(47923820)
                                (Supplemental)

                               EP (BAS 700 01 F)
                                 LD50 = 0.089
                            95% CI = 0.072 - 0.110
                               NOAEL <  0.014
                                 LOAEL = 0.014
                       Reduced number of eggs per female
                                  (47923823)
                                (Supplemental)

                               EP (BAS 700 04 F)
                                LD50 > 0.81
                                 NOAEL = 0.81
                                LOAEL > 0.81
                                      NA
                                  (47924117)
                                (Supplemental)

                               EP (BAS 703 01 F)
                                LD50 > 0.55
                                 NOAEL = 0.55
                                LOAEL > 0.55
                                      NA
                                  (47924216)
                                (Supplemental)

                               EP (BAS 703 02 F)
                                LD50 > 0.13
                                 NOAEL = 0.02
                                 LOAEL = 0.04
                       Reduced number of eggs per female
                                  (47924318)
                                (Supplemental)

                             EP (BAS 700 00 F)[2]
                                LD50 > 0.22
                                 NOAEL = 0.22
                                LOAEL > 0.22
                                      NA
                                  (47923837)
                                (Supplemental)
Toxicity to parasitoid wasp
                                Parasitoid wasp
                            (Aphidius rhopalosiphi)
                               EP (BAS 700 01 F)
                                 LD50 = 0.097
                            95% CI = 0.088 - 0.107
                               NOAEL <  0.017
                                 LOAEL = 0.017
                     Reduced number of parasitized aphids
                                  (47923821)
                                (Supplemental)

                               EP (BAS 700 01 F)
                                 LD50 = 0.340
                            95% CI = 0.302 - 0.383
                                 NOAEL = 0.113
                                 LOAEL = 0.179
                     Reduced number of parasitized aphids
                                  (47923824)
                                (Supplemental)

                               EP (BAS 700 04 F)
                                LD50 > 0.82
                                 NOAEL = 0.07
                                 LOAEL = 0.14
                                   Mortality
                                  (47924118)
                                (Supplemental)

                               EP (BAS 703 01 F)
                                 LD50 > 0.5
                                NOAEL < 0.2
                                  LOAEL = 0.2
                     Reduced number of parasitized aphids
                                  (47924217)
                                (Supplemental)

                               EP (BAS 703 02 F)
                                LD50 > 0.13
                                NOAEL < 0.04
                                 LOAEL = 0.04
                     Reduced number of parasitized aphids
                                  (47924319)
                                (Supplemental)
Toxicity to green lacewing
                                Green lacewing
                             (Chrysoperla carnea)
                               EP (BAS 700 01 F)
                                LD50 > 0.804
                                 NOAEL = 0.357
                                 LOAEL = 0.536
                                   Mortality
                                  (47923822)
                                (Supplemental)
Toxicity to rove beetle
                                  Rove beetle
                             (Aleochara bilineata)
                               EP (BAS 700 01 F)
                                LD50 > 0.809
                                 NOAEL = 0.558
                                 LOAEL = 0.809
                       Reduced number of emerged beetles
                                  (47923825)
                                (Supplemental)
[1]  Effects observed at LOAEL.  Other effects may have been observed at higher treatment rates.
[2]  BAS 700 00 F is an emulsifiable concentrate formulation of fluxapyroxad (5.9% a.i.) that is not currently submitted for registration in the United States.
 The predatory mite toxicity data for the BAS 700 00 F formulation are included for characterization to aid in comparison across end-use products (EPs), since the honey bee brood test submitted by the registrant used the BAS 700 00 F formulation.

Table 3.18  Toxicity endpoints used in risk estimation and characterization for terrestrial and semi-aquatic plants exposed to fluxapyroxad.
                                  Study Type
                                 Test Material
                            Most Sensitive Species
                                   Endpoints
                                 (lbs a.i./A)
                                    Effects
                                    (MRID)
                            (Study Classification)
Terrestrial plant toxicity:
Tier II seedling emergence
                               EP (BAS 700 01 F)
                                 Monocot: corn
                                  (Zea mays)
                                IC25> 0.356
                                 NOAEL = 0.089
                                 LOAEL = 0.178
                         Mortality, reduced emergence
                                  (47923765)
                                 (Acceptable)

                                Dicot: lettuce
                               (Lactuca sativa)
                                IC25 > 0.356
                                 NOAEL = 0.022
                                 LOAEL = 0.045
                              Seedling emergence
                                  (47923765)
                                 (Acceptable)

                               EP (BAS 703 01 F)
                                  Monocot: NA
                                IC25 > 0.189
                                 NOAEL = 0.189
                               LOAEL > 0.189
                                      NA
                                  (47924219)
                                 (Acceptable)

                                   Dicot: NA
                                IC25 > 0.189
                                 NOAEL = 0.189
                               LOAEL > 0.189
                                      NA
                                  (47924219)
                                 (Acceptable)

                               EP (BAS 703 02 F)
                                Monocot: Onion
                                 (Allium cepa)
                               IC25 > 0.0894
                                NOAEL = 0.0446
                                LOAEL = 0.0894
                           Inhibition of dry weight
                                  (47924321)
                                (Supplemental)

                                Dicot: Cabbage
                              (Brassica oleracea)
                               IC25 > 0.0894
                                NOAEL = 0.0055
                                LOAEL = 0.0111
                           Inhibition of dry weight
                                  (47924321)
                                (Supplemental)
Terrestrial plant toxicity:
Tier II vegetative vigor
                               EP (BAS 700 01 F)
                                Monocot: wheat
                              (Triticum aestivum)
                                IC25 > 0.356
                                 NOAEL = 0.178
                                 LOAEL = 0.356
                           Inhibition of dry weight
                                  (47923764)
                                 (Acceptable)

                                Dicot: soybean
                                 (Glycine max)
                                IC25> 0.356
                                 NOAEL= 0.089
                                LOAEL =  0.178
                  Inhibition  of dry weight and shoot length
                                  (47923764)
                                 (Acceptable)

                               EP (BAS 703 01 F)
                                  Monocot: NA
                                IC25 > 0.179
                                 NOAEL= 0.179
                               LOAEL > 0.179
                                      NA
                                  (47924218)
                                 (Acceptable)

                                Dicot: soybean
                                 (Glycine max)
                                IC25 > 0.183
                                NOAEL = 0.0898
                                 LOAEL = 0.183
                           Inhibition of dry weight
                                  (47924218)
                                 (Acceptable)

                               EP (BAS 703 02 F)
                                  Monocot: NA
                               IC25 > 0.0681
                                 NOAEL= 0.0681
                              LOAEL > 0.0681
                                      NA
                                  (47924320)
                                 (Acceptable)

                                 Dicot: Tomato
                           (Lycopersicon esculentum)
                               IC25 > 0.0681
                                NOAEL = 0.0167
                                LOAEL =  0.0338
                           Inhibition of dry weight
                                  (47924320)
                                 (Acceptable)

            1.15.1. Incident Reports

Fluxapyroxad has no existing registrations in North America; therefore, this assessment assumes that there are no existing incident reports associated with fluxapyroxad uses in the United States.  Previous risk assessments for the structurally similar (pyridine carboxamide) fungicide active ingredient, boscalid, and its associated end-use product Pristine (25.2% boscalid and 12.8% pyraclostrobin), have identified reports of potential effects of boscalid and/or Pristine exposure on honey bee brood (DP Barcodes D379809, D386068+).  The registrant is currently planning and conducting higher tiered larval toxicity tests with a solo formulation of boscalid and with the Pristine formulation, respectively, to address these uncertainties.  A semi-field study conducted with a formulation of fluxapyroxad (BAS 700 00 F; 5.9% a.i.) demonstrated no overall effects on honey bee brood development but did not include endpoints specific to queen cell development (MRID 47923749).  The registrant is not currently seeking U.S. registration for the BAS 700 00 F formulation.

Risk Characterization

Toxicity data and exposure estimates for fluxapyroxad are used to evaluate the potential for adverse ecological effects on non-target species. This screening-level assessment employs a deterministic risk estimation method, based on risk quotient (RQ) values, to provide a metric of potential risks (Section 4.1).  The potential for risk is characterized further in the Risk Description (Section 4.2) based on the risk estimation results and other relevant information about toxicity, incidents, ecosystems potentially at risk, and the environmental fate and transport characteristics of fluxapyroxad.  In cases where an RQ value exceeds the listed species LOC, the potential for risk to listed species is characterized in greater detail in Section 5.  The LOCATES (v. 2.2.0) database is queried to identify listed species that may co-occur within potential use areas for the proposed action, i.e., areas where affected crops are grown and where the proposed new use of fluxapyroxad may occur.

Risk Estimation

Unitless RQ values are compared to the Agency's LOCs to identify taxonomic groups potentially at risk of acute or chronic effects associated with the proposed new uses of fluxapyroxad.

Aquatic Organisms

RQ values are calculated for estimating acute and chronic risk to fish and aquatic invertebrates, including molluscs, where the submitted ecotoxicity data are sufficient to use in risk estimation.  Toxicity data for aquatic animals and plants reported in Section <IP_ADDRESS> in terms of mg/L (ppm) are converted to ug/L (ppb) so that both exposure and toxicity are in similar units, i.e., ug/L.    As shown in Table 4.1 through Table 4.4, none of the RQ values calculated for the fluxapyroxad TGAI either approach or exceed the Agency's levels of concern (LOCs) for risk to listed or nonlisted species of aquatic organisms.  RQ values are not calculated for chronic risk to estuarine/marine fish or invertebrates in the water column because acceptable chronic data for these taxa are not available.

As the endpoints for fluxapyroxad formulations are lower than those of the technical active ingredient, RQ values are calculated for freshwater acute and chronic risk to fish and aquatic invertebrates using spray drift-only EECs.  As shown in Table 4.5, RQ values for the solo formulations of fluxapyroxad (BAS 700 01 F and BAS 700 04 F) do not exceed the LOCs for acute risk to listed and nonlisted fish and aquatic invertebrates.  However, Table 4.6 shows that RQ values calculated for all evaluated uses of the dual-a.i. formulations of fluxapyroxad (BAS 703 01 F and BAS 703 02 F) exceed the Agency's LOCs for acute risk to listed freshwater species of fish and aquatic invertebrates.  RQ values for the uses of BAS 703 01 F on pome fruits and stone fruits also exceed the Agency's LOC for acute risk to non-listed freshwater fish.
The submitted ecotoxicity data indicate that nonvascular aquatic plants are in some cases more sensitive to formulated fluxapyroxad than to the TGAI.  RQ values based on the green alga LC50 and NOAEC values for BAS 703 02 F do not exceed the listed and nonlisted species LOCs for any of the evaluated uses.  RQ values for the other formulations (BAS 700 01 F, BAS 700 04 F, and BAS 703 01 F) are also not expected to exceed the LOCs for listed and nonlisted species LOCs because the alga was less sensitive to these formulations than to BAS 703 02 F.

Further characterization of the potential for adverse effects to aquatic organisms, based on the available data, is provided as part of the Risk Description in Section 4.2.1.
Table 4.1. Acute and chronic RQ values for freshwater fish and invertebrates exposed to fluxapyroxad TGAI in surface water.
                                      Use
                                   App Rate
                                  lbs a.i./A
                                    (#app)
                                  App Method
                                     EECs
                                    (ug/L)
                                   RQ Values

                                Freshwater Fish
                                LC50=290 ug/L
                                NOAEC=22 ug/L
                    Freshwater Invertebrate EC50=5100 ug/L
                                NOAEC=460 ug/L

                                     Peak
                                     21-d
                                     60-d
                                     Acute
                                    Chronic
                                     Acute
                                    Chronic
                      Barley, oat, rye, wheat, triticale
                                     0.089
                                      (2)
                                 Aerial spray
                                     5.02
                                     4.88
                                     4.61
                                     0.02
                                     0.21
                                   <0.01
                                     0.01
Corn, edible podded legume vegetables, oilseed crops (other), succulent shelled peas and beans, soybeans
                                     0.089
                                      (2)
                                 Aerial spray
                                     5.01
                                     4.87
                                     4.61
                                     0.02
                                     0.21
                                   <0.01
                                     0.01
                     Dried shelled beans (except soybeans)
                                     0.18
                                      (2)
                                 Aerial spray
                                     10.14
                                     9.85
                                     9.32
                                     0.03
                                     0.42
                                   <0.01
                                     0.02
               Fruiting vegetables, tuberous and corm vegetables
                                     0.089
                                      (3)
                                 Aerial spray
                                     7.50
                                     7.29
                                     6.89
                                     0.03
                                     0.31
                                   <0.01
                                     0.02
                        Oilseed crops (canola/rapeseed)
                                     0.089
                                      (2)
                                 Aerial spray
                                     5.00
                                     4.86
                                     4.60
                                     0.02
                                     0.21
                                   <0.01
                                     0.01
                              Peanut, sugar beet
                                     0.089
                                      (3)
                                 Aerial spray
                                     7.47
                                     7.25
                                     6.86
                                     0.03
                                     0.31
                                   <0.01
                                     0.02
                                  Pome fruits
                                     0.089
                                      (4)
                                 Aerial spray
                                     9.98
                                     9.69
                                     9.17
                                     0.03
                                     0.42
                                   <0.01
                                     0.02
                                 Stone fruits
                                     0.110
                                      (3)
                                 Aerial spray
                                     9.27
                                     9.01
                                     8.52
                                     0.03
                                     0.39
                                   <0.01
                                     0.02
                             Sunflower (low rate)
                                    0.0008
                                      (1)
                                Seed Treatment
                                     0.02
                                     0.02
                                     0.02
                                   <0.01
                                   <0.01
                                   <0.01
                                   <0.01
                          Podded legume (medium rate)
                                     0.022
                                      (1)
                                Seed Treatment
                                     0.49
                                     0.48
                                     0.45
                                   <0.01
                                     0.02
                                   <0.01
                                   <0.01
                         Wheat, triticale (high rate)
                                     0.078
                                      (1)
                                Seed Treatment
                                     1.74
                                     1.69
                                     1.59
                                   <0.01
                                     0.07
                                   <0.01
                                   <0.01

Table 4.2. Acute RQ values for estuarine/marine fish and invertebrates exposed to fluxapyroxad TGAI in surface water.
                                      Use
                                   App Rate
                                  lbs a.i./A
                                    (#app)
                                  App Method
                                     EECs
                                    (ug/L)
                                   RQ Values

                                  Estuarine/
                                  Marine Fish
                                LC50=1300 ug/L
                                  Estuarine/
                               Marine Crustacean
                                EC50=3600 ug/L
                                  Estuarine/
                                Marine Mollusc
                                IC50=960 ug/L

                                     Peak
                                     Acute
                                     Acute
                                     Acute
                      Barley, oat, rye, wheat, triticale
                                     0.089
                                      (2)
                                 Aerial spray
                                     5.02
                                   <0.01
                                   <0.01
                                     0.01
Corn, edible podded legume vegetables, oilseed crops (other), succulent shelled peas and beans, soybeans
                                     0.089
                                      (2)
                                 Aerial spray
                                     5.01
                                   <0.01
                                   <0.01
                                     0.01
                     Dried shelled beans (except soybeans)
                                     0.18
                                      (2)
                                 Aerial spray
                                     10.14
                                     0.01
                                   <0.01
                                     0.01
               Fruiting vegetables, tuberous and corm vegetables
                                     0.089
                                      (3)
                                 Aerial spray
                                     7.50
                                     0.01
                                   <0.01
                                     0.01
                        Oilseed crops (canola/rapeseed)
                                     0.089
                                      (2)
                                 Aerial spray
                                     5.00
                                   <0.01
                                   <0.01
                                     0.01
                              Peanut, sugar beet
                                     0.089
                                      (3)
                                 Aerial spray
                                     7.47
                                     0.01
                                   <0.01
                                     0.01
                                  Pome fruits
                                     0.089
                                      (4)
                                 Aerial spray
                                     9.98
                                     0.01
                                   <0.01
                                     0.01
                                 Stone fruits
                                     0.110
                                      (3)
                                 Aerial spray
                                     9.27
                                     0.01
                                   <0.01
                                     0.01
                             Sunflower (low rate)
                                    0.0008
                                      (1)
                                Seed Treatment
                                     0.02
                                   <0.01
                                   <0.01
                                   <0.01
                          Podded legume (medium rate)
                                     0.022
                                      (1)
                                Seed Treatment
                                     0.49
                                   <0.01
                                   <0.01
                                   <0.01
                         Wheat, triticale (high rate)
                                     0.078
                                      (1)
                                Seed Treatment
                                     1.74
                                   <0.01
                                   <0.01
                                   <0.01
Table 4.3. RQ values for sediment-dwelling invertebrates exposed to fluxapyroxad TGAI.
                                      Use
                                   App Rate
                                  lbs a.i./A
                                    (#app)
                                  App Method
                                     EECs
                             (ug/kg dry sediment)
                                 RQ Values[1]

                                    10-day
                            Freshwater Invertebrate
                        NOAEC=67000 ug/kg dry sediment
                                    10-day
                         Estuarine/Marine Invertebrate
                        NOAEC=27000 ug/kg dry sediment
                                    28-day
                            Freshwater Invertebrate
                        NOAEC=76000 ug/kg dry sediment

                                    Peak[2]

                     Dried shelled beans (except soybeans)
                                     0.18
                                      (2)
                                 Aerial spray
                                      237
                                   <0.01
                                     0.01
                                   <0.01
1 This assessment compares the 10- and 28-day sediment toxicity endpoints to the peak sediment EEC associated with each use.  The resulting RQ values are expected to be conservative.  However, given the demonstrated persistence of fluxapyroxad in water and sediment time-weighted concentrations are expected to be similar to peak concentrations.
2 Pore water concentration derived from PRZM/EXAMS (6.31 ug/L) was converted to ug/kg dry sediment using the sediment Koc (931 L/kgoc, Table 3.3) and the equation in Section 3.2.2, pg. 18 (USEPA, 2008).

Table 4.4. RQ values for listed and nonlisted species of aquatic plants exposed to fluxapyroxad TGAI in surface water.
                                      Use
                                   App Rate
                                  lbs a.i./A
                                    (#app)
                                  App Method
                                     EECs
                                    (ug/L)
                                   RQ Values

                                Vascular Plants
                                EC50=2400 ug/L
                                NOAEC=440 ug/L
                              Nonvascular Plants
                                EC50=370 ug/L
                                NOAEC=150 ug/L

                                     Peak
                                    Listed
                                   Nonlisted
                                    Listed
                                   Nonlisted
                      Barley, oat, rye, wheat, triticale
                                     0.089
                                      (2)
                                 Aerial spray
                                     5.02
                                     0.01
                                   <0.01
                                     0.03
                                     0.01
Corn, edible podded legume vegetables, oilseed crops (other), succulent shelled peas and beans, soybeans
                                     0.089
                                      (2)
                                 Aerial spray
                                     5.01
                                     0.01
                                   <0.01
                                     0.03
                                     0.01
                     Dried shelled beans (except soybeans)
                                     0.18
                                      (2)
                                 Aerial spray
                                     10.14
                                     0.02
                                   <0.01
                                     0.07
                                     0.03
               Fruiting vegetables, tuberous and corm vegetables
                                     0.089
                                      (3)
                                 Aerial spray
                                     7.50
                                     0.02
                                   <0.01
                                     0.05
                                     0.02
                        Oilseed crops (canola/rapeseed)
                                     0.089
                                      (2)
                                 Aerial spray
                                     5.00
                                     0.01
                                   <0.01
                                     0.03
                                     0.01
                              Peanut, sugar beet
                                     0.089
                                      (3)
                                 Aerial spray
                                     7.47
                                     0.02
                                   <0.01
                                     0.05
                                     0.02
                                  Pome fruits
                                     0.089
                                      (4)
                                 Aerial spray
                                     9.98
                                     0.02
                                   <0.01
                                     0.07
                                     0.03
                                 Stone fruits
                                     0.110
                                      (3)
                                 Aerial spray
                                     9.27
                                     0.02
                                   <0.01
                                     0.06
                                     0.03
                             Sunflower (low rate)
                                    0.0008
                                      (1)
                                Seed Treatment
                                     0.02
                                   <0.01
                                   <0.01
                                   <0.01
                                   <0.01
                          Podded legume (medium rate)
                                     0.022
                                      (1)
                                Seed Treatment
                                     0.49
                                   <0.01
                                   <0.01
                                   <0.01
                                   <0.01
                         Wheat, triticale (high rate)
                                     0.078
                                      (1)
                                Seed Treatment
                                     1.74
                                   <0.01
                                   <0.01
                                     0.01
                                   <0.01

Table 4.5. Acute RQ values for freshwater fish exposed to BAS 700 01 F and BAS 700 04 F in surface water as a result of spray drift only, based on maximum application rates for all fluxapyroxad uses.
                                      Use
                                   App Rate
                                  lbs a.i./A
                                    (#app)
                                  App Method
                                     EECs
                                    (ug/L)
                                BAS 700 01 F[1]
                                BAS 700 04 F[1]

                                     Fish
                                LC50=470 ug/L
                                 Invertebrates
                                LC50=680 ug/L
                                     Fish
                                LC50=660 ug/L
                                 Invertebrates
                               LC50=28000 ug/L

                                     Peak
                                     Acute
                                     Acute
                                     Acute
                                     Acute
                      Barley, oat, rye, wheat, triticale
                                     0.089
                                      (2)
                                 Aerial spray
                                      1.4
                                   <0.01
                                   <0.01
                                   <0.01
                                   <0.01
Corn, edible podded legume vegetables, oilseed crops (other), succulent shelled peas and beans, soybeans
                                     0.089
                                      (2)
                                 Aerial spray
                                     1.12
                                   <0.01
                                   <0.01
                                   <0.01
                                   <0.01
                     Dried shelled beans (except soybeans)
                                     0.18
                                      (2)
                                 Aerial spray
                                     1.97
                                   <0.01
                                   <0.01
                                   <0.01
                                   <0.01
               Fruiting vegetables, tuberous and corm vegetables
                                     0.089
                                      (3)
                                 Aerial spray
                                     2.45
                                     0.01
                                   <0.01
                                   <0.01
                                   <0.01
                        Oilseed crops (canola/rapeseed)
                                     0.089
                                      (2)
                                 Aerial spray
                                     1.64
                                   <0.01
                                   <0.01
                                   <0.01
                                   <0.01
                              Peanut, sugar beet
                                     0.089
                                      (3)
                                 Aerial spray
                                     2.16
                                   <0.01
                                   <0.01
                                   <0.01
                                   <0.01
                                  Pome fruits
                                     0.089
                                      (4)
                                 Aerial spray
                                     4.39
                                     0.01
                                     0.01
                                     0.01
                                   <0.01
                                 Stone fruits
                                     0.110
                                      (3)
                                 Aerial spray
                                     4.09
                                     0.01
                                     0.01
                                     0.01
                                   <0.01
1  Bold values  are RQs that exceed the Agency's acute risk LOC (RQ>0.05) for listed species; bold italics values also exceed the Agency's acute risk LOC (RQ>0.5) for nonlisted species.

Table 4.6.  Refined acute RQ values for freshwater fish and invertebrates exposed to BAS 703 01 F and BAS 703 02 F in surface water as a result of spray drift only, based on proposed uses for each formulation.
                                      Use
                                   App Rate
                                  lbs a.i./A
                                    (#app)
                                BAS 703 01 F1
                                BAS 703 02 F1

                                     EECs
                                    (ug/L)
                                     Fish
                                LC50= 7.4 ug/L
                                 Invertebrates
                                 LC50=16 ug/L
                                     EECs
                                    (ug/L)
                                     Fish
                                LC50=4.5 ug/L
                                 Invertebrates
                                LC50=8.3 ug/L

                                     Peak
                                     Acute
                                     Acute
                                     Peak
                                     Acute
                                     Acute
                      Barley, oat, rye, wheat, triticale
                                     0.087
                                      (2)
                                      NA
                                      NA
                                      NA
                                     1.36
                                     0.30
                                     0.16
Corn, edible podded legume vegetables, oilseed crops (other), succulent shelled peas and beans, soybeans[2]
                                   0.089[3]
                                      (2)
                                     1.69
                                     0.23
                                     0.11
                                     1.64
                                     0.36
                                     0.20
                     Dried shelled beans (except soybeans)
                                     0.087
                                      (2)
                                      NA
                                      NA
                                      NA
                                     1.64
                                     0.36
                                     0.20
               Fruiting vegetables, tuberous and corm vegetables
                                     0.089
                                      (3)
                                     2.45
                                     0.33
                                     0.15
                                     2.38
                                     0.53
                                     0.29
                        Oilseed crops (canola/rapeseed)
                                     0.089
                                      (2)
                                     1.64
                                     0.22
                                     0.10
                                     1.59
                                     0.35
                                     0.19
                              Peanut, sugar beet
                                     0.089
                                      (3)
                                      NA
                                      NA
                                      NA
                                     2.09
                                     0.46
                                     0.25
                                  Pome fruits
                                     0.089
                                      (4)
                                     4.39
                                     0.59
                                     0.27
                                      NA
                                      NA
                                      NA
                                 Stone fruits
                                     0.110
                                      (3)
                                     4.09
                                     0.22
                                     0.26
                                      NA
                                      NA
                                      NA
[NA]  Not applicable.
1  Bold values are RQs that exceed the Agency's acute risk LOC (RQ>0.05) for listed species; bold italics values also exceed the Agency's acute risk LOC (RQ>0.5) for nonlisted species.
2  Corn, edible podded legume vegetables, and succulent shelled peas and beans are proposed uses for BAS 703 02 F but not for BAS 703 01 F.  Oilseed crops (other) and soybeans are proposed on both labels.
3  The maximum proposed application rate for BAS 703 02 F is slightly lower at up to two applications of 0.087 lbs a.i./A.

Table 4.7.  RQ values for nonvascular aquatic plants exposed to BAS 703 02 F in surface water from spray drift only, based on maximum application rates for all proposed uses of fluxapyroxad.
                                      Use
                                   App Rate
                                  lbs a.i./A
                                    (#app)
                                  App Method
                                     EECs
                                    (ug/L)
                                 RQ Values[1]

                              Nonvascular Plants
                                EC50=120 ug/L
                                NOAEC=14 ug/L

                                     Peak
                                    Listed
                                   Nonlisted
                      Barley, oat, rye, wheat, triticale
                                     0.089
                                      (2)
                                 Aerial spray
                                      1.4
                                     0.10
                                     0.01
Corn, edible podded legume vegetables, oilseed crops (other), succulent shelled peas and beans, soybeans
                                     0.089
                                      (2)
                                 Aerial spray
                                     1.12
                                     0.08
                                     0.01
                     Dried shelled beans (except soybeans)
                                     0.18
                                      (2)
                                 Aerial spray
                                     1.97
                                     0.14
                                     0.02
               Fruiting vegetables, tuberous and corm vegetables
                                     0.089
                                      (3)
                                 Aerial spray
                                     2.45
                                     0.18
                                     0.02
                        Oilseed crops (canola/rapeseed)
                                     0.089
                                      (2)
                                 Aerial spray
                                     1.64
                                     0.12
                                     0.01
                              Peanut, sugar beet
                                     0.089
                                      (3)
                                 Aerial spray
                                     2.16
                                     0.15
                                     0.02
                                  Pome fruits
                                     0.089
                                      (4)
                                 Aerial spray
                                     4.39
                                     0.31
                                     0.04
                                 Stone fruits
                                     0.110
                                      (3)
                                 Aerial spray
                                     4.09
                                     0.29
                                     0.03
[1]  As a screen for risk from the various formulations of fluxapyroxad, RQ values are calculated based on spray drift EECs from all evaluated fluxapyroxad uses and the most sensitive toxicity endpoints from all nonvascular plant toxicity tests with formulated fluxapyroxad, which were from the test with BAS 703 02 F.

Terrestrial Organisms

In this assessment, RQ values are calculated for acute, dietary-based risk to birds (Table 4.7) and for chronic risk to mammals (Table 4.8).  RQ values are not calculated for acute, dose-based risk to birds, chronic risk to birds, or acute risk to mammals because the toxicity endpoints needed for these calculations are nondefinitive.  Specifically, the LD50 values for birds and mammals were greater than the highest dose tested in each study, whereas the NOAEC value for chronic toxicity to birds was estimated to be less than the lowest treatment level tested in the avian reproduction study with bobwhite quail.

For all foliar uses of fluxpyroxad that were evaluated, the acute dietary-based RQ values for birds are below the Agency's LOCs for acute risk to listed (RQ>=0.1) and nonlisted (RQ>=0.5) species.  Chronic, dietary-based RQ values for mammals are also below the chronic risk LOC (RQ>=1) for all uses.  However, chronic dose-based RQ values for all uses exceed the chronic risk LOC for wild mammals (RQ > 1).  Chronic risk concerns are triggered by all uses for small (15 g) and medium (35 g) mammals that consume short grass.  Chronic risk concerns for large (1000 g) mammals that consume short grass are triggered by the use on dried shelled beans; stone fruits; fruiting vegetables, tuberous and corm vegetables; peanut and sugar beet; and pome fruits.  Chronic risk to small and medium mammal consumers of other dietary items, such as tall grass, broadleaf plants, and small insects, exceeds the LOC following the proposed uses, with the exception of the uses on corn, edible podded legume vegetables, oilseed crops (other), succulent shelled peas and beans, soybeans, and oilseed crops (canola and rapeseed).

Table 4.8. Acute dietary-based RQ values for birds exposed to fluxapyroxad as a result of the proposed foliar uses.
                                   Food Type
                          Avian Dietary-Based RQs[1]

                                  Short Grass
                                  Tall Grass
                        Broadleaf Plants/Small Insects
                                 Fruits/Pods/
                                 Large Insects
                     Dried shelled beans (except soybeans)
                                     0.03
                                     0.02
                                     0.02
                                   <0.01
                                 Stone fruits
                                     0.03
                                     0.01
                                     0.02
                                   <0.01
                      Barley, oat, rye, wheat, triticale
                                     0.02
                                     0.01
                                     0.01
                                   <0.01
Corn, edible podded legume vegetables, oilseed crops (other), succulent shelled peas and beans, soybeans
                                     0.02
                                     0.01
                                     0.01
                                   <0.01
               Fruiting vegetables, tuberous and corm vegetables
                                     0.02
                                     0.01
                                     0.01
                                   <0.01
                        Oilseed crops (canola/rapeseed)
                                     0.02
                                     0.01
                                     0.01
                                   <0.01
                              Peanut, sugar beet
                                     0.02
                                     0.01
                                     0.01
                                   <0.01
                                  Pome fruits
                                     0.03
                                     0.01
                                     0.02
                                   <0.01
[N/][A]  Not applicable.
[1]  Dietary-based RQ values are based on the bobwhite quail LC50 value of 2457 mg a.i./kg diet (MRID 48485301).

Table 4.9. Chronic dietary and dose-based RQ values for mammals exposed to fluxapyroxad as a result of the proposed foliar uses.
                                   Food Type
                                 Dietary Based
                                 (mg/kg diet)
                              (mammals and birds)
                                  Dose Based
                                  (mg/kg bw)
                                   (mammals)

                               All Size Classes
                                     Small
                                    (15 g)
                                    Medium
                                    (35 g)
                                     Large
                                   (1000 g)
                     Dried shelled beans (except soybeans)
Short grass
                                     0.72
                                     3.51
                                     2.99
                                     1.61
Tall grass
                                     0.33
                                     1.61
                                     1.37
                                     0.74
Broadleaf plants/small insects
                                     0.41
                                     1.97
                                     1.68
                                     0.90
Fruits/pods/large insects
                                     0.05
                                     0.22
                                     0.19
                                     0.10
Seeds (granivore)
                                      N/A
                                     0.05
                                     0.04
                                     0.02
                                 Stone fruits
Short grass
                                     0.62
                                     3.01
                                     2.57
                                     1.38
Tall grass
                                     0.28
                                     1.38
                                     1.18
                                     0.63
Broadleaf plants/small insects
                                     0.35
                                     1.69
                                     1.45
                                     0.78
Fruits/pods/large insects
                                     0.04
                                     0.19
                                     0.16
                                     0.09
Seeds (granivore)
                                      N/A
                                     0.04
                                     0.04
                                     0.02
                      Barley, oat, rye, wheat, triticale
Short grass
                                     0.37
                                     1.80
                                     1.54
                                     0.82
Tall grass
                                     0.17
                                     0.82
                                     0.70
                                     0.38
Broadleaf plants/small insects
                                     0.21
                                     1.01
                                     0.86
                                     0.46
Fruits/pods/large insects
                                     0.02
                                     0.11
                                     0.10
                                     0.05
Seeds (granivore)
                                      N/A
                                     0.02
                                     0.02
                                     0.01
Corn, edible podded legume vegetables, oilseed crops (other), succulent shelled peas and beans, soybeans
Short grass
                                     0.36
                                     1.73
                                     1.48
                                     0.79
Tall grass
                                     0.16
                                     0.79
                                     0.68
                                     0.36
Broadleaf plants/small insects
                                     0.20
                                     0.97
                                     0.83
                                     0.45
Fruits/pods/large insects
                                     0.02
                                     0.11
                                     0.09
                                     0.05
Seeds (granivore)
                                      N/A
                                     0.02
                                     0.02
                                     0.01
               Fruiting vegetables, tuberous and corm vegetables
Short grass
                                     0.50
                                     2.44
                                     2.08
                                     1.12
Tall grass
                                     0.23
                                     1.12
                                     0.95
                                     0.51
Broadleaf plants/small insects
                                     0.28
                                     1.37
                                     1.17
                                     0.63
Fruits/pods/large insects
                                     0.03
                                     0.15
                                     0.13
                                     0.07
Seeds (granivore)
                                      N/A
                                     0.03
                                     0.03
                                     0.02
                        Oilseed crops (canola/rapeseed)
Short grass
                                     0.34
                                     1.63
                                     1.39
                                     0.75
Tall grass
                                     0.15
                                     0.75
                                     0.64
                                     0.34
Broadleaf plants/small insects
                                     0.19
                                     0.92
                                     0.78
                                     0.42
Fruits/pods/large insects
                                     0.02
                                     0.10
                                     0.09
                                     0.05
Seeds (granivore)
                                      N/A
                                     0.02
                                     0.02
                                     0.01
                              Peanut, sugar beet
Short grass
                                     0.44
                                     2.16
                                     1.85
                                     0.99
Tall grass
                                     0.20
                                     0.99
                                     0.85
                                     0.45
Broadleaf plants/small insects
                                     0.25
                                     1.22
                                     1.04
                                     0.56
Fruits/pods/large insects
                                     0.03
                                     0.14
                                     0.12
                                     0.06
Seeds (granivore)
                                      N/A
                                     0.03
                                     0.03
                                     0.01
                                  Pome fruits
Short grass
                                     0.63
                                     3.05
                                     2.60
                                     1.40
Tall grass
                                     0.29
                                     1.40
                                     1.19
                                     0.64
Broadleaf plants/small insects
                                     0.35
                                     1.71
                                     1.46
                                     0.78
Fruits/pods/large insects
                                     0.04
                                     0.19
                                     0.16
                                     0.09
Seeds (granivore)
                                      N/A
                                     0.04
                                     0.04
                                     0.02
[N/]A  Not applicable.
Bolded values exceed the Agency's Level of Concern (LOC) for chronic risk to wild mammals (RQ > 1).  RQ values of 0.99 in this assessment are conservatively rounded up and are considered to meet the chronic risk LOC.

RQ values for chronic risk to mammals, based on the range of proposed fluxapyroxad seed treatment uses, are calculated as follows:

             RQ = Exposure (mg a.i./kg seed) / NOAEC (mg/kg diet)

The resulting RQ values for seed treatment uses on wheat and triticale and on sunflower exceed the Agency's LOC for chronic risk to mammals (RQ > 1, Table 4.9).  The RQ for seed treatment use on podded legumes does not exceed the LOC.  This screening calculation indicates that a mammal that consumes 1 kg of treated wheat or triticale seed over an unspecified time period will have been exposed to a dietary concentration of fluxapyroxad that is approximately 4.5 times the chronic NOAEC.  Similarly, a mammal that consumes 1 kg of treated sunflower seed will have been exposed to a dietary concentration of fluxapyroxad that is approximately 1.8 times the chronic NOAEC.  The amount of time it would take a mammal to consume 1 kg of seed would depend upon the physiology, life history, and energy requirements of the individual.

It should be noted that the seed treatment uses presented in Table 4.9 are a subset of those proposed on the fluxapyroxad labels, used to provide a range of RQs.  For a seed treatment to be below the chronic risk LOC, it must be below 0.0112 lbs ai/100 lbs seed.  Based on the seed treatment uses on the proposed labels (see Appendix A), only the cotton, oat, rye, sorghum, and sunflower seed treatments would be below the Agency's chronic risk LOC for mammals.  Seed incorporation is not required on the label; therefore, the seed treatment EECs for terrestrial animals and associated RQ values are calculated using the assumption that seeds are not incorporated and are readily available for consumption.

RQ values are not calculated for acute, dose-based risk to birds, chronic risk to birds, or acute risk to mammals based on the proposed seed treatment uses because the toxicity endpoints from these studies are nondefinitive (i.e., outside the range of test concentrations).

Table 4.10. Chronic dietary RQ values for mammals exposed to fluxapyroxad following the proposed seed treatment uses.
                             Seed Treatment Use(s)
                                   App Rate
                            (lbs a.i./100 lbs seed)
                  Chronic EEC              (mg a.i./kg seed)
                                  Chronic RQs
                             NOAEC=112 mg/kg diet

                      Wheat, triticale (high rate per A)
                                     0.05
                                      500
                                     4.46
                       Podded legume (medium rate per A)
                                     0.01
                                      100
                                     0.89
                          Sunflower (low rate per A)
                                     0.02
                                      200
                                     1.79
[A]  Acre.
Bolded values exceed the Agency's LOC for chronic risk to wild mammals (RQ > 1).

For terrestrial plants, RQ values for the foliar and seed treatment uses are calculated based on the most sensitive toxicity endpoints from the submitted seedling emergence tests, but only the foliar uses are evaluated against the vegetative vigor tests, as foliar exposure of non-target plants is considered unlikely to result from the proposed seed treatment uses (Table 4.10).  RQ values for listed species of dicot plants exceed the Agency's LOC for all of the foliar uses evaluated for dry and semi-aquatic areas.  RQ values for listed species of monocot plants are below the LOC for all foliar uses.  RQ values based on seed treatment uses exceed the Agency's LOC for the highest seed treatment use rate for listed species of dicot plants in semi-aquatic areas.  The estimates for seed treatments are based on the assumptions that the seeds are not being incorporated and 100% of the seed treatment is available for leaching/runoff.  These assumptions are especially conservative for seeds which may routinely be incorporated at depths greater than 1 inch.  They are more representative of scenarios where seeds are broadcast applied or incorporated less than one inch (e.g., wheat may be incorporated at 0.5 inches; Conley 2007).  RQ values are not calculated for risk to non-listed species of terrestrial plants because the IC25 values are outside the range of concentrations tested.  Conclusions regarding potential risk to listed and nonlisted terrestrial plants, as they relate to RQ values based on the available NOAEC values, are discussed in Section 4.2.

Table 4.11. RQ values for listed species[1] of non-target terrestrial and semi-aquatic plants based on proposed uses of fluxapyroxad (TerrPlant).
                                    Use(s)
                                   Dry Area
                                      RQs
                             Semi-Aquatic Area RQs
                               Spray Drift Only
                                      RQs

                                    Monocot
                                     Dicot
                                    Monocot
                                     Dicot
                                    Monocot
                                     Dicot
                     Dried shelled beans (except soybeans)
                                     0.24
                                     1.96
                                     0.61
                                     4.91
                                     0.13
                                     0.54
                                 Stone fruits
                                     0.15
                                     1.20
                                     0.37
                                     3.00
                                    <0.1
                                     0.33
                      Barley, oat, rye, wheat, triticale
                                     0.12
                                     0.97
                                     0.30
                                     2.43
                                    <0.1
                                     0.81
Corn, edible podded legume vegetables, oilseed crops (other), succulent shelled peas and beans, soybeans

               Fruiting vegetables, tuberous and corm vegetables

                        Oilseed crops (canola/rapeseed)

                              Peanut, sugar beet

                                  Pome fruits

                         Wheat, triticale (high rate)
                                    <0.1
                                     0.14
                                     0.17
                                     1.42
                                      N/A
                                      N/A
                          Podded legume (medium rate)
                                    <0.1
                                    <0.1
                                    <0.1
                                     0.40
                                      N/A
                                      N/A
                             Sunflower (low rate)
                                    <0.1
                                    <0.1
                                    <0.1
                                    <0.1
                                      N/A
                                      N/A
[N/][A]  Not applicable.
Bolded values exceed the Agency's level of concern (LOC) for risk to listed species of terrestrial plants (RQ > 1).
[1]  RQ values are based on the seedling emergence NOAEL values of 0.0446 (monocot) and 0.0055 (dicot) lb ai/A (dry areas and semi-aquatic areas) and the vegetative vigor NOAEL values of 0.0681 (monocot) and 0.0167 (dicot) lb ai/A (drift only).  RQ values are not calculated in this assessment for nonlisted species of terrestrial plants because the IC25 values were all greater than the highest treatment rate tested.

Although the Agency does not typically quantify risk to non-target terrestrial invertebrates using the RQ method, acute toxicity studies with the young adult honey bee demonstrate that fluxapyroxad is practically non-toxic to young adult honey bees on an acute oral and an acute contact exposure basis (LD50 >11 ug a.i./bee).

The potential for risk to non-target terrestrial organisms, associated with the proposed uses of fluxapyroxad, is discussed further in the Risk Description (Section 4.2.2).

Risk Description and Conclusions

This assessment evaluates the potential for ecological risks associated with the proposed uses of the new fungicide fluxapyroxad as foliar applications and seed treatments.  Fluxapyroxad is a synthetic carboxamide fungicide (FRAC Group 7) that inhibits mitochondrial respiration and the subsequent production of ATP in fungal cells, which inhibits spore germination, mycelial growth, and sporulation of the fungus on the surface of leaves (proposed label).  Fluxapyroxad is persistent, i.e., is stable to most environmental degradation and some plant metabolism processes, and has demonstrated at least some systemic activity based on plant residue studies submitted by the registrant.    Two of the end-use products (BAS 703 01 F and BAS 703 02 F) in the registration petition include two active ingredients (fluxapyroxad and pyraclostrobin); however, risk estimation in this assessment (Section 4.1) evaluates potential effects based on fluxapyroxad.  Where available, information about similarly formulated end-use products is included in the discussion of incident reports.

Aquatic Organisms

For the proposed uses of fluxapyroxad, acute and chronic RQ values are below the listed (RQ>=0.05) and non-listed (RQ>=0.1) species acute and chronic (RQ>=1.0) risk LOCs for all assessed aquatic organisms based on toxicity of the TGAI.  However, based on endpoints for the fluxapyroxad formulations that contain pyraclostrobin (BAS 703 01 F and BAS 703 02 F) and spray drift-only EECs, there is acute risk to listed aquatic animals for all uses and nonlisted aquatic animals for the uses of BAS 703 01 F on pome fruits and stone fruits.  The enhanced toxicity of the dual-a.i. formulations appears to be driven by pyraclostrobin; when the toxicity endpoints for freshwater fish and invertebrates are adjusted for the percentage of pyraclstrobin in each product, they are similar to toxicity endpoints for the pyraclostrobin a.i. (e.g., USEPA 2011, DP Barcode D380640), as illustrated in Table 4.12.  In some cases, freshwater plants and animals are also more sensitive to solo (single a.i.) formulations of fluxapyroxad (e.g., BAS 700 01 F and BAS 700 04 F) than to the TGAI.  However, none of the RQ values for solo formulations approach or exceed the Agency's LOCs.  Risk to listed and nonlisted aquatic plants from fluxapyroxad TGAI and its EPs is low since RQ values are below the Agency's LOC (RQ>=1).

Table 4.12.  Comparison of aquatic ecotoxicity endpoints for BAS 703 01 F and BAS 703 02 F with existing pyraclostrobin endpoints.
                                  Study Type
                                    Species
                                   Endpoints
                          (mg pyraclostrobin a.i./L)

                                 BAS 703 01 F
                                 BAS 703 02 F
                               Pyraclostrobin[1]
Acute toxicity to freshwater fish
                                 Rainbow trout
                             (Oncorhynchus mykiss)
                                 LC50 = 0.007
                                 LC50 = 0.009
                                 LC50 = 0.006
Acute toxicity to freshwater invertebrates
                                  Water flea
                                (Daphnia magna)
                                 EC50 = 0.015
                                 EC50 = 0.016
                                 EC50 = 0.016
Acute toxicity to estuarine/marine fish
                               Sheepshead minnow
                            (Cyprinidon variegatus)
                                  LC50 = N/A
                                  LC50 = N/A
                                 LC50 = 0.077
Acute toxicity to estuarine/marine crustaceans
                                 Mysid shrimp
                             (Americamysis bahia)
                                  EC50 = N/A
                                  EC50 = N/A
                                 EC50 = 0.004
Toxicity to estuarine/marine molluscs  -  shell deposition
                                Eastern oyster
                            (Crassostrea virginica)
                                  IC50 = N/A
                                  IC50 = N/A
                                 IC50 = 0.013
[N/][A]  Not applicable.  Formulated product toxicity data using BAS 703 01 F and BAS 703 02 F were not provided for estuarine//marine fish, crustaceans, or molluscs.
[1]  Pyraclostrobin endpoints obtained from USEPA 2011 (DP Barcode D380640 et seq.).

Figures 4.1 and 4.2 depict the time series peak EECs from the PRZM/EXAMS spray drift only analysis for the highest peak EEC (use on pome fruits) and lowest peak EEC (use on corn, edible podded legume vegetables, oilseed crops (other), succulent shelled peas and beans, soybeans).  A review of the time series data indicates that, in general, the 90th percentile peak EEC for the modeled uses occurs as a result of accumulation from repeated annual application over 30 years.  However, depending on the endpoint, exceedence of the LOC can occur much sooner.  For all uses, the LOC for listed species at 4.5 μg/L is exceeded in the first year of applications.  For all uses, the LOC for listed species at 8.3 μg/L is exceeded after two years of consecutive use.  Except for the uses with the top three peak EECs (e.g., pome fruits, stone fruits, and fruiting vegetables, tuberous and corm vegetables), the LOC for nonlisted species at 4.5 μg/L is not exceeded.  For these top three EECs, this LOC is exceeded after six consecutive annual applications.  The LOC for nonlisted species at 8.3 μg/L is only exceeded for use on pome fruits, where the peak value occurs after 30 years of consecutive use.  It should be noted that EECs from the predicted accumulation reflect maximum usage of fluxapyroaxd for 30 years and a pond that has no outlet, which may not necessarily be representative of real world conditions.  However, given fluxapyroxad's high persistence in soil and aquatic environments, concentrations of fluxapyroxad over the long-term could potentially be a concern.

Figure 4-1.  Pome fruit peak EECs from spray drift only analysis.

Figure 4-2.  Corn, edible podded legume vegetables, oilseed crops (other), succulent shelled peas and beans, soybeans peak EECs from spray drift only analyses.

Depending on the percent organic matter content of benthic sediments, fluxapyroxad can partition to sediments.  The potential for risk to benthic organisms exposed to sediment pore water is also considered, using the conservative assumption that the highest concentrations tested in the amphipod studies represent the toxicity thresholds (Table 4.3).  In this estimation, the acute RQ value for benthic invertebrates (RQ<=0.01) is similar to the RQ values for fish and invertebrates exposed to TGAI in the water column, and it does not exceed the acute risk to listed or non-listed species LOCs.

In addition to potential surface water exposure, aquatic and amphibious organisms may be exposed to residues in ground water where ground water discharges into surface systems, or in unique and sensitive subsurface ecosystems such as caves, montane gravels, etc.  Because fluxapyroxad has moderate mobility and degrades slowly, it has the potential to reach ground water in certain environments.  Potential concentrations of fluxapyroxad in shallow ground water were therefore calculated (Table 4.11).  These concentrations in ground water (EEC=0.09 ug/L) are much lower than the maximum estimated concentrations in surface water (EEC=10.14 ug/L) which correspond with RQ values below acute and chronic risk LOCs.  The likelihood of adverse effects to aquatic organisms exposed to fluxapyroxad residues in ground water is therefore considered to be low.

Table 4.13. RQ values for aquatic animals exposed to fluxapyroxad residues in shallow ground water.
                                      Use
                                   App Rate
                                  lbs a.i./A
                                    (#app)
                                  App Method
                                     EECs
                                    (ug/L)
                              Toxicity Endpoints
                                 Ground Water
                                   RQ Values

                                     Peak
                                     21-d
                                     60-d
                                Aquatic Animals
                                     Acute
                                    Chronic
                     Dried shelled beans (except soybeans)
                                     0.18
                                      (2)
                                    Aerial
                                     0.09
                                     0.09
                                     0.09
                                Freshwater Fish
                                LC50=290 ug/L
                                NOAEC=22 ug/L
                                   <0.001
                                     0.004

                    Freshwater Invertebrate EC50=5100 ug/L
                                NOAEC=460 ug/L
                                   <0.001
                                   <0.001
                                    Wheat/
                                   triticale
                                     0.078
                                      (1)
                                     Seed
                                     0.02
                                     0.02
                                     0.02
                                Freshwater Fish
                                LC50=290 ug/L
                                NOAEC=22 ug/L
                                   <0.001
                                   <0.001

                    Freshwater Invertebrate EC50=5100 ug/L
                                NOAEC=460 mg/L
                                   <0.001
                                   <0.001
[App] Application.

Terrestrial Organisms

Although the available data indicate that the likelihood for adverse effects on aquatic organisms as a result of the proposed new uses of fluxapyroxad are very low, greater uncertainty surrounds the potential for risk to terrestrial organisms.  Acute RQ values are not calculated in the Risk Estimation for dose-based risk to birds or for dose- or dietary-based risk to mammals because the necessary toxicity endpoints (LD50/LC50) were determined to be greater than the limit dose in the submitted studies.  Therefore, although fluxapyroxad is classified as practically non-toxic to birds and mammals on an acute oral and subacute dietary exposure basis, the nature and potential dose-response relationship of any effects of fluxapyroxad at exposure levels above the limit dose are unknown.

For the proposed foliar uses of fluxapyroxad, the potential for acute risk to birds and mammals is characterized using the conservative assumption that the limit dose or maximum dose tested in the submitted oral toxicity studies (i.e., 2,000 mg/kg bw) represents the toxicity endpoint.  Under these conditions, the foliar use of fluxapyroxad is not expected to result in acute risk of mortality to listed or non-listed species of birds (and reptiles and terrestrial-phase amphibians for which birds serve as surrogates) or mammals because the resulting RQ values are all less than the Agency's acute risk LOC, i.e., RQ<0.5 for nonlisted species and RQ<0.1 for listed species.

The RQ values in Section 4.1 demonstrate that both foliar and seed treatment uses of fluxapyroxad may result in chronic risk to mammals (RQ>1.0).  RQ values are not calculated for chronic risk to birds because a statistically significant decrease in hatchling body weight was observed at all treatment levels in the submitted avian reproduction study with bobwhite quail.  Therefore, the chronic toxicity endpoint for bobwhite quail is nondefinitive (i.e., NOAEC<100 mg ai/kg diet).  An RQ value calculated assuming the NOAEC=100 mg ai/kg diet results in an RQ of 0.81 (based on maximum application rate to dry beans) and would be less than the Agency's LOC for chronic risk to birds (LOC=1.0).  However, chronic risk to birds cannot be precluded with confidence because the submitted data do not establish whether adverse effects may occur at dietary concentrations less than 100 mg ai/kg diet.  In order to preclude risk at the screening level, a NOAEC > 80 mg/kg-diet would need to be established, which is unlikely based on the flat concentration-response for the effect on body weight in the bobwhite quail study.  The 5  -  7% decrease in hatchling body weight was transient during the study and was not observed in the study with mallard duck; it is uncertain whether and how this effect may impact the fitness of (and therefore risk to) different species and size classes of birds, reptiles, and terrestrial-phase amphibians exposed to fluxapyroxad in the wild.

For the proposed seed treatment uses of fluxapyroxad, the potential for acute risk to birds is characterized in Table 4.14 by converting the subacute dietary toxicity endpoint for bobwhite quail (LC50, from the first experiment conducted under normal laboratory lighting conditions) to an subacute oral LD50 value that represents the total a.i. consumed per kilogram body weight (kg bw) over the 5-day study.  The calculation is performed based on information in the study report, as follows:

	LC50 = 2457 mg a.i./kg diet, corresponds to 561 mg a.i./kg bw/day (reported by the study)
	LD50 = 561 mg a.i./kg bw/day x 5 days exposure = 2805 mg a.i./kg bw

The calculated LD50 value is then compared to the dose-based EEC(USEPA 2008b) values and the spatial EECs generated by T-REX to determine RQ values for risk characterization.  Terrestrial exposure of mammals through consumption of treated seeds is characterized in Table 4.14 using the conservative assumption for mammals that the maximum dose tested (2,000 mg/kg bw) represents the toxicity endpoint (LD50).  The toxicity endpoint is then adjusted for the body weight (bw) of the test specimens (default bw=178 g for bobwhite quail and 350 g for Norway rat) and compared to the estimated exposure per unit area (mg a.i./ft[2]) and per daily dose of treated seed, i.e., dose-based EEC in terms of mg a.i./kg bw/day (USEPA 2008b) .

Table 4.14. Characterization of potential risk to terrestrial birds and mammals from consumption of treated seeds, assuming that the limit dose tested in effects studies is the definitive toxicity endpoint.
                                      Use
                                   App Rate
                                   lbs a.i.
                                      /A
                                    (#app)
                                  App Method
                                     EECs
                              Toxicity Endpoints
                               Characterization
                                  Terrestrial
                                   RQ Values

                                    Spatial
                                (mg a.i./ft[2])
                                  Dose-Based
                               (mg a.i./kg-bw/d)
                                    Animals
                                     Acute
                                    Spatial
                                     Acute
                                  Dose-Based
                             Sunflower (low rate)
                                    0.0008
                                      (1)
                                     Seed
                                     0.01
                                     50.6
                                     Birds
                              LD50=2,805 mg/kg-bw
                             LC50=2,457 mg/kg diet
                            NOAEC<100 mg/kg diet
                             NOAEL<7.8 mg/kg-bw
                                   <0.01
                                     0.03

                                     42.4
                                    Mammals
                            LD50>2,000 mg/kg-bw
                             NOAEC=112 mg/kg diet
                               NOAEL=10 mg/kg-bw
                                   <0.01
                                     0.01
                          Podded legume (medium rate)
                                     0.022
                                      (1)
                                     Seed
                                     0.23
                                     25.3
                                     Birds
                              LD50=2,805 mg/kg-bw
                             LC50=2,457 mg/kg diet
                            NOAEC<100 mg/kg diet
                             NOAEL<7.8 mg/kg-bw
                                     0.01
                                     0.01

                                     21.2
                                    Mammals
                            LD50>2,000 mg/kg-bw
                             NOAEC=112 mg/kg diet
                               NOAEL=10 mg/kg-bw
                                   <0.01
                                   <0.01
                                    Wheat/
                             triticale (high rate)
                                     0.078
                                      (1)
                                     Seed
                                     0.81
                                      127
                                     Birds
                              LD50=2,805 mg/kg-bw
                             LC50=2,457 mg/kg diet
                            NOAEC<100 mg/kg diet
                             NOAEL<7.8 mg/kg-bw
                                     0.02
                                     0.06

                                      106
                                    Mammals
                            LD50>2,000 mg/kg-bw
                             NOAEC=112 mg/kg diet
                               NOAEL=10 mg/kg-bw
                                     0.01
                                     0.02

The available data indicate that the likelihood of risk of acute mortality to birds and mammals is low as RQ values do not exceed the Agency's acute risk LOC.  Although dose-responsive mortality was observed in the subacute dietary study with bobwhite quail, mortality is not expected to occur at EECs calculated based on the proposed uses of fluxapyroxad.  All risk conclusions for birds in this assessment are intended to apply to reptiles and to amphibians in the terrestrial environment.

The low potential for acute risk to listed species of birds can be further characterized by considering how foraging ecology affects the potential for exposure.  To consume a mass of fluxapyroxad equivalent to the acute dietary toxicity endpoint in the submitted study with bobwhite quail, a 20-g bird would have to consume 40.4 mg a.i., equivalent to 51.8 g (0.114 lbs) of wheat seed treated at the maximum proposed application rate (0.078 lbs a.i./cwt).  This is considered an unlikely, though not impossible, scenario for most species.  Smaller, migrating birds that eat seeds are expected to be at the highest risk of exposure, since they have higher surface area-to-body weight ratios and they must rapidly refuel energy reserves exhausted during migration (Klassen & Lindstrom 1996).  In a short period of time (e.g., one day or less), these birds may consume larger amounts of seeds, relative to body size, in proportions that approach or exceed their own body weight.  Nonetheless, given that adult mortality was observed only in one dietary toxicity experiment with bobwhite quail and at relatively high concentrations when compared to EECs, the likelihood of frank mortality is considered low if a bird did consume the large amount of treated seed necessary to be exposed to the limit dose.

As the foraging efficiency of a granivore decreases, the area of exposure (i.e., treated field) necessary to exceed the LOC increases.  For example, assuming conservatively that the maximum dose tested in the submitted studies represents the LD50 value for birds, a 20-g, seed-eating bird with 100% foraging efficiency (i.e., that all of the seeds are treated and that the bird eats all seeds within a given area) would consume enough fluxapyroxad in a 5-ft[2] area to exceed the Agency's LOC for acute risk to listed species of birds, reptiles and terrestrial-phase amphibians.  Using the same assumption, a 20-g bird would consume enough fluxapyroxad to exceed the acute risk LOC for listed birds if it displayed 50% foraging efficiency in a 10-ft[2] foraging area, or if it displayed 10% foraging efficiency within a 50-ft[2] foraging area.  The actual foraging area necessary to result in mortality to birds at a level equivalent to an LD50 (i.e., mortality of 50% of exposed birds) is likely much greater given that no mortality was observed at the maximum dose tested.  Seed incorporation would further reduce the likelihood of exposure to birds and mammals from the proposed seed treatment uses.

As with birds and mammals, acute laboratory tests with terrestrial invertebrates (i.e., honey bee) have demonstrated that fluxapyroxad is practically non-toxic on an acute exposure basis.  However, two of the fluxapyroxad end-use products (BAS 703 01 F and BAS 703 02 F) proposed for registration are co-formulated with pyraclostrobin and are similar in that respect to the registered product, Pristine, which is a dual-a.i. formulation from the same registrant that contains the similarly structured fungicide boscalid (25.2%) and pyraclostrobin (12.8%).  Previous risk assessments for boscalid (DP Barcodes D363523, D379809, D385653), which  -  like fluxapyroxad  -  is a pyridine carboxamide, have described uncertainties regarding potential effects on development of honey bee brood, based on incident reports and communications with beekeepers.  Submitted toxicity studies indicate that neither fluxapyroxad, any of its end-use products proposed for registration in the United States, nor boscalid or Pristine are acutely toxic to young adult honey bees.  In addition, submitted semi-field studies with a formulation of fluxapyroxad (BAS 700 00 F, not proposed for US registration) and with Pristine demonstrated no overall effects on honey bee brood, although EFED identified transient effects on eggs, larvae, and forage bee mortality in the study with Pristine (DP Barcode 390033).  None of the submitted studies with fluxapyroxad or boscalid products evaluate endpoints specific to the concerns raised by beekeepers, particularly impaired honey bee queen cell development.  The registrant is currently planning and conducting additional larval toxicity tests with boscalid and Pristine to further address these uncertainties.

Finally, the proposed new uses of fluxapyroxad are expected to result in risk to listed non-target terrestrial plants.  RQ values for listed species of dicot plants exceed the Agency's LOC for all of the foliar uses evaluated.  Of the six dicot species tested in the vegetative vigor study with BAS 703 02, only tomato demonstrated a significant effect, based on inhibition of dry weight.  However, the same formulation (BAS 703 02 F) significantly inhibited cabbage (dry weight), carrot (emergence), and lettuce (height) in the seedling emergence study.  Thus, any effects on non-target dicot plants are likely to differ based on both species and route of exposure.  RQ values for listed species of monocot plants are below the LOC for all foliar uses.  RQ values are not calculate for nonlisted terrestrial plants because a 25% effect was not observed in any species exposed to fluxpayroxad at rates up to and including the maximum proposed application rate; therefore, risk to nonlisted plants in not expected to exceed the LOC.  RQ values based on seed treatment uses exceed the Agency's LOC for the highest use rate evaluated for listed species of dicot plants in semi-aquatic areas, but are below the LOC for all other nontarget plants.  This risk conclusion is sensitive to parameters such as incorporation depth of the seeds and seeding rate; in cases where seeds are incorporated greater than or equal to one inch, exposure via runoff is expected to be reduced, and risk would not exceed the LOC.  It is uncertain to what extent exposure may occur via particulate drift from abrasion of treated seeds during planting and how this type of exposure may affect risk to non-target organisms.

Conclusions

The risk hypothesis and conceptual models articulated in the initial problem formulation of this assessment identified concerns that the proposed uses of fluxapyroxad may result in adverse effects on survival, growth and/or reproduction in aquatic organisms and that the compound may pose a chronic risk to small birds, terrestrial-phase amphibians and reptiles and to all size classes of mammals.  Although fluxapyroxad was not expected to pose a risk to aquatic plants or to terrestrial monocots, the problem formulation indicated that there was uncertainty regarding the potential effects of the compound on terrestrial dicots through runoff and spray drift.

Based on this screening-level assessment, the physico-chemical properties of fluxapyroxad indicate that the fungicide is persistent and has a high potential to reach aquatic environments, including surface and ground water, for several months or more following foliar applications and seed treatments.  Although the available ecotoxicity data demonstrate that fluxapyroxad is acutely toxic to aquatic organisms and may cause chronic effects, including effects linked to reproduction and sublethal behavioral effects in some aquatic test species, the EECs that result from the proposed foliar and seed treatment uses are relatively low and the resulting risk estimates for the TGAI are below LOCs.  Therefore, based on the maximum proposed use rates, the potential for exposure to the fluxapyroxad TGAI at a level that is likely to cause direct acute or chronic effects on aquatic organisms, including fish, aquatic invertebrates, aquatic-phase amphibians, and aquatic plants, is considered low.  Acceptable chronic toxicity data for estuarine/marine animals were not available.  Additional studies are not being requested at this time because estuarine/marine animals were similarly or less acutely sensitive to the TGAI than freshwater animals in the acute studies; when considered in the context of the relatively low EECs, new data would be unlikely to change the screening level risk conclusions.  Despite the persistence of fluxapyroxad, its propensity to partition to sediments, its Kow and the available fish biocencentration data indicate that fluxapyroxad does not bioconcentrate but is instead readily metabolized and excreted in fish.  There is more uncertainty about the extent that fluxapyroxad may move, persist, and/or bioconcentrate in aquatic invertebrates, which may be more or less able to metabolize the parent compound.  However, additional biococentration and bioaccumulation modeling is not triggered in this case because of the relatively low Kow.

Formulated fluxapyroxad is in some cases more toxic than the TGAI to aquatic organisms.  Exposure to dual-a.i. formulations of fluxapyroxad (BAS 703 01 F and BAS 703 02 F) as a result of spray drift is expected to result in risk of acute mortality that exceeds the LOC for acute risk to listed freshwater fish, amphibians in the aquatic environment, and freshwater invertebrates.  Certain uses of BAS 703 01 F also result in acute risk that exceeds the LOC for nonlisted freshwater fish and amphibians.  Based on the BAS 703 02 F toxicity data for freshwater animals which is more toxic to these taxa but lacks the proposed uses on pome fruits and stone fruits, the EECs from spray drift only would need to be less than 0.225 g/L to avoid triggering acute risk to listed fish and less than 0.415 g/L to avoid triggering acute risk to listed aquatic inverterbates.  Spray drift EECs for the proposed uses of co-formulated fluxapyroxad range from 1.12 to 4.39 g/L.  Although toxicity data for estuarine/marine animals exposed to formulated fluxapyroxad were not submitted, freshwater and estuarine/marine organisms generally exhibited similar responses to the TGAI; therefore, this assessment concludes that risk of acute mortality to estuarine/marine animals is possible when the use of BAS 703 01 F or BAS 703 02 F results in spray drift to estuarine/marine habitat.  The greater toxicity of the dual a.i. formulations to fish and invertebrates, when compared to the fluxapyroxad TGAI and solo formulations, appears to be driven by pyraclostrobin.

Terrestrial vertebrates may be exposed to fluxapyroxad by contact with or ingestion of treated plants and insects.  Seed-eating (granivore) birds and mammals may also be exposed to fluxapyroxad as a result of the proposed seed treatment use.  This assessment concludes that the proposed foliar and seed treatment uses of fluxapyroxad may result in chronic risk to mammals that exceed the Agency's LOC.  Chronic risk to birds, reptiles, and terrestrial-phase amphibians cannot be precluded with certainty based on the available data, which demonstrated a slight (5-7%) and transient (< 14 day), but statistically significant (p<0.05), effect on body weight in hatchling birds at all test concentrations.  This treatment-related effect was uniform across all test concentrations (100-1,000 mg/kg diet) and is consistent with effects on body weight and body weight gain in rat pups (NOAEC=112 mg/kg diet) in a two-generation reproduction study with mammals.   In order to preclude chronic risk (i.e., RQ<1) to birds, reptiles, and terrestrial-phase amphibians, based on the proposed uses, an avian reproduction study would need to establish that no adverse effects, including effects on hatchling body weight, are observed at concentrations greater than or equal to 80 mg/kg diet.  Given the flat concentration-response in this case, EFED considers it unlikely that an additional study would yield a NOAEC that would allow risk to be precluded at the screening level  Therefore, EFED is not requesting additional data at this time.  Risk estimates for acute mortality to mammals and birds, reptiles, and terrestrial-phase amphibians do not exceed the Agency's LOC.  The proposed foliar use of fluxapyroxad may result in risk to listed species of terrestrial and semi-aquatic dicot plants, but risk to monocot plants and nonlisted dicot plants is not expected to exceed the LOC.

This assessment does not evaluate risk to terrestrial invertebrates.  However, ecotoxicity data indicate that fluxpyroxad is practically non-toxic to young adult honey bees on an acute oral and contact exposure basis.  Non-guideline studies with beneficial insects (predatory mite, parasitoid wasp, green lacewing, rove beetle) and with earthworms demonstrated effects on reproduction and resulted in mortality in some cases.  Finally, in response to concerns raised by beekeepers regarding the BASF product Pristine -- which, like the fluxapyroxad formulations BAS 703 01 F and BAS 703 02 F, contains a carboxamide fungicide (boscalid) and pyraclsotrobin -- the registrant is currently planning and conducting further tests to evaluate the potential for effects on larval honey bee development and queen cell production and survival.  The structural similarities between boscalid and fluxapyroxad and the similarities in a.i. content of Pristine, BAS 703 01 F, and BAS 703 02 F suggest that information from these forthcoming honey bee studies may be relevant to all three products.

Federally Threatened and Endangered (Listed) Species of Concern

Section 7 of the Endangered Species Act, 16 U.S.C. Section 1536(a)(2), requires all federal agencies to consult with the National Marine Fisheries Service (NMFS) for marine and anadromous listed species, and the United States Fish and Wildlife Service (USFWS) for listed wildlife and freshwater organisms, if the proposed "action" may affect listed species or their designated critical habitat.  Each federal agency is required under the Act to ensure that any action it authorizes, funds, or carries out is not likely to jeopardize the continued existence of a listed species or result in the destruction or adverse modification of designated critical habitat.  To jeopardize the continued existence of a listed species means "to engage in an action that reasonably would be expected, directly or indirectly, to reduce appreciably the likelihood of both the survival and recovery of a listed species in the wild by reducing the reproduction, numbers, or distribution of the species" (50 C.F.R. § 402.02).

To facilitate compliance with the requirements of the Endangered Species Act (subsection (a)(2)), the Office of Pesticide Programs has established procedures to evaluate whether a proposed registration action may directly or indirectly appreciably reduce the likelihood of both the survival and recovery of a listed species in the wild by reducing the reproduction, numbers, or distribution of any listed species (USEPA 2004a).  After the Agency's screening-level risk assessment is conducted, if any of the Agency's listed species LOCs are exceeded for either direct or indirect effects, an analysis is conducted to determine if any listed or candidate species may co-occur in the area of the proposed pesticide use or areas downstream or downwind that could be contaminated from drift or runoff/erosion.  If listed or candidate species may be present in the proposed action area, further biological assessment is undertaken.  The extent to which listed species may be at risk is considered, which then determines the need for the development of a more comprehensive consultation package, as required by the Endangered Species Act.

The federal action addressed herein is the proposed registration of new foliar and seed treatment uses for fluxapyroxad.  It is expected that the new uses of fluxapyroxad could occur nationwide.

Action Area

		For listed species assessment purposes, the action area is considered to be the area affected directly or indirectly by fluxapyroxad use and not merely the immediate area where fluxapyroxad is applied.  At the initial screening-level, the risk assessment considers broadly described taxonomic groups and conservatively assumes that listed species within those broad groups are co-located with 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 treatment area.  Section 5.2 of this risk assessment presents the proposed pesticide use sites that are used to establish initial co-location of species with treatment areas.

              Taxonomic Groups Potentially at Risk

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

 Assessment endpoints, exposure pathways, the conceptual models addressing the proposed new fluxapyroxad uses, and the associated exposure and effects analyses conducted for the fluxapyroxad screening-level risk assessment are in Sections 2 to 3.  The assessment endpoints used in the screening-level risk assessment include those defined operationally as reduced survival and reproductive impairment for both aquatic and terrestrial animal species and survival, reproduction, and growth of non-target aquatic and terrestrial plant species from exposure via spray drift and runoff.  These assessment endpoints address the standard set forth in the Endangered Species Act requiring federal agencies to ensure that any action it authorizes does not appreciably reduce the likelihood of both the survival and recovery of a listed species in the wild by reducing the reproduction, numbers, or distribution of the species.  Risk estimates (RQ values) integrating exposure and effects are calculated for broad-based taxonomic groups in the screening-level risk assessment and are presented in Section 4.

Both acute and chronic risk to listed species LOCs are considered in the screening-level risk assessment to identify direct and indirect effects to taxa of listed species.  This section identifies direct and indirect effect concerns, by taxa, that are triggered by exceeding listed species LOCs in the screening-level risk assessment (Table 5.1).  When applicable, probit dose response analysis is used to evaluate the probability of individual acute effects for exposures that occur at the established listed species LOC (Section 5.2.1).  Data on exposure and effects collected under field (when available) and laboratory conditions are evaluated to make determinations on the predictive utility of the direct effect screening assessment findings to listed species.

Table 5.1  Potential effects to federally listed taxa associated with the proposed uses of fluxapyroxad.
                                 Listed Taxon
                                Direct Effects
                   Indirect Effects from Risk to Other Taxa

                                    Yes/No
                                 Acute/Chronic
                                    Yes/No
                                  Through ...
Terrestrial and semi-aquatic plants  -
 monocots and dicots
                               Yes (dicots only)
                                      NA
                                      Yes
Chronic effects on birds, terrestrial-phase amphibians, and mammals, when required for pollination or seed dispersal.
Birds
                                      Yes
                                    Chronic
                                      Yes
Chronic effects on mammals that serve as prey; chronic effects on reptiles and amphibians that serve as prey.
Terrestrial-phase amphibians
                                      Yes
                                    Chronic
                                      Yes
Chronic effects on mammals which provide habitat (e.g., burrows) and serve as prey.
Reptiles
                                      Yes
                                    Chronic
                                      Yes
Chronic effects on mammals that serve as prey; chronic effects on birds, reptiles, and amphibians that serve as prey.
Mammals
                                      Yes
                                    Chronic
                                      Yes
Chronic effects on birds, reptiles, and amphibians that serve as prey; chronic effects on mammals that serve as prey.
Aquatic plants
                                      No
                                      NA
                                      Yes
Effects on semi-aquatic dicot plants that serve as primary producers.
Freshwater fish
                                      Yes
                                     Acute
                             (dual a.i. EPs only)
                                      Yes
Effects on semi-aquatic dicot plants that provide habitat and serve as primary producers.
Aquatic-phase amphibians
                                      Yes
                                     Acute
                             (dual a.i. EPs only)
                                      Yes
Chronic effects on terrestrial-phase amphibians; effects on semi-aquatic dicot plants that provide habitat and serve as primary producers.
Freshwater invertebrates
                                      Yes
                                     Acute
                             (dual a.i. EPs only)
                                      Yes
Effects on semi-aquatic dicot plants that provide habitat and serve as primary producers.
Molluscs
                                      No
                                      NA
                                      Yes
Effects on semi-aquatic dicot plants that provide habitat and serve as primary producers.
Marine/estuarine fish
                                      Yes
                                     Acute
                             (dual a.i. EPs only)
                                      Yes
Effects on semi-aquatic dicot plants that provide habitat and serve as primary producers.
Marine/estuarine invertebrates
                                      Yes
                                     Acute
                             (dual a.i. EPs only)
                                      Yes
Effects on semi-aquatic dicot plants that provide habitat and serve as primary producers.
[EP]  End-use product.  [NA] Not applicable.
Probit Dose-Response Analysis

The Agency uses the probit dose-response relationship as a tool for providing additional information on the potential for acute direct effects to individual listed species and to terrestrial and aquatic animals that may indirectly affect the listed species of concern (USEPA 2004a).  Based on the available acute toxicity data and RQ values for fluxapyroxad, a summary of the probit dose-response analysis is provided in Error! Reference source not found..  If no dose response information is available to estimate a slope for this analysis, a default slope assumption of 4.5 (with lower and upper bounds of 2 to 9) is used (Urban and Cook 1986). Individual effect probabilities are calculated based on an Microsoft[(R)] Excel spreadsheet tool IECV1.1 (Individual Effect Chance Model Version 1.1) developed by the U.S. EPA, OPP, Environmental Fate and Effects Division (June 22, 2004).  The model allows for such calculations by entering the mean slope estimate (and the 95% confidence bounds of that estimate) as the slope parameter for the spreadsheet.  The desired threshold for the probability of an individual effect is entered as the listed species LOC.  In addition, the probability of an individual effect is also derived based on the calculated acute RQ, if available.

As shown in Error! Reference source not found., the chance of acute direct effects (i.e., mortality) to individual listed fish at the listed species LOC is 1 in 4.18 x 10[8] (95% CI: 216 to 1.75 x 1031).  However, at the highest derived RQ value (0.98; Table 4.5) for the proposed uses of dual a.i. formulations of fluxapyroxad, the chances of an individual effect increase for fish to approximately 1 in 2.   For freshwater invertebrates, the chance of acute direct effects (i.e., mortality) at the listed species LOC is 1 in 8.19 x 10[31] (95% CI: 1.66 x 10[13] to 5.58 x 10[61]).  At the highest derived RQ value (0.53; Table 4.5) for dual a.i. formulations of fluxapyroxad, the chances increase to 1 in 165 (95% CI: 17.2 to 5,920).  These probabilities are based on exposure to formulated fluxapyroxad (BAS 703 02 F) in surface water from spray drift only.  In the absence of ecotoxicity data for estuarine/marine animals exposed to formulated fluxapyroxad, this assessment assumes that the likelihood of an individual effect for these taxa is similar to that for freshwater fish and invertebrates.  The likelihood of an individual acute effect is not calculated for acute oral exposure to birds and mammals because no mortality was observed in these studies and therefore an effect is considered unlikely.
Table 5.2.  Summary of fluxapyroxad probit dose response analysis for listed species.
                               Taxa (study type)
                                 Acute Effect
                               Slope (95% C.I.)
         Chance of Individual Effect at Listed Species LOC (95% C.I.)
         Chance of Individual Effect at Derived Acute RQ[1] (95% C.I.)
Bird oral dose
                             No mortality observed
                     Not calculated; no mortality observed
                     Not calculated; no mortality observed
Bird dietary
                                 Mortality[1]
                           Slope NA = 4.5 (2  -  9)
                               1 in 2.94 x 10[5]
                                  (1 in 44 to
                              1 in 8.86 x 10[18])
                              1 in 2.76 x 10[11]
                                 (1 in 862 to
                              1 in 2.14 x 10[42])
Mammal oral dose
                             No mortality observed
                     Not calculated; no mortality observed
                     Not calculated; no mortality observed
Freshwater fish
                                 Mortality[2]
                           Slope NA = 4.5 (2  -  9)
                                1 in 4.18 x 108
                                 (1 in 216 to
                               1 in 1.75 x 1031)
                               1 in 2.76 x 1011
                                 (1 in 862 to
                               1 in 2.14 x 1042)

                         Mortality (dual a.i. EPs)[3]
                           Slope NA = 4.5 (2  -  9)
                                1 in 4.18 x 108
                                 (1 in 216 to
                               1 in 1.75 x 1031)
                                   1 in 2.07
                                  (1 in 2.03
                                 to 1 in 2.13)
Freshwater invertebrate
                                  Mortality4
                           Slope NA = 4.5 (2  -  9)
                               1 in 4.18 x 10[8]
                                 (1 in 216  to
                              1 in 1.75 x 10[31])
                              1 in 8.86 x 10[18]
                             (1 in 31.6 x 10[4] to
                              1 in 1.03 x 10[72])

                         Mortality (dual a.i. EPs)[5]
                            Slope 9.1 (5.7  -  13)
                              1 in 8.19 x 10[31]
                            (1 in 1.66 x 10[13] to
                              1 in 5.58 x 10[63])
                                   1 in 165
                                (1 in 17.2 to
                                  1 in 5,920)
Estuarine/marine fish
                                  Mortality6
                           Slope NA = 4.5 (2  -  9)
                                1 in 4.18 x 108
                                 (1 in 216 to
                               1 in 1.75 x 1031)
                              1 in 8.86 x 10[18]
                             (1 in 3.16 x 10[4] to
                              1 in 1.03 x 10[72])
Estuarine/marine crustacean
                                 Mortality[6]
                           Slope NA = 4.5 (2  -  9)
                                1 in 4.18 x 108
                                 (1 in 216 to
                               1 in 1.75 x 1031)
                              1 in 8.86 x 10[18]
                             (1 in 3.16 x 10[4] to
                              1 in 1.03 x 10[72]
Estuarine/marine mollusc
                                 Mortality[6]
                           Slope NA = 4.5 (2  -  9)
                                1 in 4.18 x 108
                                 (1 in 216 to
                               1 in 1.75 x 1031)
                              1 in 8.86 x 10[18]
                             (1 in 3.16 x 10[4] to
                              1 in 1.03 x 10[72]
[1]  Maximum acute dietary RQ = 0.03 (birds).
[2]  Based on exposure to the TGAI.  Maximum acute RQ (0.03) did not exceed the LOC.
[3]  Based on exposure to the fluxpyroxad EP (BAS 703 02 F).  Maximum acute RQ used in calculation (0.98) is based on spray drift from application to stone fruit.
[4]  Based on exposure to the TGAI.  Maximum acute RQ (<0.01) did not exceed the LOC.
[5]  Based on exposure to the fluxpyroxad EP (BAS 703 02 F).  Maximum acute RQ used in calculation (0.53) is based on spray drift from application to stone fruit.
[6]  Based on exposure to the TGAI.  Maximum acute RQ (0.01) did not exceed the LOC.
[EP]  End-use product.  [NA] Not available.

Listed Species Occurrence with Proposed New Use of Fluxapyroxad

A preliminary analysis of the co-occurrence of listed species and the proposed new uses of fluxapyroxad was conducted using OPP's LOCATES database (v. 2.2.0).  The goal of the analysis for co-location is to determine whether sites of pesticide use are geographically associated with known locations of listed species.  The objective is to provide insight into the potential for exposure of listed species and to identify those areas, crop uses, and listed species that warrant further attention.  The LOCATES database uses location information for listed species at the county level and compares it to agricultural census data (from 2007) for crop production at the same county level of resolution.  The product is a listing of federally-listed species that are located within counties known to produce the crops upon which the pesticide is proposed for use.  Appendix I provides a species listing by state for those listed species that may potentially be impacted by the proposed new uses of fluxapyroxad.

A tabulation of the number of unique listed species in each state that may co-occur with the proposed new use of fluxapyroxad as a seed treatment on rapeseed is provided in Table 5.3.  Although this assessment does not evaluate risk to terrestrial invertebrates, terrestrial invertebrates are included in the tabulation of species that may co-occur with areas of fluxapyroxad use.  Secondary effects may occur in predatory birds, reptiles, amphibians, and mammals that rely on mammals, birds, reptiles, or terrestrial amphibians as prey.  LOCATES does not currently differentiate between different feeding guilds or identify those plant species that require particular interactions for pollination or seed dispersal.  Therefore, the number of potentially affected listed mammals, birds (also reptiles and terrestrial-phase amphibians), and terrestrial plants may be overestimated and include species that are not likely to be indirectly affected if they do not (1) rely on mammals, birds, amphibians, reptiles, or seeds as prey or (2) require mammals or birds for pollination or seed dispersal.

Based the results of the LOCATES database query, there are a total of 1,230 unique listed species of terrestrial plants, birds, reptiles, terrestrial and aquatic-phase amphibians, mammals, and terrestrial invertebrates associated with counties where fluxapyroxad may be used nationwide based on the proposed uses.  A total of 50 states have listed species that are potentially affected by direct or secondary effects of fluxapyroxad exposure and are associated with crops where fluxapyroxad is proposed for use.  Hawaii has the highest number (313) of listed species in the identified taxa that may co-occur with the proposed fluxapyroxad uses, followed by California (290), Alabama (96), and Florida (95).

This preliminary analysis indicates that there is a potential for fluxapyroxad use to overlap with listed species and that a more refined assessment is warranted.  The more refined assessment should involve clear delineation of the action area associated with proposed uses of fluxapyroxad and the best available information on the temporal and spatial co-location of listed species with respect to the action area.  This analysis has not been conducted for this screening level assessment.

Table 5.3.  Tabulation by state and taxonomic group of listed species at potential risk of direct or secondary effects of proposed fluxapyroxad uses.
State
 Amphibians
 Birds
 Conifer
 Corals
 Crustaceans and Bivalves
 Dicot Plants
 Ferns and Lichens
 Fish
 Other Invertebrates
 Mammals
 Monocot Plants
 Reptiles
 Total per State
Alabama

                                       3

                                      35
                                      13
                                       3
                                      14
                                      12
                                       5
                                       4
                                       4
                                      96
Alaska

                                       6