0801379000 8A   Tomato, juice                      2.000000   1.500  1.000  28
0801376000 8A   Tomato, paste                      0.110000   5.400  0.100
0801376001 8A   Tomato, paste-babyfood             0.110000   5.400  0.100
0801377000 8A   Tomato, puree                      0.110000   3.300  0.100
0801377001 8A   Tomato, puree-babyfood             0.110000   3.300  0.100
0801375001 8A   Tomato-babyfood                    2.000000   1.000  1.000  28
0902021000 9B   Balsam pear                        0.750000   1.000  1.000  20
0901075000 9A   Cantaloupe                         0.750000   1.000  1.000   8
0902088000 9B   Chayote, fruit                     0.750000   1.000  1.000  20
0902102000 9B   Chinese waxgourd                   0.750000   1.000  1.000  20
0902135000 9B   Cucumber                           0.750000   1.000  1.000  10
0901187000 9A   Honeydew melon                     0.750000   1.000  1.000   8
0902308000 9B   Pumpkin                            0.750000   1.000  1.000
0902309000 9B   Pumpkin, seed                      0.750000   1.000  1.000
0902356000 9B   Squash, summer                     0.750000   1.000  1.000  20
0902356001 9B   Squash, summer-babyfood            0.750000   1.000  1.000  20
0902357000 9B   Squash, winter                     0.750000   1.000  1.000  21
0902357001 9B   Squash, winter-babyfood            0.750000   1.000  1.000  21
0901399000 9A   Watermelon                         0.750000   1.000  1.000  26
0901400000 9A   Watermelon, juice                  0.750000   1.000  1.000  26
1100009000 11   Apple, dried                       0.001000   8.000  1.000
1100009001 11   Apple, dried-babyfood              0.001000   8.000  1.000
1100007000 11   Apple, fruit with peel             0.220000   1.000  1.000   2
1100010000 11   Apple, juice                       0.220000   1.000  1.000   3
1100010001 11   Apple, juice-babyfood              0.220000   1.000  1.000   3
1100008000 11   Apple, peeled fruit                0.220000   1.000  1.000   2
1100008001 11   Apple, peeled fruit-babyfood       0.220000   1.000  1.000   2
1100011000 11   Apple, sauce                       0.220000   1.000  1.000   4
1100011001 11   Apple, sauce-babyfood              0.220000   1.000  1.000   4
1100129000 11   Crabapple                          0.750000   1.000  1.000
1100173500 11   Goji berry                         2.000000   1.000  1.000
1100210000 11   Loquat                             0.750000   1.000  1.000
1100266000 11   Pear                               0.150000   1.000  1.000  15
1100267000 11   Pear, dried                        0.150000   6.250  1.000  15
1100268000 11   Pear, juice                        0.150000   1.000  1.000  15
1100268001 11   Pear, juice-babyfood               0.150000   1.000  1.000  15
1100266001 11   Pear-babyfood                      0.150000   1.000  1.000  15
1100310000 11   Quince                             0.750000   1.000  1.000
1202012000 12B  Apricot                            2.500000   1.000  1.000  27
1202013000 12B  Apricot, dried                     2.500000   6.000  1.000  27
1202014000 12B  Apricot, juice                     2.500000   1.000  1.000  27
1202014001 12B  Apricot, juice-babyfood            2.500000   1.000  1.000  27
1202012001 12B  Apricot-babyfood                   2.500000   1.000  1.000  27
1201090000 12A  Cherry                             2.500000   1.000  1.000   9
1201091000 12A  Cherry, juice                      2.500000   1.500  1.000   9
1201091001 12A  Cherry, juice-babyfood             2.500000   1.500  1.000   9
1201090001 12A  Cherry-babyfood                    2.500000   1.000  1.000   9
1202230000 12B  Nectarine                          2.500000   1.000  1.000  14
1202260000 12B  Peach                              2.500000   1.000  1.000  14
1202261000 12B  Peach, dried                       2.500000   7.000  1.000  14
1202261001 12B  Peach, dried-babyfood              2.500000   7.000  1.000  14
1202262000 12B  Peach, juice                       2.500000   1.000  1.000  14
1202262001 12B  Peach, juice-babyfood              2.500000   1.000  1.000  14
1202260001 12B  Peach-babyfood                     2.500000   1.000  1.000  14
1203285000 12C  Plum                               0.200000   1.000  1.000  29
1203287000 12C  Plum, prune, dried                 0.200000   5.000  1.000  29
1203287001 12C  Plum, prune, dried-babyfood        0.200000   5.000  1.000  29
1203286000 12C  Plum, prune, fresh                 0.200000   5.000  1.000  29
1203286001 12C  Plum, prune, fresh-babyfood        0.200000   5.000  1.000  29
1203288000 12C  Plum, prune, juice                 0.200000   1.400  1.000  29
1203288001 12C  Plum, prune, juice-babyfood        0.200000   1.400  1.000  29
1203285001 12C  Plum-babyfood                      0.200000   1.000  1.000  29
1301055000 13A  Blackberry                         5.000000   1.000  1.000  35
1301056000 13A  Blackberry, juice                  5.000000   1.000  1.000  35
1301056001 13A  Blackberry, juice-babyfood         5.000000   1.000  1.000  35
1301058000 13A  Boysenberry                        5.000000   1.000  1.000  35
1307130000 13G  Cranberry                          1.500000   1.000  1.000  22
1307131000 13G  Cranberry, dried                   1.500000   1.000  1.000  22
1307132000 13G  Cranberry, juice                   1.500000   1.100  1.000  22
1307132001 13G  Cranberry, juice-babyfood          1.500000   1.100  1.000  22
1307130001 13G  Cranberry-babyfood                 1.500000   1.000  1.000  22
1304175000 13D  Grape                              1.000000   1.000  1.000  11
1304176000 13D  Grape, juice                       1.000000   1.000  1.000  12
1304176001 13D  Grape, juice-babyfood              1.000000   1.000  1.000  12
1304179000 13D  Grape, wine and sherry             1.000000   1.000  1.000  12
1301208000 13A  Loganberry                         5.000000   1.000  1.000  35
1301320000 13A  Raspberry                          5.000000   1.000  1.000  35
1301321000 13A  Raspberry, juice                   5.000000   1.000  1.000  35
1301321001 13A  Raspberry, juice-babyfood          5.000000   1.000  1.000  35
1301320001 13A  Raspberry-babyfood                 5.000000   1.000  1.000  35
1307359000 13G  Strawberry                         1.500000   1.000  1.000  22
1307360000 13G  Strawberry, juice                  1.500000   1.000  1.000  22
1307360001 13G  Strawberry, juice-babyfood         1.500000   1.000  1.000  22
1307359001 13G  Strawberry-babyfood                1.500000   1.000  1.000  22
1400003000 14   Almond                             0.200000   1.000  1.000   1
1400004000 14   Almond, oil                        0.000500   1.000  1.000
1400004001 14   Almond, oil-babyfood               0.000500   1.000  1.000
1400003001 14   Almond-babyfood                    0.200000   1.000  1.000   1
1400059000 14   Brazil nut                         0.200000   1.000  1.000
1400068000 14   Butternut                          0.200000   1.000  1.000
1400081000 14   Cashew                             0.200000   1.000  1.000
1400092000 14   Chestnut                           0.200000   1.000  1.000
1400155000 14   Hazelnut                           0.200000   1.000  1.000
1400156000 14   Hazelnut, oil                      0.000500   1.000  1.000
1400185000 14   Hickory nut                        0.200000   1.000  1.000
1400213000 14   Macadamia nut                      0.200000   1.000  1.000
1400269000 14   Pecan                              0.200000   1.000  1.000  19
1400278000 14   Pine nut                           0.200000   1.000  1.000
1400282000 14   Pistachio                          0.200000   1.000  1.000
1400391000 14   Walnut                             0.200000   1.000  1.000  25
2003128000 20C  Cottonseed, oil                    0.750000   1.000  1.000
2003128001 20C  Cottonseed, oil-babyfood           0.750000   1.000  1.000
3100047000 31   Beef, fat                          0.100000   1.000  1.000
3100047001 31   Beef, fat-babyfood                 0.100000   1.000  1.000
3100048000 31   Beef, kidney                       0.020000   1.000  1.000
3100049000 31   Beef, liver                        0.020000   1.000  1.000
3100049001 31   Beef, liver-babyfood               0.020000   1.000  1.000
3100044000 31   Beef, meat                         0.020000   1.000  1.000
3100046000 31   Beef, meat byproducts              0.020000   1.000  1.000
3100046001 31   Beef, meat byproducts-babyfood     0.020000   1.000  1.000
3100045000 31   Beef, meat, dried                  0.020000   1.920  1.000
3100044001 31   Beef, meat-babyfood                0.020000   1.000  1.000
3200171000 32   Goat, fat                          0.100000   1.000  1.000
3200172000 32   Goat, kidney                       0.020000   1.000  1.000
3200173000 32   Goat, liver                        0.020000   1.000  1.000
3200169000 32   Goat, meat                         0.020000   1.000  1.000
3200170000 32   Goat, meat byproducts              0.020000   1.000  1.000
3300189000 33   Horse, meat                        0.020000   1.000  1.000
3400293000 34   Pork, fat                          0.100000   1.000  1.000
3400293001 34   Pork, fat-babyfood                 0.100000   1.000  1.000
3400294000 34   Pork, kidney                       0.020000   1.000  1.000
3400295000 34   Pork, liver                        0.020000   1.000  1.000
3400290000 34   Pork, meat                         0.020000   1.000  1.000
3400292000 34   Pork, meat byproducts              0.020000   1.000  1.000
3400292001 34   Pork, meat byproducts-babyfood     0.020000   1.000  1.000
3400290001 34   Pork, meat-babyfood                0.020000   1.000  1.000
3400291000 34   Pork, skin                         0.100000   1.000  1.000
3500341000 35   Sheep, fat                         0.100000   1.000  1.000
3500341001 35   Sheep, fat-babyfood                0.100000   1.000  1.000
3500342000 35   Sheep, kidney                      0.020000   1.000  1.000
3500343000 35   Sheep, liver                       0.020000   1.000  1.000
3500339000 35   Sheep, meat                        0.020000   1.000  1.000
3500340000 35   Sheep, meat byproducts             0.020000   1.000  1.000
3500339001 35   Sheep, meat-babyfood               0.020000   1.000  1.000
3600222000 36   Milk, fat                          0.020000   1.000  1.000
3600222001 36   Milk, fat-baby food/infant formu   0.020000   1.000  1.000
3600223000 36   Milk, nonfat solids                0.020000   1.000  1.000
3600223001 36   Milk, nonfat solids-baby food/in   0.020000   1.000  1.000
3600225001 36   Milk, sugar (lactose)-baby food/   0.020000   1.000  1.000
3600224000 36   Milk, water                        0.020000   1.000  1.000
3600224001 36   Milk, water-babyfood/infant form   0.020000   1.000  1.000
3800221000 38   Meat, game                         0.020000   1.000  1.000
3900312000 39   Rabbit, meat                       0.020000   1.000  1.000
8601000000 86A  Water, direct, all sources         0.037300   1.000  1.000
8602000000 86B  Water, indirect, all sources       0.037300   1.000  1.000

Attachment 7.  Bifenazate Acute RDFs.

Note:  Titles, spaces, and commas were added and hard returns deleted between data points in RDF files by the reviewer in order to condense the information.
Almond:  (RDF 1)
Almond(10 %CT) 2007-08 PDP data
TOTALZ=492
TOTALLOD=55
LODRES=0.005
Apple:  (RDF 2)
Apple(5 %CT) 2009 PDP data
TOTALZ=609
TOTALLOD=32
LODRES=0.02
Apple Juice:  (RDF 3)
Apple Juice(5 %CT) 2007-08 PDP data
TOTALZ=203
TOTALLOD=11
LODRES=0.01
Apple Sauce:  (RDF 4)
Apple Sauce(5 %CT) 2006 PDP data
TOTALZ=205
TOTALLOD=11
LODRES=0.01
Green Beans:  (RDF 5)
Green Beans(2.5 %CT) 2008 PDP data
TOTALZ=210
TOTALLOD=5
LODRES=0.01
Green Beans babyfood:  (RDF 6)
Green Beans babyfood(2.5 %CT) 2010 PDP data
TOTALZ=187
TOTALLOD=5
LODRES=0.0015
Blueberry:  (RDF 7)
Blueberry(30 %CT) 2008 PDP data
TOTALZ=148
TOTALLOD=63
LODRES=0.03
Note:  This RDF File was not used in the analysis.
Cantaloupe:  (RDF 8)
Cantaloupe(2.5 %CT) 2004-05 PDP data
TOTALZ=471
TOTALLOD=12
LODRES=0.007
Cherry:  (RDF 9)
Cherry (5 %CT) 2007 PDP data
TOTALZ=116
TOTALLOD=6
LODRES=0.01
Cucumber:  (RDF 10)
Cucumber (5 %CT) 2009-10 PDP data
TOTALZ=553
TOTALLOD=28
LODRES=0.02
0.02
Grape:  (RDF 11)
Grape(20 %CT) 2009-10 PDP data
TOTALZ=1191
TOTALLOD=278
LODRES=0.02
0.11, 0.073, 0.064, 0.052, 0.042, 0.019, 0.015, 0.014, 0.012, 0.005, 0.005, 0.005, 0.077, 0.07, 0.059, 0.045, 0.033, 0.033, 0.029, 0.027
Grape Juice:  (RDF 12)
Grape Juice(20 %CT) 2008 PDP data
TOTALZ=171
TOTALLOD=43
LODRES=0.01

Grape raisin:  (RDF 13)
Grape raisin(20 %CT) 2009-10 PDP data
TOTALZ=173
TOTALLOD=38
LODRES=0.01
0.067, 0.067, 0.067, 0.067, 0.067
Peach:  (RDF 14)
Peach(20 %CT) 2007-08 PDP data
TOTALZ=805
TOTALLOD=190
LODRES=0.015
0.084, 0.05, 0.05, 0.033, 0.11, 0.05, 0.05, 0.05, 0.05, 0.033, 0.033
Pear:  (RDF 15)
Pear(30 %CT) 2004-05 PDP data
TOTALZ=264
TOTALLOD=109
LODRES=0.01
0.033, 0.033, 0.033, 0.033
Pepper sweet bell:  (RDF 16)
Pepper sweet bell(10 %CT) 2010 PDP data
TOTALZ=670
TOTALLOD=74
LODRES=0.0085

Potato:  (RDF 17)
Potato(5 %CT) 2008-09 PDP data
TOTALZ=405
TOTALLOD=21
LODRES=0.02
Potato frozen:  (RDF 18)
Potato frozen(5 %CT) 2006-07 PDP data
TOTALZ=1105
TOTALLOD=58
LODRES=0.01
Pecan:  (RDF 19)
Pecan(2.5 %CT) Almond 2007-08 PDP data
TOTALZ=533
TOTALLOD=14
LODRES=0.005
Squash, summer:  (RDF 20)
Squash, summer(2.5 %CT) 2006-08 PDP data
TOTALZ=415
TOTALLOD=11
LODRES=0.01
Squash, winter:  (RDF 21)
Squash, winter(2.5 %CT) 2005-06 PDP data
TOTALZ=1299
TOTALLOD=33
LODRES=0.02
RDF 22 see below
Strawberry:  (RDF 22)
Strawberry(65 %CT) 2008-09 PDP data
TOTALZ=504
TOTALLOD=777
LODRES=0.03
0.55, 0.52, 0.46, 0.37, 0.32, 0.31, 0.23, 0.22, 0.22, 0.2, 0.18, 0.18, 0.18, 0.18, 0.16, 0.16, 0.15, 0.15, 0.14, 0.14, 0.14, 0.14, 0.14, 0.14, 0.13, 0.13, 0.13, 0.12, 0.11, 0.1, 0.096, 0.091, 0.088, 0.088, 0.085, 0.084, 0.083, 0.079, 0.077, 0.076, 0.07, 0.07, 0.069, 0.033, 0.033, 0.033, 0.033, 0.033, 0.033, 0.033, 0.033, 0.033, 0.033, 0.033, 0.03, 0.87, 0.81, 0.67, 0.62, 0.57, 0.56, 0.53, 0.5, 0.49, 0.45, 0.42, 0.4, 0.34, 0.33, 0.33, 0.32, 0.3, 0.29, 0.25, 0.23, 0.222, 0.22, 0.21, 0.19, 0.16, 0.16, 0.16, 0.15, 0.15, 0.15, 0.15, 0.15, 0.14, 0.14, 0.13, 0.13, 0.12, 0.12, 0.12, 0.11, 0.11, 0.11, 0.1, 0.1, 0.097, 0.094, 0.093, 0.079, 0.077, 0.073, 0.073, 0.07, 0.07, 0.07, 0.07, 0.07, 0.07, 0.07, 0.07, 0.07, 0.07, 0.07, 0.07, 0.07, 0.07, 0.07, 0.07, 0.07, 0.065, 0.064, 0.063, 0.059, 0.055, 0.053, 0.053, 0.048, 0.045, 0.042, 0.04, 0.04, 0.04, 0.039, 0.038, 0.036, 0.036, 0.036, 0.035, 0.035, 0.034, 0.034, 0.034, 0.033, 0.032, 0.031, 0.031, 0.029, 0.029, 0.029, 0.026, 0.025, 0.023, 0.022, 0.022, 0.019, 0.018
Sweet Potato:  (RDF 23)
Sweet Potato(5 %CT) 2009-10 PDP data
TOTALZ=725
TOTALLOD=38
LODRES=0.02
Sweet Potato babyfood:  (RDF 24)
Sweet Potato babyfood(5 %CT) 2009-10 PDP data
TOTALZ=181
TOTALLOD=10
LODRES=0.015
Walnut:  (RDF 25)
Walnut(5 %CT) 2007-08 PDP data
TOTALZ=520
TOTALLOD=27
LODRES=0.005
Watermelon:  (RDF 26)
Watermelon(2.5 %CT) 2005, 2006, 2010 PDP data
TOTALZ=362
TOTALLOD=9
LODRES=0.02
Apricot:  (RDF 27)
Apricot(10 %CT) Peach data 2007-08 PDP data
TOTALZ=888
TOTALLOD=88
LODRES=0.015
0.084, 0.05, 0.05, 0.033, 0.11, 0.05, 0.05, 0.05, 0.05, 0.033, 0.033
Tomato:  (RDF 28)
Tomato(10 %CT) FT data
TOTALZ=90
TOTALNZ=10
0.185, 0.14, 0.065, 0.035, 0.095, 0.035, 0.04, 0.135, 0.05, 0.345

Plum:  (RDF 29)
Plum (20 %CT) FT data
TOTALZ=28
TOTALNZ=7
0.13, 0.01, 0.035, 0.06, 0.035, 0.03, 0.035
Guava:  (RDF 30)
Guava (100 %CT) FT data
TOTALZ=0
TOTALNZ=6
0.26, 0.30, 0.039, 0.28, 0.24, 0.21
Avocado:  (RDF 31)
Avocado (100 %CT) translated from sugar apples FT data
TOTALZ=0
TOTALNZ=6
0.9890, 0.2284, 0.2097, 0.1504, 0.2297, 0.08628
Lychee:  (RDF 32)
Lychee (100 %CT) FT data
TOTALZ=0
TOTALNZ=6
2.8, 2.9, 3.6, 3.7, 2.2, 3.3
Papaya:  (RDF 33)
Papaya (100 %CT) FT data
TOTALZ=0
TOTALNZ=6
0.11, 0.14, 0.62, 1.89, 0.76, 0.81
Hops: (RDF 34)
Hops (100 %CT) Crop field trial data
TOTALZ=0
TOTALNZ=3
9.31, 7.79, 7.10
Caneberries: (RDF 35)
Caneberries FT Data 30%CT
TotalNZ = 8
TotalZ = 19
1.9, 3.25, 1.55, 1.45, 2.0, 1.3, 2.3, 3.55

Attachment 7.  Bifenazate Acute Results for Females 13 to 49 Years Old.

US EPA                                                      Ver. 3.18, 03-08-d
DEEM-FCID ACUTE Analysis for BIFENAZATE                  NHANES 2003-2008 2-Day
Residue file: 03_25_2014_Bifenazate_Acute.R08         Adjustment factor #2 used.
Analysis Date: 03-28-2014/10:58:10    Residue file dated: 03-25-2014/15:05:16
NOEL (Acute) =   1.000000 mg/kg body-wt/day
RAC/FF intake summed over 24 hours
MC iterations = 100; MC list in residue file; MC seed = 1000; RNG = MS VB
Run Comment: "aPAD for General Pop - 6 mg/kg/day; aPAD for Females 13 to 49 ye
ars - 0.1 mg/kg/day; cPAD - 0.01 mg/kg/day"
===============================================================================

Summary calculations--per capita:

---   95th Percentile----   ---   99th Percentile----     ---99.9th Percentile----
 Exposure  % aRfD     MOE    Exposure  % aRfD     MOE    Exposure  % aRfD     MOE
---------- ------- -------- ---------- ------- -------- ---------- ------- --------
Female 13-49:
  0.002774    2.77     360    0.004394    4.39     227    0.009941    9.94     100

Attachment 9.  Bifenazate Chronic Residue Input File.

Filename: J:\Work Files\$ Bifenazate\$$New\DEEM\03_25_2014_Tolerance levels_Bifenazate_chronic.R08
Chemical: Bifenazate
RfD(Chronic): 0 mg/kg bw/day  NOEL(Chronic): 1 mg/kg bw/day
RfD(Acute): 0 mg/kg bw/day  NOEL(Acute):  10 mg/kg bw/day
Date created/last modified: 08-20-2013/11:37:52       Program ver. 3.16, 03-08-d
Comment: aPAD for General Pop - 6 mg/kg/day; aPAD for Females 13 to 49 years - 0.1 mg/kg/day; cPAD - 0.01 mg/kg/day
--------------------------------------------------------------------------------
   EPA     Crop                                   Def Res     Adj.Factors   Comment
   Code     Grp  Commodity Name                    (ppm)       #1    #2
---------- ---- -------------------------------  ----------  ------ ------  ----
9500001000 O    Acerola                            0.900000   1.000  1.000
9500019500 O    Atemoya                            1.600000   1.000  1.000
9500020000 O    Avocado                            7.000000   1.000  1.000
9500074000 O    Canistel                           7.000000   1.000  1.000
9500089000 O    Cherimoya                          1.600000   1.000  1.000
9500151000 O    Feijoa                             0.900000   1.000  1.000
9500177000 O    Grape, leaves                      0.750000   1.000  0.100
9500178000 O    Grape, raisin                      1.200000   1.000  0.100
9500183000 O    Guava                              0.900000   1.000  1.000
9500183001 O    Guava-babyfood                     0.900000   1.000  1.000
9500188000 O    Hop                               15.000000   1.000  1.000
9500209000 O    Longan                             5.000000   1.000  1.000
9500211000 O    Lychee                             5.000000   1.000  1.000
9500212000 O    Lychee, dried                      5.000000   1.850  1.000
9500214000 O    Mamey apple                        7.000000   1.000  1.000
9500215000 O    Mango                              7.000000   1.000  1.000
9500216000 O    Mango, dried                       7.000000   1.000  1.000
9500217000 O    Mango, juice                       7.000000   1.000  1.000
9500217001 O    Mango, juice-babyfood              7.000000   1.000  1.000
9500215001 O    Mango-babyfood                     7.000000   1.000  1.000
9500245000 O    Papaya                             7.000000   1.000  1.000
9500246000 O    Papaya, dried                      7.000000   1.800  1.000
9500247000 O    Papaya, juice                      7.000000   1.500  1.000
9500245001 O    Papaya-babyfood                    7.000000   1.000  1.000
9500252000 O    Passionfruit                       0.900000   1.000  1.000
9500253000 O    Passionfruit, juice                0.900000   1.000  1.000
9500253001 O    Passionfruit, juice-babyfood       0.900000   1.000  1.000
9500252001 O    Passionfruit-babyfood              0.900000   1.000  1.000
9500275000 O    Peppermint                        25.000000   1.000  1.000
9500276000 O    Peppermint, oil                   25.000000   1.000  1.000
9500333000 O    Sapote, Mamey                      7.000000   1.000  1.000
9500346000 O    Soursop                            1.600000   1.000  1.000
9500351000 O    Spanish lime                       5.000000   1.000  1.000
9500352000 O    Spearmint                         25.000000   1.000  1.000
9500353000 O    Spearmint, oil                    25.000000   1.000  1.000
9500358000 O    Starfruit                          0.900000   1.000  1.000
9500361000 O    Sugar apple                        1.600000   1.000  1.000
0103015000 1CD  Arrowroot, flour                   0.100000   1.000  1.000
0103015001 1CD  Arrowroot, flour-babyfood          0.100000   1.000  1.000
0103017000 1CD  Artichoke, Jerusalem               0.100000   1.000  1.000
0103082000 1CD  Cassava                            0.100000   1.000  1.000
0103082001 1CD  Cassava-babyfood                   0.100000   1.000  1.000
0103139000 1CD  Dasheen, corm                      0.100000   1.000  1.000
0103166000 1CD  Ginger                             0.100000   1.000  1.000
0103167000 1CD  Ginger, dried                      0.100000   1.000  1.000
0103166001 1CD  Ginger-babyfood                    0.100000   1.000  1.000
0103296000 1C   Potato, chips
                   211-Cooked; Fresh or N/S; Baked
                                                   0.100000   1.000  0.050
                   213-Cooked; Fresh or N/S; Fried
                                                   0.100000   1.000  0.050
0103297000 1C   Potato, dry (granules/ flakes)
                   211-Cooked; Fresh or N/S; Baked
                                                   0.100000   6.500  0.050
                   212-Cooked; Fresh or N/S; Boiled
                                                   0.100000   6.500  0.050
                   213-Cooked; Fresh or N/S; Fried
                                                   0.100000   6.500  0.050
                   221-Cooked; Frozen; Baked       0.100000   6.500  0.050
                   230-Cooked; Dried; Cook Meth N/S
                                                   0.100000   6.500  0.050
                   232-Cooked; Dried; Boiled       0.100000   6.500  0.050
0103297001 1C   Potato, dry (granules/ flakes)-b   0.100000   6.500  0.050
0103298000 1C   Potato, flour
                   110-Uncooked; Fresh or N/S; Cook Meth N/S
                                                   0.100000   6.500  0.050
                   120-Uncooked; Frozen; Cook Meth N/S
                                                   0.100000   6.500  0.050
                   130-Uncooked; Dried; Cook Meth N/S
                                                   0.100000   6.500  0.050
                   140-Uncooked; Canned; Cook Meth N/S
                                                   0.100000   6.500  0.050
                   210-Cooked; Fresh or N/S; Cook Meth N/S
                                                   0.100000   6.500  0.050
                   211-Cooked; Fresh or N/S; Baked
                                                   0.100000   6.500  0.050
                   212-Cooked; Fresh or N/S; Boiled
                                                   0.100000   6.500  0.050
                   213-Cooked; Fresh or N/S; Fried
                                                   0.100000   6.500  0.050
                   214-Cooked; Fresh or N/S; Fried/baked
                                                   0.100000   6.500  0.050
                   221-Cooked; Frozen; Baked       0.100000   6.500  0.050
                   222-Cooked; Frozen; Boiled      0.100000   6.500  0.050
                   223-Cooked; Frozen; Fried       0.100000   6.500  0.050
                   230-Cooked; Dried; Cook Meth N/S
                                                   0.100000   6.500  0.050
                   231-Cooked; Dried; Baked        0.100000   6.500  0.050
                   232-Cooked; Dried; Boiled       0.100000   6.500  0.050
                   233-Cooked; Dried; Fried        0.100000   6.500  0.050
                   240-Cooked; Canned; Cook Meth N/S
                                                   0.100000   6.500  0.050
                   242-Cooked; Canned; Boiled      0.100000   6.500  0.050
                   250-Cooked; Cured etc; Cook Meth N/S
                                                   0.100000   6.500  0.050
                   251-Cooked; Cured etc; Baked    0.100000   6.500  0.050
                   252-Cooked; Cured etc; Boiled   0.100000   6.500  0.050
                   253-Cooked; Cured etc; Fried    0.100000   6.500  0.050
0103298001 1C   Potato, flour-babyfood
                   110-Uncooked; Fresh or N/S; Cook Meth N/S
                                                   0.100000   6.500  0.050
                   130-Uncooked; Dried; Cook Meth N/S
                                                   0.100000   6.500  0.050
                   211-Cooked; Fresh or N/S; Baked
                                                   0.100000   6.500  0.050
                   240-Cooked; Canned; Cook Meth N/S
                                                   0.100000   6.500  0.050
0103300000 1C   Potato, tuber, w/o peel
                   110-Uncooked; Fresh or N/S; Cook Meth N/S
                                                   0.100000   1.000  0.050
                   210-Cooked; Fresh or N/S; Cook Meth N/S
                                                   0.100000   1.000  0.050
                   211-Cooked; Fresh or N/S; Baked
                                                   0.100000   1.000  0.050
                   212-Cooked; Fresh or N/S; Boiled
                                                   0.100000   1.000  0.050
                   213-Cooked; Fresh or N/S; Fried
                                                   0.100000   1.000  0.050
                   221-Cooked; Frozen; Baked       0.100000   1.000  0.050
                   223-Cooked; Frozen; Fried       0.100000   1.000  0.050
                   232-Cooked; Dried; Boiled       0.100000   1.000  0.050
                   233-Cooked; Dried; Fried        0.100000   1.000  0.050
                   240-Cooked; Canned; Cook Meth N/S
                                                   0.100000   1.000  0.050
                   242-Cooked; Canned; Boiled      0.100000   1.000  0.050
                   252-Cooked; Cured etc; Boiled   0.100000   1.000  0.050
0103300001 1C   Potato, tuber, w/o peel-babyfood   0.100000   1.000  0.050
0103299000 1C   Potato, tuber, w/peel
                   110-Uncooked; Fresh or N/S; Cook Meth N/S
                                                   0.100000   1.000  0.050
                   210-Cooked; Fresh or N/S; Cook Meth N/S
                                                   0.100000   1.000  0.050
                   211-Cooked; Fresh or N/S; Baked
                                                   0.100000   1.000  0.050
                   212-Cooked; Fresh or N/S; Boiled
                                                   0.100000   1.000  0.050
                   213-Cooked; Fresh or N/S; Fried
                                                   0.100000   1.000  0.050
0103299001 1C   Potato, tuber, w/peel-babyfood     0.100000   1.000  0.050
0103366000 1CD  Sweet potato                       0.100000   1.000  1.000
0103366001 1CD  Sweet potato-babyfood              0.100000   1.000  1.000
0103371000 1CD  Tanier, corm                       0.100000   1.000  1.000
0103387000 1CD  Turmeric                           0.100000   1.000  1.000
0103407000 1CD  Yam bean                           0.100000   1.000  1.000
0103406000 1CD  Yam, true                          0.100000   1.000  1.000
0603035000 6C   Bean,  great northern, seed        0.600000   1.000  1.000
0603030000 6C   Bean, black, seed                  0.600000   1.000  1.000
0603032000 6C   Bean, broad, seed                  0.600000   1.000  1.000
0602031000 6B   Bean, broad, succulent             0.700000   1.000  1.000
0603034000 6C   Bean, cowpea, seed                 0.600000   1.000  1.000
0602033000 6B   Bean, cowpea, succulent
                   212-Cooked; Fresh or N/S; Boiled
                                                   0.700000   1.000  1.000
                   222-Cooked; Frozen; Boiled      0.700000   1.000  1.000
                   242-Cooked; Canned; Boiled      0.700000   1.000  1.000
0603036000 6C   Bean, kidney, seed                 0.600000   1.000  1.000
0603038000 6C   Bean, lima, seed                   0.600000   1.000  1.000
0602037000 6B   Bean, lima, succulent              0.700000   1.000  1.000
0603039000 6C   Bean, mung, seed                   0.600000   1.000  1.000
0603040000 6C   Bean, navy, seed                   0.600000   1.000  1.000
0603041000 6C   Bean, pink, seed                   0.600000   1.000  1.000
0603042000 6C   Bean, pinto, seed                  0.600000   1.000  1.000
0601043000 6A   Bean, snap, succulent              6.000000   1.000  0.010
0601043001 6A   Bean, snap, succulent-babyfood     6.000000   1.000  0.010
0603099000 6C   Chickpea, flour                    0.600000   1.000  1.000
0603098000 6C   Chickpea, seed                     0.600000   1.000  1.000
0603098001 6C   Chickpea, seed-babyfood            0.600000   1.000  1.000
0603182000 6C   Guar, seed                         0.600000   1.000  1.000
0603182001 6C   Guar, seed-babyfood                0.600000   1.000  1.000
0603203000 6C   Lentil, seed                       0.600000   1.000  1.000
0603256000 6C   Pea, dry                           0.600000   1.000  1.000
0603256001 6C   Pea, dry-babyfood                  0.600000   1.000  1.000
0601257000 6A   Pea, edible podded, succulent      6.000000   1.000  1.000
0603258000 6C   Pea, pigeon, seed                  0.600000   1.000  1.000
0602259000 6B   Pea, pigeon, succulent             0.700000   1.000  1.000
0602255000 6B   Pea, succulent                     0.700000   1.000  1.000
0602255001 6B   Pea, succulent-babyfood            0.700000   1.000  1.000
0600347000 6    Soybean, seed                      0.700000   1.000  1.000
0802148000 8BC  Eggplant                           4.000000   1.000  1.000
0802234000 8BC  Okra                               4.000000   1.000  1.000
0802270000 8B   Pepper, bell                       4.000000   1.000  0.050
0802271000 8B   Pepper, bell, dried                4.000000   1.000  0.050
0802271001 8B   Pepper, bell, dried-babyfood       4.000000   1.000  0.050
0802270001 8B   Pepper, bell-babyfood              4.000000   1.000  0.050
0802272000 8BC  Pepper, nonbell                    4.000000   1.000  0.050
0802273000 8BC  Pepper, nonbell, dried             4.000000   1.000  0.050
0802272001 8BC  Pepper, nonbell-babyfood           4.000000   1.000  0.050
0801374000 8A   Tomatillo                          4.000000   1.000  0.050
0801375000 8A   Tomato                             4.000000   1.000  0.050
0801380000 8A   Tomato, Tree                       4.000000   1.000  0.050
0801378000 8A   Tomato, dried                      4.000000  14.300  0.050
0801378001 8A   Tomato, dried-babyfood             4.000000  14.300  0.050
0801379000 8A   Tomato, juice                      4.000000   1.500  0.050
0801376000 8A   Tomato, paste                      4.000000   5.400  0.050
0801376001 8A   Tomato, paste-babyfood             4.000000   5.400  0.050
0801377000 8A   Tomato, puree                      4.000000   3.300  0.050
0801377001 8A   Tomato, puree-babyfood             4.000000   3.300  0.050
0801375001 8A   Tomato-babyfood                    4.000000   1.000  0.050
0902021000 9B   Balsam pear                        0.750000   1.000  1.000
0901075000 9A   Cantaloupe                         0.750000   1.000  0.010
0902088000 9B   Chayote, fruit                     0.750000   1.000  1.000
0902102000 9B   Chinese waxgourd                   0.750000   1.000  1.000
0902135000 9B   Cucumber                           0.750000   1.000  0.025
0901187000 9A   Honeydew melon                     0.750000   1.000  0.010
0902308000 9B   Pumpkin                            0.750000   1.000  0.025
0902309000 9B   Pumpkin, seed                      0.750000   1.000  0.025
0902356000 9B   Squash, summer                     0.750000   1.000  0.010
0902356001 9B   Squash, summer-babyfood            0.750000   1.000  0.010
0902357000 9B   Squash, winter                     0.750000   1.000  0.010
0902357001 9B   Squash, winter-babyfood            0.750000   1.000  0.010
0901399000 9A   Watermelon                         0.750000   1.000  0.010
0901400000 9A   Watermelon, juice                  0.750000   1.000  0.010
1100009000 11   Apple, dried                       0.750000   8.000  0.050
1100009001 11   Apple, dried-babyfood              0.750000   8.000  0.050
1100007000 11   Apple, fruit with peel             0.750000   1.000  0.050
1100010000 11   Apple, juice                       0.750000   1.000  0.050
1100010001 11   Apple, juice-babyfood              0.750000   1.000  0.050
1100008000 11   Apple, peeled fruit                0.750000   1.000  0.050
1100008001 11   Apple, peeled fruit-babyfood       0.750000   1.000  0.050
1100011000 11   Apple, sauce                       0.750000   1.000  0.050
1100011001 11   Apple, sauce-babyfood              0.750000   1.000  0.050
1100129000 11   Crabapple                          0.750000   1.000  1.000
1100173500 11   Goji berry                         4.000000   1.000  1.000
1100210000 11   Loquat                             0.750000   1.000  1.000
1100266000 11   Pear                               0.750000   1.000  0.150
1100267000 11   Pear, dried                        0.750000   6.250  0.150
1100268000 11   Pear, juice                        0.750000   1.000  0.150
1100268001 11   Pear, juice-babyfood               0.750000   1.000  0.150
1100266001 11   Pear-babyfood                      0.750000   1.000  0.150
1100310000 11   Quince                             0.750000   1.000  1.000
1202012000 12B  Apricot                            2.500000   1.000  0.050
1202013000 12B  Apricot, dried                     2.500000   6.000  0.050
1202014000 12B  Apricot, juice                     2.500000   1.000  0.050
1202014001 12B  Apricot, juice-babyfood            2.500000   1.000  0.050
1202012001 12B  Apricot-babyfood                   2.500000   1.000  0.050
1201090000 12A  Cherry                             2.500000   1.000  0.025
1201091000 12A  Cherry, juice                      2.500000   1.500  0.025
1201091001 12A  Cherry, juice-babyfood             2.500000   1.500  0.025
1201090001 12A  Cherry-babyfood                    2.500000   1.000  0.025
1202230000 12B  Nectarine                          2.500000   1.000  0.050
1202260000 12B  Peach                              2.500000   1.000  0.100
1202261000 12B  Peach, dried                       2.500000   7.000  0.100
1202261001 12B  Peach, dried-babyfood              2.500000   7.000  0.100
1202262000 12B  Peach, juice                       2.500000   1.000  0.100
1202262001 12B  Peach, juice-babyfood              2.500000   1.000  0.100
1202260001 12B  Peach-babyfood                     2.500000   1.000  0.100
1203285000 12C  Plum                               0.200000   1.000  0.050
1203287000 12C  Plum, prune, dried                 0.200000   5.000  0.050
1203287001 12C  Plum, prune, dried-babyfood        0.200000   5.000  0.050
1203286000 12C  Plum, prune, fresh                 0.200000   1.000  0.050
1203286001 12C  Plum, prune, fresh-babyfood        0.200000   1.000  0.050
1203288000 12C  Plum, prune, juice                 0.200000   1.400  0.050
1203288001 12C  Plum, prune, juice-babyfood        0.200000   1.400  0.050
1203285001 12C  Plum-babyfood                      0.200000   1.000  0.050
1301055000 13A  Blackberry                         5.000000   1.000  0.250
1301056000 13A  Blackberry, juice                  5.000000   1.000  0.250
1301056001 13A  Blackberry, juice-babyfood         5.000000   1.000  0.250
1301058000 13A  Boysenberry                        5.000000   1.000  0.250
1307130000 13G  Cranberry                          1.500000   1.000  1.000
1307131000 13G  Cranberry, dried                   1.500000   1.000  1.000
1307132000 13G  Cranberry, juice                   1.500000   1.100  1.000
1307132001 13G  Cranberry, juice-babyfood          1.500000   1.100  1.000
1307130001 13G  Cranberry-babyfood                 1.500000   1.000  1.000
1304175000 13D  Grape                              0.750000   1.000  0.100
1304176000 13D  Grape, juice                       0.750000   1.000  0.100
1304176001 13D  Grape, juice-babyfood              0.750000   1.000  0.100
1304179000 13D  Grape, wine and sherry             0.750000   1.000  0.100
1301208000 13A  Loganberry                         5.000000   1.000  0.250
1301320000 13A  Raspberry                          5.000000   1.000  0.250
1301321000 13A  Raspberry, juice                   5.000000   1.000  0.250
1301321001 13A  Raspberry, juice-babyfood          5.000000   1.000  0.250
1301320001 13A  Raspberry-babyfood                 5.000000   1.000  0.250
1307359000 13G  Strawberry                         1.500000   1.000  0.450
1307360000 13G  Strawberry, juice                  1.500000   1.000  0.450
1307360001 13G  Strawberry, juice-babyfood         1.500000   1.000  0.450
1307359001 13G  Strawberry-babyfood                1.500000   1.000  0.450
1400003000 14   Almond                             0.200000   1.000  0.050
1400004000 14   Almond, oil                        0.200000   1.000  0.050
1400004001 14   Almond, oil-babyfood               0.200000   1.000  0.050
1400003001 14   Almond-babyfood                    0.200000   1.000  0.050
1400059000 14   Brazil nut                         0.200000   1.000  1.000
1400068000 14   Butternut                          0.200000   1.000  1.000
1400081000 14   Cashew                             0.200000   1.000  1.000
1400092000 14   Chestnut                           0.200000   1.000  1.000
1400155000 14   Hazelnut                           0.200000   1.000  1.000
1400156000 14   Hazelnut, oil                      0.200000   1.000  1.000
1400185000 14   Hickory nut                        0.200000   1.000  1.000
1400213000 14   Macadamia nut                      0.200000   1.000  1.000
1400269000 14   Pecan                              0.200000   1.000  0.010
1400278000 14   Pine nut                           0.200000   1.000  1.000
1400282000 14   Pistachio                          0.200000   1.000  0.025
1400391000 14   Walnut                             0.200000   1.000  0.025
1901029000 19A  Basil, dried leaves              300.000000   1.000  1.000
1901029001 19A  Basil, dried leaves-babyfood     300.000000   1.000  1.000
1901028000 19A  Basil, fresh leaves               30.000000   1.000  1.000
1901028001 19A  Basil, fresh leaves-babyfood      30.000000   1.000  1.000
1901102500 19A  Chive, dried leaves              300.000000   1.000  1.000
1901118000 19A  Cilantro, leaves                  30.000000   1.000  1.000
1901118001 19A  Cilantro, leaves-babyfood         30.000000   1.000  1.000
1901144000 19A  Dillweed                          30.000000   1.000  1.000
1901184000 19A  Herbs, other                      30.000000   1.000  1.000
1901184001 19A  Herbs, other-babyfood             30.000000   1.000  1.000
1901202000 19A  Lemongrass                        30.000000   1.000  1.000
1901220000 19A  Marjoram                          30.000000   1.000  1.000
1901220001 19A  Marjoram-babyfood                 30.000000   1.000  1.000
1901249000 19A  Parsley, dried leaves            300.000000   1.000  1.000
1901249001 19A  Parsley, dried leaves-babyfood   300.000000   1.000  1.000
1901334000 19A  Savory                            30.000000   1.000  1.000
2003128000 20C  Cottonseed, oil                    0.750000   1.000  1.000
2003128001 20C  Cottonseed, oil-babyfood           0.750000   1.000  1.000
3100047000 31   Beef, fat                          0.100000   1.000  1.000
3100047001 31   Beef, fat-babyfood                 0.100000   1.000  1.000
3100048000 31   Beef, kidney                       0.020000   1.000  1.000
3100049000 31   Beef, liver                        0.020000   1.000  1.000
3100049001 31   Beef, liver-babyfood               0.020000   1.000  1.000
3100044000 31   Beef, meat                         0.020000   1.000  1.000
3100046000 31   Beef, meat byproducts              0.020000   1.000  1.000
3100046001 31   Beef, meat byproducts-babyfood     0.020000   1.000  1.000
3100045000 31   Beef, meat, dried                  0.020000   1.920  1.000
3100044001 31   Beef, meat-babyfood                0.020000   1.000  1.000
3200171000 32   Goat, fat                          0.100000   1.000  1.000
3200172000 32   Goat, kidney                       0.020000   1.000  1.000
3200173000 32   Goat, liver                        0.020000   1.000  1.000
3200169000 32   Goat, meat                         0.020000   1.000  1.000
3200170000 32   Goat, meat byproducts              0.020000   1.000  1.000
3300189000 33   Horse, meat                        0.020000   1.000  1.000
3400293000 34   Pork, fat                          0.100000   1.000  1.000
3400293001 34   Pork, fat-babyfood                 0.100000   1.000  1.000
3400294000 34   Pork, kidney                       0.020000   1.000  1.000
3400295000 34   Pork, liver                        0.020000   1.000  1.000
3400290000 34   Pork, meat                         0.020000   1.000  1.000
3400292000 34   Pork, meat byproducts              0.020000   1.000  1.000
3400292001 34   Pork, meat byproducts-babyfood     0.020000   1.000  1.000
3400290001 34   Pork, meat-babyfood                0.020000   1.000  1.000
3400291000 34   Pork, skin                         0.100000   1.000  1.000
3500341000 35   Sheep, fat                         0.100000   1.000  1.000
3500341001 35   Sheep, fat-babyfood                0.100000   1.000  1.000
3500342000 35   Sheep, kidney                      0.020000   1.000  1.000
3500343000 35   Sheep, liver                       0.020000   1.000  1.000
3500339000 35   Sheep, meat                        0.020000   1.000  1.000
3500340000 35   Sheep, meat byproducts             0.020000   1.000  1.000
3500339001 35   Sheep, meat-babyfood               0.020000   1.000  1.000
3600222000 36   Milk, fat                          0.020000   1.000  1.000
3600222001 36   Milk, fat-baby food/infant formu   0.020000   1.000  1.000
3600223000 36   Milk, nonfat solids                0.020000   1.000  1.000
3600223001 36   Milk, nonfat solids-baby food/in   0.020000   1.000  1.000
3600225001 36   Milk, sugar (lactose)-baby food/   0.020000   1.000  1.000
3600224000 36   Milk, water                        0.020000   1.000  1.000
3600224001 36   Milk, water-babyfood/infant form   0.020000   1.000  1.000
3800221000 38   Meat, game                         0.020000   1.000  1.000
3900312000 39   Rabbit, meat                       0.020000   1.000  1.000
8601000000 86A  Water, direct, all sources         0.011200   1.000  1.000
8602000000 86B  Water, indirect, all sources       0.011200   1.000  1.000

Attachment 10.  Bifenazate Chronic Results.

US EPA                                                          Ver. 3.16, 03-08-d
DEEM-FCID Chronic analysis for BIFENAZATE                  NHANES 2003-2008 2-day
Residue file name: J:\Work Files\$ Bifenazate\$$New\DEEM\03_25_2014_Tolerance levels_Bifenazate_chronic.R08
                                                     Adjustment factor #2 used.
Analysis Date 03-25-2014/14:54:33     Residue file dated: 03-25-2014/14:52:49
Reference dose (RfD, Chronic) = .01 mg/kg bw/day
COMMENT 1: aPAD for General Pop - 6 mg/kg/day; aPAD for Females 13 to 49 years - 0.1 mg/kg/day; cPAD - 0.01 mg/kg/day
===============================================================================
                    Total exposure by population subgroup
-------------------------------------------------------------------------------
                                                    Total Exposure
                                         -----------------------------------
          Population                         mg/kg             Percent of
           Subgroup                       body wt/day             Rfd
--------------------------------------   -------------       ----------------
Total US Population                         0.002360                23.6%
Hispanic                                    0.003420                34.2%
Non-Hisp-White                              0.002143                21.4%
Non-Hisp-Black                              0.002101                21.0%
Non-Hisp-Other                              0.003131                31.3%
Nursing Infants                             0.002897                29.0%
Non-Nursing Infants                         0.004077                40.8%
Female 13+ PREG                             0.002598                26.0%
Children 1-6                                0.006035                60.3%
Children 7-12                               0.002852                28.5%
Male 13-19                                  0.001867                18.7%
Female 13-19/NP                             0.001852                18.5%
Male 20+                                    0.002009                20.1%
Female 20+/NP                               0.001828                18.3%
Seniors 55+                                 0.001652                16.5%
All Infants                                 0.003713                37.1%
Female 13-50                                0.001941                19.4%
Children 1-2                                0.007438                74.4%
Children 3-5                                0.005635                56.4%
Children 6-12                               0.003053                30.5%
Youth 13-19                                 0.001858                18.6%
Adults 20-49                                0.002106                21.1%
Adults 50-99                                0.001681                16.8%
Female 13-49                                0.001950                19.5%


10464 Federal Register / Vol. 68, No. 43 / Wednesday, March 5, 2003 / Notices population utilizing 0.1% of the RfD. A Tier 3 chronic analysis was done using the DEEMTM software, Version 7.76 ( Novigen Sciences, Inc.). The 1994   96, 1998 CSFII consumption data from USDA were used. Average anticipated residue values were calculated from the appropriate field trial studies conducted for pyrimethanil. The average residue values were adjusted by the projected PCT at product maturity. Concentration factors derived from processing studies were included where appropriate. Secondary residues were calculated using theoretical dietary burdens derived from sensible diets for beef and dairy cattle and tissue to feed ratios from the ruminant feeding study. ii. Drinking water. U. S. EPA's Standard Operating Procedure ( SOP) for Drinking Water Exposure and Risk Assessments was followed to perform the Tier 1 drinking water assessment. This SOP uses a variety of tools to conduct drinking water assessments, including water models such as Screening Concentration in Ground Water ( SCI GROW), FIRST, Pesticide Root Zone Model ( PRZMS)/ EXAMS, and monitoring data. If monitoring data are not available then the models are used to predict potential residues in surface and ground water and the highest levels ( whether ground or surface) are assumed to be the drinking water residue. In the case of pyrimethanil, monitoring data are not available. SCI GROW and FIRST were used to estimate a drinking water residue. Calculation of the Drinking Water Estimate Concentration ( DWEC) for surface water for the worst case pyrimethanil use scenario results in an acute DWEC of 122 parts per billion ( ppb) and a chronic DWEC of 37 ppb. DWLOCs calculated based on the acute and chronic risk assessments described above are many fold higher than these conservative DWECs. The adult acute and chronic DWLOCs are 10,146 ppb and 5,944 ppb respectively. Children's acute and chronic DWLOCs are 2,762 ppb and 1,695 ppb respectively. 2. Non dietary exposure. Pyrimethanil products are not labeled for residential uses ( food or non food), thereby eliminating the potential for residential exposure or non occupational exposure.

D. Cumulative Effects Section 408( b)( 2)( D)( v) requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider `` available information'' concerning the cumulative effects of a particular pesticide's residues and `` other substances that have a common mechanism of toxicity.'' There are no available data to determine whether pyrimethanil has a common mechanism of toxicity with other substances or how to include this pesticide in a cumulative risk assessment. Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, pyrimethanil does not appear to form a toxic metabolite produced by other substances. For the purposes of the tolerance petition and this reduced risk rationale, therefore, it has been assumed that pyrimethanil does not have a common mechanism of toxicity with other substances.

E. Safety Determination 1. U. S. population. Using the assumptions and data described above, based on the completeness and reliability of the toxicity data, it is concluded that dietary risk from the proposed uses of pyrimethanil are acceptable for all populations examined. Chronic exposure for the U. S. population utilizes 0.1% ( 0.00015 mg/ kg bwt/ day) of the cRfD. Acute exposure for the U. S. population utilizes 3.4% ( 0.01012 mg/ kg bwt/ day) of the aRfD. The most highly exposed population of children 1   6 utilizes only 0.3% of the cRfD and 7.9% of the aRfD. The actual exposures are likely to be much less as more realistic data and models are developed. EPA generally has no concern for exposures below 100% of the RfD ( acute or chronic), because the RfD represents the level at or below which exposure will not pose appreciable risk to human health. DWLOC for adults both acute ( 10,146 ppb) and chronic ( 5,944 ppb) are several orders of magnitude above the conservative DWEC for acute ( 122 ppb) and chronic ( 37 ppb) worst case scenarios. Therefore, there is a reasonable certainty that no harm will occur to the U. S. population from aggregate exposure ( food and drinking water) to residues of pyrimethanil. 2. Infants and children. The relevant toxicity studies as discussed in the toxicology section above show no extra sensitivity of infants and children to pyrimethanil, therefore, the FQPA safety factor can be removed. Using the assumptions and data described in the exposure section above, it is concluded that dietary risk from the proposed uses of pyrimethanil are acceptable for all infant and children sub populations examined. The most highly exposed sub population was children 1   6 for both the chronic and acute analyses. The sub population children 1   6 utilizes 0.3% ( 0.00047 mg/ kg bwt/ day) of the cRfD and 7.9% ( 0.02377 mg/ kg bwt/ day) of the aRfD. All other infant and children populations have less exposure. The chronic and acute drinking water levels of concern for children ( 1,695 ppb and 2,762 ppb respectively) are well above the conservative DWEC for chronic and acute scenarios. The chronic DWEC is 37 ppb and the acute DWEC is 122 ppb. Therefore, there is a reasonable certainty that no harm will occur to infants and children from aggregate exposure to residues of pyrimethanil.

F. International Tolerances Maximum residue limits for pyrimethanil have not been established by the Codex Alimentarius Commission.

[ FR Doc. 03   5032 Filed 3   4   03; 8: 45 am]

BILLING CODE 6560   50   S ENVIRONMENTAL PROTECTION AGENCY [ OPP   2003   0027; FRL   7291   1]

Imidacloprid; Notice of Filing a Pesticide Petition to Establish a Tolerance for a Certain Pesticide Chemical in or on Food AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice.

SUMMARY: This notice announces the initial filing of a pesticide petition proposing the establishment of regulations for residues of a certain pesticide chemical in or on various food commodities. DATES: Comments, identified by docket ID number OPP   2003   0027, must be received on or before April 4, 2003. ADDRESSES: Comments may be submitted electronically, by mail, or through hand delivery/ courier. Follow the detailed instructions as provided in Unit I. of the SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: Dani Daniel, Registration Division ( 7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001; telephone number: ( 703) 305   5409; e mail address: daniel. dani@ epa. gov.

SUPPLEMENTARY INFORMATION:

I. General Information A. Does this Action Apply to Me?

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to:

VerDate Jan< 31> 2003 21: 44 Mar 04, 2003 Jkt 200001 PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 05MRN1. SGM 05MRN1 10465 Federal Register / Vol. 68, No. 43 / Wednesday, March 5, 2003 / Notices   Crop production ( NAICS 111)   Animal production ( NAICS 112)   Food manufacturing ( NAICS 311)   Pesticide manufacturing ( NAICS 32532) This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System ( NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Copies of this Document and Other Related Information? 1. Docket. EPA has established an official public docket for this action under docket identification ( ID) number OPP   2003   0027. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information ( CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The docket telephone number is ( 703) 305   5805. 2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the`` Federal Register'' listings at http:// www. epa. gov/ fedrgstr/. An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http:// www. epa. gov/ edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I. B. 1. Once in the system, select `` search,'' then key in the appropriate docket ID number. Certain types of information will not be placed in the EPA Dockets. Information claimed as CBI and other information whose disclosure is restricted by statute, which is not included in the official public docket, will not be available for public viewing in EPA's electronic public docket. EPA's policy is that copyrighted material will not be placed in EPA's electronic public docket but will be available only in printed, paper form in the official public docket. To the extent feasible, publicly available docket materials will be made available in EPA's electronic public docket. When a document is selected from the index list in EPA Dockets, the system will identify whether the document is available for viewing in EPA's electronic public docket. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I. B. EPA intends to work towards providing electronic access to all of the publicly available docket materials through EPA's electronic public docket. For public commenters, it is important to note that EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing in EPA's electronic public docket as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EPA's electronic public docket. The entire printed comment, including the copyrighted material, will be available in the public docket. Public comments submitted on computer disks that are mailed or delivered to the docket will be transferred to EPA's electronic public docket. Public comments that are mailed or delivered to the docket will be scanned and placed in EPA's electronic public docket. Where practical, physical objects will be photographed, and the photograph will be placed in EPA's electronic public docket along with a brief description written by the docket staff.

C. How and To Whom Do I Submit Comments? You may submit comments electronically, by mail, or through hand delivery/ courier. To ensure proper receipt by EPA, identify the appropriate docket ID number in the subject line on the first page of your comment. Please ensure that your comments are submitted within the specified comment period. Comments received after the close of the comment period will be marked `` late.'' EPA is not required to consider these late comments. If you wish to submit CBI or information that is otherwise protected by statute, please follow the instructions in Unit I. D. Do not use EPA Dockets or e mail to submit CBI or information protected by statute. 1. Electronically. If you submit an electronic comment as prescribed in this unit, EPA recommends that you include your name, mailing address, and an email address or other contact information in the body of your comment. Also include this contact information on the outside of any disk or CD ROM you submit, and in any cover letter accompanying the disk or CD ROM. This ensures that you can be identified as the submitter of the comment and allows EPA to contact you in case EPA cannot read your comment due to technical difficulties or needs further information on the substance of your comment. EPA's policy is that EPA will not edit your comment, and any identifying or contact information provided in the body of a comment will be included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. i. EPA Dockets. Your use of EPA's electronic public docket to submit comments to EPA electronically is EPA's preferred method for receiving comments. Go directly to EPA Dockets at http:// www. epa. gov/ edocket, and follow the online instructions for submitting comments. Once in the system, select `` search,'' and then key in docket ID number OPP   2003   0027 The system is an `` anonymous access'' system, which means EPA will not know your identity, e mail address, or other contact information unless you provide it in the body of your comment. ii. E mail. Comments may be sent by e mail to opp docket@ epa. gov, Attention: Docket ID number OPP   2003   0027. In contrast to EPA's electronic public docket, EPA's e mail system is not an `` anonymous access'' system. If you send an e mail comment directly to the docket without going through EPA's electronic public docket, EPA's e mail system automatically captures your e mail address. E mail addresses that are automatically captured by EPA's e mail system are included as part of the comment that is VerDate Jan< 31> 2003 21: 44 Mar 04, 2003 Jkt 200001 PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 05MRN1. SGM 05MRN1 10466 Federal Register / Vol. 68, No. 43 / Wednesday, March 5, 2003 / Notices placed in the official public docket, and made available in EPA's electronic public docket. iii. Disk or CD ROM. You may submit comments on a disk or CD ROM that you mail to the mailing address identified in Unit I. C. 2. These electronic submissions will be accepted in WordPerfect or ASCII file format. Avoid the use of special characters and any form of encryption. 2. By mail. Send your comments to: Public Information and Records Integrity Branch ( PIRIB) ( 7502C), Office of Pesticide Programs ( OPP), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001, Attention: Docket ID number OPP   2003   0027. 3. By hand delivery or courier. Deliver your comments to: Public Information and Records Integrity Branch ( PIRIB), Office of Pesticide Programs ( OPP), Environmental Protection Agency, Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA, Attention: Docket ID number OPP   2003   0027. Such deliveries are only accepted during the docket's normal hours of operation as identified in Unit I. B. 1.

D. How Should I Submit CBI To the Agency?

Do not submit information that you consider to be CBI electronically through EPA's electronic public docket or by e mail. You may claim information that you submit to EPA as CBI by marking any part or all of that information as CBI ( if you submit CBI on disk or CD ROM, mark the outside of the disk or CD ROM as CBI and then identify electronically within the disk or CD ROM the specific information that is CBI). Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. In addition to one complete version of the comment that includes any information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket and EPA's electronic public docket. If you submit the copy that does not contain CBI on disk or CD ROM, mark the outside of the disk or CD ROM clearly that it does not contain CBI. Information not marked as CBI will be included in the public docket and EPA's electronic public docket without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the person listed under FOR FURTHER INFORMATION CONTACT. E. What Should I Consider as I Prepare My Comments for EPA?

You may find the following suggestions helpful for preparing your comments: 1. Explain your views as clearly as possible. 2. Describe any assumptions that you used. 3. Provide copies of any technical information and/ or data you used that support your views. 4. If you estimate potential burden or costs, explain how you arrived at the estimate that you provide. 5. Provide specific examples to illustrate your concerns. 6. Make sure to submit your comments by the deadline in this notice. 7. To ensure proper receipt by EPA, be sure to identify the docket ID number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and Federal Register citation.

II. What Action is the Agency Taking?

EPA has received a pesticide petition as follows proposing the establishment and/ or amendment of regulations for residues of a certain pesticide chemical in or on various food commodities under section 408 of the Federal Food, Drug, and Cosmetic Act ( FFDCA), 21 U. S. C. 346a. EPA has determined that this petition contains data or information regarding the elements set forth in FFDCA section 408( d)( 2); however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data support granting of the petition. Additional data may be needed before EPA rules on the petition.

List of Subjects Environmental protection, Agricultural commodities, Feed additives, Food additives, Pesticides and pests, Reporting and recordkeeping requirements.

Dated: February 11, 2003. Debra Edwards, Acting Director, Registration Division, Office of Pesticide Programs.

Summary of Petition The petitioner's summary of the pesticide petition is printed below as required by FFDCA section 408( d)( 3). The summary of the petition was prepared by the petitioner and represents the views of the petitioner. The petition summary announces the availability of a description of the analytical methods available to EPA for the detection and measurement of the pesticide chemical residues or an explanation of why no such method is needed.

Bayer CropScience PP 0E6074 EPA has received a pesticide petition ( 0E6074) from Bayer CropScience, 2 T. W. Alexander Drive, PO Box 12014, Research Triangle Park, NC 27709 proposing, pursuant to section 408( d) of the FFDCA, 21 U. S. C. 346a( d), to amend 40 CFR 180.472, by establishing an import tolerance for residues of imidacloprid, [( 1[ 6 chloro 3 pyridinyl) methyl] N nitro 2 imidazolidinimine) and its metabolites containing the 6 chloropyridinyl moiety, all expressed as 1[( 6 chloro 3 pyridinyl) methyl] Nnitro 2 imidazolidinimine] in or on the raw agricultural commodity ( RAC): Banana at 0.01 parts per million ( ppm). EPA has determined that the petition contains data or information regarding the elements set forth in section 408( d)( 2) of the FFDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data supports granting of the petition. Additional data may be needed before EPA rules on the petition.

A. Residue Chemistry 1. Plant metabolism. The nature of the imidacloprid residue in plants and livestock is adequately understood. The residues of concern are combined residues of imidacloprid and it metabolites containing the 6 chloropyridinyl moiety, all calculated as imidacloprid. 2. Analytical method. The analytical method is a common moiety method for imidacloprid and its metabolites containing the 6 chloropyridinyl moiety using a permanganate oxidation, silyl derivatization, and capillary gas chromatography mass spectrometry ( GCMS selective ion monitoring. This method has successfully passed a petition method validation in EPA labs. There is a confirmatory method specifically for imidacloprid and several metabolites utilizing GC/ MS and high performance liquid chromatography ultraviolet ( HPLC UV) which has been validated by EPA as well. Imidacloprid and its metabolites are stable for at least 24 months in the commodities when frozen. 3. Magnitude of residues. For bananas, Bayer conducted 12 residue crop field trials to evaluate the quantity of imidacloprid expected in bananas from applications of Confidor 70 WG and Confidor 350 SC. Trials were conducted at eight sites in the Caribbean coastal area of Central America and 4 sites in VerDate Jan< 31> 2003 21: 44 Mar 04, 2003 Jkt 200001 PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 05MRN1. SGM 05MRN1 10467 Federal Register / Vol. 68, No. 43 / Wednesday, March 5, 2003 / Notices the Pacific coastal area of Ecuador. Imidacloprid residues in banana whole fruit were quantitated by GC using a mass selective detector. The limit of quantitation ( LOQ) was 0.01 ppm. The highest average field trial ( HAFT) was 0.01 ppm in bananas.

B. Toxicological Profile 1. Acute toxicity. The acute oral LD50 values for imidacloprid technical ranged from 424 milligrams/ kilograms ( mg/ kg) in the male rat and < 450 mg/ kg in the female rat. The acute dermal LD50 was < 5,000 mg/ kg in the rat. The 4   hour rat inhalation LC50 was < 5.33 mg/ L. Imidacloprid was not irritating to rabbit skin or eyes. Imidacloprid did not cause skin sensitization in guinea pigs. In an acute neurotoxicity study the lowest observed adverse effect level ( LOAEL) = 42 mg/ kg body weight day ( bwt/ day). 2. Genotoxicty. Mutagenicity studies have demonstrated that imidacloprid is non mutagenic both in vivo and in vitro. 3. Reproductive and developmental toxicity. In a developmental toxicity study with Sprague Dawley rats, groups of pregnant animals ( 25/ group) received oral administration of imidacloprid ( 94.2%) at 0, 10, 30, or 100 mg/ kg bwt/ day during gestation days 6 through 16. Maternal toxicity was manifested as decreased body weight gain at all dose levels and reduced food consumption at 100 milligrams/ kilograms of body weight/ day ( mg/ kg bwt/ day. No treatment related effects were seen in any of the reproductive parameters ( i. e., Cesarean section evaluation). At 100 mg/ kg bwt/ day, developmental toxicity manifested as wavy ribs ( fetus = 7/ 149 in treated vs. 2/ 158 in controls and litters, 4/ 25 vs. 1/ 25). For maternal toxicity, the LOAEL was 10 mg/ kg bwt/ day lowest dose tested ( LDT) based on decreased body weight gain; a NOAEL was not established. For developmental toxicity, the NOAEL was 30 mg/ kg bwt/ day and the LOAEL was 100 mg/ kg bwt/ day based on increased wavy ribs master record identification ( MRID No. 42256338). In a developmental toxicity study with Chinchilla rabbits, groups of 16 pregnant does were given oral doses of imidacloprid ( 94.2%) at 0, 8, 24, or 72 mg/ kg bwt/ day during gestation days 6 through 18. For maternal toxicity, the NOAEL was 24 mg/ kg bwt/ day and the LOAEL was 72 mg/ kg bwt/ day based on mortality, decreased body weight gain, increased resorptions, and increased abortions. For developmental toxicity, the NOAEL was 24 mg/ kg bwt/ day and the LOAEL was 72 mg/ kg bwt/ day based on decreased fetal body weight, increased resorptions, and increased skeletal abnormalities ( MRID No. 42256339). In a 2 generation reproductive toxicity study, imidacloprid ( 95.3%) was administered to Wistar/ Han rats at dietary levels of 0, 100, 250, or 700 ppm ( 0, 7.3, 18.3, or 52.0 mg/ kg bwt/ day for males and 0, 8.0, 20.5, or 57.4 mg/ kg bwt/ day for females) ( MRID No. 42256340, Doc. No. 010537). For parental/ systemic/ reproductive toxicity, the NOAEL was 250 ppm ( 18.3 mg/ kg bwt/ day) and the LOAEL was 750 ppm ( 52 mg/ kg bwt/ day), based on decreases in body weight in both sexes in both generations. Based on these factors, EPA recommended that the Data Evaluation Record should be revised to indicate the parental/ systemic/ reproductive NOAEL and LOAEL to be 250 and 700 ppm, respectively, based upon the body weight decrements observed in both sexes in both generations. 4. Subchronic toxicity. In a dermal toxicity study, groups of five male and five female New Zealand white rabbits received repeated dermal applications of imidacloprid ( 95%) at 1,000 mg/ kg bwt/ day ( LD), 6 hours/ day, 5 days/ week for 3 weeks. No dermal or systemic toxicity was seen. For systemic and dermal toxicity, the NOAEL was < 1,000 mg/ kg bwt/ day, a LOAEL was not established ( MRID No. 42256329). In an oral toxicity study, groups of Fischer 344 rats ( 12/ sex/ dose) were fed diets containing imidacloprid ( 98.8%) at 0, 150, 1,000, or 3,000 ppm ( 0, 9.3, 63.3, or 196 mg/ kg bwt/ day in males and 0, 10.5, 69.3 or 213 mg/ kg bwt/ day in females, respectively) for 90 days. No treatment related effects were seen at 150 ppm. Treatment related effects included decreases in body weight gain during the first 4 weeks of the study at 1,000 ppm ( 22% in males and 18% in females) and 3,000 ppm ( 50% in males and 25% in females) with an associated decrease in forelimb grip strength especially in males. The NOAEL was 150 ppm ( 9.3 and 10.5 mg/ kg bwt/ day in males and females, respectively) and the LOAEL was 1,000 ppm ( 63.3 and 69.3 mg/ kg bwt/ day in males and females, respectively) ( MRID No. 43286401). In a rat inhalation study ( 28   day study in which rats were exposed 6 hours/ day, 5 days/ week for 4 weeks), the NOAEL for imidacloprid was 5.5 mg/ m3 ( MRID No. 422730   01). 5. Chronic toxicity. In a chronic toxicity study, groups of beagle dogs ( 4/ sex/ dose) were fed diets containing imidacloprid ( 94.9%) at 0, 200 or 1,250/ 2,500 ppm ( 0, 6.1, 15 or 41/ 72 mg/ kg bwt/ day, respectively) for 52 weeks. The 1,250 ppm dose was increased to 2,500 ppm from week 17 onwards. The threshold NOAEL was 1,250 ppm ( 41 mg/ kg bwt/ day). The LOAEL was 2,500 ppm ( 72 mg/ kg bwt/ day) based on increased cytochrome P 450 levels in both sexes and was considered to be a threshold dose. Due to the lack of toxicity at 1,250 ppm, a LOAEL was not established in this study following the dose increase to the 2,500 ppm level, toxicity was observed, thus making 1,250 ppm the threshold NOAEL and 2,500 ppm the threshold LOAEL ( MRID No. 42273002). 6. Animal metabolism. The metabolism imidacloprid in rats was reported in seven studies. These data show that imidacloprid was rapidly absorbed and eliminated in the excreta ( 90% of the dose within 24 hours), demonstrating no biologically significant differences between sexes, dose levels, or route of administration. Elimination was mainly renal ( 70   80% of the dose) and fecal ( 17   25%). The major part of the fecal activity originated in the bile. Total body accumulation after 48 hours consisted of 0.5% of the radioactivity with the liver, kidney, lung, skin and plasma being the major sites of accumulation. Therefore, bioaccumulation of imidacloprid is low in rats. Maximum plasma concentration was reached between 1.1 and 2.5 hours. Two major routes of biotransformation were proposed for imidacloprid. The first route included an oxidative cleavage of the parent compound rendering 6 chloronicotinic acid and its glycine conjugate. Dechlorination of this metabolite formed the 6 hydroxynicotinic acid and its mercapturic acid derivative. The second route included the hydroxylation followed by elimination of water of the parent compound rendering imidacloprid. A comparison between [ methylene 14C] imidacloprid and [ imidazolidine 4,5 14C] imidacloprid showed that while the rate of excretion was similar, the renal portion was higher with the imidazolidine labeled compound. In addition, accumulation in tissues was generally higher with the imidazolidine labeled compound. A comparison between imidacloprid and one of its metabolites, WAK 3839, showed that the total elimination was the same for both compounds. The proposed metabolic pathways for these two compounds were different. WAK 3839 was formed following pretreatment ( repeated dosing) of imidacloprid. 7. Endocrine disruption. The toxicology data base for imidacloprid is current and complete. Studies in this data base include evaluation of the potential effects on reproduction and development, and an evaluation of the pathology of the endocrine organs following short term or long term exposure. These studies revealed no VerDate Jan< 31> 2003 21: 44 Mar 04, 2003 Jkt 200001 PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 05MRN1. SGM 05MRN1 10468 Federal Register / Vol. 68, No. 43 / Wednesday, March 5, 2003 / Notices primary endocrine effects due to imidacloprid.

C. Aggregate Exposure 1. Dietary exposure. Assessments were conducted to evaluate potential risks due to chronic and acute dietary exposure of the U. S. population and selected population subgroups to residues of imidacloprid. These analyses cover all registered crops including rotational crops; uses pending with EPA in the 2003 work plan including dry beans, peas, bushberries, lingonberry, juneberries, salal, carrots, turnips, okra, cranberries, artichoke ( globe), watercress, beet roots, leaves of root and tuber vegetables, stone fruit, mamey sapote, guava, feijoa, jaboticaba, wax jambu, starfruit, passion fruit, acerola, strawberry, cucumber ( greenhouse), and tomato ( greenhouse), this import tolerance petition on bananas; and active and proposed section 18 uses on blueberries, cranberries, table beets, strawberries, turnips. Novigen Sciences, Inc.' s Dietary Exposure Evaluation Model ( DEEMTM), which is licensed to Bayer, was used to estimate the chronic and acute dietary exposure. This software uses the food consumption data from the 1994   1998 Department of Agriculture ( USDA) continuing surveys of food intake by individuals ( CSFII) 1994   1998. The endpoint for acute dietary risk assessments is based on neurotoxicity characterized by decreases in motor or locomotor activity in female rats at 42 mg/ kg bwt/ day, the LOAEL from an acute neurotoxicity study. Based on an uncertainty factor ( UF) of 10x for interspecies and 10x for intra species the acute reference dose ( aRfD) = 0.42 mg/ kg bwt/ day. EPA has determined that an additional UF for FQPA ( reduced to 3x) applies to all population subgroups for acute risk. Application of the additional 3x safety factor results in an acute population adjusted dose ( aPAD) 0.14 mg/ kg bwt/ day or a margin of exposure ( MOE) of 300. For chronic dietary analyses, EPA has established the reference dose ( RfD) for imidacloprid at 0.057 mg/ kg/ day based on a NOAEL of 5.7 mg/ kg bwt/ day from a rat chronic toxicity carcinogenicity study and uncertainty factors of 10x for interspecies and 10x for intra species. EPA has determined that an additional UF for FQPA ( reduced to 3x) applies to all population subgroups for chronic risk. Application of the additional 3x safety factor results in a chronic population adjusted dose ( cPAD) of 0.019 mg/ kg bwt/ day. Results from the acute and chronic dietary exposure analyses described below demonstrate a reasonable certainty that no harm to the overall U. S. population or any population subgroup will result from the use of imidacloprid on currently registered and pending uses. i. Food. Acute and chronic ( tier 3) risk assessments were made using the results of field trials conducted at maximum label application rates and the shortest pre harvest intervals. For some of the vegetable crops, these residue data were collected at 1.5x or greater than the maximum label rate of 0.5 lb active ingredient/ acre per season. In addition, no adjustments were made to account for dissipation of residues during storage, transportation from the field to the consumer, washing or peeling. Therefore, the actual dietary exposure will be less than that presented here. For the chronic analysis, mean field trial residues were calculated. For the acute Monte Carlo analysis, the entire distribution of residue field trial data was used for the `` non blended'' and `` partially blended'' foods as determined by EPA's HED SOP 99.6. For the foods considered as `` blended'' by EPA'S HED SOP 99.6, mean field trial residue data were used. As allowed in EPA's draft guidance for submission of probabilistic human health exposure assessments one half limit of detection ( LOD)/ LOQ values were used for all non detected values ( values below the sensitivity of the method). Bayer's acute Monte Carlo dietary exposure assessment estimated percent of the aPAD and corresponding MOE for the overall U. S. population, ( all seasons), and various subpopulations. In this analysis, the exposure for the total U. S. population was equal to 7.73% of the aPAD at the 99.9th percentile. The most highly exposed population subgroup, children ( 1   6 years), had an exposure equal to 16.42% of the aPAD at the 99.9th percentile. Therefore, the acute dietary exposure estimates are below EPA's level of concern for the overall U. S. population as well as the various subpopulations. Bayer's chronic dietary exposure estimated the percent of the cPAD for the overall U. S. population ( all seasons) and various subpopulations. In this analysis, the exposure for the total U. S. population was equal to 1.4% of the cPAD. The most highly exposed population subgroup, children ( 1 6 years), had an exposure equal to 3.0% of the cPAD. Therefore, the chronic exposure estimates are below EPA's level of concern for the overall U. S. population as well as the various subpopulations. ii. Drinking water. EPA, as published in the Federal Register of April 10, 2001 ( 66 FR 18554) ( FRL   6777   6), calculated acute and chronic DWLOCs and compared them with the EECs for surface and ground water. Based on this comparison, they determined that acute exposure and chronic exposure would not be expected to exceed the aPAD and cPAD, respectively. It is not expected that the additional exposure from the minor crops pending in EPA's 2003 work plan would significantly change EPA's water assessment. 2. Non dietary exposure   i. Residential turf. Bayer has conducted an exposure study to address the potential exposures of adults and children from contact with imidacloprid treated turf. The population considered to have the greatest potential exposure from contact with pesticide treated turf soon after pesticides are applied are young children. Margins of safety ( MOS) of 7,587  41,546 for 10   year old children and 6,859  45,249 for 5   year old children were estimated by comparing dermal exposure doses to the imidacloprid NOAEL of 1,000 mg/ kg/ day established in a 15   day dermal toxicity study in rabbits. The estimated safe residue levels of imidacloprid on treated turf for 10   year old children ranged from 5.6  38.2 µ g/ cm2 and for 5   year old children from 5.1  33.5 µ g/ cm2. This compares with the average imidacloprid transferable residue level of 0.080 µ g/ cm2 present immediately after the sprays have dried. These data indicate that children can safely contact imidacloprid treated turf as soon after application as the spray has dried. ii. Termiticide. Imidacloprid is registered as a termiticide. Due to the nature of the treatment for termites, exposure would be limited to that from inhalation and was evaluated by EPA and Bayer. Data indicate that the MOS for the worst case exposures for adults and infants occupying a treated building who are exposed continuously ( 24 hours/ day) are 8.0 x 10 7 and 2.4 x 10 8, respectively  and exposure can thus be considered negligible. iii. Tobacco. Smoke Studies have been conducted to determine residues in tobacco and the resulting smoke following treatment. Residues of imidacloprid in cured tobacco following treatment were a maximum of 31 ppm ( 7 ppm in fresh leaves). When this tobacco was burned in a pyrolysis study only 2% of the initial residue was recovered in the resulting smoke ( main stream plus side stream). This would result in an inhalation exposure to imidacloprid from smoking of approximately 0.0005 mg per cigarette. Using the measured subacute rat inhalation NOAEL of 5.5 mg/ m3, it is apparent that exposure to imidacloprid from smoking ( direct and/ or indirect exposure) would not be significant.

VerDate Jan< 31> 2003 21: 44 Mar 04, 2003 Jkt 200001 PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 05MRN1. SGM 05MRN1 10469 Federal Register / Vol. 68, No. 43 / Wednesday, March 5, 2003 / Notices iv. Pet treatment. Human exposure from the use of imidacloprid to treat dogs and cats for fleas has been addressed by EPA with the conclusion that due to the fact that imidacloprid is not an inhalation or dermal toxicant and that while dermal absorption data are not available, imidacloprid is not considered to present a hazard via the dermal route.

D. Cumulative Effects Imidacloprid is a chloronicotinyl insecticide. At this time, EPA has not made a determination that imidacloprid and other substances that may have a common mechanism of toxicity would have cumulative effects. Therefore, for these tolerance petitions, it is assumed that imidacloprid does not have a common mechanism of toxicity with other substances and only the potential risks of imidacloprid in its aggregate exposure are considered.

E. Safety Determination 1. U. S. population. EPA has considered data from developmental toxicity studies in the rat and rabbit and a 2 generation reproduction study in the rat. These studies are discussed under section A ( Toxicology Profile) above. The developmental toxicity data demonstrated no increased sensitivity of rats or rabbits to in utero exposure to imidacloprid. In addition, the multigeneration reproductive toxicity study did not identify any increased sensitivity of rats to in utero or postnatal exposure. Parental NOAELs were lower or equivalent to developmental or offspring NOAELs. The developmental toxicity studies are designed to evaluate adverse effects on the developing organism resulting from maternal pesticide exposure during gestation. Reproduction studies provide information relating to effects from exposure to the pesticide on the reproductive capability of mating animals and data on systemic toxicity. FFDCA section 408 provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base unless EPA determines that a different MOS will be safe for infants and children. MOS are incorporated into EPA risk assessments either directly through use of a MOE analysis or through using uncertainty ( safety) factors ( UF) in calculating a dose level that poses no appreciable risk to humans. EPA believes that reliable data support using the standard UF ( usually 100 for combined inter species and intraspecies variability) and not the additional tenfold MOE/ UF when EPA has a complete data base under existing guidelines and when the severity of the effect in infants or children or the potency or unusual toxic properties of a compound do not raise concerns regarding the adequacy of the standard MOE/ UF. Although developmental toxicity studies showed no increased sensitivity in fetuses as compared to maternal animals following in utero exposures in rats and rabbits, no increased sensitivity in pups as compared to adults was seen in the 2 generation reproduction toxicity study in rats, and the toxicology data base is complete as to core requirements, EPA has determined that the additional safety factor for the protection of infants and children will be retained but reduced to 3x based on the following weight of the evidence considerations relating to potential sensitivity and completeness of the data: i. There is concern for structure activity relationship. Imidacloprid, a chloronicotinyl compound, is an analog to nicotine and studies in the published literature suggests that nicotine, when administered causes developmental toxicity, including functional deficits, in animals and/ or humans that are exposed in utero. ii. There is evidence that imidacloprid administration causes neurotoxicity following a single oral dose in the acute study and alterations in brain weight in rats in the 2   year carcinogenicity study. iii. The concern for structure activity relationship along with the evidence of neurotoxicity dictates the need of a developmental neurotoxicity study for assessment of potential alterations on functional development. Because a developmental neurotoxicity study potentially relates to both acute and chronic effects in both the mother and the fetus, EPA has applied the additional UF for FQPA for all population subgroups, and in both acute and chronic risk assessments. Based on the exposure assessments described above and on the completeness and reliability of the toxicity data, it can be concluded that the dietary exposure estimates from all label and pending uses of imidacloprid are 7.73% of the aPAD at the 99.9th percentile and 1.4% of the cPAD for the U. S. population. Thus, it can be concluded that there is a reasonable certainty that no harm will result from aggregate exposure to imidacloprid residues. 2. Infants and children. Based on the exposure assessments described above for the safety determination of the U. S. population and on the completeness and reliability of the toxicity data, it can be concluded that the dietary exposure estimates from all label and pending uses of imidacloprid are 16.42% of the aPAD at the 99.9th percentile and 3.0% of the cPAD for the most sensitive population subgroup, children 1   6 years. Thus, it can be concluded that there is a reasonable certainty that no harm will result from aggregate exposure to imidacloprid residues.

F. International Tolerances No CODEX Maximum Residue Levels have been established for residues of imidacloprid on any crops pending in EPA's 2003 work plan. [ FR Doc. 03   5034 Filed 3   4   03; 8: 45 am]

BILLING CODE 6560   50   S ENVIRONMENTAL PROTECTION AGENCY [ OPP   2003   0047; FRL   7294   5]

Trifloxystrobin; Notice of Filing a Pesticide Petition to Establish a Tolerance for a Certain Pesticide Chemical in or on Food AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice.

SUMMARY: This notice announces the initial filing of a pesticide petition proposing the establishment of regulations for residues of a certain pesticide chemical in or on various food commodities. DATES: Comments, identified by docket ID number OPP   2003   0047, must be received on or before April 4, 2003. ADDRESSES: Comments may be submitted electronically, by mail, or through hand delivery/ courier. Follow the detailed instructions as provided in Unit I. of the SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: Sidney Jackson, Registration Division ( 7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001; telephone number: ( 703) 305   7610; e mail address: jackson. sidney@ epa. gov.

SUPPLEMENTARY INFORMATION:

I. General Information A. Does this Action Apply to Me?

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to:

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