     0.282
                                     0.143
                                     0.152
                                     0.068
Cucumber
                                  0.894-0.920
                                 (1.002-1.035)

                                       6
                                     0.046
                                     0.168
                                     0.053
                                     0.157
                                     0.099
                                     0.105
                                     0.038
Summer squash
                                  0.884-1.042
                                 (0.993-1.168)

                                      14
                                     0.067
                                     0.357
                                     0.072
                                     0.305
                                     0.127
                                     0.162
                                     0.079
1. Except for sample min/max, values reflect per trial averages; n = number of field trials.
2. LAFT = Lowest Average Field Trial; HAFT = Highest Average Field Trial.

Cucurbits Conclusions:  The submitted cucurbit vegetable field trial data are scientifically acceptable.  Following three (or four) foliar broadcast or directed applications of a 2.5 lb ai/gal SC formulation of metrafenone (BAS560 03 F SC) at a total seasonal rate of 0.884-1.042 lb ai/A (0.993-1.168 kg ai/ha), residues (and per trial averages) of metrafenone in cantaloupe, cucumber and summer squash harvested at a 0-day PHI, were 0.038-0.332 (0.038-0.282), 0.046-0.168 (0.053-0.157), and 0.067-0.357 (0.072-0.305) ppm, respectively.  It was noted that residues at the one summer squash trial in which four applications were made for a total seasonal rate of 1.042 lb ai/A, residues were consistent with those observed at other trials, and are included in the values reported above.  In the residue decline studies, residues of metrafenone generally declined with increasing PHI in cantaloupe, cucumbers and summer squash.

An acceptable method was used for residue quantitation, and the study is supported by adequate storage stability data.

5.3.2	Field Rotational Crops (860.1900)

A study investigating field accumulation in rotational crops has not been conducted with metrafenone, and is not required.

5.3.3	Processed Food and Feed (860.1520)

Apple (MRID #49055902):  An apple processing study was conducted to determine the potential for concentration of residues of metrafenone in apple processed fractions.  Two trials were conducted to generate samples for processing in NAFTA Growing Zones 1 (NY, one trial) and 11 (ID, one trial) during the 2010 growing season.

At each test location, one untreated control and one treated plot were established.  The treated plots received three foliar airblast applications of metrafenone (2.5 lb ai/gal SC) applying at roughly 1.68 kg ai/ha/application (1.5 lb ai/A/application), with a nominal 7-day RTI, resulting in a total exaggerated rate of roughly 5.0 kg ai/ha (4.5 lb ai/A/season).  The actual application rates were 1.67-1.71 kg ai/ha/application (1.49-1.53 lb ai/A/application), with 6- or 7-day RTIs, for a total rate of 5.1 kg ai/ha/season (4.52-4.53 lb ai/A/season).  The applications were made in 80-102 GPA of water (748-954 L/ha) using ground equipment (airblast sprayers).  An NIS adjuvant was added to the spray mixture for all applications.

At each site, one untreated control and one treated bulk apple RAC sample were harvested at normal crop maturity, at a 6- or 7-day PHI.  The samples were shipped to the processing facility, ACDS Research (North Rose, NY), where they were processed, according to simulated commercial procedures, into processed apple commodities (juice, wet pomace, apple sauce, canned apples, and dried apples).  Adequate descriptions of the processing procedures were provided, including material balance summaries.

The residues of parent metrafenone in apple RAC and processed commodity samples were quantitated using an LC/MS/MS multi-residue QuEChERS method (BASF Study #398340).  The method was successfully validated on dried apples in conjunction with this study prior to analysis of the field samples.  Acceptable concurrent method recovery data for each apple matrix were also obtained for metrafenone.  The validated LOQ for metrafenone residues in apple RAC and processed commodity samples was 0.01 ppm.  The method LOD was 0.003 ppm.

The processing residue results are summarized in Table <IP_ADDRESS>, below.  After three exaggerated rate applications of metrafenone (2.5 lb ai/gal SC) to apples at a rate of 1.68 kg ai/ha/application (roughly 5.0 kg ai/ha/season), metrafenone residues were 1.46 ppm (New York) and 2.17 ppm (Idaho) in two treated apple RAC samples (whole fruit) harvested at a 6- or 7-day PHI.  The apple RAC samples were separately processed, using simulated commercial processing procedures, into the currently EPA-regulated commodities of apple, wet pomace and juice.  Apple sauce, canned apples, and dried apples were also generated and collected for analysis.

Metrafenone residues were 0.28 ppm in juice, 1.88 ppm in wet pomace, 7.01 ppm in apple sauce, 0.20 ppm in canned apples, and 1.05 ppm in dried apples collected from New York.  Metrafenone residues were 0.49 ppm in juice, 2.37 ppm in wet pomace, 8.94 ppm in apple sauce, 0.23 ppm in canned apples, and 0.85 ppm in dried apples collected from Idaho.

A comparison of the residues in the RAC samples with those in each processed fraction indicated that metrafenone residues do not concentrate (processing factors <1X to 1.2X, average of two trials) in any apple processed commodities, with the exception of apple sauce, in which the processing factor was 4.5X on average, with individual results of 4.8X and 4.1X calculated from the samples collected at the sites in New York and Idaho, respectively.

The processing factors calculated in this study were less than the maximum theoretical concentration factor of >14X for apples (based on the maximum theoretical/experimental concentration factor; OCSPP 860.1520, Table 1), and 14X for apple pomace (based on the maximum observed experimental concentration factor; OCSPP 860.1520, Table 4).

The apple RAC and processed commodity samples were stored frozen for a maximum of 683 days (roughly 22 months) from collection to extraction for analysis.  Samples were analyzed on the day of extraction.  Processing was completed within 4 days of harvest.

Table <IP_ADDRESS>	Metrafenone Residues in Apple Processed Fractions.
                                   Trial ID
                              (City, State/Year)
                                Total Use Rate
                                    lb ai/A
                                  (kg ai/ha)
                                      PHI
                                    (days)
                                   Processed
                                   Commodity
                                  Metrafenone
                                Residues (ppm)
                                  Processing
                                   Factor[1]
                                    Average
                               Processing Factor
R080753
(Alton, NY/2010)

4.52
(5.06)

                                       7
                               Whole Fresh Fruit
                                     1.46
                                     NA[2]

                                  Juice (raw)
                                     0.276
                                     0.189
                                  <1 (0.2)

                                  Wet Pomace
                                     1.88
                                     1.29
                                      1.2

                                  Apple Sauce
                                     7.01
                                     4.80
                                      4.5

                                 Canned Apples
                                     0.204
                                     0.140
                                  <1 (0.1)

                                 Dried Apples
                                     1.05
                                     0.719
                                  <1 (0.6)
R080754
(Weiser, ID/2010)

4.53
(5.07)
                                       6
                               Whole Fresh Fruit
                                     2.17
                                      NA

                                  Juice (raw)
                                     0.489
                                     0.225

                                  Wet Pomace
                                     2.37
                                     1.09

                                  Apple Sauce
                                     8.94
                                     4.12

                                 Canned Apples
                                     0.226
                                     0.104

                                 Dried Apples
                                     0.851
                                     0.392

1. The processing factor was calculated by dividing the residue in the apple processed commodity by the residue in the apple RAC sample (LOQ = 0.01 ppm).
2. NA = Not Applicable (whole fresh fruit, the representative apple RAC sample).

Apple Conclusions:  A comparison of the residues in the RAC with those in each processed fraction indicated that metrafenone residues do not concentrate appreciably (<1X to 1.2X on average) in any apple processed commodities, with the exception of apple sauce, in which the processing factor was 4.5X on average.  The observed concentration factors were less than the theoretical concentration factors.

An acceptable method was used for residue quantitation, and the study is supported by adequate storage stability data.

Tomato (MRID #49119109):  Tomato processing studies were conducted to determine the potential for concentration of residues of metrafenone (BAS 560 F) in the processed fractions of tomato.

During the 2010 growing season, four tomato field trials were conducted in Germany at 04668 Motterwitz, Saxony; 04827 Gerichshain, Saxony; 19348 Düpow, Brandenburg; and 16248 Oderberg, Brandenburg.  At each location a treated plot was established; two of the trials also included an untreated control plot.

The treated plots received two foliar applications of metrafenone (4.2 lb ai/gal SC, formulation code BAS 560 02 F) targeting 0.60 lb ai/A/application (0.675 kg ai/ha/application) with a nominal 7-day RTI, resulting in a total rate of 1.2 lb ai/A (1.35 kg ai/ha/season).  The actual application rates were 0.54-0.65 lb ai/A/application (0.61-0.73 kg ai/ha/application), with 6-8 day RTIs, resulting in a total rate of 1.18-1.28 lb ai/A/season (1.32-1.44 kg ai/ha/season).  The applications were made in 48-58 GPA of water (450-544 L/ha) using ground equipment, and no adjuvant was added to the spray mixtures.

At each location, tomato RAC samples (fruit) were harvested at PHIs of 0 and 3 or 4 days.  The bulk tomato samples collected at 3- or 4-day PHIs at each site were promptly processed, according to simulated commercial procedures, into tomato processed fractions.

The tomato RAC and processed commodity samples were analyzed for residues of metrafenone by SGS Institut Fresenius GmbH, Taunusstein, Germany, using BASF Method Number 535/1 (L0076/01).  Acceptable concurrent method recovery data for tomato RAC and processed commodity samples were obtained for metrafenone.  The validated LOQ for residues of metrafenone in tomato RAC and processed commodity samples was 0.01 ppm.

As summarized below in Table <IP_ADDRESS>, the results from the processing study show that after two applications of metrafenone targeting 0.60 lb ai/A/application (0.675 kg ai/ha/application), metrafenone in treated tomato RAC samples (unwashed whole fruit) collected at 0- and 3- to 4-day PHIs were 0.675-1.189 ppm and 0.40-0.78 ppm, respectively (n=4 for each sampling interval).

A total of four separate treated bulk samples were processed for a total of four processing tests.  The treated bulk tomato RAC samples harvested at 3- or 4-day PHIs and bearing quantifiable metrafenone residues (levels discussed above) were separately processed using simulated commercial processing procedures into paste and puree, the currently EPA-regulated commodities of tomato.  In addition, blanched tomatoes, blanching water, canned tomatoes, peeled tomatoes, wash water, tomato peel, wet pomace, washed tomatoes, raw juice, ketchup after pasteurization, and vegetable stock were collected for analysis.  A comparison of the residues in the RAC with those in each processed fraction indicates that residues of metrafenone do not concentrate in tomato processed commodities with the exception of peel and wet pomace, in which residues concentrate, on average, by factors of 6.3X (range, 3.51-7.86X, n=4) and 5.1X (range, 3.31-6.16X, n=4), respectively.

The processing factors calculated in this study were greater than the maximum theoretical concentration factors of 1.4X for tomato puree and 5.5X for tomato paste (based on loss of water; OCSPP 860.1520, Table 2) and 1.4X for tomato juice (based on separation into components; OCSPP 860.1520, Table 3).

The tomato RAC and processed commodity samples were stored frozen for a maximum of 165 days (5.4 months) from collection to analysis for residues of metrafenone.

TABLE <IP_ADDRESS>	Metrafenone Residues in Tomato Processed Fractions
                                Trial Location
                             (City, Country/ Year)
                                  Total Rate
                                   lbs ai/A
                                  (kg ai/ha)
                                   Processed
                                   Commodity
                                      PHI
                                   (Days)[1]
                                  Metrafenone
                             Processing Factor[2]
04668 Motterwitz, Saxony, Germany/2010 (L100261)
1.26 (1.41)
                                Fruit, 0 PHI[3]
                                       0
                                     0.675
                                      ---

                                Fruit, 3 PHI[3]
                                       3
                                     0.401
                                      ---

                                 Fruit, RAC[4]

                                     0.423
                                      1.0

                               Blanched tomatoes

                                     0.353
                                     0.83

                                Blanching water

                                   < 0.01
                                     0.02

                                Canned tomatoes

                                   < 0.01
                                     0.02

                                Peeled tomatoes

                                   < 0.01
                                     0.02

                                  Wash water

                                     0.066
                                     0.16

                                  Tomato peel

                                     3.184
                                     7.53

                                  Wet pomace

                                     2.034
                                     4.81

                                Washed tomatoes

                                     0.382
                                     0.90

                                   Raw juice

                                     0.168
                                     0.40

                         Ketchup after pasteurization

                                     0.177
                                     0.42

                                     Paste

                                     0.225
                                     0.53

                                     Puree

                                     0.335
                                     0.79

                                Vegetable stock

                                   < 0.01
                                     0.02
04827 Gerichshain, Saxony, Germany/2010 (L100262)
1.28 (1.44)
                                Fruit, 0 PHI[3]
                                       0
                                     0.962
                                      ---

                                Fruit, 3 PHI[3]
                                       3
                                     0.778
                                      ---

                                 Fruit, RAC[4]

                                     0.775
                                      1.0

                               Blanched tomatoes

                                     0.352
                                     0.45

                                Blanching water

                                     0.013
                                     0.02

                                Canned tomatoes

                                     0.015
                                     0.02

                                Peeled tomatoes

                                   < 0.01
                                     0.01

                                  Wash water

                                     0.507
                                     0.65

                                  Tomato peel

                                     4.807
                                     6.20

                                  Wet pomace

                                     2.567
                                     3.31

                                Washed tomatoes

                                     0.477
                                     0.62

                                   Raw juice

                                     0.198
                                     0.26

                         Ketchup after pasteurization

                                     0.327
                                     0.42

                                     Paste

                                     0.207
                                     0.27

                                     Puree

                                     0.501
                                     0.65

                                Vegetable stock

                                   < 0.01
                                     0.01
19348 Düpow, Brandenburg, Germany/2010 (L100263)
1.18 (1.32)
                                Fruit, 0 PHI[3]
                                       0
                                     1.189
                                      ---

                                Fruit, 4 PHI[3]
                                       4
                                     0.782
                                      ---

                                 Fruit, RAC[4]

                                     0.583
                                      1.0

                               Blanched tomatoes

                                     0.528
                                     0.91

                                Blanching water

                                     0.017
                                     0.03

                                Canned tomatoes

                                   < 0.01
                                     0.02

                                Peeled tomatoes

                                     0.013
                                     0.02

                                  Wash water

                                     0.218
                                     0.37

                                  Tomato peel

                                     4.585
                                     7.86

                                  Wet pomace

                                     3.592
                                     6.16

                                Washed tomatoes

                                     0.488
                                     0.84

                                   Raw juice

                                     0.194
                                     0.33

                         Ketchup after pasteurization

                                     0.219
                                     0.38

                                     Paste

                                     0.174
                                     0.30

                                     Puree

                                     0.487
                                     0.84

                                Vegetable stock

                                   < 0.01
                                     0.02
16248 Oderberg, Brandenburg, Germany/2010 (L100264)
1.18 (1.32)
                                Fruit, 0 PHI[3]
                                       0
                                     0.925
                                      ---

                                Fruit, 3 PHI[3]
                                       3
                                     0.435
                                      ---

                                 Fruit, RAC[4]

                                     0.452
                                      1.0

                               Blanched tomatoes

                                     0.398
                                     0.88

                                Blanching water

                                     0.012
                                     0.03

                                Canned tomatoes

                                   < 0.01
                                     0.02

                                Peeled tomatoes

                                     0.01
                                     0.02

                                  Wash water

                                     0.152
                                     0.34

                                  Tomato peel

                                     1.588
                                     3.51

                                  Wet pomace

                                     2.679
                                     5.93

                                Washed tomatoes

                                     0.242
                                     0.54

                                   Raw juice

                                     0.149
                                     0.33

                         Ketchup after pasteurization

                                     0.211
                                     0.47

                                     Paste

                                     0.201
                                     0.44

                                     Puree

                                     0.478
                                     1.06

                                Vegetable stock

                                   < 0.01
                                     0.02
1. The pre-harvest interval (PHI) for the bulk tomato RAC sample.
2. The processing factor is calculated by dividing the residue in the processed fraction by the mean residue in the tomato RAC sample.  Processing factor  is equivalent to "transfer factor".
3. Result from the analysis of the smaller tomato fruit RAC sample.
4. Result from the representative "fresh fruit" sample collected at the processing facility.

Tomato Conclusions:  A comparison of the residues in the RAC with those in each processed fraction indicated that residues of metrafenone do not concentrate in tomato processed commodities with the exception of peel and wet pomace, in which residues concentrate, on average, by factors of 6.3X and 5.1X, respectively.  The mean transfer factor of tomato peel and wet pomace (>1) indicates that the metrafenone residues are mainly located in the peel of the tomatoes.

An acceptable method was used for residue quantitation, and the study is supported by adequate storage stability data.

5.3.4	Meat, Milk, Poultry and Eggs (860.1480)
	Metabolism DER for MRID #49267201 (Goat)

The only livestock feed item associated with the proposed metrafenone new uses is apple wet pomace, and it is fed only to dairy cattle, at a mazimum of 10% of the diet.  Twelve apple field trials were conducted, with a HAFT value of 0.760 ppm.  An average processing factor of 1.2 was determined for apple wet pomace in the apple processing study (MRID #49055902).  Therefore, the adjusted metrafenone residues in apple pomace are 0.760 ppm x 1.2 PF = 0.912 ppm.

When goats in the metabolism study were dosed at 87 ppm in the feed, the highest metrafenone residue in tissues was in liver at 0.269 ppm.  Scaling down to the anticipated dietary burden to dairy cattle of 0.228 mg/kg in feed, anticipated metrafenone residues are not expected to exceed 0.000705 ppm in liver, well below the LOD.  Residues would occur at lower levels in muscle, fat and milk.  Ergo, there is no reasonable expectation of residues above the LOQ of 0.01 ppm in the milk or tissues of ruminant animals.

TABLE 5.3.4	Dietary Burden to Dairy Cattle from Metrafenone.
                                   Feedstuff
                               Feedstuff Type[1]
                                % Dry Matter 2
                                   % Diet[2]
                              Feeding Level (ppm)
                         Dietary Contribution (ppm)[3]
                                 Dairy Cattle
                               Apple wet pomace
                                      CC
                                      40
                                      10
                                     0.912
                                     0.228
                                 TOTAL BURDEN
                                      --
                                      --
                                     10[4]
                                     0.912
                                     0.228
1. CC = Carbohydrate Concentrate.
2. OCSPP Residue Chemistry Test Guideline 860.1000, Table 1 Feedstuffs (30 June 2008).
3. Contribution = (tolerance / % DM x % diet) for beef and dairy cattle.
4. The remainder of the diet will be composed of feedstuffs (roughage and protein concentrate sources) derived from crops that do not have registered metrafenone uses or tolerances.

Conclusions:  Based on the dietary burden to dairy cattle of metrafenone residues in apple wet pomace, and the results of the goat metabolism study, it is not expected that detectable residues would be found in cattle commodities.  Therefore, tolerances in livestock commodities are not required, nor is a livestock feeding study required.

5.3.5	Food Handling (860.1460)

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

5.3.6	Water, Fish, and Irrigated Crops (860.1400)

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

5.4	Food Residue Profile

Residues of metrafenone from the new uses proposed in the current action are expected to vary from low (up to 0.70 ppm in apricot and peaches) to high levels (up to 70 ppm in dried hops cones).

6.0	  Tolerance Derivation

Adequate pome fruit field trial data were submitted in support of the proposed use.  The submitted data support the proposed tolerance of 1.5 ppm in pome fruits (group 11-10).

Adequate fruiting vegetable field trial data were submitted in support of the proposed use.  The submitted data support a recommended tolerance of 0.90 ppm, rather than the proposed tolerance of 1.0 ppm, in fruiting vegetables (group 8-10).

Adequate cucurbit vegetable field trial data were submitted in support of the proposed use.  The submitted data support the proposed tolerance of 0.5 ppm in cucurbit vegetables (group 9); HED recommends that the tolerance be established at 0.50 ppm.

Adequate cherry field trial data were submitted in support of the proposed use.  The submitted data support the proposed tolerance of 2 ppm in the cherry subgroup (12-12A); HED recommends that the tolerance be established at 2.0 ppm.

Adequate peach field trial data were submitted in support of the proposed use.  The submitted data support the proposed tolerance of 0.7 ppm in the peach subgroup (12-12B); HED recommends that the tolerance be established at 0.70 ppm.

Adequate hops field trial data were submitted in support of the proposed use.  The submitted data support the proposed tolerance of 70 ppm in hops.

The proposed tolerance of 4.5 ppm in small vine climbing fruits except fuzzy kiwifruit (subgroup 13-07F) is based upon existing data for grapes (the representative commodity for the subgroup).  Upon establishment of the tolerance in subgroup 13-07F, the existing tolerance in grapes should be removed.

The proposed tolerance of 0.7 ppm in apricots is based upon the submitted data for peaches.  HED recommends that the tolerance be established at 0.70 ppm.

The rationales for the establishment and concurrent removal of tolerances associated with the current action are listed in Table 6, below.

An International Residue Limit Status sheet is appended as Attachment 1.  Data sets and results from the OECD tolerance calculation procedure for the various commodities are appended as Attachment 2.

TABLE 6	Tolerance Summary for Metrafenone (40CFR §624[a]).
                                   Commodity
                           Existing Tolerance (ppm)
                          Recommended Tolerance (ppm)
                                   Rationale
Apricot
                                     None
                                     0.70
Based on submitted peach data.
Cherry subgroup 12-12A
                                     None
                                      2.0
Based on submitted cherry data.
Fruit, pome, group 11-10
                                     None
                                      1.5
Based on submitted pome fruits data.
Fruit, small, vine climbing, except fuzzy kiwifruit, subgroup 13-07F
                                     None
                                      4.5
Based on data supporting the existing tolerance in grape.
Grape
                                      4.5
                                    Remove
Covered by the subgroup 13-07F tolerance to be established.
Hop, dried cones
                                     None
                                      70
Based on submitted hops data.
Peach subgroup 12-12B
                                     None
                                     0.70
Based on submitted peach data.
Vegetable, cucurbit, group 9
                                     None
                                     0.50
Based on submitted cucurbit data.
Vegetable, fruiting, group 8-10
                                     None
                                     0.90
Based on submitted fruiting vegetable data.

References

Metrafenone.  Petition for the Establishment of Tolerances on Imported Grapes.  Summary of Analytical Chemistry and Residue Data.  PP#4E6884.; D312307; D. McNeilly.  24 August 2006.

Metrafenone:  Human Health Risk Assessment for Foliar Use on Grapes.; D354166; D. McNeilly; 1 March 2010.

Metrafenone.  Report of the Residues of Concern Knowledgebase Subcommittee (ROCKS).; D370903; G.F. Kramer; 18 Nov 2009.

Metrafenone: Chronic Aggregate Dietary Exposure (Food and Drinking Water) and Risk Assessment for the Section 3 Registration on Grapes.; D371367; D. McNeilly; 18 February 2010.

Metrafenone.  Application for Section 3 Registration for Use on Grape.  Summary of Analytical Chemistry and Residue Data.; D331685; D. McNeilly; 18 February 2010.

PP#4E6884.  New Chemical, Food Use of Metrafenone on Table and Wine Grapes.  Request for Petition Method Validation (PMV) of the Proposed Tolerance Enforcement Methods.; D331185; D. McNeilly; 3 August 2006.

Review of Proposed Tolerance Enforcement Method for Metrafenone.; ACB Project #B06-38. D. Wright, D. McNeilly; 29 September 2008.

Drinking Water Assessment for the Proposed Uses of Metrafenone [(3-bromo-6-methyoxy-2-methylphenyl) (2,3,4-trimethoxy-6-methylphenyl) methanone] on Pome Fruits, Fruiting Vegetables, Peach Subgroup 12-12B, Apricot, Cherry Subgroup 12-12A, Cucurbit Vegetables (Group 9), and Fruit, Small, Vine Climbing (except Fuzzy Kiwifruit) Subgroup 13-07F; D411540, D414403, D416312; J.A. Hetrick; 25 November 2013.

Metrafenone.  Review of Residue Data from Hops Field Trials  -  Statistical Test for Outlier.; D421923; Bayazid Sarkar; 21 August 2014.

Attachments

Attachment 1:  International Residue Limit Status sheet.
Attachment 2:  OECD MRL (Tolerance) Assessment Calculations.

Attachment 1:  International Residue Limit Status

                         Metrafenone (PC Code 000325)
      Summary of US Tolerances and International Maximum Residue Limits.
                              Residue Definitions
                             US (40CFR §180.624)
                                    Canada
                                     Codex
Plants:  Metrafenone (3-bromo-6-methoxy-2-methylphenyl)(2,3,4-trimethoxy-6-methylphenyl)methanone.
Metrafenone (3-bromo-6-methoxy-2-methylphenyl)(2,3,4-trimethoxy-6-methylphenyl)methanone.

                                 Commodity[2]
                              Tolerance (ppm)[3]
                                   Commodity
                                  MRL (mg/kg)
                                   Commodity
                                  MRL (mg/kg)
Apricot
                                     0.70

Cherry subgroup 12-12A
                                      2.0

Fruit, small, vine climbing, except fuzzy kiwifruit, subgroup 13-07F
                                      4.5
Grapes
Raisins
                                      4.5
                                      17

Fruits, pome, group 11-10
                                      1.5

Hop, cones, dried
                                      70

Peach subgroup 12-12B
                                     0.70

Vegetable, cucurbit, group 9
                                     0.50

Vegetables, fruiting, group 8-10
                                     0.90

Completed:  M. Negussie, 12 November 2013.
1. Mexico adopts US tolerances, and/or Codex MRLs, for its export purposes.
2. Includes only commodities of interest for this action.
3. Tolerance values are those recommended by HED, not those proposed by the petitioner.

Attachment 2:  OECD MRL (Tolerance) Assessment Calculations.

Apple

Residues (mg/kg)
                                     0.218
                                     0.158
                                     0.492
                                     0.446
                                     0.360
                                     0.230
                                     0.214
                                     0.314
                                     0.141
                                     0.155
                                     0.165
                                     0.078
                                     0.536
                                     0.760
                                     0.392

                                  Metrafenone

                                     Apple

                                      USA

                            0.90 lb ai/A, 7-day PHI

Total number of data (n)
                                      15

Percentage of censored data
                                      0%

Number of non-censored data
                                      15

Lowest residue
                                     0.078

Highest residue
                                     0.760

Median residue
                                     0.230

Mean
                                     0.311

Standard deviation (SD)
                                     0.187

Correction factor for censoring (CF)
                                     1.000

Proposed MRL estimate

- Highest residue
                                     0.760

- Mean + 4 SD
                                     1.058

- CF x 3 Mean
                                     0.932

Unrounded MRL
                                     1.058

Rounded MRL
                                      1.5

Pear

Residues (mg/kg)
                                     0.405
                                     0.409
                                     0.189
                                     0.141
                                     0.160
                                     0.477
                                     0.392

                                  Metrafenone

                                     Pear

                                      USA

                            0.90 lb ai/A, 7-day PHI

Total number of data (n)
                                       7

Percentage of censored data
                                      0%

Number of non-censored data
                                       7

Lowest residue
                                     0.141

Highest residue
                                     0.477

Median residue
                                     0.392

Mean
                                     0.310

Standard deviation (SD)
                                     0.141

Correction factor for censoring (CF)
                                     1.000

Proposed MRL estimate

- Highest residue
                                     0.477

- Mean + 4 SD
                                     0.874

- CF x 3 Mean
                                     0.931

Unrounded MRL
                                     0.931

Rounded MRL
                                       1

 High uncertainty of MRL estimate.

[Small dataset]

Tomato

Residues (mg/kg)
                                     0.101
                                     0.228
                                     0.079
                                     0.110
                                     0.170
                                     0.105
                                     0.176
                                     0.246
                                     0.088
                                     0.285
                                     0.109
                                     0.095
                                     0.103
                                     0.234
                                     0.427
                                     0.099
                                     0.041
                                     0.222

                                  Metrafenone

                                   Tomatoes

                                      USA

                            0.90 lb ai/A, 0-day PHI

Total number of data (n)
                                      18

Percentage of censored data
                                      0%

Number of non-censored data
                                      18

Lowest residue
                                     0.041

Highest residue
                                     0.427

Median residue
                                     0.110

Mean
                                     0.162

Standard deviation (SD)
                                     0.096

Correction factor for censoring (CF)
                                     1.000

Proposed MRL estimate

- Highest residue
                                     0.427

- Mean + 4 SD
                                     0.547

- CF x 3 Mean
                                     0.486

Unrounded MRL
                                     0.547

Rounded MRL
                                      0.6

Pepper

Residues (mg/kg)
                                     0.417
                                     0.402
                                     0.148
                                     0.248
                                     0.270
                                     0.353
                                     0.081
                                     0.498

                                  Metrafenone

                             Bell/non-bell peppers

                                      USA

                            0.90 lb ai/A, 0-day PHI

Total number of data (n)
                                       8

Percentage of censored data
                                      0%

Number of non-censored data
                                       8

Lowest residue
                                     0.081

Highest residue
                                     0.498

Median residue
                                     0.312

Mean
                                     0.302

Standard deviation (SD)
                                     0.142

Correction factor for censoring (CF)
                                     1.000

Proposed MRL estimate

- Highest residue
                                     0.498

- Mean + 4 SD
                                     0.869

- CF x 3 Mean
                                     0.906

Unrounded MRL
                                     0.906

Rounded MRL
                                      0.9

Cherry

Residues (mg/kg)
                                     0.699
                                     0.393
                                     0.429
                                     0.494
                                     0.317
                                     0.738
                                     0.368
                                     0.438
                                     1.160
                                     0.492
                                     0.334
                                     0.596
                                     0.647
                                     0.547

                                  Metrafenone

                                    Cherry

                                      USA

                            0.60 lb ai/A, 7-day PHI

Total number of data (n)
                                      14

Percentage of censored data
                                      0%

Number of non-censored data
                                      14

Lowest residue
                                     0.317

Highest residue
                                     1.160

Median residue
                                     0.493

Mean
                                     0.547

Standard deviation (SD)
                                     0.221

Correction factor for censoring (CF)
                                     1.000

Proposed MRL estimate

- Highest residue
                                     1.160

- Mean + 4 SD
                                     1.430

- CF x 3 Mean
                                     1.640

Unrounded MRL
                                     1.640

Rounded MRL
                                       2

Hops

Residues (mg/kg)
                                    16.870
                                    21.890
                                    21.120
                                    23.520
                                    21.300
                                    22.800
                                    13.300
                                    19.700
                                    34.400
                                    33.100

                                  Metrafenone

                                     Hops

                                      USA

                            0.60 lb ai/A, 3-day PHI

Total number of data (n)
                                      10

Percentage of censored data
                                      0%

Number of non-censored data
                                      10

Lowest residue
                                    13.300

Highest residue
                                    34.400

Median residue
                                    21.595

Mean
                                    22.800

Standard deviation (SD)
                                     6.516

Correction factor for censoring (CF)
                                     1.000

Proposed MRL estimate

- Highest residue
                                    34.400

- Mean + 4 SD
                                    48.863

- CF x 3 Mean
                                    68.400

Unrounded MRL
                                    68.400

Rounded MRL
                                      70

Peach

Residues (mg/kg)
                                     0.211
                                     0.247
                                     0.227
                                     0.185
                                     0.166
                                     0.489
                                     0.208
                                     0.139
                                     0.208
                                     0.136
                                     0.051
                                     0.289
                                     0.222
                                     0.186

                                  Metrafenone

                                     Peach

                                      USA

                            0.60 lb ai/A, 7-day PHI

Total number of data (n)
                                      14

Percentage of censored data
                                      0%

Number of non-censored data
                                      14

Lowest residue
                                     0.051

Highest residue
                                     0.489

Median residue
                                     0.208

Mean
                                     0.212

Standard deviation (SD)
                                     0.098

Correction factor for censoring (CF)
                                     1.000

Proposed MRL estimate

- Highest residue
                                     0.489

- Mean + 4 SD
                                     0.604

- CF x 3 Mean
                                     0.635

Unrounded MRL
                                     0.635

Rounded MRL
                                      0.7

Cantaloupe

Residues (mg/kg)
                                     0.154
                                     0.226
                                     0.133
                                     0.088
                                     0.282
                                     0.177
                                     0.132
                                     0.038
                                     0.132
                                     0.209
                                     0.178
                                     0.080

                                  Metrafenone

                                  Cantaloupe

                                      USA

                            0.90 lb ai/A, 0-day PHI

Total number of data (n)
                                      12

Percentage of censored data
                                      0%

Number of non-censored data
                                      12

Lowest residue
                                     0.038

Highest residue
                                     0.282

Median residue
                                     0.144

Mean
                                     0.152

Standard deviation (SD)
                                     0.068

Correction factor for censoring (CF)
                                     1.000

Proposed MRL estimate

- Highest residue
                                     0.282

- Mean + 4 SD
                                     0.423

- CF x 3 Mean
                                     0.457

Unrounded MRL
                                     0.457

Rounded MRL
                                      0.5

Cucumber

Residues (mg/kg)
                                     0.100
                                     0.142
                                     0.084
                                     0.157
                                     0.053
                                     0.097

                                  Metrafenone

                                   Cucumber

                                      USA

                            0.90 lb ai/A, 0-day PHI

Total number of data (n)
                                       6

Percentage of censored data
                                      0%

Number of non-censored data
                                       6

Lowest residue
                                     0.053

Highest residue
                                     0.157

Median residue
                                     0.099

Mean
                                     0.106

Standard deviation (SD)
                                     0.038

Correction factor for censoring (CF)
                                     1.000

Proposed MRL estimate

- Highest residue
                                     0.157

- Mean + 4 SD
                                     0.258

- CF x 3 Mean
                                     0.317

Unrounded MRL
                                     0.317

Rounded MRL
                                      0.4

 High uncertainty of MRL estimate.

[Small dataset]

Summer Squash

Residues (mg/kg)
                                     0.305
                                     0.294
                                     0.125
                                     0.129
                                     0.101
                                     0.174
                                     0.072
                                     0.137
                                     0.216
                                     0.105
                                     0.100
                                     0.113
                                     0.277
                                     0.124

                                  Metrafenone

                                 Summer squash

                                      USA

                            0.90 lb ai/A, 0-day PHI

Total number of data (n)
                                      14

Percentage of censored data
                                      0%

Number of non-censored data
                                      14

Lowest residue
                                     0.072

Highest residue
                                     0.305

Median residue
                                     0.127

Mean
                                     0.162

Standard deviation (SD)
                                     0.079

Correction factor for censoring (CF)
                                     1.000

Proposed MRL estimate

- Highest residue
                                     0.305

- Mean + 4 SD
                                     0.476

- CF x 3 Mean
                                     0.487

Unrounded MRL
                                     0.487

Rounded MRL
                                      0.5