Ornamental
                                  (NJ Nursery)
                                    Ground
                                      250
                                     46.79

                                   >0.08
                                   >0.19

                                    Aerial
                                      240
                                     43.92

                                   >0.08
                                   >0.18
                                   Ornamental
                                  (TN Nursery)
                                    Ground
                                      130
                                     23.24

                                   >0.04
                                   >0.09

                                    Aerial
                                      110
                                     19.94

                                   >0.04
                                   >0.08
 1Using 3 mg a.i/kg sediment and 0.25 mg a.i/L as upper bound estimates of sediment and pore water toxicity, respectively.
 [2]PRZM/EXAMS 21-day average EECs will be used for estimation of RQs.
 [3]Chronic aquatic LOC is 1.

                     a. Aquatic Plants

 RQs were estimated for listed and non-listed vascular and non-vascular (algae) plants.  The most sensitive EC50 values for vascular and non-vascular plants were used with the peak EEC for all proposed uses of fenpyrazamine to yield non-listed aquatic plant RQs.  Similarly, the most sensitive NOAEC values for vascular and non-vascular plants were with the peak EECs to yield listed aquatic plant RQs.  The LOC for both listed and non-listed aquatic plants is 1.  Table 25 below summarizes the peak EECs for each use, as well as the most sensitive EC50 and NOAEC values from available toxicity studies.  For the proposed uses of fenpyrazamine, there were no non-listed vascular plant LOC exceedances (RQs ranged from 0.001  -  0.08) and for non-vascular plants, all but two uses (almonds and pistachios) exceeded the non-listed LOC (RQs ranged from 0.67  -  7.87).  For listed aquatic plants, there was a similar trend with no vascular plant LOC exceedances (RQs ranged from 0.01  -  0.14) and non-vascular aquatic plant exceedances for all proposed uses (RQs ranged from 1.51  -  17.67)

Table 25.  RQs for evaluating toxic risk of fenpyrazamine exposure to vascular and non-vascular aquatic plants.
                                     Crop
                                (PRZM Scenario)
                                     Taxa
                              Application Method
                                    EEC[c]
                                     Peak
                                 (ug a.i./L)
                                     EC50
                                 (ug a.i./L)
                                     NOAEC
                                 (ug a.i./L)
                 Non-listed aquatic plants RQ (Peak EEC/EC50)
                           Listed aquatic plants RQ
                           (Peak EEC/NOAEC or EC05)
                                    Almonds
                                  (CA Almond)
                          Nonvascular aquatic plants
                                    Aerial
                                     10.21
                                      11
                                      4.9
                                     0.93
                                     2.08

                                    Ground
                                     7.41

                                     0.67
                                     1.51

                            Vascular aquatic plants
                                    Aerial
                                     10.21
                                     1100
                                      600
                                     0.01
                                     0.02

                                    Ground
                                     7.41

                                     0.01
                                     0.01
                                  Pistachios
                                  (CA Almond)
                          Nonvascular aquatic plants
                                    Aerial
                                     10.21
                                      11
                                      4.9
                                     0.93
                                     2.08

                                    Ground
                                     7.41

                                     0.67
                                     1.51

                            Vascular aquatic plants
                                    Aerial
                                     10.21
                                     1100
                                      600
                                     0.01
                                     0.02

                                    Ground
                                     7.41

                                     0.01
                                     0.01
                                    Lettuce
                                 (CA Lettuce)
                          Nonvascular aquatic plants
                                    Aerial
                                     30.51
                                      11
                                      4.9
                                     2.77
                                     6.23

                                    Ground
                                     27.6

                                     2.51
                                     5.63

                            Vascular aquatic plants
                                    Aerial
                                     30.51
                                     1100
                                      600
                                     0.03
                                     0.05

                                    Ground
                                     27.6

                                     0.03

                                     0.05

                                    Grapes
                                  (NY Grapes)
                          Nonvascular aquatic plants
                                    Aerial
                                     25.61
                                      11
                                      4.9
                                     2.33
                                     5.23

                                    Ground
                                     21.73

                                     1.98
                                     4.43

                            Vascular aquatic plants
                                    Aerial
                                     25.61
                                     1100
                                      600
                                     0.02
                                     0.04

                                    Ground
                                     21.73

                                     0.02
                                     0.04
                           Bushberries (NY Grapes)
                          Nonvascular aquatic plants
                                    Aerial
                                     25.61
                                      11
                                      4.9
                                     2.33
                                     5.23

                                    Ground
                                     21.73

                                     1.98
                                     4.43

                            Vascular aquatic plants
                                    Aerial
                                     25.61
                                     1100
                                      600
                                     0.02
                                     0.04

                                    Ground
                                     21.73

                                     0.02
                                     0.04
                            Caneberries (NY Grapes)
                          Nonvascular aquatic plants
                                    Aerial
                                     25.61
                                      11
                                      4.9
                                     2.33
                                     5.23

                                    Ground
                                     21.73

                                     1.98
                                     4.43

                            Vascular aquatic plants
                                    Aerial
                                     25.61
                                     1100
                                      600
                                     0.02
                                     0.04

                                    Ground
                                     21.73

                                     0.02
                                     0.04
                                 Strawberries
                                (FL Strawberry)

                          Nonvascular aquatic plants
                                    Aerial
                                     30.92
                                      11
                                      4.9
                                     2.81
                                     6.31

                                    Ground
                                     27.42

                                     2.49
                                     5.60

                            Vascular aquatic plants
                                    Aerial
                                     30.92
                                     1100
                                      600
                                     0.03
                                     0.05

                                    Ground
                                     27.42

                                     0.02
                                     0.05
                                   Ginseng
                                (MN Sugarbeet)
                          Nonvascular aquatic plants
                                    Aerial
                                     14.3
                                      11
                                      4.9
                                     3.88
                                     8.70

                                    Ground
                                     9.98

                                     3.41
                                     7.65

                            Vascular aquatic plants
                                    Aerial
                                     14.3
                                     1100
                                      600
                                     0.04
                                     0.07

                                    Ground
                                     9.98

                                     0.03
                                     0.06
                                   Ginseng
                                (MI Asparagus)
                          Nonvascular aquatic plants
                                    Aerial
                                     61.92
                                      11
                                      4.9
                                     1.30
                                     2.92

                                    Ground
                                     56.43

                                     0.91
                                     2.04

                            Vascular aquatic plants
                                    Aerial
                                     61.92
                                     1100
                                      600
                                     0.01
                                     0.02

                                    Ground
                                     56.43

                                     0.01
                                     0.02
                                  Ornamentals
                                 (MI Nursery)
                          Nonvascular aquatic plants
                                    Aerial
                                     86.6
                                      11
                                      4.9
                                     5.63
                                     12.64

                                    Ground
                                     81.22

                                     5.13
                                     11.52

                            Vascular aquatic plants
                                    Aerial
                                     86.6
                                     1100
                                      600
                                     0.06
                                     0.10

                                    Ground
                                     81.22

                                     0.05
                                     0.09
                                  Ornamentals
                                 (NJ Nursery)
                          Nonvascular aquatic plants
                                    Aerial
                                     44.67
                                      11
                                      4.9
                                     7.87
                                     17.67

                                    Ground
                                     38.41

                                     7.38
                                     16.58

                            Vascular aquatic plants
                                    Aerial
                                     44.67
                                     1100
                                      600
                                     0.08
                                     0.14

                                    Ground
                                     38.41

                                     0.07
                                     0.14
                                  Ornamentals
                                 (TN Nursery)
                          Nonvascular aquatic plants
                                    Aerial
                                     14.3
                                      11
                                      4.9
                                     4.06
                                     9.12

                                    Ground
                                     9.98

                                     3.49
                                     7.84

                            Vascular aquatic plants
                                    Aerial
                                     61.92
                                     1100
                                      600
                                     0.04
                                     0.07

                                    Ground
                                     56.43

                                     0.03
                                     0.06
Bolded represent LOC exceedances.
LOC for non-listed and listed aquatic plants (vascular and non-vascular) is 1.

                        7.1.1 Non-target Terrestrial Animals
                     a. Acute and Chronic Risk to Birds

 T-REX provides acute dose based RQs for three size classes of birds as well as acute and chronic dietary based RQs resulting from ingestion of six different food items exposed to fenpyrazamine.  Table 26 below summarizes the acute dose-based RQs to birds for all proposed uses of fenpyrazamine.  The acute endangered species LOC was exceeded for small birds eating short grass for all proposed uses and for medium sized birds eating short grass for all uses except almonds and pistachios.  The acute restricted use LOC was exceeded for small birds eating short grass for all uses except almonds and pistachios.  Exceedances of the endangered species and restricted use LOC from other food items were only for small birds except for the ornamental use with medium sized birds eating short grass, tall grass, and broadleaf plants.  There was one acute high risk (non-listed species) LOC exceedance which was for small birds eating short grass due to exposure from the ornamental use.

Table 26.  Dose-based RQs for birds due to exposure to proposed uses of fenpyrazamine.
                                      Use
                              Size Class (grams)
                               Adjusted LD50 -
                                    RQs[1]

                                  Short grass
                                  Tall grass
                               Broadleaf plants
                                  Fruits/pods
                                  Arthropods
                                     Seeds
                              Almonds, pistachios
                                      20
                                    1440.86
                                   <0.18
                                   <0.08
                                   <0.10
                                   <0.01
                                   <0.07
                                   <0.003

                                      100
                                    1834.29
                                   <0.08
                                   <0.04
                                   <0.05
                                   <0.01
                                   <0.03
                                   <0.001

                                     1000
                                    2591.00
                                   <0.03
                                   <0.01
                                   <0.01
                                   <0.002
                                   <0.01
                                  <0.0004
                                    Lettuce
                                      20
                                    1440.86
                                   <0.24
                                   <0.11
                                   <0.14
                                   <0.02
                                   <0.10
                                   <0.003

                                      100
                                    1834.29
                                   <0.11
                                   <0.05
                                   <0.06
                                   <0.01
                                   <0.04
                                   <0.002

                                     1000
                                    2591.00
                                   <0.03
                                   <0.02
                                   <0.02
                                   <0.002
                                   <0.01
                                  <0.0005
                       Grapes, bushberries, caneberries
                                      20
                                    1440.86
                                   <0.24
                                   <0.11
                                   <0.14
                                   <0.02
                                   <0.10
                                   <0.003

                                      100
                                    1834.29
                                   <0.11
                                   <0.05
                                   <0.06
                                   <0.01
                                   <0.04
                                   <0.002

                                     1000
                                    2591.00
                                   <0.03
                                   <0.02
                                   <0.02
                                   <0.002
                                   <0.01
                                  <0.0005
                                 Strawberries
                                      20
                                    1440.86
                                   <0.31
                                   <0.14
                                   <0.17
                                   <0.02
                                   <0.12
                                   <0.004

                                      100
                                    1834.29
                                   <0.14
                                   <0.06
                                   <0.08
                                   <0.01
                                   <0.05
                                   <0.002

                                     1000
                                    2591.00
                                   <0.04
                                   <0.02
                                   <0.02
                                   <0.003
                                   <0.02
                                   <0.01
                                    Ginseng
                                      20
                                    1440.86
                                   <0.31
                                   <0.14
                                   <0.17
                                   <0.02
                                   <0.12
                                   <0.004

                                      100
                                    1834.29
                                   <0.14
                                   <0.06
                                   <0.08
                                   <0.01
                                   <0.05
                                   <0.002

                                     1000
                                    2591.00
                                   <0.04
                                   <0.02
                                   <0.02
                                   <0.003
                                   <0.02
                                   <0.01
                                  Ornamentals
                                      20
                                    1440.86
                                   <0.53
                                   <0.24
                                   <0.30
                                   <0.03
                                   <0.21
                                   <0.01

                                      100
                                    1834.29
                                   <0.24
                                   <0.11
                                   <0.13
                                   <0.01
                                   <0.09
                                   <0.003

                                     1000
                                    2591.00
                                   <0.08
                                   <0.03
                                   <0.04
                                   <0.005
                                   <0.03
                                   <0.001
Bolded values represent LOC exceedances
[1]LOCs are: acute endangered species = 0.1, acute restricted use = 0.2; acute high risk = 0.5

 Table 27 summarizes the acute and chronic dietary based RQs for birds resulting from ingestion of five different food items exposed to fenpyrazamine.  There were no acute LOC exceedances for any of the proposed uses on fenpyrazamine.  The chronic LOC of 1 was exceeded for birds eating short grass in all proposed uses except for the use on almonds and pistachios, and for birds eating tall grass and broadleaf plants for the ornamental use only.  For both acute oral toxicity studies to birds, there were non-definitive values (>2000 mg a.i/kg-bw for both the northern bobwhite quail and canary).
 Acute dose-based RQs for birds ranged from 0.0004  -  0.53 thus indicating a potential for acute risks to various size classes of  birds species ingesting various food items for  all proposed uses.  Acute dietary-based RQs for birds ranged from 0.2  -  0.15 indicating a potential for acute risks to endangered avian species eating short grass exposed to the ornamental use of fenpyrazamine. Chronic-dietary based RQs ranged from 0.06  -  2.72 indicating a potential for chronic risks to mammals ingesting various food items for all proposed uses except almonds and pistachios.

 For both dietary toxicity studies, there were also non-definitive values (>4430 ppm) that were used to estimate RQs.  Therefore, while the estimates are shown in Table 26 and Table 27, the precise values of these acute RQs are uncertain.  The RQs summarized in Table 26 and Table 27 lists the upper bound of the acute RQ, that is, the value of risk at most for a given use.   This is still useful for risk assessment despite the uncertainties associated with non-definitive toxicity endpoints.

Table 27.  Dietary-based RQs for birds due to exposure to proposed uses of fenpyrazamine.
                                      Use
                                    RQs[1]

                                   Exposure
                                  Short grass
                                  Tall grass
                               Broadleaf plants
                               Fruits/pods/seeds
                                  Arthropods
                              Almonds, pistachios
                                     Acute
                                   <0.05
                                   <0.02
                                   <0.03
                                   <0.003
                                   <0.02

                                    Chronic
                                     0.94
                                     0.43
                                     0.53
                                     0.06
                                     0.37
                                    Lettuce
                                     Acute
                                   <0.07
                                   <0.03
                                   <0.04
                                   <0.004
                                   <0.03

                                    Chronic
                                     1.25
                                     0.57
                                     0.70
                                     0.08
                                     0.49
                       Grapes, bushberries, caneberries
                                     Acute
                                   <0.07
                                   <0.03
                                   <0.04
                                   <0.004
                                   <0.03

                                    Chronic
                                     1.25
                                     0.57
                                     0.70
                                     0.08
                                     0.49
                                 Strawberries
                                     Acute
                                   <0.09
                                   <0.04
                                   <0.05
                                   <0.01
                                   <0.03

                                    Chronic
                                     1.56
                                     0.71
                                     0.88
                                     0.10
                                     0.61
                                    Ginseng
                                     Acute
                                   <0.09
                                   <0.04
                                   <0.05
                                   <0.01
                                   <0.03

                                    Chronic
                                     1.56
                                     0.71
                                     0.88
                                     0.10
                                     0.61
                                  Ornamentals
                                     Acute
                                   <0.15
                                   <0.07
                                   <0.09
                                   <0.01
                                   <0.06

                                    Chronic
                                     2.72
                                     1.25
                                     1.53
                                     0.17
                                     1.07
Bolded values represent LOC exceedances
[1]LOCs are: acute endangered species = 0.1, acute restricted use = 0.2; acute high risk = 0.5; chronic LOC = 1
                     a. Acute and Chronic Risk to Mammals

 T-REX provides acute and chronic dose- based RQs for three size classes of mammals as well as chronic dietary based RQs resulting from ingestion of six different food items exposed to fenpyrazamine.  Table 28 below summarizes the acute dose-based RQs to mammals for all proposed use of fenpyrazamine.  The acute endangered species LOC was exceeded for mammals eating short grass for only the proposed use on ornamentals.  There are no other acute dose-based LOC exceedances for mammals.  Table 29 summarizes the chronic dose-based RQs to mammals for all proposed uses.  The chronic LOC of 1 was exceeded for all size classes of mammals eating various food items for the ornamental use only.  The chronic LOC was exceeded by small and medium sized mammals eating tall grass, broadleaf plants, and arthropods was exceeded for all uses except almonds and pistachios (no exceedances) and lettuce, grapes, bushberries, and caneberries (exceedances only for small mammals).  Table 30 summarizes the chronic dietary-based RQ for all proposed uses of fenpyrazamine. There are no LOC exceedances for these RQs.

 Acute dose-based RQs for mammals ranged from 0.0004  -  0.15 thus indicating a potential for acute risks to endangered mammalian species ingesting short grass for the ornamental use only.  Chronic dose-based RQs ranged from 0.1  -  5.86 indicating a potential for chronic risks to mammals for all various size class ingesting various food items for all proposed uses.  There are no chronic dietary based LOC exceedances for mammals.

 For the acute oral toxicity study to mammals, there was a non-definitive endpoint (>2000 mg a.i/kg-bw) determined.  Therefore, while the estimates are shown in Table 28, the precise values of these acute RQs are uncertain.  The RQs summarized in Table 28 lists the upper bound of the acute RQ, that is, the value of risk at most for a given use.   This is still useful for risk assessment despite the uncertainties associated with non-definitive toxicity endpoints.

Table 28.  Acute dose-based RQs for mammals due to exposure to proposed uses of fenpyrazamine.
                                      Use
                              Size Class (grams)
                               Adjusted LD50 -
                                    RQs[1]

                                  Short grass
                                  Tall grass
                               Broadleaf plants
                                  Fruits/pods
                                  Arthropods
                                     Seeds
                              Almonds, pistachios
                                      15
                                    4395.66
                                   <0.05
                                   <0.02
                                   <0.03
                                   <0.003
                                   <0.02
                                   <0.001

                                      35
                                    3556.56
                                   <0.04
                                   <0.02
                                   <0.02
                                   <0.003
                                   <0.02
                                   <0.001

                                     1000
                                    1538.32
                                   <0.02
                                   <0.01
                                   <0.01
                                   <0.001
                                   <0.01
                                  <0.0003
                                    Lettuce
                                      15
                                    4395.66
                                   <0.07
                                   <0.03
                                   <0.04
                                   <0.004
                                   <0.03
                                   <0.001

                                      35
                                    3556.56
                                   <0.06
                                   <0.03
                                   <0.03
                                   <0.004
                                   <0.02
                                   <0.001

                                     1000
                                    1538.32
                                   <0.03
                                   <0.01
                                   <0.02
                                   <0.002
                                   <0.01
                                  <0.0004
                       Grapes, bushberries, caneberries
                                      15
                                    4395.66
                                   <0.07
                                   <0.03
                                   <0.04
                                   <0.004
                                   <0.03
                                   <0.001

                                      35
                                    3556.56
                                   <0.06
                                   <0.03
                                   <0.03
                                   <0.004
                                   <0.02
                                   <0.001

                                     1000
                                    1538.32
                                   <0.03
                                   <0.01
                                   <0.02
                                   <0.002
                                   <0.01
                                  <0.0004
                                 Strawberries
                                      15
                                    4395.66
                                   <0.08
                                   <0.04
                                   <0.05
                                   <0.01
                                   <0.03
                                   <0.001

                                      35
                                    3556.56
                                   <0.07
                                   <0.03
                                   <0.04
                                   <0.004
                                   <0.03
                                   <0.001

                                     1000
                                    1538.32
                                   <0.04
                                   <0.02
                                   <0.02
                                   <0.002
                                   <0.02
                                   <0.001
                                    Ginseng
                                      15
                                    4395.66
                                   <0.08
                                   <0.04
                                   <0.05
                                   <0.01
                                   <0.03
                                   <0.001

                                      35
                                    3556.56
                                   <0.07
                                   <0.03
                                   <0.04
                                   <0.004
                                   <0.03
                                   <0.001

                                     1000
                                    1538.32
                                   <0.04
                                   <0.02
                                   <0.02
                                   <0.002
                                   <0.02
                                   <0.001
                                  Ornamentals
                                      15
                                    4395.66
                                   <0.15
                                   <0.07
                                   <0.08
                                   <0.01
                                   <0.06
                                   <0.002

                                      35
                                    3556.56
                                   <0.13
                                   <0.06
                                   <0.07
                                   <0.01
                                   <0.05
                                   <0.002

                                     1000
                                    1538.32
                                   <0.07
                                   <0.03
                                   <0.04
                                   <0.004
                                   <0.03
                                   <0.001
Bolded values represent LOC exceedances
[1]LOCs are: acute endangered species = 0.1, acute restricted use = 0.2; acute high risk = 0.5; chronic LOC = 1

Table 29.  Chronic dose-based RQs for mammals from exposure to proposed uses of fenpyrazamine.
                                      Use
                              Size Class (grams)
                               Adjusted LD50 -
                                    RQs[1]

                                  Short grass
                                  Tall grass
                               Broadleaf plants
                                  Fruits/pods
                                  Arthropods
                                     Seeds
                              Almonds, pistachios
                                      15
                                    4395.66
                                     1.27
                                     0.58
                                     0.71
                                     0.08
                                     0.50
                                     0.02

                                      35
                                    3556.56
                                     1.08
                                     0.50
                                     0.61
                                     0.07
                                     0.42
                                     0.02

                                     1000
                                    1538.32
                                     0.58
                                     0.27
                                     0.33
                                     0.04
                                     0.23
                                     0.01
                                    Lettuce
                                      15
                                    4395.66
                                     1.68
                                     0.77
                                     0.94
                                     0.10
                                     0.66
                                     0.02

                                      35
                                    3556.56
                                     1.43
                                     0.66
                                     0.81
                                     0.09
                                     0.56
                                     0.02

                                     1000
                                    1538.32
                                     0.77
                                     0.35
                                     0.43
                                     0.05
                                     0.30
                                     0.01
                       Grapes, bushberries, caneberries
                                      15
                                    4395.66
                                     1.68
                                     0.77
                                     0.94
                                     0.10
                                     0.66
                                     0.02

                                      35
                                    3556.56
                                     1.43
                                     0.66
                                     0.81
                                     0.09
                                     0.56
                                     0.02

                                     1000
                                    1538.32
                                     0.77
                                     0.35
                                     0.43
                                     0.05
                                     0.30
                                     0.01
                                 Strawberries
                                      15
                                    4395.66
                                     2.10
                                     0.96
                                     1.18
                                     0.13
                                     0.82
                                     0.03

                                      35
                                    3556.56
                                     1.79
                                     0.82
                                     1.01
                                     0.11
                                     0.70
                                     0.02

                                     1000
                                    1538.32
                                     0.96
                                     0.44
                                     0.54
                                     0.06
                                     0.38
                                     0.01
                                    Ginseng
                                      15
                                    4395.66
                                     2.10
                                     0.96
                                     1.18
                                     0.13
                                     0.82
                                     0.03

                                      35
                                    3556.56
                                     1.79
                                     0.82
                                     1.01
                                     0.11
                                     0.70
                                     0.02

                                     1000
                                    1538.32
                                     0.96
                                     0.44
                                     0.54
                                     0.06
                                     0.38
                                     0.01
                                  Ornamentals
                                      15
                                    4395.66
                                     3.66
                                     1.68
                                     2.06
                                     1.44
                                     0.05
                                     0.05

                                      35
                                    3556.56
                                     3.13
                                     1.43
                                     1.76
                                     0.20
                                     1.23
                                     0.04

                                     1000
                                    1538.32
                                     1.68
                                     0.77
                                     0.94
                                     0.10
                                     0.66
                                     0.02
Bolded values represent LOC exceedances
[1]LOCs are: acute endangered species = 0.1, acute restricted use = 0.2; acute high risk = 0.5; chronic LOC = 1

Table 30.  Chronic dietary-based RQs for mammals due to exposure to proposed uses of fenpyrazamine.
                                      Use
                                    RQs[1]

                                   Exposure
                                  Short grass
                                  Tall grass
                               Broadleaf plants
                               Fruits/pods/seeds
                                  Arthropods
                              Almonds, pistachios
                                    Chronic
                                     0.23
                                     0.11
                                     0.13
                                     0.01
                                     0.09
                                    Lettuce
                                    Chronic
                                     0.31
                                     0.14
                                     0.17
                                     0.02
                                     0.12
                       Grapes, bushberries, caneberries
                                    Chronic
                                     0.31
                                     0.14
                                     0.17
                                     0.02
                                     0.12
                                 Strawberries
                                    Chronic
                                     0.39
                                     0.18
                                     0.22
                                     0.02
                                     0.15
                                    Ginseng
                                    Chronic
                                     0.39
                                     0.18
                                     0.22
                                     0.02
                                     0.15
                                  Ornamentals
                                    Chronic
                                     0.67
                                     0.31
                                     0.38
                                     0.04
                                     0.26
Bolded values represent LOC exceedances
[1]LOCs are: acute endangered species = 0.1, acute restricted use = 0.2; acute high risk = 0.5; chronic LOC = 1

                     a. Non-target Beneficial Insects

 The Agency does not currently conduct quantitative risk assessments for non-target beneficial insects (e.g., honeybee).  Rather, the potential exposure of honeybees to pesticides is assessed qualitatively based on laboratory data and if available, field data.  Furthermore, when used alone, fenpyrazamine, consistent with other carboxamide pyrazole fungicides, does not possess a mode of action consistent with systemic fungicides.  Therefore, potential exposure via transport within the plant to pollen and nectar is reduced.  It is also noted that fenpyrazamine is classified as practically non-toxic to honeybee (acute contact LD50 >100 ug a.i/bee) and was shown to be non-toxic at a dose of 100 ug a.i/bee in an acute oral exposure study.  Therefore, while the potential exists via exposure pathways such as spray drift to impact insects like honeybees, the limited available data show that fenpyrazamine is not shown to be toxic.

                     a. Risks to Terrestrial Plants

 Seedling emergence and vegetative vigor studies are available for fenpyrazamine.  The estimates of exposure generated by TerrPlant and described in Section 6.2.2 were compared to estimates of toxicity to estimate RQ for listed and non listed plants in dry and semi aquatic areas.  For almonds and pistachios, the chronic LOC of 1 was exceeded for listed dicot species in semi aquatic areas.  There are no other LOC exceedances for this use.  For lettuce, grapes, bushberries, caneberries, strawberries, and ginseng, the chronic LOC of 1 was exceeded for listed dicot species in semi aquatic areas with no other LOC exceedances.  For the use on ornamentals, listed monocot species in semi aquatic areas and listed dicot areas in dry, semi aquatic, and areas resulting from spray drift all exceeded the chronic LOC.  Therefore, the potential for risk is indicated to these groups of terrestrial plants from the uses exceeding the LOC of 1.

 It is important to note that the RQs summarized in Table 32 did not have EC25 endpoints input into the TerrPlant model for vegetative vigor on account of a lack of toxicity for these studies precluding that endpoint to be estimated.  Furthermore, the NOAEC for seedling emergence for dicot species was a non-definitive endpoint (<0.035 lbs a.i/A).  Additionally, the EC25 values for seedling emergence (monocot and dicot) were non definitive (>1.54 ad >0.53 for monocots and dicots, respectively).  Therefore while the RQs are summarized in Table 31, the RQs are not determined to be precise, and there exists uncertainty with these endpoints that arises from the use of non-definitive RQs.  This is detailed further as it pertains to terrestrial plants in the Risk Description, Section 7.2.3.   The complete input and output files from TerrPlant can be found in Appendix D.

Table 31.  RQs for terrestrial plants resulting from the propose uses of fenpyrazamine.
                                  Crop Use[1]
                                   Plant Type
                                 Listed Status
                                      Dry
                                  Semi-aquatic
                                  Spray Drift
                              Almonds, pistachios
                                    Monocot
                                   Non-listed
                                    <0.1
                                    <0.01
                                    <0.1

                                    Monocot
                                     Listed
                                      0.17
                                      0.62
                                    <0.1

                                     Dicot
                                   Non-listed
                                    <0.1
                                      0.17
                                    <0.1

                                     Dicot
                                     Listed
                                      0.74
                                      2.64
                                      0.53
        Lettuce, Grapes, Caneberries, Bushberries, Strawberries, Ginseng
                                    Monocot
                                   Non-listed
                                    <0.01
                                      0.20
                                    <0.01

                                    Monocot
                                     Listed
                                      0.23
                                      0.82
                                    <0.1

                                     Dicot
                                   Non-listed
                                    <0.01
                                      0.23
                                    <0.1

                                     Dicot
                                     Listed
                                      0.98
                                      3.50
                                      0.70

                                  Ornamentals
                                    Monocot
                                   Non-listed
                                      0.12
                                      0.45
                                    <0.1

                                    Monocot
                                     Listed
                                      0.50
                                      1.78
                                    <0.1

                                     Dicot
                                   Non-listed
                                      0.14
                                      0.50
                                      0.1

                                     Dicot
                                     Listed
                                      2.14
                                      7.64
                                      1.53
 [1]Single application rates for TerrPlant modeling are 0.37 lbs a.i/A for almonds and pistachios, 0.49 lbs a.i/A for lettuce, grapes, caneberries, bushberries, strawberries, and ginseng, and 1.07 lbs a.i/A for ornamentals
 Bolded values represent LOC exceedances of the listed and non-listed terrestrial plant LOC of 1

         7.1 Risk Description

 In risk description, the results from the risk estimation are interpreted and synthesized into overall risk conclusions. When available, other lines of evidence are considered for characterizing ecological risk (e.g., monitoring data, ecological incident reports, refined exposure and effects modeling, data for structurally similar pesticides, etc.). In the case of fenpyrazamine, no information is available on monitored concentrations in the environment or ecological incident reports because it is a new pesticide.  The risk description also contains a discussion of relevant sources of uncertainty in the risk assessment and sensitivity of the risk assessment findings to important methodological assumptions.  Those uncertainties that are specific to certain taxonomic groups are discussed in the following sections.  Those uncertainties that are generic to this assessment (i.e., extending across taxonomic groups) are described in Section 7.2.6.d.

Risks to Aquatic Animals

                     a.                         Potential for Acutely Toxic Exposures

                  * Fish

 The previous risk estimation indicates a low potential for acutely toxic exposures to freshwater and estuarine/marine fish animals from the proposed uses of fenpyrazamine.  The highest estimated acute RQs for freshwater fish are 3 times below the listed species LOC of 0.05 and the lowest RQs are one order of magnitude lower.  For acute risk to estuarine/marine fish, RQs were estimated from a non-definitive endpoint (>3900 ug a.i/L).  As a result, the RQs that were estimated represent at most what the RQ would fall but the precise value of the RQ is uncertain.  An LC50 of >3900 ug a.i./L would yield an RQ that be preceded with an "<" indicating that the estimated value would at most be the calculated RQ.  Even with the uncertainty in these RQs calculated from non-definitive endpoints, they are still useful in risk assessment in terms of serving as a screen and in this case indicate that acute risk to estuarine/marine fish is at most approximately 2 times below the listed species LOC of 0.05.

 Acute toxicity data was available for two degradates of fenpyrazamine to freshwater fish (S-2188-DC and S-2188-OH).  These studies indicated that freshwater fish (using rainbow trout as a surrogate) was approximately 17 times more sensitive to parent fenpyrazamine than to these degradation products.  While there were no degradate studies to estuarine/marine fish, degradates are expected to be of lower toxicity to this taxa similar to freshwater fish as indicated by a small difference in acute LC50 values for freshwater and estuarine/marine fish (5.2 mg a.i/L and >3.9 mg a.i/L, respectively).  Significant acute exposure to degradates in the water column is not expected.  The most significant mechanism contributing to the potential input of degradation products into water bodies is anaerobic soil metabolism where degradation of fenpyrazamine of S-2188-OH and S-2188-DC occurs of levels up to 22.9 percent and 22 percent applied, respectively.  There were no other cases where degradate residues contributed to greater than 10 percent of the applied in soil.  Once in the water column, fenpyrazamine is moderately persistent to persistent in the water column, especially in acidic environments, with half-lives ranging from 12.2 days  -  280 days under aerobic and anaerobic conditions.

                  * Aquatic Invertebrates

 A low potential for acutely toxic exposure is also indicated for freshwater and estuarine/marine invertebrates.  Freshwater invertebrate RQs at their highest are marginally close to the listed species LOC of 0.05 (NJ ornamental aerial use RQ of 0.02  Estuarine/marine invertebrates were shown to be more sensitive in ecotoxicological testing and as a result, the highest acute RQs for this taxa marginally exceed the acute restricted use  LOC of 0.1 with aerial and ground application to ornamental (NJ nursery scenario) RQs of 0.11 and 0.1.  .  For two other scenarios of the ornamental use (MI and TN nursery), there was a marginal exceedance of the listed species LOC of 0.05 (RQs = 0.08 and 0.06 for the scenarios, respectively), as well as for the ginseng use (MN sugarbeet scenario, RQ = 0.06)   Three acute toxicity studies with freshwater invertebrates (Daphnia magna) were submitted with three degradation products of fenpyrazamine (MCNI, S-2188-DC, and S-2188-OH).  The results of these studies were similar to those of the results of the freshwater fish degradate studies.  In the case of MCNI (the most toxic of the degradates) the LC50 was still approximately 10 times less toxic than parent fenpyrazamine. The degradates S-2188-DC and S-2188-OH were approximately 17 times less toxic than parent fenpyrazamine.  Although, there were no degradate studies conducted on estuarine/marine invertebrates, the degradation products are expected to be less toxic than parent fenpyrazamine to this taxa  as it was for freshwater invertebrates despite the fact that estuarine/marine invertebrates were shown to be more sensitive to parent chemical than freshwater invertebrates.  Biodegradation and abiotic degradation of fenpyrazamine in the water column and availability of degradate products to runoff as described above for fish species also suggest that exposure of degradate residues will not cause adverse impacts to aquatic invertebrates on an acute basis.
                     a. Potential for Chronically Toxic Exposures

                  * Fish

Chronic toxicity studies are available for freshwater and estuarine/marine fish as early life stage studies.  While the freshwater fish study (rainbow trout, MRID 48400003) reached a definitive NOAEC, the study with an estuarine/marine species (sheepshead minnow, MRID 48400004) yielded a non-definitive endpoint, <39 ug a.i/L.  While estimation of RQs with this endpoint will not be entirely precise, it is still useful to quantify a lower bound estimate of risk since the RQs generated would be at least that value (i.e. a ">" value).  Because of this, there is a high degree of uncertainty where the actual RQ falls.  For example, an RQ of >0.18, while below the chronic LOC of 1 does have the potential to be in exceedance of the LOC and therefore an indicator for the potential of chronic effects.  For the proposed uses on fenpyrazamine, estimated freshwater fish chronic RQs ranged from 0.02  -  0.22.  The highest RQ is 5 times away from the  chronic LOC of 1.  For estuarine/marine fish, RQs were estimated using the NOAEC of 39 ug a.i/L for bounding purposes. The resultant RQs would be preceded with a ">" sign to distinguish these RQs because the actual NOAEC is known to be below 39 ug a.i/L.  Consequently, such unbounded RQs do not enable a conclusive determination of risk (or lack thereof) to be made.  With the proposed uses of fenpyrazamine, the unbounded RQ for the ornamental use does exceed the chronic LOC of 1, yet how far above this threshold the actual RQ falls is an uncertainty.  As mentioned previously, RQs derived from non-definitive endpoints are uncertain yet are still useful to quantify the potential effects in risk assessment.

 Despite the unbounded estimates of risk and the indication that the chronic LOC of 1 may be exceeded, there are two reasons why chronic risk to estuarine/marine fish may be presumed to be low.  The first point relates to the fact the NOAEC for the chronic fish study was based on mean body length and the lowest treatment concentration of the study (39 ug a.i/L) resulted in a 4.3% reduction from the negative control.  This response is considered relatively modest in nature from a biological perspective.  Furthermore for this endpoint, the effects did not follow a dose response pattern with the next two higher concentrations (62 and 150 ug a.i/L) resulting in percent reductions from the control of 1.9 and 2.7% respectively. Additionally, the structure activity relationships tool, ECOSAR (v. 1.10) was employed to get a conservative estimation of chronic toxicity to estuarine/marine fish.  ECOSAR estimates toxicity to various taxa by way of breaking down toxicity estimates by ECOSAR-specific classes (See Appendix G for further information on ECOSAR and its estimates of toxicity for the various degradation products of fenpyrazamine.)  When the chemical structure is input into ECOSAR, the results of 4 ECOSAR classes are returned that includes aliphatic amines, hydrazines, amides, and thiocarbamates.  For the aliphatic amines and hydrazine classes, only chronic results for fish are specified (as opposed to estuarine/marine fish) and for the amide and thiocarbamates classes there are specific chronic toxicity estimates for estuarine/marine fish estimated.  The estimates of a chronic NOAEC for fish range from 0.2 to 19.6 mg/L, depending on the chemical class.  For fenpyrazamine, the highest 1-in-10 year 60 day average EEC was for the NJ ornamental use and was 80.35 ug/L or 0.08 mg/L.  As the most sensitive estimate of chronic toxicity for fish as determined by ECOSAR is one order of magnitude below the highest 60-day average EEC, the conservative estimates indicate risk below the chronic LOC.  Taken with the unbounded estimated chronic RQs from the registrant submitted data, chronic risk for fish is indicated for the ornamental use only but it remains an uncertainty of where the actual estimate of the chronic RQs fall.

 The second point relates to the likely conservative estimate of exposure for fenpyrazamine in the water column.  The lower bound aspect of the risk quotient is mitigated due to the fact that hydrolysis is conservatively not included as a degradation pathway due to significant uncertainties in the hydrolysis study (MRID No. 48399923).  The existing data on hydrolysis indicates that fenpyrazamine degrades to some extent, especially in alkaline environments.  However, the exact rate at which it degrades under neutral conditions is unknown due to the lack of data available at environmentally relevant conditions.  The exclusion of hydrolysis from water column under neutral conditions contributes to the overall steady EEC values of fenpyrazamine occurring over all averaging periods as shown in Table 12 and Table 13.  In addition, the aquatic exposure modeling utilized the very conservative default assumption for input parameterization of anaerobic aquatic metabolism as only one sediment  -  water system was available.  Therefore, the single anaerobic aquatic metabolism half life available for modeling was multiplied by three.  Given the evidence for fenpyrazamine degradation due to hydrolysis especially over alkaline environments and that fenpyrazamine may be less persistent than modeled over neutral environments, it is possible that chronic EECs would be lower.  Additionally, a new chronic ELS study that reaches a definitive NOAEC would address this uncertainty but refined EECs could negate the need for that data if it is indicated that exposure would be significantly reduced from present levels.

                  * Aquatic Invertebrates (Water Column)

 Chronic toxicity studies are available for both freshwater and estuarine/marine invertebrates.  For freshwater invertebrates, chronic RQs ranged from 0.02  -  0.25.  The highest RQ is 4 times lower than the chronic LOC of 1.  For estuarine/marine invertebrates, RQs were estimated using the NOAEC of 98 ug a.i/L for bounding purposes.  The resultant RQs would therefore be preceded by a "<" sign to distinguish these RQs because the actual NOAEC is known to be above 98 ug a.i/L.  Consequently, such unbounded RQs do not enable a conclusive determination of risk (or lack thereof) to be made.  In the case of chronic risk to estuarine/marine invertebrates however, there were no exceedances of the chronic LOC of 1 with the estimated unbounded RQs.  As the actual bounded RQs are known to be below the estimated unbounded RQs, chronic risk to estuarine/marine invertebrates is expected to be low.

                  * Aquatic Invertebrates (Benthic)

 Chronic toxicity studies are available for freshwater and estuarine/marine benthic invertebrates. Studies with the freshwater invertebrates Hyalella azteca and Chironomus riparius were conducted for 42-d and 28-d exposures, respectively.  Additionally, a 28-day study with the estuarine/marine organism Leptocheirus plumulosus is available for risk estimation.  The 21-day 1-in-10 year EEC for pore water  is compared to the toxicity endpoint expressed in terms of pore water are compared to each other for pore water RQs and the same is done for 1-in-10-year sediment EECs and endpoints expressed in terms of sediment concentrations.  Both the most sensitive endpoints from the freshwater and estuarine/marine benthic invertebrate studies resulted in NOAECs that were non-definitive.

For the most sensitive freshwater benthic invertebrate study (C. riparius, MRID 48400007), the sediment and pore water expressed endpoints were <101 ug a.i/kg sediment and <20 ug a.i/L.  The resultant RQs would be preceded with a ">" sign to distinguish these RQs because the actual NOAEC is known to be below 101 ug a.i/kg sediment and 20 ug a.i/L.  Similarly, the most sensitive endpoints for the estuarine/marine benthic invertebrate were <3000 ug a.i/kg sediment and <250 ug a.i/L.   The resultant RQs would be preceded with a ">" sign to distinguish these RQs because the actual NOAEC is known to be below 3000 ug a.i/kg sediment and 250 ug a.i/L.     Consequently, such unbounded RQs do not enable a conclusive determination of risk (or lack thereof) to be made.  It is noted however that the PRZM/EXAMS estimated pore water and sediment EECs do not significantly decline (rather in most cases, remain the same) from their peak values when extended out to 21-day and 60-day averages (Table 14, Table 15, Table 16, and Table 17).  This likely is the artifact of using the conservative default assumption for input parametrization of anaerobic aquatic metabolism since only one study is available.  With this uncertainty in mind, it is possible that sediment and pore water EECs would be lower than this assessment assumes but to what extent is also uncertain.

 Currently, the highest sediment 1-in-10 year 21-day average EECs is 250 ug a.i/kg sediment (Table 16), which is approximately 2.5 fold higher than the most sensitive freshwater benthic organism endpoint (<101 ug a.i/kg sediment) and almost 12 fold lower than the most sensitive estuarine/marine benthic invertebrate endpoint (<3000 ug a.i/kg sediment). Similarly, the highest pore water 1-in-10 year 21-d average EEC is 46.8 ug a.i/L (Table 14) which is approximately 2 fold higher than the most sensitive freshwater benthic invertebrate endpoint (<20 ug a.i/L) and approximately 5 fold lower than the most sensitive estuarine/marine benthic invertebrate endpoint (<250 ug a.i/L).  This illustrates the assumption that sediment and pore water EECs which are calculated incorporating a robust sampling of water-sediment systems in an anaerobic environment may reduce the uncertainty of the non-definitive RQs by providing concentrations that are several fold or even orders of magnitude lower than the most sensitive sediment and pore water-expressed toxicity endpoints.  Additionally, further sediment toxicity studies that reach definitive endpoints would also reduce the uncertainty of non-definitive RQs.

 It should also be stated that as mentioned in Section 3, unextracted residues incorporated in soil or sediment layers are not included for benthic pore water or sediment EECs.  The reasons for not including unextracted residues include the following rationale:  1.) It was sufficiently demonstrated that bound residues do not desorb into the water column based on aerobic aquatic and aerobic soil metabolism laboratory studies, where exhaustive methods of extraction were used (MRID Nos. 48399920, 48399927, and 48399929), 2.)  Unextracted residues comprised of a negligible amount of the material balance based on the anaerobic aquatic metabolism lab study (MRID No. 48399930), and 3.)  Inclusion of unextracted residues on eroded soil particles input into the sediment layer had no effect on the pore water EECs since input parameter half-lives with and without the residues were similar.  Therefore, uncertainties related to the identity of unextracted residues should have no impact on this risk assessment.

                  * Aquatic Plants

Aquatic plant toxicity data are available for one species of vascular plant and four species of non-vascular algal organisms.  For both vascular and non-vascular aquatic plants, the non-listed species RQ is derived by a comparison of the peak EEC to the EC50 of the toxicity study while the listed species RQ is derived by a comparison of the peak EEC to the NOAEC of the study.  The LOC for both measures is 1.  For non-vascular aquatic plants, the non-listed LOC was exceeded for all proposed uses of fenpyrazamine except almonds and pistachios with the RQs ranging from 1.30  -  7.87 indicating the potential for toxic effects to this taxa.  For listed aquatic vascular plants, the LOC was exceeded for every proposed use of fenpyrazamine with RQs ranging from 1.51  -  17.67, indicating the potential for toxic effects to this taxa.  Vascular aquatic plants were substantially less sensitive and there were no listed or non-listed LOC exceedances for all proposed uses of fenpyrazamine.  Conservative EECs resulting from excluding hydrolysis as a degradation pathway given fenpyrazamine's uncertainties of hydrolysis under environmentally relevant conditions are also applicable for aquatic plants in this case particularly due to its impact between applications.  As a result, peak EECs may be substantially lower when considering hydrolysis as a viable degradation pathway. .

 Additional non-vascular aquatic plant toxicity studies were submitted for two degradation products of fenpyrazamine.  Studies conducted on the freshwater green algae (Pseudokirchneriella subcapita) using the degradates S-2188-DC and S-2188-OH (MRIDs 48400019 and 48400020, respectively). Both studies determined that the degradates that were tested were  approximately 150 times less toxic to freshwater green algae than parent fenpyrazamine by 3 orders of magnitude for-2188-DC and S-2188-OH (based on EC50 values). As the NOAEC value was non-definitive for parent fenpyrazamine freshwater green algae study, the EC05 of 0.029 mg a.i/L was used which is approximately 55 times more sensitive than the most sensitive NOAEC from both degradation product studies (1.6 mg a.i/L).  Given the varying sensitivities of freshwater green algae to parent fenpyrazamine and two of its degradates, the estimated listed and non-listed RQs would be significantly less for these degradation products than those estimated for parent fenpyrazamine.  Biodegradation and abiotic degradation of fenpyrazamine in the water column and availability of degradate products to runoff as described above for fish species also suggest that exposure of degradate residues will not cause adverse impacts to aquatic plants.

Risks to Terrestrial Animals

                     a. Potential for Acutely Toxic Exposures

                  * Birds

 The analysis conducted in risk estimation determined there to be acute dose-based risk to small and medium sized birds depending on the food item and crop use of fenpyrazamine.  RQs ranged from <0.0004  -  <0.53, which marginally exceeds the acute non-listed species LOC of 0.5.   These RQ values are based on the most sensitive LD50 value available (> 2,000 mg a.i./kg bw for the canary and northern bobwhite quail (Table 26).  Acute dietary-based RQs ranged from <0.05  -  <0.15 with the high end of the range marginally exceeding the endangered species LOC of 0.1 (ornamental use, Table 27).  These RQs values are also based on the most sensitive LD50 -  value available, which is also a non-definitive endpoint (LC50 >4430 ppm).  Only upper bound (non-definitive) RQs could be determined because no treatment related mortality occurred at the highest dose tested in the available toxicity studies (i.e., non-definitive LD50/LC50 values).  A review of the acute oral studies for sub lethal effects also indicates no treatment-related effects on endpoints such as food consumption, body weight and behavior.  A review of the subacute dietary studies shows a significant reduction (p<0.05) in mean body weight gain as compared to the negative control in the three highest treatment concentrations for the bobwhite study and the highest treatment concentration for the mallard study.  Despite the uncertainty in non-definitive endpoints, these estimates are still useful in risk assessment as they give an indication of where potential acute risk to birds may be a concern

                  * Mammals

 Similar to birds, acute dose-based risks to mammals are considered low as indicated by acute RQs of <0.0003 to <0.15 (Table 28).  These RQ values are based the most sensitive acute toxicity endpoint available (>2000 mg a.i/kg bw for the rat (Table 9).  Only upper bound (non-definitive) RQs could be determined because no treatment related mortality occurred at the highest dose tested in the available toxicity studies (i.e., non-definitive LD50 values).  A review of the acute oral studies for sub lethal effects also indicates no treatment-related effects on endpoints such as food consumption, body weight and behavior.

                     a. Potential for Chronically Toxic Exposures

                  * Birds

 Chronic dietary-based RQs for birds (0.06 - 2.72; Table 27) indicate chronically toxic exposure to fenpyrazamine with all proposed uses except almonds and pistachios (for which the chronic RQ on short grass approaches the LOC at 0.94).  Chronic dietary-based risk exceeds the LOC for birds ingesting short and tall grass as well as broadleaf plants exposed to fenpyrazamine resulting from the ornamental use, and from ingesting only short grass for all other uses (except almonds and pistachios).  These chronic RQs are based on a dietary NOAEL of 248 ppm for the northern bobwhite quail (MRID 48400014) based on effects to hatching body weight (day 14) which occurred at the LOAEL of 495 ppm in the diet.  It is noted that while significant effects (p<0.05) to hatching weight at day 14 occurred at the two highest treatment concentrations (495 and 978 ppm), the percent reduction from the negative control was 6.2 and 4.9%, respectively which is considered modest in terms of a biological effect.

                  * Mammals

 Chronic dose-based risks associated with mammalian consumption of fenpyrazamine exposed food items are indicated in this assessment, with chronic RQs ranging from 0.01 to 3.66 (Table 29).  Chronic risks are identified for all size classes of mammals considered (15, 35 and 1000g)  for the proposed use on ornamentals only and for the small and medium sized class mammals for all other uses (for mammals eating short grass).  Small and medium sized mammals ingesting fenpyrazamine exposed broadleaf plants are in exceedance of the LOC for the strawberries, ginseng, and ornamental use and tall grass for the ornamental use only.    These RQ values are based on a NOAEL of 1000 ppm in the diet (73.7 mg a.i/kg bw) identified for the Norway rat (MRID 48400127).  The LOAEL from this study was 3000 ppm in the diet based on reduced number of implantation sites.  Significant (p<0.05) effects also included increased post natal loss and body weight reduction in the highest treatment level (3000 ppm).

                  * Non-target beneficial insects and other non-target terrestrial organisms

 The potential exposure of honeybees to pesticides is assessed qualitatively based on laboratory data and if available, field data.  There is a small potential for exposure via transport within the plant to pollen and nectar.  It is noted that fenpyrazamine is classified as practically non-toxic to honeybee (acute contact LD50 >100 ug a.i/bee and an acute oral LC50 of >100 a.i/bee).  Clinical sings of toxicity included bees showing lethargic symptoms at varying numbers that increased with concentration in the acute contact toxicity study.  While conceptually potential routes of exposure exist for fenpyrazamine to honeybees and other insect pollinators, the very low toxicity of fenpyrazamine to honeybees suggest that this route of exposure is not likely to be a concern.

 An acute toxicity study was also submitted for the earthworm which showed no significant effects on mortality.  Sublethal effects included effects on body weight which was reduced at all but the highest treatment concentration and lethargy observed in earthworms in the highest treatment concentration.

Risks to Terrestrial Plants

Seedling emergence and vegetative vigor studies are available to estimate RQs for listed and non-listed terrestrial plants.  The results of TerrPlant indicate an exceedance of the LOC of 1 for listed dicot species in semi-aquatic plants, and listed monocots in semi-aquatic as well as listed dicots in dry areas and those resulting from spray drift for the ornamental use only.  RQs for both listed and non-listed plants were derived from the use of non-definitive endpoints.  For non-listed plants, for which the EEC is compared to the EC25 value, both the seedling emergence and vegetative vigor studies had a determined EC25 value of >0.53 lbs a.i/A due to a lack of effects.  The NOAEC for the vegetative vigor study was also the highest treatment concentration (0.53 lbs a.i/A).  For the seedling emergence study, the NOAEC could not be definitively determined for the most sensitive dicot based on effects at the lowest treatment concentration on biomass (dry weight, NOAEC of <0.035 lbs a.i/A).   In the event a NOAEC being non-definitive, EFED policy is to use the EC05 for that endpoint.  In this case however,  although the statistical regression model was able to converge, the model  determined the  EC05 to be 0.0.  As a result, the value of 0.035 was used to estimate RQs for listed dicot in the TerrPlant model with the RQs being preceded by a ">" sign to signify the RQs may lie higher than this estimated value but to what extent is uncertain.

Review of Incident Data

 As fenpyrazamine has not been previously approved for use in the United States, there are no incident reports for this chemical.

Threatened and Endangered Species Concerns

For listed species assessment purposes, the action area is considered to be the area affected directly or indirectly by the Federal action and not merely the immediate area involved in the action.  At the initial screening-level, the risk assessment considers broadly described taxonomic groups and so conservatively assumes that list species within those broad groups are collocated within the pesticide treatment area.  This means that terrestrial plants and wildlife are assumed to be located on or adjacent to the treated site and aquatic organisms are assumed to be located in a surface water body adjacent to the treated site.  The assessment also assumes that the listed species are located within an assumed area which has the relatively highest potential exposure to the pesticide, and that exposures are likely to decrease with distance from the treated area.

If the assumptions associated with the screening-level action area result in RQs that are below the listed species LOCs, "no effect," determination conclusion may be made with respect to listed species in that taxa (for direct effects), and no further refinement of the action is necessary.  Furthermore, RQs below the listed species LOCs for a given taxonomic group indicate no concern for indirect effects upon listed species that depend upon the taxonomic group as a resource.  However, in situations where the screening assumptions lead to RQs in excess of the listed species LOCs for a given taxonomic group, a potential "may affect," conclusion exists and may be associated with direct effects on listed species belonging to that taxonomic group or may extend to indirect effects upon listed species that depend on that taxonomic group as a resource.  In such cases, additional information on the biology of the listed species, the locations of these species, and the locations of use sites could be considered along with available information on the fate and transport properties of the pesticide to determine the extent to which screening assumptions regarding an action area apply to a particular listed organism.  These subsequent refinement steps could consider how this information would impact the action area for a particular listed organism and may potentially include areas of exposure that are downwind and downstream of the pesticide use site.

In conducting a screen for indirect effects, direct effects LOCs for each taxonomic group are used to make inferences concerning the potential for indirect effects upon listed species that rely upon non-listed organisms in these taxonomic groups as resources critical to their cycle.  Pesticide use scenarios resulting in RQs that are below all direct effect listed species LOCs for all taxonomic groups assessed are considered of no concern for risks to listed species either by direct or indirect effects.

For fenpyrazamine, the potential direct effects to listed species should they co-occur with application sites are indicated for mammals (acute and chronic toxicity) and birds (acute and chronic toxicity) based on ingestion of fenpyrazamine contaminated food items.  Listed species LOCs are exceeded for any other taxonomic group assessed (aquatic animals, aquatic plants, nontarget invertebrates).  For the maximum proposed fenpyrazamine application rates, there may be a potential concern for direct effects to the following groups of organisms:

 Birds
 Mammals
 Terrestrial-phase reptiles
 Terrestrial-phase amphibians

A spatial co-occurrence analysis would be necessary to delineate the action area.

            6.3.6 Description of Assumptions, Limitations, Uncertainties, Strengths and Data Gaps

 There are a number of areas of uncertainty in the aquatic and terrestrial risk assessments.  The toxicity assessment for terrestrial and aquatic plants and animals is limited by the number of species tested in the available toxicity studies.  Use of toxicity data on representative species does not provide information on the potential variability in susceptibility to acute and chronic exposures.

                     a. Incidental Pesticide Releases Associated with Use

 This risk assessment is based on the assumption that the entire treatment area is subject to fenpyrazamine application at the rates specified on the label.  In reality, there is the potential for uneven application of fenpyrazamine through such plausible incidents as changes in calibration of application equipment, spillage, and localized releases at specific areas of the treated field that are associated with specifics of the type of application equipment.

                     b. Exposure for Aquatic Species

 This Tier II risk assessment relies on best available estimates of environmental fate and physicochemical properties, maximum application rate of fenpyrazamine, maximum number of applications, and the shortest interval between applications.  However, several modeling limitations are noted and should be considered in interpreting the results of this aquatic risk assessment.

 ::	The frequency at which actual fenpyrazamine uses approach the use estimates modeled is dependent on resistance to the fungicide, timing of applications, and market forces. In general, model output values represent the upper bound estimates of concentrations that might be observed in surface water due to the application of fenpyrazamine, given available data and model limitations.

 ::	Although there are uncertainties associated with using the standard PRZM/EXAMS runoff scenario (10 ha field draining into 20,000 m[3] pond with no outlet) for an aquatic exposure assessment, it is designed to represent pesticide exposure from an agricultural watershed impacting a vulnerable aquatic environment.  Extrapolating the risk conclusions from this standard pond scenario to a specific body of water of different dimensions, may either underestimate or overestimate the potential risks.

 ::	Major uncertainties associated with the standard runoff scenario include the physical construct of the watershed and representation of vulnerable aquatic environments for different geographic regions.  The physicochemical properties (pH, redox conditions, etc.) of the standard farm pond are based on a Georgia farm pond.  These properties are likely to be regionally specific because of local hydrogeological conditions.  Any alteration in water quality parameters may impact the environmental behavior of a pesticide.  The farm pond represents a well mixed, static water body.  Because the farm pond is a static water body (no flow through), it does not account for pesticide removal through flow through or water releases.  The lack of flow through the farm pond provides an environmental condition for accumulation of persistent pesticides.  The assumption of uniform mixing does not account for stratification due to thermoclines (e.g., seasonal stratification in deep water bodies).  Additionally, the dimensions of the standard runoff scenario assume a watershed area to water body volume ratio of 10 ha: 20,000m[3].  This ratio is recommended to maintain a sustainable constructed pond in the Southeastern United States.  The use of higher watershed area to water body volume ratios (as recommended for sustainable ponds in drier regions of the United States) may lead to higher pesticide concentrations when compared to the standard watershed area to water body volume ratio.

 ::	The standard runoff scenario assumes uniform soils and agronomic management practices across the standard 10 hectare field.  Soils can vary substantially across even small areas; this variation is not reflected in the model simulations.  Additionally, the impact of unique soil characteristics and soil management practices (e.g., tile drainage) are not considered in the standard runoff scenario.  The assumption of uniform site and management conditions is not expected to represent some site-specific conditions.  Extrapolating the risk conclusions from the standard pond scenario to other aquatic habitats (e.g., marshes, streams, creeks, and shallow rivers, intermittent aquatic areas) may either underestimate or overestimate the potential risks in those habitats.

 ::	Aquatic EECs are based on a conservative scenario the entire watershed area is impacted by a treated crop.  However, in reality, only a percentage of the watershed is impacted by a crop treatment.

 ::	For an acute risk assessment, there is no averaging time for exposure.  A peak concentration, with a 1 in 10 year return frequency, is assumed.  The use of the peak concentration in the calculation of risk quotients assumes that exposure is sufficient to elicit acute effects comparable to those observed over more protracted exposure periods tested in the laboratory, typically 48 to 96 hours.  In the absence of data regarding time-to-toxic event analyses and latent responses to peak exposure, the degree to which risk is overestimated cannot be quantified.

There are also several significant uncertainties with the environmental fate profile of fenpyrazamine. These uncertainties can impact estimation of acute and chronic EECs in surface water, benthic pore water, as well as sediment.

The first major uncertainty concerns fenpyrazamine's rate of hydrolysis in the environment.  The existing hydrolysis study suggests that fenpyrazamine degrades over all environments, especially in alkaline environments, with metabolites S-2188-OH and S-2188-DC detected (MRID No. 48399923).  This is also evident from the aerobic aquatic metabolism study (MRID No. 48399929), which also shows a trend of decreased half-lives at higher pHs.  However, environmentally relevant hydrolysis data were not provided to the Agency for neutral environments (pH7).  .  In the absence of adequate data, EFED conservatively assumed that the chemical persists to hydrolysis at pH 7.  This uncertainty could be addressed by a guideline hydrolysis study conducted at environmentally relevant temperatures.  The study may be used to recalculate aquatic EECs more representative of fenpyrazamine levels in the environment.  Additional data can especially impact future new uses with high application rates resulting in higher risk quotients.  However, no additional data will be requested at this time.

 A second significant uncertainty relates to the limited systems evaluated in the anaerobic aquatic study  (MRID Nos. 48399930).  Only one system was evaluated in each study.  Additional studies could provide a more robust representation for the degradation of fenpyrazamine in suboxic environments.  Therefore, more refined aquatic EECs, especially related to benthic organisms, may result considering that the single half-life values were multiplied by three as a conservative default to address this uncertainty.  However, no additional data will be requested at this time.

 A third uncertainty regards unextracted residues incorporated in soil or sediment layers.  In soil, unextracted residues accounted for approximately up to 70 percent of applied in two alkaline soils in aerobic soil metabolism studies (MRID No. 48399920).  In water, unextracted residues in sediment from the Calwich Abbey, UK study sample accounted for up to 48.4 percent of applied.  Despite these large levels of unextracted residues detected in aerobic soil and aerobic aquatic metabolism, unextracted residues were excluded from the expression of the "total residues of concern" and, therefore, from the aquatic EECs.   First, it was sufficiently demonstrated that bound residues do not desorb into the water column based on aerobic aquatic and aerobic soil metabolism laboratory studies, in which exhaustive methods of extraction were used (MRID Nos. 48399920, 48399927, and 48399929).  Second, unextracted residues comprised of a negligible amount of the material balance based on the anaerobic aquatic metabolism lab study (MRID No. 48399930).  Third, inclusion of unextracted residues incorporated in eroded soil input into the sediment layer had no effect on the pore water EECs since the aerobic soil metabolism half life parameterization without the unextracted residues was generally similar.  Therefore, uncertainties related to the identity of unextracted residues should have no impact on EECs or the risk conclusions in this risk assessment.  However, it should be noted that unextracted residues are likely bonded chemically to the humin matrices within the soil and sediment layers.  Soil-water partition coefficients of fenpyrazamine and degradates as well as inconsistencies in the amount of unextracted residues between the aerobic and anaerobic aquatic metabolism studies suggest that unextracted residues are not forming due to sorbtion of fenpyrazamine.

 A fourth uncertainty which exists is that water-sediment systems with variable pHs were evaluated in the aerobic aquatic metabolism study (MRID No. 48399929).  Since degradation is much different between acidic and alkaline conditions, it appears that degradation is mediated pH.  Additional soil-sediment systems evaluated over a similar pH range would provide insight on the effect of degradation solely on microbial activity.

 The fifth uncertainty concerns the lacking information on the representativeness on foreign soils evaluated in aerobic soil metabolism and batch equilibrium studies to domestic soils.  Regardless of these deficiencies, the studies conducted  on soils in the United Kingdom in batch equilibrium and aerobic soil metabolism studies (MRID Nos. 48399919 and 48399920, respectively) were considered since soils from the UK are traditionally similar in their physical chemical characteristics to soils that exist within the United States.

                     b. Exposure for Terrestrial Species

 This risk assessment relies on the best available estimates of environmental fate and physicochemical properties, maximum application rate of fenpyrazamine, maximum number of applications, and the shortest interval between applications.  However, several uncertainties and model limitations are noted and should be considered in interpreting the results of this terrestrial risk assessment.

                  * Dietary Exposure

 For screening terrestrial risk assessments, a generic bird or mammal is assumed to consume 100% of its diet on food which is contaminated with fenpyrazamine from the application site.  This assumption may lead to an overestimation of exposure to species that do not occupy the treated field. The actual habitat requirements of any particular terrestrial species are not considered, and it is assumed that species occupy, exclusively and permanently, the treated area being modeled.  This assumption leads to a maximum level of exposure in the risk assessment.

                  * Dermal Exposure

 The screening assessment does not consider fenpyrazamine dermal exposure to terrestrial organisms. The Agency is actively pursuing modeling techniques to account for dermal exposure via direct application of spray and by incidental contact with contaminated vegetation, soil and water.

                  * Inhalation Exposure

 Preliminary results of the screening level tool STIR (described earlier in this assessment) indicate that inhalation exposure alone is not expected to be a significant route of exposure for fenpyrazamine to wildlife.  The input and output file can be found in Appendix B.

                  * Drinking Water Exposure

 Preliminary results of the screening level tool SIP (described earlier in this assessment) indicate that drinking water exposure alone is not expected to be a significant route of exposure for fenpyrazamine to wildlife.  The input and output file can be found in Appendix C.

                     b. Effects Assessment

As the data available to support the terrestrial and aquatic effects assessment for fenpyrazamine is largely complete, the primary uncertainty with the available data is the presence of non-definitive endpoints for several taxa.  Non-definitive endpoints were reached for acute oral and dietary studies for birds, acute oral data for rats, acute toxicity studies for honey bees, acute and chronic studies for estuarine/marine fish, chronic freshwater and estuarine/marine sediment toxicity studies, and terrestrial plant studies.  However the non-definitive endpoints were "<," values (which would yield a ">" RQ) only for chronic estuarine/marine fish, freshwater and estuarine/marine sediment toxicity studies, and the terrestrial plant study for seedling emergence.  In these cases, it is uncertain where the actual RQ falls as the estimates are unbounded, or rather bounded on only one end.  As a result, estimates of chronic toxicity to estuarine/marine fish and sediment toxicity studies are in exceedances of the chronic LOC for some uses, but even those uses that are not in exceedance, it is an uncertainty where the actual RQ would fall.  Despite this uncertainty, the estimated chronic RQs could be refined with a suitable hydrolysis study as the assumptions that are made in its absence lead to conservative estimates of 1-in-10 year 60 day averages that are used to estimate chronic LOCs.  This is detailed further in Section 7.2.6.b.

                  * Age Class and Sensitivity of Effects Thresholds

 It is generally recognized that test organism age may have a significant impact on the observed sensitivity to a toxicant.  The screening risk assessment acute toxicity data for fish are collected on juvenile fish and aquatic invertebrate acute testing is performed on recommended immature age classes. Similarly, acute dietary testing with birds is also performed on juveniles, with mallard being 5-10 days old and quail at 10-14 days of age.

 Testing of juveniles may overestimate the toxicity of direct acting pesticides in adults. As juvenile organisms do not have fully developed metabolic systems, they may not possess the ability to transform and detoxify xenobiotics equivalent to the older/adult organism. The screening risk assessment has no current provisions for a generally applied method that accounts for this uncertainty.  In so far as the available toxicity data may provide ranges of sensitivity information with respect to age class, the risk assessment uses the most sensitive life-stage information as the conservative screening endpoint.

                  * Lack of Effects Data for Amphibians and Reptiles

 Currently, toxicity studies on amphibians and reptiles are not required for pesticide registration.  Since these data are lacking, the Agency uses fish as surrogates for aquatic phase amphibians and birds as surrogates for terrestrial phase amphibians and reptiles. If other species are more or less sensitive to fenpyrazamine than the surrogates, risks may be under- or overestimated, respectively. The Agency is not limited to a base set of surrogate toxicity information in establishing risk assessment conclusions. The Agency also considers toxicity data on non-standard test species when available.  Further research is needed to determine whether, in general, reptiles and terrestrial-phase amphibians are suitably represented by bird species in assessing risks for fenpyrazamine and fish are an appropriate surrogate for aquatic-phase amphibians.

                  * Use of the Most Sensitive Species Tested

Although the screening risk assessment relies on a selected toxicity endpoint from the most sensitive species tested, it does not necessarily mean that the selected toxicity endpoints reflect sensitivity of the most sensitive species existing in a given environment.  The relative position of the most sensitive species tested in the distribution of all possible species is a function of the overall variability among species to a particular chemical.  The relationship between the sensitivity of the most sensitive tested species versus wild species (including listed species) is unknown and a source of significant uncertainty. In addition, in the case of listed species, there is uncertainty regarding the relationship of the listed species' sensitivity and the most sensitive species tested.

                     5. IDENTIFICATION OF DATA GAPS

Environmental Fate and Exposure

Despite numerous uncertainties, the Agency is not asking for any additional studies at this time.  Please refer to Section 7.2.6b for further details.

Ecological Effects

The ecological toxicity database is essentially complete.  However the ELS study for sheepshead minnow and the sediment toxicity studies for Chironomus riparius and Leptocheirus plumulosus yielded non-definitive endpoints which raises uncertainty in the estimation of RQs to these organisms.  The need for new studies may be waived if uncertainties in the hydrolysis and soil metabolism studies can be worked out as lower estimates of aquatic exposure may result.  However, the Agency is not asking for any additional studies at this time.

                     6. REFERENCES

                        * Environmental Fate Studies

MRID
Author(s)
Year
Title
Hydrolysis
48399923
Lewis, C.
2007
[Carbon 14]S-2188: Hydrolytic Stability. Project Number: 200700497, 0333/257, QNM/0017. Unpublished study prepared by Covance Laboratories, Ltd. 184 p.
Aqueous Photolysis
48399924
Lewis, C.; Troth, K.
2007
[Carbon 14]S-2188: Photodegradation and Quantum Yield in Sterile, Aqueous Solution. Project Number: 200800010, 0333/258, QNM/0029. Unpublished study prepared by Covance Laboratories, Ltd. 195 p.
Air Photolysis
48399925
Liney, P.; Jarvis, T.
2009
S-1288 - Stability in Air. Project Number: 200900604, SU25005, QNM/0032. Unpublished study prepared by Exponent International, Ltd. 7 p.
Soil Photolysis
48399926
Lewis, C.; Troth, K.
2007
[Carbon 14]S-2188: Photodegradation on a Soil Surface. Project Number: 200700495, 0333/259, QNM/0020. Unpublished study prepared by Covance Laboratories, Ltd. 115 p.
Batch Equilibrium
48399919
Lewis, C.; Scholey, A.
2006
[Carbon 14]S-2188: Adsorption/Desorption in Soil. Project Number: 200600614, 0333/255, QNM/0012. Unpublished study prepared by Covance Laboratories, Ltd. 71 p.
48399922
Gohre, K.
2008
S-2188: Soil Adsorption/Desorption. Project Number: 200800201, VP/29272. Unpublished study prepared by Valent Dublin Laboratory. 90 p.
Aerobic Soil Metabolism
48399920
Lewis, C.; Troth, K.
2006
S-2188:  Aerobic Soil Metabolism and Degradation. Project Number: 200700498, 0333/256, QNM/0016. Unpublished study prepared by Covance Laboratories, Ltd. 127 p.
48399927
Gohre, K.
2008
S-2188:  Degradation Under Aerobic Conditions in Soil. Project Number: VP/29719, 200800286. Unpublished study prepared by Valent Dublin Laboratory. 169 p.
Aerobic Aquatic Metabolism
48399929
Lewis, C.; Troth, K.
2007
[Carbon 14] S-2188: Degradation and Retention in Water-Sediment Systems. Project Number: 200800017, 0333/260, QNM/0028. Unpublished study prepared by Covance Laboratories, Ltd. 188 p.

Anaerobic Aquatic Metabolism
48399930
Gohre, K.
2008
S-2188: Degradation Under Anaerobic Aquatic Conditions. Project Number: 200800200, VP/30465. Unpublished study prepared by Valent Dublin Laboratory. 152 p.
Fish BCF

48400005
Panthani, A.; Herczog, K.
2007
Bioconcentration of [Carbon 14] S-2188 by Bluegill Sunfish (Lepomis macrochirus). Project Number: 200700494, 019492/1, QNM/0018. Unpublished study prepared by Ricerca Biosciences, LLC. 241 p.
Terrestrial Field Dissipation
48399931
Kowalsky, J.
2010
Terrestrial Field Soil Dissipation of S-2188 on Bare Ground in California (2006). Project Number: 201000303, 30311. Unpublished study prepared by Valent Dublin Laboratory. 251 p.
48399932
Green, C.
2010
Terrestrial Field Soil Dissipation of S/2188 on Bare Ground in California (2009). Project Number: 33068. Unpublished study prepared by Valent Dublin Laboratory. 196 p.
48399933
Kowolsky, J.
2010
Terrestrial Field Soil Dissipation of S-2188 on Bare Ground in Idaho. Project Number: 201000313, 30309. Unpublished study prepared by Valent Dublin Laboratory. 264 p.
48399934
Kowolsky, J.
2010
Terrestrial Field Soil Dissipation of S-2188 on Bare Ground in New York. Project Number: 201000302, 30296. Unpublished study prepared by Valent Dublin Laboratory. 266 p.
Storage Stability
48399921
Peatman, M.
2008
S-2188: Storage Stability of Residues in EU Soil Stored Deep Frozen. Project Number: 200900605, 0333/268, QNM/0036. Unpublished study prepared by Covance Laboratories, Ltd. 35 p.
Environmental Chemistry Method in Water
48399918
Bacher, R.
2008
S-2188: Analytical Method for the Determination in Water. Project Number: 200900211, P/1401/G, QNA/0015. Unpublished study prepared by PTRL Europe Gmbh. 36 p.
Independent Laboratory Validation for Water ECM
48400034
Dix, M.
2006
S-2188 - Validation of the Analytical Method for the Determination of a Test Substance in Aqueous Solutions. Project Number: 200600063, 13048/6503, ELECTRONIC/COPY. Unpublished study prepared by Springborn Smithers Laboratories. 39 p.
Environmental Chemistry Method in Soil/ Independent Laboratory Validation for Soil ECM
48400026
Green, C.
2010
Independent Laboratory Validation of Method RM-45S, Determination of S-2188 and S-2188-DC in Soil. Project Number: 201000244, 33001. Unpublished study prepared by Valent U.S.A. Corporation. 90 p.
                        * Ecological Effects Studies

MRID
Author(s)
Year
Title
48399935
Hoberg, J.R.
2006
S-2188 Technical Grade- Acute Oral Toxicity Test with the Honey Bee (Apis mellifera).  Springborn Smithers Laboratories, 790 Main Street Wareham, Massachusetts 02571-1037.  Sumitomo Chemical Company, Ltd. Laboratory Report ID: 13048.6510. 39 p.
48399936
Hara, T.
2008
Acute Immobilization Test of MCNI with Daphnia magna. Unpublished study performed by Sumika Technoservice Corporation, 2-1, Takatsukasa 4-chome, Takarazuka-City, Hyogo 665-0051, Japan. Laboratory report number 0705EFA. Study sponsored by Sumitomo Chemical Corporation. Study completed March 20, 2008. 29 p.
48399937
Hara, T.
2008
Acute Immobilization Test of S-2188-OH with Daphnia magna. Unpublished study performed by Sumika Technoservice Corporation, 2-1, Takatsukasa 4-chome, Takarazuka-City, Hyogo 665-0051, Japan. Laboratory report number 0705EDI. Study sponsored by Sumitomo Chemical Corporation. Study completed March 20, 2008. 27 p.
48399938
Hara, T.
2008
Acute Immobilization Test of S-2188-DC with Daphnia magna. Unpublished study performed by Sumika Technoservice Corporation, 2-1, Takatsukasa 4-chome, Takarazuka-City, Hyogo 665-0051, Japan. Laboratory report number 0706EDI. Study sponsored by Sumitomo Chemical Corporation. Study completed March 20, 2008.  32 p.
48399939
Putt, AE
2006
S-2188 Technical Grade- Acute Toxicity to Water Fleas (Daphnia magna) Under Flow-Through Conditions. Unpublished study performed by Springborn Smithers Laboratories, Wareham, MA. Laboratory report number 13048.6507. Study sponsored by Sumitomo Chemical Corporation. Study completed June 23, 2006.  91 p.
48399940
York, DO
2010
V-10135 T.G. (S-2188 T.G.): Acute Toxicity to Eastern Oyster (Crassostrea virginica) Under Flow-Through Conditions.  Smithers Viscient Laboratories 790 Main Street, Wareham, Massachusetts 02571-1037.  Laboratory Report ID: 12709.6302.  81 p.
48399941
Fournier, A.E
2010
V-10135 T.G. (S-2188 T.G.): Acute Toxicity to Mysid (Americamysis bahia) Under Static Conditions, Following OPPTS Guideline 850.1035.  Smithers Viscient Laboratories, 790 Main Street, Wareham, MA 02571-1037.  Laboratory Report ID: 12709.6303.  82 p.
48399942
Ashida, S.
2008
Acute Toxicity Test of S-2188-DC With Rainbow Trout (Oncorhynchus mykiss). Unpublished study performed by Sumika Technoservice Corporation, 2-1, Takatsukasa 4-chome, Takarazuka-City, Hyogo 665-0051, Japan. Laboratory report number 0706EFA. Study sponsored by Sumitomo Chemical Company and submitted by Valent U.S.A. Corporation. Study completed March 20, 2008.  27 p.
48399943
Ashida, S.
2008
Acute Toxicity Test of S-2188-OH With Rainbow Trout (Oncorhynchus mykiss). Unpublished study performed by Sumika Technoservice Corporation, 2-1, Takatsukasa 4-chome, Takarazuka-City, Hyogo 665-0051, Japan. Laboratory report number 0705EFA. Study sponsored by Sumitomo Chemical Company and submitted by Valent U.S.A. Corporation. Study completed March 20, 2008.  27 p.
48399944
Cafarella, MA.
2006
S-2188 Technical Grade- Acute Toxicity to Bluegill Sunfish (Lepomis macrochirus) Under Flow-Through Conditions. Unpublished study performed by Springborn Smithers Laboratories, 790 Main Street, Wareham, Massachusetts 02571-1037. Laboratory report number 13048.6505. Study sponsored by Sumitomo Chemical Company and submitted by Valent U.S.A. Corporation. Study completed April 14, 2006. 89 p.
48399945
Cafarella, MA.
2006
S-2188 Technical Grade- Acute Toxicity to Rainbow Trout (Oncorhynchus mykiss) Under Flow-Through Conditions. Unpublished study performed by Springborn Smithers Laboratories, 790 Main Street, Wareham, Massachusetts 02571-1037. Laboratory report number 13048.6504. Study sponsored by Sumitomo Chemical Company and submitted by Valent U.S.A. Corporation. Study completed March 30, 2006.  88 p.
48399946
Fournier, AE.
2010
V-10135 T.G, (S-2188 T.G.) Acute Toxicity to Sheepshead Minnow (Cyprinodon variegatus) Under Static Conditions. Unpublished study performed by Smithers Viscient Laboratories (formerly Springborn Smithers Laboratories), Wareham, Massachusetts. Laboratory report number 12079.6301. Study sponsored by Valent U.S.A. Corporation. Study completed November 18, 2010.  77 p.
48400001
Putt, AE.
2006
S-2188 Technical Grade  -  Full Life-Cycle Toxicity Test with Water Fleas, Daphnia Magna under Flow-Through Conditions.  Unpublished study performed by Springborn Smithers Laboratories, Wareham, MA.  Laboratory Study No. 13048.6508.  Study sponsored by Sumitomo Chemical Company, Ltd., Tokyo, Japan and submitted by Valent U.S.A. Corporation, Walnut Creek, CA.  Study initiated February 17, 2006 and completed September 27, 2006.  112 p.
48400002
Lee, M.R
2010
V-10135 T.G. (S-2188 T.G.)  -  Life-Cycle Toxicity Test with Mysids (Americamysis bahia) Following Draft OPPTS Guideline 850.1350.  Springborn Viscient Laboratories, 790 Main Street, Wareham, MA  02571-1037.  Laboratory Report ID: 13845.6109.  150 p.
48400003
Cafarella, M.A
2006
S-2188 Technical Grade  -  Early Life-Stage Toxicity Test with Rainbow Trout (Oncorhynchus mykiss).  Unpublished study performed by Springborn Smithers Laboratories, Wareham, MA.  Laboratory Study No. 13048.6506.  Study sponsored by Sumitomo Chemical Company, Ltd., Tokyo, Japan and submitted by Valent U.S.A. Corporation, Walnut Creek, CA.  Study initiated January 23, 2006 and completed September 19, 2006. 111 p.
48400004
Lee, M.R
2010
V-10135 T.G. (S-2188 T.G.) Early Life-Stage Toxicity Test with Sheepshead Minnow (Cyprinodon variegatus).  Unpublished study performed by Springborn Smithers Laboratories, Wareham, MA.  Laboratory Study No. 12709.6292.  Study sponsored by Valent U.S.A. Corporation, Walnut Creek, CA.  Study initiated December 9, 2009 and completed October 8, 2010.  87 p.
48400006
Picard, C.R
2010
42-Day Toxicity Test Exposing Freshwater Amphipods (Hyalella azteca) to V-10135 (S-218) Applied to Sediment Under Static-Renewal Conditions Following EPA Test Methods. Springborn Smithers Laboratories, 790 Main Street, Wareham, MA  02571-1037.  Valent USA Corporation, 1600 Riveria Avenue, Suite 200, Walnut Creek, CA  94596-8025.  Laboratory Report ID: 12709-6290.  193 p.
48400007
Putt, A.E
2009
S-2188 Technical Grade  -  Full Life-Cycle Toxicity Test with Sediment-Dwelling Midges (Chironomus riparius) Under Static Conditions, Following OECD Guideline 219.  Springborn Smithers Laboratories, 790 Main Street, Wareham, MA  02571-1037.  Valent U.S.A. Corporation 1600 Riveria Avenue, Suite 200 Walnut Creek, CA.    Laboratory Report ID: 13048.6535.  106 p.
48400008
Picard, C.R
2010
V-10135 (S-2188)  -  28-Day Toxicity Test Exposing Estuarine Amphipods (Leptocheirus plumulosus) to a Test Substance Applied to Sediment Following EPA Test Methods.  Springborn Smithers Laboratories 790 Main Street Wareham, MA  02571-1037.  Valent U.S.A. Corporation 1600 Riveria Avenue, Suite 200 Walnut Creek, CA.  Laboratory Report ID: 12709.6291.  121 p.
48400009
Stafford, J.M
2006
-2188 Technical Grade- Acute Oral Toxicity Test (LD50) with Northern Bobwhite Quail (Colinus virginianus).  Unpublished study performed by Springborn Smithers Laboratories, Snow Camp, North Carolina.  Laboratory Report No. 13048.4104.  Study sponsored by Sumitomo Chemical Company, Ltd, Tokyo, Japan and submitted by Valent USA Corporation.  Study initiated December 30, 2005 and completed April 11, 2006. 50 p.
48400010
Hubbard, P.M
2010
V-10135: An Acute Oral Toxicity Study with the Canary (Serinus canaria).  Unpublished study performed by Wildlife International, Ltd, Easton, Maryland.  Laboratory Project No. 263-165.  Study submitted by Valent USA Corporation.  Study initiated June 29, 2010 and completed September 9, 2010.  46.
48400011
Stafford, J.M
2006
S-2188 Technical Grade- Dietary Toxicity Test with Northern Bobwhite Quail (Colinus virginianus).  Unpublished study performed by Springborn Smithers Laboratories, Snow Camp, North Carolina and Wareham, Massachusetts.  Laboratory Project ID 13048.4105.  Study sponsored by Sumitomo Chemical Company, Ltd., Tokyo, Japan and submitted by Valent U.S.A. Corporation.  Study initiation date April 1, 2006; completion date July 3, 2006.  102 p.
48400012
Stafford, J.M
2006
S-2188 Technical Grade- Dietary Toxicity Test with the Mallard Duck (Anas platyrhynchos).  Unpublished study performed by Springborn Smithers Laboratories, Snow Camp, North Carolina and Wareham, Massachusetts.  Laboratory Project ID 13048.4106.  Study sponsored by Sumitomo Chemical Company, Ltd., Tokyo, Japan and submitted by Valent U.S.A. Corporation.  Study initiation date June 12, 2006; completion date September 28, 2006.  99 p.
48400013
Stafford, J.M
2008
S-2188 Technical Grade- Reproductive Toxicity Test with Mallard Ducks (Anas platyrhynchos) Following OPPTS 850.2300 and OECD 206.  Unpublished study performed by Springborn Smithers Laboratories, Wareham, Massachusetts.  Laboratory Project ID 13048.4108.  Study sponsored by Sumitomo Chemical Company, Ltd., Tokyo, Japan and submitted by Valent U.S.A. Corporation.  Study initiation date May 29, 2007; completion date April 25, 2008.  179 p.
48400014
Stafford, J.M
2008
S-2188 Technical Grade- Reproductive Toxicity Test with Northern Bobwhite (Colinus virginianus) Following OPPTS 850.2300 and OECD 206.  Unpublished study performed by Springborn Smithers Laboratories, Snow Camp, North Carolina and Wareham, Massachusetts.  Laboratory Project ID 13048.4107.  Study sponsored by Sumitomo Chemical Company, Ltd., Tokyo, Japan and submitted by Valent U.S.A. Corporation.  Study initiation date January 19, 2007; completion date April 25, 2008.  177 p.
48400015
Hoberg, J.R
2006
S-2188 Technical Grade- Acute Contact Toxicity Test with the Honey Bee (Apis mellifera).  Springborn Smithers Laboratory 790 Main Street Wareham, Massachusetts 02571-1037.  40 p.
48400016
Porch, J.R
2010
V-10135: A Toxicity Test to Determine the Effects of the Test Substance on Seedling Emergence of Ten Species of Plants.  Unpublished study performed by Wildlife International, Ltd., Easton, Maryland.  Laboratory Project Number: 263-166.  Study sponsored by Valent U.S.A. Corporation.  Study completed September 15, 2010.  147 p.
48400017
Porch, J.R
2010
A Toxicity Test to Determine the Effects of the Test Substance on Vegetative Vigor of Ten Species of Plants.  Unpublished study performed by Wildlife International, Ltd., Easton, Maryland.  Laboratory Project Number: 263-167.  Study sponsored by Valent U.S.A. Corporation.  Study completed December 14, 2010.  167 p.
48400018
Softcheck, K.A
2010
7-Day Toxicity Test with Duckweed (Lemna gibba) Following OPPTS Draft Guideline 850.4400. Unpublished study performed by Smithers Viscient Laboratories, 790 Main Street, Wareham, Massachusetts 02571-1037. Laboratory report number 12709.6305. Study sponsored by Valent U.S.A. Corporation. Study completed November 8, 2010.  110 p.
48400019
Matsuura, Y.
2008
Growth Inhibition Test of S-2188-DC with the Freshwater Green Alga (Pseudokirchneriella subcapitata). Unpublished study performed by Sumika Technoservice Corporation, 2-1, Takatsukasa 4-chrome, Takarazuka-City, Hyogo 665-0051, Japan. Laboratory report number 0706EAI. Study sponsored by Valent U.S.A. Corporation. Study completed March 19, 2008.  37 p.
48400020
Matsuura, Y.
2008
Growth Inhibition Test of S-2188-OH with the Freshwater Green Alga (Pseudokirchneriella subcapitata). Unpublished study performed by Sumika Technoservice Corporation, 2-1, Takatsukasa 4-chrome, Takarazuka-City, Hyogo 665-0051, Japan. Laboratory report number 0705EAI. Study sponsored by Valent U.S.A. Corporation. Study completed March 19, 2008.  37 p.
48400021
Hoberg, J.R
2008
Growth Inhibition Test of S-2188-DC with the Freshwater Green Alga (Pseudokirchneriella subcapitata). Unpublished study performed by Springborn Smithers Laboratories, Wareham, Massachusetts 02571-1037. Laboratory report number 13048.6509. Study sponsored by Valent U.S.A. Corporation. Study completed April 12, 2008.  109 p.
48400022
Softcheck, K.A
2010
V-10135 T.G. (S-2188 T.G.) 96-Hour Toxicity Test with the Marine Diatom, Skeletonema costatum, Following OPPTS Draft Guideline 850.5400. Unpublished study performed by Smithers Viscient Laboratories, Wareham, Massachusetts 02571-1037. Laboratory report number 12079.6307. Study sponsored by Valent U.S.A. Corporation. Study completed November 18, 2010.  89 p.
48400023
Softcheck, K.A
2010
V-10135 T.G. (S-2188 T.G.) 96-Hour Toxicity Test with the Freshwater Diatom, Navicula pelliculosa, Following OPPTS Draft Guideline 850.5400. Unpublished study performed by Smithers Viscient Laboratories, Wareham, Massachusetts 02571-1037. Laboratory report number 12079.6304. Study sponsored by Valent U.S.A. Corporation. Study completed November 17, 2010.  89 p.
48400024
Softcheck, K.A
2010
V-10135 T.G. (S-2188 T.G.) 96-Hour Toxicity Test with the Freshwater Blue-Green Alga, Anabaena flos-aquae, Following OPPTS Draft Guideline 850.5400. Unpublished study performed by Smithers Viscient Laboratories, Wareham, Massachusetts 02571-1037. Laboratory report number 12079.6306. Study sponsored by Valent U.S.A. Corporation. Study completed December 2, 2010.  93p.
48400025
Teixeira, D
2006
S-2188 Technical Grade- Acute Toxicity to Earthworms (Eisenia fetida). Unpublished study performed by Springborn Smithers Laboratories, Wareham, Massachusetts 02571-1037. Laboratory report number 13048.6512. Study sponsored by Valent U.S.A. Corporation. Study completed April 11, 2006.  38 p.

 Open Literature and Government Reports

 Burns, Lawrence, 1997. Exposure Analysis Modeling System (EXAMS): User Manual and System Documentation. Ecosystem Research Division, National Exposure Research Laboratory. U. S. Environmental Protection Agency, Athens, GA.

 Carsel, R. F., J. C. Imhoff, P. R. Humel, J. M. Cheplick, and A. S. Donigian, Jr. 1997. PRZM-3, A Model for Predicting Pesticide and Nitrogen Fate in the Crop Root and Unsaturated Zones: User's Manual for Release 3.0. National Exposure Research Laboratory, Office of Research and Development, U. S. Environmental Protection Agency, Athens, GA.