UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                            WASHINGTON, D.C. 20460

                          OFFICE OF CHEMICAL SAFETY
                           AND POLLUTION PREVENTION

                              Environmental Fate
                        and Ecological Risk Assessment
                          for Fluopyram Registration

Fluopyram: (N-[2-[3-chloro-5-(trifluoromethyl)-2-pyridinyl]ethyl]-2(trifluoromethyl)benzamide
                       (CAS 658066-35-4, PC code 080302)

Prepared by:
Mohammed A. Ruhman, Ph.D.
Amanda Solliday, M.S.

Reviewed by:
Keith Sappington, M.S.
Mah Shamim, Ph.D.

                                  United States Environmental Protection Agency
                                                   Office of Pesticide Programs
                                        Environmental Fate and Effects Division
                                                    Environmental Risk Branch V
                                                         1200 Pennsylvania Ave.
                                                               Mail Code 7507P
                                                         Washington, D.C. 20460

Table of Contents

I.	Executive Summary	1
A.  Nature of Chemical Stressor	1
B.  Potential Risks to Non-target Organisms	1
C.  Conclusions - Exposure Characterization	8
E.  Conclusions - Effects Characterization	8
F.  Data Gaps and Uncertainties	8
1. Environmental Fate	8
2. Ecological Effects	9
II.	Problem Formulation	9
A.  Stressor Source and Distribution	9
1.  Source and Intensity	9
2.  Physicochemical, Fate, and Transport Properties	10
3.  Pesticide Type, Class, and Mode of Action	10
4.  Overview of Pesticide Usage	10
B.  Receptors	11
1.  Ecological Effects	11
a.  Aquatic Effects	13
b.  Terrestrial Effects	13
2.  Ecosystems at Risk	13
C.  Assessment Endpoints	13
D.  Conceptual Model	14
1.  Risk Hypotheses	14
2.  Diagram	15
Figure 1a The aquatic conceptual model for spray application of fluopyram to agricultural crops (dotted lines indicate unlikely routes of chemical dissipation).	16
Figure 1b The terrestrial conceptual model for spray application of fluopyram to agricultural crops (dotted lines indicate unlikely routes of chemical dissipation)	17
E.  Analysis Plan	17
1.  Methods for Conducting Ecological Risk Assessment and Identification of Data Gaps	17
2.  Measures to Evaluate Risk Hypotheses and Conceptual Model	18
a. Measures of Exposure	18
b. Measures of Effect	20
c. Measures of Ecosystem and Receptor Characteristics	20
III.	Analysis	22
A.  Use Characterization	22
B.  Exposure Characterization	24
1.  Environmental Fate and Transport Characterization	24
a. Abiotic Degradation	25
b. Biotic Degradation	26
c. Tranformation Profile	28
d. Mobility	30
2.  Measures of Aquatic Exposure	31
a. Application Methods	32
b. Label Application Rates and Intervals	32
c. Modeling Approach	34
d. Model Inputs	35
e. Aquatic EECs	35
g. Aquatic Exposure Monitoring (Field Data)	37
3.  Terrestrial Exposure Assessment	37
a. Terrestrial Animal Exposure Modeling- Spray Applications	38
b. Terrestrial Exposure Monitoring (Field Data)	40
4.  Non-Target Terrestrial Plant Exposure Assessment	40
C.  Ecological Effects Characterization	40
1.  Aquatic Effects	41
2.  Terrestrial Effects	51
IV.	Risk Characterization	61
A.  Risk Estimation - Integration of Exposure and Effects Data	61
1.  Non-target Aquatic Animals and Plants	61
a. Water Column Exposure: Acute and Chronic Risk to Animals	61
b. Sediment Exposure: Acute and Chronic Risk to Benthic Invertebrates	63
c.  Aquatic Plants	65
2.  Non-target Terrestrial Animals	66
a.  Spray Applications: Acute Risk to Birds and Mammals	66
b. Spray Applications: Chronic Risk to Birds and Mammals	66
3.  Non-target Terrestrial and Semi-Aquatic Plants	68
B.  Risk Description - Interpretation of Direct Effects	68
1.  Risks to Aquatic Organisms	68
a.  Aquatic Animals and Plants:  Water Column Exposure	69
b.  Aquatic Animals:  Sediment Exposure	72
3.  Risks to Terrestrial Organisms	72
a.  Spray Applications: Acute and Chronic Risk to Birds and Mammals	72
b.  Non-target Terrestrial Invertebrates	74
c.  Terrestrial Plants	75
4.  Review of Incident Data	76
5.  Threatened and Endangered Species Concerns	76
C.  Description of Assumptions, Limitations, Uncertainties, Strengths and Data Gaps	77
1.  Exposure for All Taxa	77
2.  Exposure for Aquatic Species	78
3.  Exposure for Terrestrial Species	79
a.  Location of Wildlife Species	83
b.  Routes of Exposure	83
c.  Incidental Pesticide Releases Associated with Use	84
d.  Residue Levels Selection	84
4.  Effects Assessment	84
a.  Age Class and Sensitivity of Effects Thresholds	87
b.  Lack of Effects Data for Amphibians and Reptiles	88
c.  Use of the Most Sensitive Species Tested	88
Environmental Fate Studies	89
B.  Ecological Effects Studies Submitted to EPA	91
C.  Open Literature and Government Reports	96

VI. Appendices

   A. Environmental Fate and Transport Data Summaries

   B. Aquatic Exposure PRZM/EXAMS Modeling and Ground Water Modeling
   C. Terrestrial Residue EXposure (T-REX; Version 1.4.1, October 2008) and TERR-PLANT models
   D. List of Ecological Effects Data
   E. The Risk Quotient Method and Levels of Concern
   F. Detailed Risk Quotients
   G. Data Requirements

         I. Executive Summary

 A.  Nature of Chemical Stressor

Fluopyram (N-[2-[3-chloro-5-(trifluoromethyl)-2-pyridinyl]ethyl]-2(trifluoromethyl)benzamide; fluopyram; CAS 658066-35-4, PC code 080302) represents a new group of fungicide chemistry, pyridinyl-ethylbenzamides. The biochemical mode of action of this chemical involves the inhibition of the enzyme succinate dehydrogenase within the fungal mitochondrial respiratory chain, thus blocking electron transport. Other fungicides that share the same target site, or succinate dehydrogenase inhibitors (SDHIs), include boscalid and carboxin, among others (FRAC, 2009).

The registrant reported that fluopyram is a fungicide with penetrative and trans-laminar properties. The active substance is also trans-located by the xylem vascular system.

Current formulations for fluopyram include suspension concentrates for the chemical alone (41.5% a.i), or with other fungicides including: tebuconazole (17.6% with 17.6% fluopyram), trifloxystrobin (21.4% with 21.4% fluopyram), pyrimethanil (33.8% with 11.3% fluopyram), or prothioconazole (17.4% with 17.4% fluopyram).  Fluopyram and /or its mixtures is proposed for agricultural uses on apples, watermelons, selected dry beans, grapes (wine), peanuts, potatoes, strawberries, sugerbeet, and tree nuts.

 Fluopyram is stable to hydrolysis and soil photolysis and highly persistent in both aerobic and anaerobic aquatic systems. Based on laboratory studies, degradates that are expected to form in the terrestrial environment were observed at low concentrations and are considered minor (<=1 to 4.2% of the applied). In aerobic aquatic and anaerobic aquatic metabolism studies, no degradates were observed. If these degradates do not form in the aquatic systems, then these compounds may reach these systems via run-off at low concentrations based on the level of formation in laboratory aerobic soil studies. Limited ecological effects data show low comparative toxicity of degradates compared to parent. One algal study with fluopyram-lactame and one dietary rat study with fluopyram-PCA have been submitted and no treatment-related effects were observed in either study. Therefore, based on the high persistence of fluopyram, the low occurrence of degradates and the low comparative toxicity of degradates, only the parent compound (fluopyram) was considered of concern in aquatic and terrestrial ecosystems.

 Fluopyram is stable to hydrolysis and soil photolysis and highly persistent in both aerobic and anaerobic aquatic systems. Based on the high persistence of fluopyram, the low occurrence of degradates and the low comparative toxicity of degradates, only the parent compound (fluopyram) is considered of concern in aquatic and terrestrial ecosystems.

 B.  Potential Risks to Non-target Organisms
 This is the Environmental Fate and Effects Division's (EFED) national screening-level ecological risk assessment for the proposed registration of fluopyram.  Tables 1 and 2 summarize the major conclusions and uncertainties of this assessment for aquatic and terrestrial receptors, respectively. Functionally, the estimated risks may translate to reduced survival, growth and/or reproduction of impacted species.

 The results of this screening-level risk assessment suggest the potential for chronic risk to non-target mammals, birds, reptiles and terrestrial-phase amphibians based on modeled exposure resulting from spray applications of fluopyram.  Low acute risk concerns exist for mammals, birds, reptiles and terrestrial-phase amphibians. Fluopyram shows low acute toxicity to terrestrial invertebrates on a mortality basis and some reproductive effects to this taxon were observed at high levels of fluopyram exposure. Overall risk to terrestrial plant species is low, but some uncertainty exists with the effects of fluopyram on the seedling emergence of one dicot species, buckwheat. The use of the fluopyram at proposed label rates presents low risk to all aquatic taxa, including freshwater fish and aquatic invertebrates, estuarine/marine fish and aquatic invertebrates, aquatic-phase amphibians, freshwater and estuarine/marine benthic invertebrates and aquatic vascular and non-vascular plants.

 For all risk calculations, the estimated environmental exposure concentrations of the fluopyram-only product are assumed to be equal or greater than the EECs of the proposed products containing fluopyram and another active ingreadient, based on the application rates in the proposed labels. Overall, the coformulations for all fluopyram products with dual active ingredients appear to have low acute toxicity to terrestrial organisms, but no avian data were submitted for any co-formulated product. In addition, only rat acute oral studies were submitted for pyrimethanil and prothioconazole coformulations. From the available toxicity data, it appears as if use of the fluopyram co-formulated products with tebuconazole, trifloxystrobin, pyrimethanil, and prothioconazole have a higher potential to adversely impact aquatic ecosystems than use of the proposed fluopyram-only product.

 Table 1.  Summary of Environmental Risk Conclusions for Aquatic Organisms Exposed to Fluopyram
 Risk Conclusion
 Summarized Risk Characterization and Major Uncertainties
 Low acute and chronic risk for freshwater and estuarine/marine fish and invertebrates (water column)
 For acute risk to freshwater and estuarine/marine fish species, risk quotients were not calculated because the available toxicity endpoints were non-definitive (LC50 > highest test concentration). The peak estimated exposure concentration for aquatic organisms is more than two orders of magnitude less than the highest tested fluopyram technical concentrations in acute toxicity tests which caused no adverse effects to freshwater and estuarine/marine fish species. No mortality or sublethal effects were observed in acute fish studies with the fluopyram active ingredient. In studies with the fluopyram formulated product (fluopyram 500 SC, 41.5% active ingredient), sublethal effects included fish lying on the bottom of the test chamber, dark coloration, labored respiration, mucous secretion from intestine, surfacing, and lying on side/back. However, these effects were observed at much higher concentrations than is expected to occur in the environment.

 The level-of-concern for chronic risk to freshwater fish was not exceeded, based on the results of an early-life stage study. A chronic risk quotient was not calculated for estuarine/marine fish, because no chronic toxicity data were submitted for this taxon and appropriate acute-to-chronic ratios could not be determined due to lack of available data on definitive acute toxicity endpoints for any aquatic taxa.

For acute risk to freshwater and estuarine/marine invertebrate species, risk quotients were not calculated because the available toxicity endpoints were non-definitive (LC50 > highest test concentration). However, the peak estimated exposure concentration for aquatic organisms is two orders of magnitude less than the lowest level at which immobility was observed in any aquatic invertebrate test. No other sublethal effects were noted in the submitted acute aquatic invertebrate studies. Therefore, acute risk to aquatic invertebrate species due to water column exposure appears to be low.

 The level-of-concern for chronic risk to aquatic organisms was not exceeded for freshwater invertebrates. No chronic data was submitted for estuarine/marine invertebrates. An acute-to-chronic ratio could not be calculated because no definitive acute endpoints were provided in any acute aquatic study. As an additional line of evidence to examine potential chronic effects to estuarine/marine invertebrates in the water column, the chronic water column estimated exposure concentration was compared to the available estuarine/marine benthic invertebrate NOAEC based on pore water concentrations. The potential chronic aquatic exposure level is approximately four orders of magnitude less than the level at which no adverse chronic effects were observed for estuarine/marine invertebrates. Based on the available information, the overall chronic risk to aquatic invertebrates appears to be low.
 ---------------------------------------------------------------------------------------------------------
 No studies were submitted to examine fluopyram chronic effects on estuarine/marine fish and estuarine/marine invertebrates in the water column. However, due to the low expected aquatic exposure concentrations and overall aquatic toxicity profile, additional data is not required.

 In the test conditions of the aquatic organism toxicity studies, the solubility of fluopyram technical appears to be much lower than that reported in the environmental fate information. However, the modeled potential exposure to aquatic ecosystems, utilizing the higher value for water solubility reported in the available fate information, is much lower than any of the levels at which effects were observed in the submitted aquatic organism toxicity tests.
 Low acute and chronic risk for freshwater and estuarine/marine benthic invertebrates
 No treatment-related effects on survival or growth occurred in a short-term 10-day study for estuarine/marine benthic invertebrates. Chronic data for both freshwater and estuarine/marine benthic invertebrates suggest adverse effects on reproductive, growth and development at high levels of fluopyram exposure. Estimated environmental exposure concentrations are much lower than the levels at which effects were observed in the submitted chronic sediment toxicity tests, and no levels-of-concern (LOCs) were exceeded for these taxa.
 ---------------------------------------------------------------------------------------------------------
 A short-term 10-day study with freshwater benthic invertebrates was not submitted for fluopyram. Due to the low estimated aquatic exposure concentrations and overall aquatic toxicity profile, additional data is not expected to change the risk conclusions. In addition, for persistent chemicals such as fluopyram, only chronic sediment toxicity tests are typically required.
 Low risk for aquatic vascular and non-vascular plants.
 No acute risk quotients for non-vascular or vascular aquatic plants exceeded any of the levels-of-concern (1.0) for the modeled crop use with the highest estimated exposure values (watermelon). Based on submitted algal studies, fluopyram showed similar toxicity whether the exposure was from the technical or end-use product. One algal study was submitted for the degradate fluopyram lactame, and no treatment-related effects were observed. Levels of concern were not exceeded for aquatic vascular or non-vascular plant species.
 ---------------------------------------------------------------------------------------------------------

 Table 2.  Summary of Environmental Risk Conclusions for Terrestrial Organisms Exposed to Fluopyram
 Risk Conclusion
 Summarized Risk Characterization and Major Uncertainties
 Low acute risk for birds

 Risk quotients were not calculated for acute risk to birds based on the non-definitive endpoints in the submitted acute and dietary studies (LD50 > 2000 mg ai/kg bw; LC50 > 4785 mg ai/kg bw). Less than 50% mortality occurred at the highest treatment level in all submitted avian acute oral and dietary studies. As a conservative assumption to approximate risk, the highest levels tested in acute oral and dietary studies were compared to the maximum acute dose and dietary-based EECs. All calculated ratios were < 0.1, the level-of-concern for listed species. Mortality and sublethal effects, such as soft excrement, fluffed feathers and a decrease in food consumption, were noted at all treatment levels in the most sensitive acute oral test with bobwhite quail. The lowest treatment level at which observations of mortality and sublethal effects occurred is approximately 4 to 71 times higher than the peak upper bound EECs of the highest fluopyram use scenario, depending on the dietary item and using the smallest size of the bird (most conservative) in the terrestrial exposure modeling. Therefore, overall acute risk to avian species appears to be low.

 Inhalation and drinking water exposure are not expected to be an appreciable route of acute exposure for birds.
 ----------------------------------------------------------------------------------------------------------
 In a limit acute oral test conducted with zebra finch, mortality was noted in the single treatment group (2000 mg ai/kg bw). A subsequent limit test was conducted with the same species, and no mortalities were observed at 2000 mg ai/kg bw. However, a definitive test is recommended if mortality occurs in a limit test (OCSPP 850.2100). Therefore, this study does not meet the data requirements for passerine species.

 In an acute oral definitive test with bobwhite quail, mortality was observed at all treatment levels, but no LD50 endpoint was established as only 40% mortality occurred at the highest treatment level (2000 mg ai/kg bw). In the two submitted dietary studies with mallard duck and bobwhite quail, no mortalities were observed (LC50 > 4604 mg ai/kg diet and LC50 > 4785 mg ai/kg diet, respectively). Sublethal toxicity effects observed in all submitted studies include soft excrement, fluffed feathers, reduced vigilance, reduced food consumption and red pancreases noted during post-mortem examinations. Body weight reduction occurred in the highest treatment level in the dietary study with bobwhite quail, 4785 mg ai/kg diet. A NOAEL and NOAEC were not established due to observations of effects at the lowest treatment level in the most sensitive acute oral and dietary studies, both with bobwhite quail. Observations of a single mortality and reduced food consumption in the acute oral study at 500 mg ai/kg bw and reduced food consumption in dietary study at 279 mg ai/kg diet level. Therefore, some uncertainty exists in defining the lowest level at which mortality or sublethal effects would occur.

 Based on the available information, risk to listed birds from acute exposure to fluopyram is not expected. A definitive acute LD50 endpoint has not been established for avian species. However, due to the overall low toxicity of fluopyram to avian species and relatively low exposure concentrations, a request for additional acute oral studies with bobwhite quail and a passerine species to define this endpoint is not recommended at this time.
 Chronic risk concerns exist for birds.
 Submitted fluopyram toxicity studies for avian species showed adverse effects such as reductions in hatchling body weight and survival, adult female body weight gain, numbers of eggs laid, embryo survival and egg shell thickness. For birds that consume short grass, tall grass, and broadleaf plants/small insects exposed to fluopyram via spray applications, dietary-based chronic RQs exceed levels-of-concern. One dietary item (seeds) did not result in chronic risk concerns.

 Exceedances of the chronic dietary levels-of-concern for this taxa occurred for all crops on the proposed label, with the exception of cherry. In addition, chronic exposure through drinking water is a concern for birds.
 ----------------------------------------------------------------------------------------------------------

 Low acute risk for mammals
 Results of oral, dermal and inhalation toxicity studies on rats show that fluopyram TGAI is practically non-toxic to mammals on an acute basis (LD50 > 2000 mg a.i./kg bw for both oral and dermal exposure routes and acute 4-hour LC50 > 2.091 mg/L and 5.1 mg/L in the two rat inhalation studies). The highest fluopyram concentration in the acute oral study with rats did not result in any mortality or sublethal effects and is approximately 20 times greater than the highest EEC predicted for the most conservative use scenario. Therefore, acute dose-based risk to mammalian species is presumed to be low.

 Inhalation and drinking water exposure are not expected to be an appreciable route of acute exposure for mammals.
 ----------------------------------------------------------------------------------------------------------
 No mammalian toxicity data was available for formulated fluopyram 500 SC.
 Chronic risk concerns exist for mammals.
 For the maximum application scenario considered in this risk assessment, dietary-based and dose-based RQs for chronic risk to mammalian species are above the chronic risk level-of-concern for three of the four dietary items (short grass, tall grass and broadleaf plants/small insects, with the exception of seeds). Exceedances of the chronic levels-of-concern for this taxa occurred for all crops on the proposed label.

 Based on this analysis, the potential for chronic adverse affects to mammalian species could occur at environmentally-relevant exposure concentrations. These potential effects include decreased body weight in adults and offspring, as well as reduced food consumption.

 Based on a screening estimate, chronic exposure through drinking water is not expected to be a concern for mammals.
 ----------------------------------------------------------------------------------------------------------

 Risk concerns exist for terrestrial plants.
 For terrestrial plants, Tier I seedling emergence and vegetative vigor toxicity tests showed no detrimental effects >=25% in survival, dry weight or height compared to the controls for any test species except buckwheat. Because buckwheat showed a 50.4% reduction in dry weight at 0.444 lbs a.i./A (twice the proposed maximum application rate) in the seedling emergence test, a Tier II was conducted with this species. This test resulted in highly variable results for the most sensitive endpoint, biomass, and an EC25 and NOAEC could not be determined.
 ----------------------------------------------------------------------------------------------------------
 Because uncertainty exists in determining the levels at which fluopyram may cause adverse effects to at least one species, buckwheat, and additional Tier II test is requested. In the absence of additional data, risk is presumed for some species of terrestrial plants.

 Low direct toxicity to beneficial non-target insects and other terrestrial invertebrates. Some reproductive effects observed at high exposure concentrations.
 Results of acute oral and contact toxicity studies with honey bees demonstrate that fluopyram technical and the formulated product show low direct toxicity to beneficial insects. Additional toxicity studies were submitted for other nontarget terrestrial invertebrates, such as the rove beetle (Aleochara bilineata), predatory mite (Typhlodromus pyri), springtail, (Folsomia candida), parasitic wasp, Aphidius rhopalosiphi, soil mite (Hypoaspis aculeifer) and earthworm (Eisenia fetida). No definitive acute toxicity endpoints were provided for honeybees or other nontarget terrestrial invertebrates, due to lack of 50% mortality or more in any of the toxicity tests (at levels greater than >83.2 ug a.i./bee, the maximum application rate, or observed soil concentrations following fluopyram application at twice the maximum proposed label rate, depending on the exposure units measured in the toxicity study). Therefore, acute toxicity to these additional nontarget terrestrial invertebrates appears to be low, based on mortality.

 In submitted reproduction studies with soil-dwelling invertebrates, reductions in the number of surviving offspring were observed at nominal concentrations of 5.81 mg a.i./kg dw soil and greater in the 28-day study conducted with earthworms, and at nominal concentrations of 207.5 mg a.i./kg dw soil and greater in the 28-day study conducted with springtail. No reproductive effects were observed in studies with any studies with other terrestrial invertebrate species.

 C.  Conclusions - Exposure Characterization

 Fluopyram has low vapor pressure/Henry's Law constant (2.33x10[-8] torr/2.94 x 10[-10] atm m[3] mole[-1]) and its solubility in water is 16 ppm.  Fluopyram is stable to hydrolysis and soil photolysis; highly persistent in aerobic/anaerobic aquatic systems (90[th] % t(1/2) ranges from 1,360 to 1,757 days); relatively stable to aqueous photolysis (t(1/2)= 57 days), and persistence under aerobic soil conditions (90[th] percentile t(1/2)= 464 days).  In field studies, fluopyram has shown similar persistence in three out of five terrestrial field dissipation studies on bare-ground plots (dissipation half-lives ranged from 24 to 83 days in two studies in GA and ND and 163 to 539 days in three studies in WA, CA, and NY).  For mobility, fluopyram appears to have medium absorption affinity to soil and sediment particles rendering it to be moderately mobile in systems with varied textures and organic matter content (Koc ranges from 316 to 591 L/Kg).  The major routes of dissipation for fluopyram are bio-transformations in aerobic systems.  The high persistent and moderate mobility of fluopyram suggests that it may cause contaminate ground water.  Furthermore, fluopyram can reach surface water through erosion, drift and/or run-off events.

 E.  Conclusions - Effects Characterization

 Chronic effects were observed at environmentally-relevant concentrations for birds and mammals, based on modeled EECs that are the peak upper-bound estimates of exposure. Overall acute toxicity to avian species appears to be low, but some uncertainty exists in defining the LD50. Low acute toxicity was observed in the submitted studies for mammals and terrestrial invertebrates. For terrestrial plants, some adverse effects on dry weight were observed in terrestrial plant toxicity studies for one species, buckwheat. The variability in response of this species during the Tier II seedling emergence test did not allow reliable calculation of toxicity endpoints. Therefore, some uncertainty exists with the levels at which fluopyram may cause adverse effects to some species of plants. Acute and chronic toxicity of fluopyram to fish and aquatic water-column and benthic organisms is low. Acute toxicity to non-vascular and vascular aquatic plants is low. Fluopyram technical and the formulated product show similar toxicity based on studies conducted with terrestrial invertebrates, fish, aquatic invertebrates and algae. Limited ecological effects data show low comparative toxicity of degradates compared to parent.

 F.  Data Gaps and Uncertainties

 	1. Environmental Fate

At this time, the screening level assessment for fluopyram has been conducted with only limited environmental fate and transport data gaps.  The assessment would have been strengthened if hydrolysis and aerobic soil studies were conducted on at least two of fluopyram degradates, namely Fluopyram-7-hydroxy and fluopyram pyridyl-carboxylic acid (Fluopyram-PCA).  This would have confirmed the suggested degradation pathway for fluopyram and collected data necessary for confirming conclusions on the degree of persistence for these degradates.

 	2. Ecological Effects

 The screening level risk assessment for fluopyram has been conducted despite an unfulfilled guideline requirement. An additional Tier II seedling emergence study is requested for buckwheat (Fagopyrum esculentum). Table G-1 (Appendix G) lists the status of the ecological effects data requirements for fluopyram.

         I. Problem Formulation

 A.  Stressor Source and Distribution

 	 1.  Source and Intensity

 Fluopyram is formulated as a suspension concentrate (SC) alone and mixed with four other fungicides: tebuconazole, trifloxystrobin, pyrimethanil, and prothioconazole.  These formulations are proposed to be applied as liquid spray to foliage using ground, airblast or aerial spray equipments. The rate of application for fluopyram formulations ranges from a maximum single rate of 0.092 lb a.i/A to 0.222 lb a.i/A with a maximum rate of 0.445 lb a.i/A/crop cycle and a range of 5 to 14 days between applications.  The range of application rates for fluopyram in mixtures is from a maximum single rate of 0.091 lb a.i/A to 0.222 lb a.i/A with a maximum rate of 0.445 lb a.i/A/crop cycle. For this risk assessment, EFED considered application rates for the mixtures when rates resulting from their application are either higher and/or applied differently than formulations containing fluopyram alone. The maximum numbers of applications were mostly not specified but were calculated from allowed maximum crop cycle rate and the maximum single rate.

 Fluopyram parent is considered to be the stressor that would result from the proposed application of the chemical and/or its mixtures to crops, as discussed further below.  Partitioning to the air is not expected to be important due to the low vapor pressure and Henry's Law constant for fluopyram.

 The Agency does not routinely include, in its screening risk assessments, an evaluation of mixtures of active ingredients, either those mixtures of multiple active ingredients in product formulations or those in the applicator's tank. In the case of the product formulations of active ingredients, each active ingredient is subject to an individual risk assessment for regulatory decision regarding the active ingredient on a particular use site (US EPA, 2004). Nonetheless, the available effects data for the fluopyram products that are co-formulated with tebuconazole, trifloxystrobin, pyrimethanil, and prothioconazole are documented in the effects characterization of this risk assessment.

 	2.  Physicochemical, Fate, and Transport Properties

Fluopyram is characterized by a water solubility of 16 ppm in acidic and alkaline conditions.  The chemical has a low potential for volatilization from dry and wet surfaces (vapor pressure= 2.33 x 10[-8] torr and Henry's Law constant= 2.94 x 10[-10] atm m[3] mole[-1], respectively at 25 °C). Therefore fluopyram has low potential to partition into the atmosphere.

 In the laboratory, fluopyram was stable to hydrolysis and photolysis and showed high persistence to photolysis in water. The same high persistence was observed in aerobic/anaerobic soil systems (90[th] percentile t(1/2)= 464 days in aerobic systems and stable in anaerobic systems) and in aerobic/anaerobic water/sediment systems (extrapolated t(1/2) ranged from 648 to 5,240 days). Due to persistence, degradation products observed in all systems in the laboratory were low in number and concentration and were not considered as part of the stressor. In the field, dissipation half-lives ranged from 24 to 83 days in two bare-ground soils in GA and ND and between 164 to 539 days in three bare-ground soils in WA, CA, and NY.  In these field studies, the transient transformation product 7-hydroxy which was observed at low concentrations (maximum of 3%) as was the case in the laboratory (maximum of 4%).  In contrast, the other two degradates (PCA and benzamide) reached higher concentrations (maximum of 16 and 19%, respectively) than the laboratory (maximums of 1% each) but maximums were followed by rapid decline suggesting non-persistence.

 	3.  Pesticide Type, Class, and Mode of Action

Fluopyram represents a new group of fungicide chemistry (pyridinyl-ethylbenzamides). The biochemical mode of action involves the inhibition of the enzyme succinate dehydrogenase (complex II) within the fungal mitochondrial respiratory chain, thus blocking electron transport. Other fungicides that share the same target site (succinate dehydrogenase inhibitors or SDHIs) include boscalid and carboxin, among others (FRAC, 2009). As reported by the registrant, at the fungal cell level, fluopyram has an effect on several stages of the life cycle of the fungi including spore germination, germ tube elongation, mycelium growth and sporulation.

 	4.  Overview of Pesticide Usage

Fluopyram is a new pesticide that is proposed to be used in the United States to prevent and/or control certain fungal diseases on some major crops and therefore is expected to be applied in most agricultural areas of the US.  Fluopyram is formulated as a suspension concentrate (SC) alone and mixed with four other fungicides: tebuconazole, trifloxystrobin, pyrimethanil, and prothioconazole.  Formulations are proposed to be applied by ground, airblast, and aerial spray into foliage (leaves, stems, and shoots), flowers and fruits.

 B.  Receptors

 	1.  Ecological Effects

 Ecological measures of effect for this screening level risk assessment are based on a suite of registrant-submitted toxicity studies performed on a limited number of organisms in broad groupings.  Table 3 gives examples of taxonomic groups and test species evaluated for ecological effects in this screening level risk assessment.  Within each of these very broad taxonomic groups, an acute and/or chronic endpoint is selected from the available test data (see Table 4). A complete discussion of all toxicity data available for this risk assessment and the resulting measures of effect selected for each taxonomic group are included in Appendix D.

 Table 3.  Taxonomic groups and test species evaluated for ecological effects in this screening-level risk assessment.
 Taxonomic group
 Representative species
 Birds [a]
 Mallard duck (Anas platyrhynchos)
 Bobwhite quail (Colinus virginianus)
 Zebra finch (Taeniopygia guttata)
 Mammals
 Laboratory rat (Rattus norvegicus)

 Terrestrial Invertebrates
 Honey bee (Apis mellifera)
 Freshwater fish [b]
 Bluegill sunfish (Lepomis macrochirus)
 Rainbow trout (Oncorhynchus mykiss)
 Fathead minnow (Pimephales promelas)
 Freshwater Invertebrates
 Water flea (Daphnia magna)
 Estuarine/marine Fish
 Sheepshead minnow (Cyprinodon variegatus)
 Estuarine/marine Mollusk
 Eastern oyster (Crassostrea virginica)
 Estuarine/marine Invertebrates
 Mysid (Americamysis bahia)
 Benthic Freshwater Invertebrates
 Midge (Chironomus tentans)
 Benthic Estuarine/Marine Invertebrates
 Amphipod (Leptocheirus plumulosus)
 Terrestrial Plants
 Monocots  -  corn (Zea mays), oat (Avena sativa), perennial ryegrass, (Lolium perenne), barley (Hordeum vulgare) and onion (Allium cepa)

 Dicots  -  soybean (Glycine max), sugarbeet (Beta vulgaris), oilseed rape (Brassica napus), cucumber (Cucumis sativus), buckwheat (Fagopyrum esculentum) and sunflower (Helianthus annuus)
 Aquatic Plants and Algae
 Duckweed (Lemna gibba)
 Green algae (Pseudokirchneriella subcapitata)
 Blue-Green Algae (Anabaena flos-aquae)
 Freshwater Diatom (Navicula pelliculosa)
 Saltwater Diatom (Skeletonema costatum)
 [a] Birds may be surrogates for amphibians (terrestrial phase) and reptiles.
 [b] Freshwater fish may be surrogates for amphibians (aquatic phase).

For screening risk assessments, the following toxicity endpoints presented in Table 4 are used as inputs to the risk quotient (RQ) method for expressing risk (US EPA, 2004). The designation of "listed species" refers to either federally threatened or endangered species.
 Table 4.  Toxicity endpoints used in risk quotient calculations
 Taxonomic group
 Representative species
Aquatic Animals
 Acute assessment

Chronic assessment

Lowest tested EC50 or LC50 for freshwater fish and invertebrates and estuarine/marine fish and invertebrates acute toxicity tests.

Lowest no-observed-adverse-effects- concentration (NOAEC) for freshwater fish and invertebrates and estuarine/marine fish and invertebrates early life-stage or full life-cycle tests.

Terrestrial Animals
Acute avian assessment

Chronic avian assessment

Acute mammalian assessment

Chronic mammalian assessment

Lowest LD50 (single oral dose) and LC50 (subacute dietary).

Lowest NOAEC for 21-week avian reproduction test.

Lowest LD50 from single oral dose test.

Lowest NOAEC for two-generation reproduction test or chronic dietary study

Plants
Terrestrial non-listed species

Aquatic vascular and algae

Terrestrial listed species

Lowest EC25 values from both seedling emergence and vegetative vigor for both monocots and dicots.

Lowest EC50 for both vascular and algae.

Lowest EC5 or NOAEC for both seedling emergence and vegetative vigor for both monocots and dicots.

 [a] Freshwater fish may be surrogates for amphibians (aquatic phase).
 [b] Birds may be surrogates for amphibians (terrestrial phase) and reptiles.

 		a.  Aquatic Effects

 Acute and chronic laboratory and field tests on fluopyram provide information regarding lethality, as well as sublethal measures of effect.  Data are available on both the technical grade active ingredient (TGAI) and the typical end-use product (TEP) and corresponding effects on freshwater and saltwater fish, aquatic invertebrates, aquatic plants and algae.

 		b.  Terrestrial Effects

 For terrestrial effects, registrant-submitted studies on fluopyram technical are available for acute, subacute, and chronic exposure to birds, and acute and chronic exposure to mammals. Additional ecological effects data for fluopyram are available for honey bees (Apis mellifera) and other nontarget terrestrial invertebrates. Data are available on the toxicity of fluopyram formulations to the vegetative vigor and seedling emergence of terrestrial plants.

 	2.  Ecosystems at Risk

 Ecosystems potentially at risk reflect a potential concern by the Agency and can be expressed in terms of the selected assessment endpoints.  The typical assessment endpoints for screening-level pesticide ecological risk assessments are reduced survival, growth and reproductive impairment for both aquatic and terrestrial animal species.  Potential effects on a set of surrogate species are used to extrapolate risk to all species.  For both aquatic and terrestrial animal species, direct acute and direct chronic effects are considered.  Although these endpoints are measured at the individual level, they provide insight about risks at higher levels of biological organization (such as populations and communities).

 C.  Assessment Endpoints

 This risk assessment considers the maximum application rate of fluopyram, the maximum number of applications, and the minimum application intervals as stated in the proposed labels to estimate exposure concentrations as a result of its proposed use.   This assessment is not intended to represent a site or time-specific analysis.  Instead, this assessment is intended to represent high-end exposures at a national level.  Likewise, the most sensitive toxicity endpoints are used from surrogate test species to estimate treatment-related direct effects on acute mortality and chronic reproductive, growth and survival assessment endpoints.

 For plants in terrestrial and semi-aquatic environments, the screening assessment endpoint is the survival and growth of non-target species (crops and non-crop plant species).  Endpoints assessed include emergence of seedlings and vegetative vigor.  Although it is recognized that the endpoints of seedling emergence and vegetative vigor may not address all plant life cycle components, it is assumed that impacts at emergence and in active growth have the potential to impact individual competitive ability and reproductive success.  Data on the formulated product (as opposed to the active ingredient) are used to characterize potential effects on terrestrial plants.

 For aquatic plants, the assessment endpoint is the maintenance and growth of standing crop or biomass.  Measurement endpoints for this assessment endpoint focus on algal and vascular plant growth rates and biomass measurements.

 The toxicity studies are used to evaluate the potential of fluopyram to cause adverse effects, to determine whether further testing is required, and to determine the need for precautionary label statements to minimize the potential adverse effects to non-target animals and plants (40 CFR §158.202, 2002).

 D.  Conceptual Model

 	1.  Risk Hypotheses

For fluopyram, the following ecological risk hypothesis is being employed for this risk assessment:

      Given the uses of fluopyram and its environmental fate properties, there is a likelihood of exposure to non-target terrestrial and aquatic organisms.

      When used in accordance with the label, fluopyram results in potential adverse effects upon the survival, growth, and reproduction of non-target terrestrial and aquatic organisms.

 In order for a chemical to pose an ecological risk, it must reach ecological receptors in biologically significant concentrations.  An exposure pathway is the means by which a pesticide moves in the environment from a source to an ecological receptor.  For an ecological exposure pathway to be complete, it must have a source, a release mechanism, an environmental transport medium, a point of exposure for ecological receptors, and a feasible route of exposure.  In addition, the potential mechanisms of transformation (i.e., which transformation products may form in the environment, in which media, and how much) must be understood, especially for a chemical whose metabolites/transformation products are of greater toxicological concern than the parent compound.  The assessment of ecological exposure pathways, therefore, includes an examination of the source and potential migration pathways for constituents, and the determination of potential exposure routes (e.g., ingestion, inhalation, and dermal absorption).

 Ecological receptors that may potentially be exposed to fluopyram and its transformation products include terrestrial and semi-aquatic wildlife (i.e., mammals, birds, amphibians, and reptiles), terrestrial and semi-aquatic plants, and soil invertebrates.  Aquatic receptors (e.g., freshwater and estuarine/marine fish and invertebrates, and amphibians) may also be exposed as a result of potential migration of fluopyram via spray drift and/or runoff/erosion from the site of application to various watersheds and other aquatic environments.  This information formed the basis for identifying potential endpoints, stressor, and ecological effects associated with uses of fluopyram.

 	2.  Diagram

 Based on the preliminary iterative process of examining fate, transport and effects data, the conceptual model or the risk hypothesis model for spray application to agricultural crops has been established, refined and included in Figure 1.  In establishing the diagram for the conceptual model it was necessary to go through an iterative process to identify: (1) likely stressors/exposure pathways and (2) organisms that are most relevant and applicable to this assessment.  Sources of chemical contamination included spray drift and run-off and leaching to ground water is added given the persistence of parent fluopyram.

 Figure 1a The aquatic conceptual model for spray application of fluopyram to agricultural crops (dotted lines indicate unlikely routes of chemical dissipation).

 Figure 1b The terrestrial conceptual model for spray application of fluopyram to agricultural crops (dotted lines indicate unlikely routes of chemical dissipation).

 E.  Analysis Plan

 	1.  Methods for Conducting Ecological Risk Assessment and Identification of Data Gaps

 The primary method used to assess risk in this screening-level assessment is the risk quotient (RQ) and follows the methods outlined in the EPA Overview Document (EPA, 2004).  The RQ is the primary risk value for the screening-level assessment and is the result of comparing measures of exposure to measures of effect. A commonly used measure of exposure is the estimated exposure concentration (EEC) and commonly used measures of effect include toxicity values such as the LD50 or NOAEC. The resulting RQ is then compared to a specified level of concern (LOC), which represents a point of departure for concern. For example, if the RQ exceeds the LOC, then risks are triggered. In general, the higher the RQ, the more certain the potential risks. However, the risk quotients are not necessarily a true estimate of risk since there is no estimated probability of effect. Risk presumptions, along with the corresponding RQs and LOCs, are summarized in Appendix E.

 Generation of robust risk quotients is dependent on the quality of data from both fate and toxicological studies.  The adequacy of the submitted data is evaluated relative to Agency guidelines.  The following identified data gaps for ecological fate and toxicity endpoints result in a degree of uncertainty in evaluating the ecological risk of fluopyram.

 For the ecological effects, Table G-1 (Appendix G) lists the status of ecological data requirements for fluopyram. An additional Tier II seedling emergence study is requested for buckwheat (Fagopyrum esculentum).

For fate and transport, Table G-2 (Appendix G) lists the status of fate and transport data requirements for fluopyram.  The adequacy of the submitted data was evaluated relative to Agency guidelines.  In this respect, it is noted that there were no hydrolysis and aerobic soil studies for two of the fluopyram degradates, namely Fluopyram-7-hydroxy and fluopyram pyridyl-carboxylic acid (Fluopyram-PCA). None existence of these data is not expected to affect this assessment which is based on the current conclusions about fate and transport of the chemical.

 	2.  Measures to Evaluate Risk Hypotheses and Conceptual Model

 		a. Measures of Exposure

 Measures of exposure are estimates of exposure for a receptor determined by modeling or monitoring data.  Measures of exposure for fluopyram in this assessment are obtained from modeling efforts only, since this is a new chemical and national-scale monitoring data is not expected to be present.  Exposure models used for this assessment include the suite of standard exposure models commonly used in pesticide risk assessments (EPA, 2004).  Generally, aquatic exposure estimates are generated from EFED models and incorporate maximum proposed use rates, minimum application intervals, and empirically-derived fate properties.  Further details of the exposure models can be found in the Exposure Characterization section of the risk assessment and on the web.

Exposure to aquatic organisms is assumed to occur through direct contact with ground water contaminated by leaching and surface water contaminated by drift and/or runoff/erosion from agricultural fields. Aquatic exposure concentrations for this assessment were based on EECs calculated using Tier II linked, Pesticide Root Zone Model PRZM (v3.12.2, May 2005) and EXAMS (v<IP_ADDRESS>, April, 2005).  PRZM/EXAMS are fate and transport simulation models coupled together with the input shell pe5.pl (August, 2007) to generate daily exposures and 1-in-10 year EECs. More information on these models can be found at http://www.epa.gov/oppefed1/models/water/index.htm.

 Measures of exposure for terrestrial mammals, birds, reptiles and amphibians similarly incorporate maximum proposed use rates but rely less on fate properties. Terrestrial exposures were estimated using a number of methods.  For fluopyram, acute and chronic terrestrial exposure estimates are derived directly from empirically determined observations of pesticide residues on various terrestrial food items.  The Kenaga nomogram, as modified by Fletcher et al., (Kenaga and Hoerger, 1972; Fletcher et al., 1994) is used to relate pesticide application rates to residues on terrestrial food items.  The surface residue concentration (ppm) is estimated by multiplying the application rate (pounds active ingredient per acre) by a value specific to each food item. For numerous applications for a given use, the exposure model incorporates a first-order decay rate dependent on the foliar dissipation half-life of the chemical. In the absence of data, a default half-life of 35 days is used. In this assessment, the T-REX model was run for fluopyram uses (watermelon and strawberries) with the maximum proposed application rate (0.222 lb a.i./A), a maximum of 2 applications, and a 5-day application interval to screen risk to terrestrial organisms. The default foliar dissipation half-life was used for terrestrial exposure calculations, but some data were submitted by the registrant regarding the foliar dissipation half-life (see the Description of Assumptions, Limitations, Uncertainties, Strengths and Data Gaps section). Additional risk quotients for crop-specific application rates are presented in Appendix F. The conceptual approach taken to estimate residues (upper-bound and mean) in potential dietary sources for mammals and birds is presented in the model T-REX Version 1.4.1 (October 2008). For more details see Appendix C and the Exposure Characterization section of this document.

 TerrPlant is used by the Environmental Fate and Effects Division (EFED) as a Tier 1 model for screening level assessments of pesticides. The purpose of TerrPlant is to provide screening level estimates of exposure to terrestrial plants from single pesticide applications.  The model does not consider exposures to plants from multiple pesticide applications. TerrPlant derives pesticide EECs in runoff and in drift.  RQs are developed for non-listed and listed species of monocots and dicots inhabiting dry and semi-aquatic areas which are adjacent to treatment sites. A preliminary run of TERR-PLANT was conducted using the maximum application scenarios for ground application (labeled use rates for watermelon) and aerial application (labeled use rates for almond, pecan, pistachios and tree nuts). For more details see Appendix C and the Exposure Characterization section of this document.

Two screening tools were utilized to assess the potential for exposure to terrestrial organisms via inhalation and drinking water exposure. The potential for inhalation risk to birds and mammals was assessed using the Screening Tool for Inhalation Risk (STIR, version 1.0, November 2010). The STIR tool estimates spray droplet and vapor phase exposure using the physical properties of each chemical, application method and rate and then compares these exposure estimates to avian and mammalian toxicity data. The model estimates avian-inhalation toxicity values, when not directly available, from mammalian data by applying an adjustment factor representing the difference in lung tissue thickness and surface area between birds and mammals to the relationship between mammalian-oral, mammalian-inhalation, and avian-oral toxicity values to account for differences in avian and mammalian inhalation toxicity. The Screening Imbibition Program (SIP, version 1.0, July 2010) was used to upper-bound drinking water exposure potential using fluopyram's solubility, the most sensitive acute and chronic avian toxicity endpoints and the most sensitive acute and chronic mammalian toxicity endpoints.

 Additional information on the terrestrial exposure models and screening tools employed in this risk assessment can be found at http://www.epa.gov/oppefed1/models/terrestrial/.

 		b. Measures of Effect

 Measures of ecological effects are obtained from a suite of registrant-submitted guideline studies conducted with a limited number of surrogate species.  The test species are not intended to be representative of the most sensitive species but rather were selected based on their ability to thrive under laboratory conditions.  Measures of effect are based on deleterious changes in an organism as a result of chemical exposure.  Functionally, measures of effect typically used in risk assessments include changes in survival, reproduction, or growth as determined from standard laboratory toxicity tests.  The focus on these effects for quantitative risk assessment is due to their clear relationship to higher-order ecological systems such as populations, communities, and ecosystems.  Although monitoring data may also be used to provide supporting lines of evidence for the risk characterization, monitoring data is lacking for this new chemical. Commonly used laboratory-derived toxicity values include estimates of acute mortality (such as LD50, LC50, or EC50) and estimates of effects due to longer term, chronic exposures (such as the NOAEC or NOAEL). In addition, effects other than survival, reproduction, and growth may be considered, (such as changes in biochemical, cellular, organ-level responses) but are typically used qualitatively  to characterize risks since, in many cases, the relationship between these effects and higher-order processes is highly uncertain. The latter can reflect changes seen in mortality, reproduction, or growth.  In general, for a given assessment endpoint, the lowest relevant measure of effect is used in calculating the risk quotient.

 		c. Measures of Ecosystem and Receptor Characteristics

 The assessment endpoints can be summarized as survival, growth, and reproduction of terrestrial and aquatic receptors to include birds, mammals, reptiles, amphibian, fish, terrestrial and aquatic invertebrates and terrestrial and aquatic plants. The response of these receptors to fluopyram exposure is represented by a small number of toxicity studies on representative or surrogate species.  Hence, there is considerable uncertainty regarding the response of a receptor since data for all species potentially exposed are not available.  The lowest available measure of effect for a given assessment endpoint is used to calculate risk to accommodate for some of this inherent uncertainty.

 The ecosystems selected for modeling using PRZM/EXAMS aquatic assessment and T-REX for the terrestrial animal assessment are intended to be generally representative of any aquatic or terrestrial ecosystem associated with areas where fluopyram is used. The receptors addressed by the aquatic and terrestrial risk assessments for fluopyram are summarized in Table 3.  For aquatic assessments, generally fish and aquatic invertebrates in both freshwater and estuarine/marine environments are represented. For terrestrial assessments, three different size classes of small mammals are represented, along with five potential foraging categories (short grass, tall grass, broadleaf plants/small insects, fruits/pods/seeds/large insects, and seeds). For the three different size classes of small birds, four potential foraging categories are considered (short grass, tall grass, broadleaf plants/small insects, and fruits/pods/seeds/large insects).  For terrestrial plants, both dicots and monocots are represented by a variety of agricultural species.  In addition, data are available so that earthworms, terrestrial insects, and sediment-dwelling organisms are represented. Detailed information regarding the toxicity data available for these various classes of aquatic and terrestrial receptors is provided in the Ecological Effects Characterization section and in Appendix D.
         I. Analysis

 A.  Use Characterization

Fluopyram is proposed to be widely used in the US to prevent and/or control certain fungal diseases on many crops including apples, watermelons, selected dry beans, grapes (wine), peanuts, potatoes, cherries, strawberries, sugarbeet, pecans, pistachios, almonds and other tree nuts.  Fluopyram is formulated as a suspension concentrate (SC) alone and mixed with four other fungicides: tebuconazole, trifloxystrobin, pyrimethanil, and prothioconazole.  Formulations are proposed to be applied by ground, airblast, and aerial into foliage (leaves, stems, and shoots), flowers and fruits in addition to application through drip irrigation.

 Table III-1 contains a summary of all crops proposed to be treated with fluopyram and/or its mixtures.

Table III-1 Crops included in the proposed crop group use patterns for fluopyram its four premixed formulation
Crop Or Crop Group
Crops In the Group
Almonds
Almonds
Apples
Apples
Cherry
Sweet and Tart Cherries
Watermelon
Watermelon
Beans (Selected / Dry, except Soybeans)
Bean (Lupinus spp., includes grain lupin, sweet lupin, white lupin, and white sweet lupin), Bean (Phaseolus spp., includes field bean, kidney bean, lima bean, navy bean, pinto bean, tepary bean), Bean (Vigna spp., includes adzuki bean, black-eyed pea, catjang, Crowder pea, moth bean, mung bean, rice bean, southern pea, urd bean), Broad Bean (dry), Chickpea, Guar, Lablab Bean, Lentil
Grapes (Wine)
Wine grape varieties only such as but not limited to these varieties: Chardonnay, abernet sauvignon, Syrah, Merlot, Pinot Noir, and Zinfandel
Peanuts
Peanuts
Pecans
Pecans
Pistachios
Pistachios
Potatoes
Potatoes
Strawberries
Strawberries
Sugerbeet
Sugerbeet
Tree Nuts
Almonds, Pecan, Pistachio, Beech nut, Brazil nut, Butternut, Cashew, Chestnut, Chinquapin, Filbert (hazelnut), Hickory nut, Macadamia nut (bush nut), Walnut [including black and English (Persian) walnuts].

 Application information for the use patterns is included in Table III-2.

Table III-2 Proposed use patterns for fluopyram and its four premixed formulation including labeled application parameters
Crop
Formulation [1]
                               Maximum Rate per
                                 Application
                                 (kg a.i. /ha)
                                Maximum Number
                              of Applications [2]
                               Maximum Seasonal
                               Rate (kg a.i./ha)
                      Minimum Application Interval (days)
Application Method
Almond
FLU SOLO
                                     0.249
                                       2
                                     0.499
                                       7
Ground, Air

FLU+PYM
                                     0.246
                                       2
                                     0.498
                                       7

FLU+TFS
                                     0.140
                                      3+
                                     0.498
                                       7

FLU+TEB
                                     0.249
                                       2
                                     0.497
                                       7

Apple
FLU SOLO
                                     0.249
                                       2
                                     0.499
                                       7
Ground

FLU+PYM
                                     0.146
                                      3+
                                     0.498
                                       7

FLU+TFS
                                     0.107
                                      3+
                                     0.386
                                       7

FLU+TEB
                                     0.146
                                      3+
                                     0.497
                                       7

Cherry
FLU SOLO
                                     0.103
                                       2
                                     0.206
                                       5
Ground,  Air

FLU+TFS
                                     0.107
                                       2
                                     0.204
                                       7

FLU+TEB
                                     0.103
                                       2
                                     0.206
                                       7

Watermelon
FLU SOLO
                                     0.249
                                       2
                                     0.499
                                       5
Ground, Drip,
Green House

FLU+TFS
                                     0.140
                                      3+
                                     0.498
                                       7

FLU+TEB
                                     0.249
                                       2
                                     0.497
                                      10

Beans (Selected / Dry)
FLU SOLO
                                     0.150
                                       2
                                     0.300
                                       7
Ground,  Air

FLU+PTZ
                                     0.150
                                       2
                                     0.300
                                       7

Grapes (Wine)
FLU SOLO
                                     0.249
                                       2
                                     0.499
                                      12
Ground

FLU+PYM
                                     0.246
                                       2
                                     0.498
                                      12

FLU+TFS
                                     0.140
                                      3+
                                     0.498
                                      12

FLU+TEB
                                     0.126
                                      3+
                                     0.497
                                      14

Peanuts
FLU SOLO
                                     0.249
                                       2
                                     0.499
                                      14
Ground,  Air

FLU+PTZ
                                     0.178
                                      2+
                                     0.500
                                      14

FLU+TFS
                                     0.129
                                      3+
                                     0.498
                                      14

FLU+TEB
                                     0.230
                                      2+
                                     0.497
                                      14

Pecan
FLU SOLO
                                     0.249
                                       2
                                     0.499
                                       7
Ground, Air

FLU+TFS
                                     0.140
                                      3+
                                     0.498
                                      14

FLU+TEB
                                     0.249
                                       2
                                     0.497
                                      14

 Pistachios
FLU SOLO
                                     0.249
                                       2
                                     0.499
                                       7
Ground, Air

FLU+PYM
                                     0.246
                                       2
                                     0.498
                                       7

FLU+TFS
                                     0.140
                                       3
                                     0.423
                                      14

FLU+TEB
                                     0.249
                                       2
                                     0.497
                                      10

Potatoes
FLU SOLO
                                     0.103
                                       3
                                     0.309
                                       5
Air

FLU+PYM
                                     0.102
                                       3
                                     0.306
                                       7

FLU+TFS
                                     0.103
                                       3
                                     0.309
                                      14

FLU SOLO
                                     0.199
                                       2
                                     0.399
                                       5
Ground

FLU+PYM
                                     0.102
                                      3+
                                     0.399
                                       7

FLU+TFS
                                     0.107
                                      3+
                                     0.399
                                      14

Strawberries
FLU SOLO
                                     0.249
                                       2
                                     0.499
                                       5
Drip, Greenhouse
Sugerbeet
FLU SOLO
                                     0.125
                                       2
                                     0.250
                                       5
Ground

FLU+TFS
                                     0.125
                                       2
                                     0.250
                                      10

FLU+PTZ
                                     0.111
                                      2+
                                     0.250
                                      14

Tree Nuts
FLU SOLO
                                     0.249
                                       2
                                     0.499
                                       7
Ground, Air

FLU+TFS
                                     0.140
                                       2
                                     0.281
                                       7

FLU+TEB
                                     0.249
                                       2
                                     0.497
                                       7

[1]Premixed Formulations: Fluopyram alone= FLU SOLO; With Tebuconazole= FLU+TEB; With Trifloxystrobin= FLU+TFS; With Pyrimethanil= FLU+PYM; and With Prothioconazole= FLU+PTZ.
[2]Number of applications: 2+ Or 3+ means 2 Or 3 equal applications with one lower application to arrive at the maximum seasonal rate; for example, the Almond rate for  FLU+TFS is three application of 0.140 kg/ha each + 0.078 kg/ha [0.498- (0.140x 3)]=0.078

 B.  Exposure Characterization

 	1.  Environmental Fate and Transport Characterization

Physical and chemical properties

The physical and chemical properties of fluopyram are summarized in Table 5.  The chemical is characterized by a water solubility of 16 ppm in acidic and alkaline conditions.  The chemical has a low potential for volatilization from dry and wet surfaces (vapor pressure= 2.33 x 10[-8] torr and Henry's Law constant= 2.94 x 10[-10] atm m[3] mole[-1], respectively at 25 °C). Therefore relatively low partitioning to the air is expected and the small amounts that may partition into the air.

 Table 5 Physical and chemical properties of fluopyram
 Property
 Description or Value
 Reference
 CAS Name
 Fluopyram (N-[2-[3-chloro-5-(trifluoromethyl)-2-pyridinyl]ethyl]-2(trifluoromethyl)benzamide
 Registrant Data

 Molecular Formula
 C16 H11 Cl F6 N2 O

 CAS number
 658066-35-4

 PC code
 080302

 Molecular Weight
 (g/mol)
 396.72

 Solubility
 (@ 20 ̊C)

pH 4                --> 15 mg/L
pH 6.7 & 7.0   --> 16 mg/L
 pH 9                --> 15 mg/L
 In neutral/near neutral de-ionized water (pH 6.7): 16 ppm;
 In aqueous buffers: 15 ppm @ pH 4; 16 ppm  @ pH 7; and 15 ppm @ pH 9
In heptane	             0.66 x 10 [3] ppm
In toluene	           62.20 x 10 [3] ppm
In dichloromethane, methanol, acetone, ethyl acetate,
and di-methyl sulfoxide          > 250 x 10 [3] ppm

 Water
 MRID 47372247

 Solvents
 MRID 4732248

 Vapor pressure
20°C --> 9.00 x 10[-9] torr;   1.2 x 10[-6] Pa;    1.18 x 10[-11]atm
25°C --> 2.33 x 10[-8] torr;    3.1 x 10[-6] Pa;    3.06 x 10[-11]atm
50°C --> 2.18 x 10[-6] torr;   2.9 x 10[-4] Pa;    2.86 x 10-9 atm
 MRID 47372249
 Henry's Law Constant (@ pH 7 & 20 ̊C)
 2.94 x 10[-10] atm m[3] mole[-1]
 Calculated from VP at 25°C
 Kow
 2,060 (Log Kow = 3.314)
 MRID 47372245

 The n-octanol water partition coefficient (Kow) of fluopyram (2,060) suggests a moderate potential for bioaccumulation in aquatic organisms such as fish.

Fate and Transport Properties

The fate and transport behaviour of fluopyram has been investigated in a series of laboratory and field studies. The laboratory studies were all conducted with 14C-labelled active substance uniformly labelled in one of the two rings: the phenyl and the pyridyl rings (Figure 3).

    * denotes position of radiolabel, uniformly labelled in the phenyl ring

* denotes position of radiolabel, labelled in the 2- and 6-position of the pyridyl ring

                           [phenyl-UL-14C] Fluopyram
                          [pyridyl-2,6-14C] Fluopyram
 Figure 3 Positions of radiolabels for fluopyram used in fate and transport studies

 a. Abiotic Degradation

 Fluopyram labeled at both the [phenyl-UL-[14]C] and the [pyrrdyl-2,6 [14]C] was used in conducting hydrolysis and photolysis studies.  In the hydrolysis study, the chemical was shown to be practically stable in acidic/neutral/alkaline aqueous buffered solutions (pHs 4, 7 and 9; MRIDs 473723-03/04).  The chemical was also shown to degrade relatively slowly by aqueous photolysis (t(1/2)= 57 days; MRID 473723-07) and was practically stable by photolysis on soil surfaces subjected to sunlight (t(1/2)= 54 days, MRID 473723-06).  Results indicate that hydrolysis and aqueous and on soil photolysis are not important in fluopyram dissipation in the natural environment. The fate properties of fluopyram in abiotic systems are summarized in Table 6.

 Table 6 Fate properties of fluopyram in abiotic systems
 Property
 Description or Value
 Reference*
 Hydrolysis half-life
 Stable
 473723-03
 Aqueous photolysis
 half-lives (two labels)

 57 days  (mean value) in aqueous buffered solution at pH 7 **
 87 days  (mean value) in sterile natural water from the Rhine River
 473723-04
 And
 473723-05
 Soil photolysis half-life
 Stable
 473723-06
 * Reference numbers are the studies MRID numbers
** No degradation was observed in dark controls and only phenyl labeled 13-d sample was analyzed, which indicated 96.7% of the applied amount; therefore, no rate constant for the dark controls could be calculated.

 b. Biotic Degradation

The biotic fate properties of fluopyram in biotic systems are summarized in Table 7.

 Table 7 Fate and transport properties of fluopyram in biotic systems
 Property
 Description or Value
 Reference*
 Aerobic soil metabolism
 half-lives (1[st] value for Pyridyl label and the 2[nd] value for Phenyl label)

210 & 221 days Hoefchen am Hohenseh soil, Germany (silt loam, pH 6.7, OC 2.4%)
464 & 231 days Laacherhof AXXa soil, Germany (sandy loam, pH 6.2, OC 2.2%)
250 & 339 days Laacherhof Wurmwiese soil, Germany (sandy loam, pH 5.2, OC 1.8%)
162 & 165 days Dollendorf soil, Germany (clay loam, pH 7.3, OC 5.1%)
561 & 746 days Porterville soil, CA (sandy loam, pH 7.9, OC 0.5%)
583 & 654 days Springfield soil, NE (silty clay loam, pH 6.5, OC 1.7%)
 Major Degradation products: None
Minor Degradation products: Fluopyram-7-hydroxy (7-Hydroxy: max. 4.2%); Fluopyram-pyridyl-carboxylic acid (PCA: max. 0.7%); Fluopyram-methyl-sulfoxide (Methyl Sulfoxide: max. 1.0%) and Fluopyram-benzamide (Benzamide: 1.1%)
 473723-07
 473723-08
 and
 473723-09

 Anaerobic soil half-lives
 Stable for two labels
 Major & Minor Degradation products: None
 473723-10
 Aerobic aquatic
 Half-lives (two labels, two systems)
 Pond water/sediment system from Lawrence , Kansas: Water (pH 7.7 and dissolved OC 15.6 ppm) and sediment: (Clay loam, OC 3.7%, pH 5.3):
 1,000  days (Phenyl label) & 648 days ([Pyridyl label) in the total system (extrapolated beyond the study duration of 120 days)
 (Note: the chemical dissipated from the water into the sediment with a half-life of 17 & 14 days, respectively)
 Pond water/sediment system from Germany: Water (pH 6.8) and sediment: (sand, OC 1.1%, pH 5.7):
 1,190 days (Phenyl label) & 1,470  days ([Pyridyl label) in the total system (extrapolated beyond the study duration of 120 days),
 Major & Minor Degradation products: practically None
 473723-11
 Anaerobic aquatic
 half-lives (two Labels/one system)

 Pond water/sediment system from Lawrence , Kansas: Water (pH 7.7 and dissolved OC 15.6 ppm) and sediment: (Clay loam, OC 3.7%, pH 5.3):
 1,580 days (Phenyl label) & 1,410 days ([Pyridyl label) in the total system (extrapolated beyond the study duration of 121 days,
 Major & Minor Degradation products: practically None
 473723-12
 and
 473723-13

 Terrestrial field dissipation
 half-lives (US soils)

   24 days (GA bare-ground Loamy sand soil);
   83 days (ND bare-ground loam soil);
 163 days (WA bare-ground sandy loam soil);
 174 days (CA bare-ground sandy loam soil); and
 539 days (NY bare-ground loamy sand soil)

 Major Degradation products: Two major transformation products, Fluopyram-benzamide and Fluopyram-PCA with maximum concentrations of 9.8 ug/kg (equivalent to 19% of 0-day parent) and 10.2  ug/kg (16%), respectively, at 6 DAT
 Minor Degradation products: one minor transformation product, Fluopyram-7-hydroxy with a maximum concentration of 3.0 ug/kg (3% of 0-day parent equivalent) were observed at the CA site
 475670-01
 475670-02
 475670-03
 475670-04
 and
 475670-05

 Fish
 Bio-concentration
 (BCF= Bio concentration Factor)

 Bluegill sunfish at low dose (6 ppb) and 42-day exposure/14-day depuration: Max. BCFs= 49 (edible) and 169 (non-edible)
 Max. Observed at 28 days of exposure (reached steady state)
 59% and 81% depurated after 14 days from edible and non-edible tissues, respectively

 Bluegill sunfish at high dose (60 ppb) and 42-day exposure/14-day depuration:  Max. BCFs= 42 (edible) and 147 (non-edible)
 Max. Observed at 28 days of exposure (reached steady state)
 72% and 85% depurated after 14 days from edible and non-edible tissues, respectively

 Transformation products:
 In water: parent accounted for >97% with 1% of the total radioactive residue was Fluopyram-7-hydroxy in water samples collected late during the exposure period.
 In Fish tissue: parent accounted for 25-55% in the edible tissue and 11.0-21.9% in the non-edible tissue. Transformation products were identified in edible and non-edible tissues and included 18-7% of Fluopyram-7-hydroxy @ 7 and 14-day exposure. Other minor degradates included Fluopyram-7-OH-GA (isomer 1), Fluopyram-8-OH-GA (isomer 2) and Fluopyram-pyridyl acetic acid
 473723-37

 * Reference numbers are the studies MRID numbers

Fate data presented in Table 7 are a summary of the results obtained from studies including: laboratory degradation studies in aerobic/anaerobic soil and water/sediment systems, field dissipation in terrestrial systems, and fish bio-concentration. A summary of these studies is included in Appendix A.

 c. Tranformation Profile

The primary metabolic pathway for fluopyram in soil is hydroxylation in the 7-position of the molecule to form the hydroxylated metabolite, Fluopyram-7-hydroxy.  Fluopyram-7-hydroxy has been identified in all soils tested in the laboratory and in the field in concentrations ranging from 3 to <5% throughout the study periods of nearly one year.  The maintained nearly constant low concentration of this degradate suggests that it is a transient species.  It appears that the transient Fluopyram-7-hydroxy is cleaved to form, in most cases, minor quantities of the metabolites Fluopyram-PCA (pyridyl-carboxylic acid) and Fluopyram benzamide. Further degradation of the pyridyl- Fluopyram-PCA appear to result in the formation of the degradate methyl-sulfoxide.  In addition the expected very limited aquatic photo-degradation of fluopyram results in the degradate lactam in quantities ranging from 1 to 13% (Figure 4).

Figure 4 Environmental degradation pathways for fluopyram

                                                   Fluopyram Parent
Limited aerobic soil degradation (Parent hydroxylation)
                        Very limited aqueous photolysis

                           Molecular Cleavage

                                    Lactam
                                                     7-Hydroxy

        Cleavage

                                   Benzamide
                                      PCA

                               Methyl Sulfoxide
Chemical Names (Molecular Formula  -  Weight; No CAS number reported)
Lactam: 2,9-bis(trifluoromethyl)-6,7-dihydropyrido[2,3-e][2]benza-zocin-8(5H)-one [C16H10F6N2O - 360.26 g mol-1]
7-Hydroxy: N-{2-[3-chloro-5-(trifluoromethyl)pyridin-2-yl]-2-hydroxyethyl}-2-(trifluoromethyl)benzamide [C16H11Cl F6N2O2 - 412.72 g mol-1]
Benzamide: 2-(trifluoromethyl)benzamide [C8H6F3NO -189.14 g mol-1]
PCA: 3-chloro-5-(trifluoromethyl)pyridine-2-carboxylic acid [C7H3Cl F3NO2 - 225.26 g mol-1]
Methyl Sulfoxide: 3-(methylsulfinyl)-5-(trifluoromethyl)pyridine-2-carboxylic acid [C8H6F3NO3S - 253.20 g mol-1 ]

 d. Mobility

The adsorption/desorption characteristics of fluopyram were determined for five soils in a concentration range of two orders of magnitude 0.01 and 1 mg a.i./L (MRID 473723-01) . The percent adsorption of applied amount were 48-76%, 71-83%, 58-74%, 44-62% and 55 to 74% in sandy loam, silt loam, loam, loamy sand and clay loam soils, respectively.  For this adsorption phase, the range of adsorption values was 3.16 to 8.37 L/Kg for Kd, 266 to 460 L/Kg for Koc, and 316 to 591 for Kfoc.  For Freundlich isotherm, 1/n values were below 1.0 for all soils (0.763 to 0.863) indicating that the concentration of the test item affected the adsorption behavior.  Based on Kfoc values, mobility of fluopyram in the tested soils is classified as moderate in accordance to the FAO mobility classification.  Additionally, the adsorption/desorption behavior of the degradate [pyridine-2,6-14C] Fluopyram-7-hydroxy was studied in four German soils: sandy loam, silt loam, sandy loam, and loam soils (MRID 473723-02).  The percent of applied amount adsorbed in sandy loam, silt loam, sandy loam, and loam soils were 40-49, 56-66, 40-48 and 34-44, respectively.  The adsorption Kd values for sandy loam, silt loam, sandy loam, and loam soils were 1.36, 2.54, 1.38 and 1.03 L/Kg, respectively.  The corresponding Koc values were 91, 159, 86 and 94 L/Kg and Kfoc values were 209, 327, 220, and 277 L/Kg.    Based on Kfoc values, the mobility of the 7-hydroxy degradate of fluopyram in the tested soils is classified as high to moderate in accordance to the FAO mobility classification.

For the parent desorption phase, the amounts of desorbed material desorbed were 15-59%, 12-49%, 17-58%, 25-67% and 18 to 61% in sandy loam, silt loam, loam, loamy sand and clay loam soils, respectively.  For this desorption phase, the range of desorption values was 6.32 to 13.15 L/Kg for Kd and 444 to 834 L/Kg for Koc.  Furthermore, the amount of degradate Fluopyram-7-hydroxy desorbed from the adsorbed material ranged from 18 to 38%.  The desorption Kd for sandy loam, silt loam, sandy loam, and loam soils were 3.78, 7.16, 3.88 and 3.54 L/Kg and the Koc values were 252, 447, 243 and 322.  For both parent and 7-hydroxy degradate, desorption Koc values were higher than the adsorption Koc values, indicating a strengthened binding of the test material once adsorbed to the soil. Adsorption coefficients for tested soils are summarized in Table 8.

 Table 8 Transport properties of fluopyram and degradate
 Property
 Description or Value
 Reference*
 I. Fluopyram parent
 Adsorption coefficient

Kfoc= 397 L kg [-1] (Laacherhof AXXa soil, Germany, sandy loam, pH 6.0, OC 1.3%);
Kfoc= 388 L kg [-1] (Hoefchen am Hohenseh soil, Germany, silt loam, pH 6.1, OC 2.6%);
Kfoc= 316 L kg [-1] (Laacherhof Wurmwiese soil, Germany, Loam, pH 5.4, OC 2.1%);
Kfoc= 501 L kg [-1] (Pikeville soil, North Carolina, Loamy sand, pH 5.0, OC 1.1%); and
 Kfoc= 591 L kg [-1] (Stilwell soil, Kansas, clay loam, pH 5.4, OC 1.1%)
 473723-01

 II. Fluopyram 7-hydroxy degradate
 Adsorption coefficient

pyridine-2,6-[14]C] Fluopyram-7-hydroxy

Kfoc= 290 L kg [-1] (Laacherhof AIIIa soil, Germany, sandy loam, pH 6.4, OC 1.1%);
Kfoc= 277 L kg [-1] (Laacherhof  AXXa soil, Germany, sandy loam, pH 6.1, OC 1.5%);
Kfoc= 327 L kg [-1] (Hoefchen am Hohenseh soil, Germany, silt loam, pH 6.6, OC 1.6%); and
 Kfoc= 220 L kg [-1] (Laacherhof, Wurmwiese soil, Germany (sandy loam, pH 5.1, OC 1.6%)
 473723-02

 * Reference numbers are the studies MRID numbers.

 	2.  Measures of Aquatic Exposure
 Fluopyram has a low vapor pressure (9x10[-9] torr) and its solubility in water is 16 ppm.  Fluopyram is highly persistence under all other abiotic/biotic conditions tested in the laboratory.  The chemical is stable to aqueous hydrolysis in neutral and alkaline conditions, photolysis on soil, anaerobic soil metabolism, aerobic and anaerobic aquatic metabolism in sediment/water systems.  Aqueous photolysis half-lives ranged from 87 days in natural water system to 57 days in laboratory pH 7 buffered systems.  In field studies, fluopyram has shown similar persistence especially in two out of five terrestrial field dissipation studies on bare-ground plots (half-lives ranged from 24 to 83 days in two studies in GA and ND and 163 to 539 days in three studies in WA, CA, and NY).  For mobility, fluopyram appears to have medium affinity to soil and sediment particles rendering it to be moderately mobile in systems with varied textures and organic matter content (Kfoc ranges from 316 to 591 L/Kg).  The major routes of dissipation for fluopyram in important compartments of the natural environment appear to be the slight bio-transformation in aerobic systems.  The relative high persistent, and mobility of fluopyram suggests that the chemical may cause contamination to ground water.  However, estimated EEC for ground water was one order of magnitude lower than surface water EECs. Fluopyram can also reach surface water through erosion, drift and/or run-off events.

Based on fate and transport properties and the degradation profile of fluopyram, environmental exposure of aquatic systems may occur from parent and two main degradates, namely: methyl sulfoxide and benzamide in addition to limited quantities of lactam in shallow clear water systems.  Examination of the soil metabolism data suggests that a limited quantity of these degradates is expected to be released to the environment.  Therefore, parent exposure is expected to represent environmental exposure based on the limited amount of degradates formed and their expected equal or lower toxicity. Only one study was submitted for degradate toxicity which suggest parent is more toxic than degradate. In this respect, the Global Residues of Concern Knowledgebase Subcommittee (Global ROCKS) decided that only parent is the residue of concern in drinking water exposure. The decision was based on the degradation profile of the parent which shows a very low level of degradation in important environmental compartments.

 a. Application Methods

Fluopyram is formulated as suspension concentrates alone or admixed with other fungicides and applied as liquid sprays or through drip irrigation (watermelons and strawberries). Application equipment includes various types of ground, airblast, and aerial sprayers.  Ground application is permitted for all crops while aerial application is limited to specific crops sometimes with lower application rates. Exposure was evaluated for all crops and all application methods.

 b. Label Application Rates and Intervals

Fluopyram labels may be categorized into two types: labels for manufacturing uses (including technical grade fluopyram) and its formulated products or end-use products.  While technical products, which contain fluopyram of high purity, are not used directly in the environment, they are used to make formulated products, which can be applied in specific areas to control fungal diseases.  The formulated product labels legally limit fluopyram potential use to only those sites that are specified on the labels.  Uses being assessed are summarized in Table 9 along with representative scenarios and the chosen first application dates.

Table 9 Rates (maximums) and application intervals (minimums) representing labeled uses for fluopyram and its four mixtures
Crop
Scenario*
                            Single Application Rate
                            Number of Applications
                                Date of 1[st]
                             Application (DD/MM)**

                                   lb a.i./A
                                  Kg a.i./ha

(1) Aerial Application (95% efficiency, 5% drift)
Beans (dry)
MIbeansSTD
                                     0.134
                                     0.150
                                       2
                                     01-08

WAbeansNMC
                                     0.134
                                     0.150
                                       2
                                     15-08

ILbeansNMC
                                     0.134
                                     0.150
                                       2
                                     15-08
Cherries Only
MICherriesSTD
                                     0.092
                                     0.103
                                       2
                                     10-07

CAfruit_WirrigSTD
                                     0.092
                                     0.103
                                       2
                                     30-04
Peanuts
NCpeanutSTD
                                     0.222
                                     0.249
                                       2
                                     15-07
Potatoes
CAPotatoRLF_V2
                                     0.092
                                     0.103
                                       3
                                     01-06

FLpotatoNMC
                                     0.092
                                     0.103
                                       3
                                     15-03

IDNpotato_WirrigSTD
                                     0.092
                                     0.103
                                       3
                                     20-06

WApotatoNMC
                                     0.092
                                     0.103
                                       3
                                     20-06

MEpotatoSTD
                                     0.092
                                     0.103
                                       3
                                     01-07
Tree Nuts
CAalmond_WirrigSTD
                                     0.222
                                     0.249
                                       2
                                     20-02

GAPecansSTD
                                     0.222
                                     0.249
                                       2
                                     01-08

ORfilbertsSTD
                                     0.222
                                     0.249
                                       2
                                     20-03

WAorchardsNMC
                                     0.222
                                     0.249
                                       2
                                     15-04
(2) Ground Application (99% efficiency; Airblast 3% drift/CAM=2, Ground 1% drift/CAM=2, and/or drip 0% drift/CAM=1)
Apples
NCappleSTD
                                     0.222
                                     0.249
                                       2
                                     15-05

ORappleSTD
                                     0.222
                                     0.249
                                       2
                                     15-05

WA orchards 1
                                     0.222
                                     0.249
                                       2
                                     15-04

PAappleSTD_V2
                                     0.222
                                     0.249
                                       2
                                     15-05

CAfruit_WirrigSTD
                                     0.222
                                     0.249
                                       2
                                     15-04
Beans (dry)
MIbeansSTD
                                     0.134
                                     0.15
                                       2
                                     01-08

WAbeansNMC
                                     0.134
                                     0.15
                                       2
                                     15-08

ILbeansNMC
                                     0.134
                                     0.15
                                       2
                                     15-08
Cherries Only
MICherriesSTD
                                     0.092
                                     0.103
                                       2
                                     10-07

CAfruit_WirrigSTD
                                     0.092
                                     0.103
                                       2
                                     30-04
Watermelon
CAMelonsRLF_V2
                                     0.222
                                     0.249
                                       2
                                     20-06

FLcucumberSTD
                                     0.222
                                     0.249
                                       2
                                     20-11

MImelonStd
                                     0.222
                                     0.249
                                       2
                                     01-07

MOmelonStd
                                     0.222
                                     0.249
                                       2
                                     25-06

NJmelonStd
                                     0.222
                                     0.249
                                       2
                                     01-07

STXmelonNMC
                                     0.222
                                     0.249
                                       2
                                     20-06
Watermelon, Drip
CAMelonsRLF_V2
                                     0.222
                                     0.249
                                       2
                                     20-06

FLcucumberSTD
                                     0.222
                                     0.249
                                       2
                                     20-11

MImelonStd
                                     0.222
                                     0.249
                                       2
                                     01-07

MOmelonStd
                                     0.222
                                     0.249
                                       2
                                     25-06

NJmelonStd
                                     0.222
                                     0.249
                                       2
                                     01-07

STXmelonNMC
                                     0.222
                                     0.249
                                       2
                                     20-06
Grapes (Wine
CAWineGrapesRLF_V2
                                     0.222
                                     0.249
                                       2
                                     01-04

NYGrapesSTD
                                     0.222
                                     0.249
                                       2
                                     15-04
Peanuts
NCpeanutSTD
                                     0.222
                                     0.249
                                       2
                                     15-07
Potatoes
CAPotatoRLF_V2
                                     0.178
                                     0.199
                                       2
                                     01-06

FLpotatoNMC
                                     0.178
                                     0.199
                                       2
                                     15-03

IDNpotato_WirrigSTD
                                     0.178
                                     0.199
                                       2
                                     20-06

WApotatoNMC
                                     0.178
                                     0.199
                                       2
                                     20-06

MEpotatoSTD
                                     0.178
                                     0.199
                                       2
                                     01-07
Strawberries, Drip only
FLstrawberry_WirrigSTD
                                     0.222
                                     0.249
                                       2
                                     01-12

CAStrawberry-noplasticRLF_V2
                                     0.222
                                     0.249
                                       2
                                     15-06
Sugerbeet
MNsugarbeetSTD
                                     0.112
                                     0.125
                                       2
                                     01-05

CAsugarbeet_WirrigOP
                                     0.112
                                     0.125
                                       2
                                     01-04
Tree Nuts
CAalmond_WirrigSTD
                                     0.222
                                     0.249
                                       2
                                     20-02

GAPecansSTD
                                     0.222
                                     0.249
                                       2
                                     01-08

ORfilbertsSTD
                                     0.222
                                     0.249
                                       2
                                     20-03

WAorchardsNMC
                                     0.222
                                     0.249
                                       2
                                     15-04
* NMC= N-methyl carbamate cumulative scenario; RLF= Red Legged Frog scenario; and OP= organophosphate pesticides: These scenarios were used for the risk assessments stated and may represent high vulnerable use sites for this assessment.
** 1[st] application dates were selected based on information in the label, pest and stage of crop growth that may be associated with the first application date.

 c. Modeling Approach

Aquatic exposures are quantitatively estimated for all of assessed uses using scenarios that represent high exposure sites for fluopyram use.  Each of these sites represents a 10-hectare field that drains into a 1-hectare pond that is 2 meters deep and has no outlet.  Exposure estimates generated using the standard pond are intended to represent a wide variety of vulnerable water bodies that occur at the top of watersheds including prairie pot holes, playa lakes, wetlands, vernal pools, man-made and natural ponds, and intermittent and first-order streams.  As a group, there are factors that make these water bodies more or less vulnerable than the standard surrogate pond.  Static water bodies that have larger ratios of drainage area to water body volume would be expected to have higher peak EECs than the standard pond.  These water bodies will be either shallower or have large drainage areas (or both).  Shallow water bodies tend to have limited additional storage capacity, and thus, tend to overflow and carry pesticide in the discharge whereas the standard pond has no discharge.  As watershed size increases beyond 10 hectares, at some point, it becomes unlikely that the entire watershed is planted to a single crop, which is all treated with the pesticide.  Headwater streams can also have peak concentrations higher than the standard pond, but they tend to persist for only short periods of time and are then carried downstream.

 d. Model Inputs

Environmental fate and transport and other data used as parameters for the three PRZM/EXAMS runs are listed in Table 10.

Table 10 Summary of PRZM/EXAMS environmental fate and transport data used as aquatic exposure inputs
Input Parameter [1] (Unit)
                                    Value*
Molecular Weight g/mole
                                    396.72
Henry's constant (atm-m3 mol-1 @ 20 [o]C)
                                   2.94E-10
Solubility in Water(mg/L)
                                      16
Photolysis in Water (t(1/2) in days @ pH 7)
                                      57
Aerobic Soil Metabolism (90[th] % t(1/2) in days for 6 soils x two labels)
                                      464
Hydrolysis (t(1/2) in days @ pH 7)
                                    Stable
Aerobic Aquatic Metabolism (90[th] % t(1/2) in days whole system t(1/2) in days for two systems x two labels)
                                     1,360
Anaerobic Aquatic Metabolism (90[th] % t(1/2) in days whole system t(1/2) in days for one system x two labels)
                                     1,757
Koc (Average of five values in L/Kg)
                                      439
Application rate and frequency
                 Depends on the crop (refer to Table 2, above)
Application intervals

Chemical Application Method (CAM)
                                       2
Application Efficiency
                            95% Aerial; 99% Ground
Spray Drift Fraction
                         0.05 Aerial; 0.03 Airblast,
                                and 0.01 Ground

 e. Aquatic EECs

Aquatic exposure EECs for the various crop use patterns are summarized in Table 11.  Peak concentrations varied from 0.01 to 5.47 ug a.i./L.

Table 11 Surface water 1-in-10 Year EECs (μg/L) for fluopyram use patterns applied by aerial and ground equipment
Crop
Scenario
                                     Peak
                                    21-day
                                    60-day
Aerial
Beans (dry)
MIbeansSTD
                                     1.56
                                     0.228
                                     0.104

WAbeansNMC
                                     0.47
                                     0.112
                                     0.039

ILbeansNMC
                                     1.31
                                     0.225
                                     0.122
Cherries Only
MICherriesSTD
                                     0.59
                                     0.105
                                     0.047

CAfruit_WirrigSTD
                                     0.29
                                     0.059
                                     0.021
Peanuts
NCpeanutSTD
                                     2.29
                                     0.304
                                     0.119
Potatoes
CAPotatoRLF_V2
                                     0.37
                                     0.072
                                     0.025

FLpotatoNMC
                                     3.22
                                     0.430
                                     0.172

IDNpotato_WirrigSTD
                                     0.22
                                     0.074
                                     0.032

WApotatoNMC
                                     1.26
                                     0.188
                                     0.071

MEpotatoSTD
                                     1.29
                                     0.322
                                     0.140
Tree Nuts
CAalmond_WirrigSTD
                                     0.98
                                     0.344
                                     0.130

GAPecansSTD
                                     3.71
                                     0.402
                                     0.148

ORfilbertsSTD
                                     2.79
                                     0.407
                                     0.168

WAorchardsNMC
                                     0.73
                                     0.247
                                     0.087
Ground
Apples
NCappleSTD
                                     4.00
                                     0.671
                                     0.240

ORappleSTD
                                     0.43
                                     0.139
                                     0.062

WA orchards 1
                                     0.55
                                     0.154
                                     0.054

PAappleSTD_V2
                                     2.59
                                     0.465
                                     0.167

CAfruit_WirrigSTD
                                     0.55
                                     0.152
                                     0.053
Beans (dry)
MIbeansSTD
                                     1.63
                                     0.190
                                     0.104

WAbeansNMC
                                     0.40
                                     0.054
                                     0.019

ILbeansNMC
                                     1.36
                                     0.227
                                     0.125
Cherries Only
MICherriesSTD
                                     0.62
                                     0.095
                                     0.041

CAfruit_WirrigSTD
                                     0.17
                                     0.036
                                     0.013
Watermelon
CAMelonsRLF_V2
                                     0.01
                                     0.002
                                     0.001

FLcucumberSTD
                                     4.63
                                     0.491
                                     0.204

MImelonStd
                                     1.14
                                     0.160
                                     0.062

MOmelonStd
                                     2.34
                                     0.315
                                     0.112

NJmelonStd
                                     2.00
                                     0.179
                                     0.071

STXmelonNMC
                                     7.31
                                     0.652
                                     0.257
Watermelon, Drip
CAMelonsRLF_V2
                                     0.01
                                     0.002
                                     0.001

FLcucumberSTD
                                     5.47
                                     0.712
                                     0.286

MImelonStd
                                     4.37
                                     0.381
                                     0.145

MOmelonStd
                                     3.86
                                     0.347
                                     0.123

NJmelonStd
                                     4.77
                                     0.376
                                     0.142

STXmelonNMC
                                     7.31
                                     0.639
                                     0.257
Grapes (Wine)
CAWineGrapesRLF_V2
                                     0.37
                                     0.073
                                     0.030

NYGrapesSTD
                                     2.25
                                     0.526
                                     0.207
Peanuts
NCpeanutSTD
                                     2.32
                                     0.245
                                     0.096
Potatoes
CAPotatoRLF_V2
                                     0.33
                                     0.035
                                     0.012

FLpotatoNMC
                                     4.39
                                     0.476
                                     0.217

IDNpotato_WirrigSTD
                                     0.32
                                     0.095
                                     0.040

WApotatoNMC
                                     1.70
                                     0.250
                                     0.088

MEpotatoSTD
                                     1.68
                                     0.380
                                     0.150
Strawberries, Drip only
FLstrawberry_WirrigSTD
                                     3.77
                                     0.668
                                     0.236

CAStrawberry-noplasticRLF_V2
                                     1.08
                                     0.164
                                     0.062
Sugerbeet
MNsugarbeetSTD
                                     0.98
                                     0.202
                                     0.076

CAsugarbeet_WirrigOP
                                     0.23
                                     0.042
                                     0.016
Tree Nuts
CAalmond_WirrigSTD
                                     0.81
                                     0.261
                                     0.101

GAPecansSTD
                                     3.61
                                     0.382
                                     0.142

ORfilbertsSTD
                                     2.90
                                     0.392
                                     0.157

WAorchardsNMC
                                     0.55
                                     0.154
                                     0.054

Estimation of Sediment Concentrations

Exposure to sediment and pore water in aquatic systems was also obtained for selected runs including scenarios with the highest and lowest surface water EECs. These data are summarized in Table 12.

Table 12 Sediment (μg/Kg) and pore water EECs (μg/L) for fluopyram use patterns applied by aerial and ground application methods
Crop
Scenario
Pore Water EECs (ppb)
Sediment EECs (ppb)

Peak
21-day
60 day
Peak
21-day
60 day
                                    Ground
Tree Nuts
GA pecans
                                     0.05
                                     0.01
                                     0.004
                                     0.898
                                     0.184
                                     0.067
Potatoes
FL potato
                                     0.09
                                     0.027
                                     0.01
                                     1.619
                                     0.487
                                     0.183
Potatoes
IDN potato
                                     0.004
                                     0.002
                                     0.001
                                     0.072
                                     0.039
                                     0.017
Cherries Only
CA fruits 2
                                     0.004
                                     0.002
                                     0.001
                                     0.079
                                     0.034
                                     0.012
                                    Aerial
Watermelon, Ground
STX melon
                                     0.142
                                     0.02
                                     0.007
                                     2.55
                                     0.362
                                     0.127
Watermelon, Drip
FL cucumber
                                     0.069
                                     0.02
                                     0.009
                                     1.246
                                     0.355
                                     0.16
Watermelon, Drip
CA Melons
                                       0
                                       0
                                       0
                                     0.009
                                     0.008
                                     0.005

 g. Aquatic Exposure Monitoring (Field Data)

 This is a new pesticide and therefore no data were identified to provide information on aquatic monitoring.

 	3.  Terrestrial Exposure Assessment

 Terrestrial wildlife exposure estimates are typically calculated for bird and mammals, emphasizing a dietary exposure route for uptake of pesticide active ingredients. These exposures are considered as surrogates for terrestrial-phase amphibians as well as reptiles. For exposure to terrestrial organisms, such as birds and small mammals, pesticide residues on food items are estimated, based on the assumption that organisms are exposed to residues from a single pesticide in a given exposure scenario. Application methods of fluopyram include ground or aerial spray application and drip irrigation for agricultural uses. For this terrestrial exposure assessment, spray applications are considered as described below. When considering residues on wildlife dietary items, drip irrigation applications are considered to have substantially reduced exposure potential to non-target wildlife compared to foliar spray applications, with the exception of soil-dwelling organisms.

 		a. Terrestrial Animal Exposure Modeling- Spray Applications

 One concern with pesticide applications is that birds and mammals may be exposed shortly after application through oral or dietary exposure to vegetative plant material or insects when foraging in the treated fields for nesting material or food.  Therefore, for fluopyram spray applications, estimation of pesticide concentrations in wildlife food items focuses on quantifying possible dietary ingestion of residues on vegetative matter and insects. The Terrestrial Residue EXposure model (T-REX, Version 1.4.1, dated October 8, 2008) is used to estimate exposures and risks to avian and mammalian species.  Input values for avian and mammalian acute and chronic toxicity as well as chemical application and foliar dissipation half-life data are required to run the model. The model provides estimates of exposure concentrations and risk quotients (RQs).  Specifically, the model provides estimates of concentrations (upper-bound and mean) of chemical residues on the surface of different types of foliage and insects that may be dietary sources of exposure to mammalian and avian species (with birds as surrogates for terrestrial-phase amphibians and reptiles). The surface residue concentration (ppm) is estimated by multiplying the application rate (pounds active ingredient per acre) by a value specific to each food item. These values (termed the Hoerger-Kenaga estimates) along with a more detailed discussion of the methodology implemented by T-REX, are presented in Appendix D (T-REX Model).

 For multiple applications, the EEC is determined by adding the mass on the surface immediately following the application to the mass of the chemical still present on the surfaces on the day of application (determined based on first order kinetics using the foliar half-life as the rate constant).  Input values used for estimating avian and mammalian exposure risks to fluopyram are summarized in Table 8.  In the absence of available foliar dissipation studies, a default foliar half-life of 35 days is used based on the work of Willis and McDowell (1987). For this screening level assessment, the default foliar half-life of 35 days was used for the terrestrial exposure modeling, with an additional analysis of available submitted foliar dissipation data (see the Description of Assumptions, Limitations, Uncertainties, Strengths and Data Gaps section). In this respect, the EECs for fluopyram may be an overestimation of actual concentrations, if the half-life under field conditions is lower than the default value.

 Risks could also be overestimated if the actual application rate, frequency of application or number of applications is lower than the input parameters used for the conservative exposure scenario that was modeled. For this risk assessment, the T-REX model was run for agricultural uses with the maximum proposed application rate (0.222 lb a.i./A), 2 applications (maximum number of applications), and a 5-day application interval (the minimum application interval), to assess risk to terrestrial organisms (see Table 13).

 However, terrestrial EECs could be an underestimation of actual exposure concentrations in the environment. Although the label stated that fluopyram can be applied via foliar spray application up to 2 times per season for the crops with the highest seasonal application rate (watermelons, and strawberries), for this risk assessment, EFED assumed that fluopyram was applied at a maximum of 2 times per year.  If there are conditions under which there is more than one growing season for a crop within a single year, exposure estimates and risk to terrestrial organisms could be significantly underestimated.

 Table 13.  Input parameters used in T-REX v1.4.1 to determine terrestrial EECs for the maximum fluopyram spray application scenario. a
                                 Input Variable
                                Parameter Value
                                     Source
 Maximum application rate
                                0.222 lbs a.i./A
                         Fluopyram 500 SC Product Label
 Maximum # of applications per year
                                       2
                         Fluopyram 500 SC Product Label
 Minimum application interval
                                     5 days
         Fluopyram 500 SC Product Label (watermelons and strawberries)
 Foliar half-life
                                    35 days
                              T-REX Default Value
 [a] Representative of the maximum exposure scenario for all crop uses.

 The EECs on food items may be compared directly with dietary toxicity data or converted to an oral dose.  For mammals, the residue concentration is converted to daily oral dose based on the fraction of body weight consumed daily as estimated through mammalian allometric relationships. The screening-level risk assessment for fluopyram considers upper-bound predicted residues as the measure of exposure. Summaries of the predicted upper-bound and mean residues of fluopyram that may be expected to occur on selected avian or mammalian food items immediately following application for the maximum use scenario are presented in Table 14.

 For the maximum fluopyram spray application scenario, acute concentrations on foliar surfaces ranged from 6.35 to 101.54 ppm for upper-bound residues and 2.96 to 35.96 ppm for mean residues.

 Table 14.  Upper-bound and mean terrestrial dietary EECs estimated for the maximum fluopyram spray application scenario (Kenaga values). [a]
                                  Forage Type
                           Upper-bound Residues (ppm)
                              Mean Residues (ppm)
 short grass
                                     101.54
                                     35.96
 tall grass
                                     46.54
                                     15.23
 broadleaf plants and small insects
                                     57.11
                                     19.04
 fruits/pods/large insects
                                      6.35
                                      2.96

 		b. Terrestrial Exposure Monitoring (Field Data)

 Fluopyram is a new chemical, therefore no data are available on terrestrial monitoring for fluopyram.

 	4.  Non-Target Terrestrial Plant Exposure Assessment

 A preliminary run of TERR-PLANT was conducted using the maximum application rate for ground application and aerial applications, 0.222 lbs a.i./acre. The modeled drift fraction varies depending on application method, either 1% for ground applications or 5% for aerial applications. The maximum modeled EECs ranged from 0.002 (spray drift) to 0.047 (semi-aquatic areas) lbs a.i./A for ground application and from 0.011 (spray drift) to 0.055 (semi-aquatic areas) lbs a.i./A for aerial application.

 C.  Ecological Effects Characterization

 This, effects characterization describes the types of effects fluopyram can produce in aquatic or terrestrial organisms.  As fluopyram is a new pesticide, this characterization is based on registrant-submitted studies that describe acute and chronic effects toxicity information for various aquatic and terrestrial animals and plants.  Appendix E summarizes the results of the registrant-submitted toxicity studies used to characterize effects for this risk assessment.  Toxicity testing reported in this section does not represent all species of birds, mammals, or aquatic organisms.  Only a few surrogate species for both freshwater fish and birds are used to represent all freshwater fish (2000+) and bird (680+) species in the United States.  For mammals, acute studies are usually limited to Norway rat or the house mouse.  Estuarine/marine testing is usually limited to a crustacean, a mollusk, and a fish.  Also, neither reptiles nor amphibians are commonly tested.  In the absence of toxicity data for reptiles and terrestrial phase amphibians, this risk assessment assumes that the sensitivity of birds, terrestrial-phase amphibians, and reptiles are similar.  The same assumption is used for fish and aquatic-phase amphibians.

 In general, categories of acute toxicity ranging from "practically nontoxic" to "very highly toxic" have been established for aquatic organisms (based on LC50 and EC50 values or limit of solubility), mammals (based on LD50 values), avian species (based on and LD50 and  LC50 values), and non-target insects (based on LD50 values for honey bees) (U.S. EPA 2001).  These categories are presented in Appendix E.

 	1.  Aquatic Effects

 The acute and chronic toxicity reference values associated with freshwater and estuarine/marine species exposure to fluopyram are summarized in Table 15. These toxicity reference values represent the most sensitive species tested within each taxonomic group.  A more detailed summary of the aquatic toxicity data available to characterize risks associated with fluopyram applications is given in Appendix E.

For fluopyram, all fluopyram technical toxicity endpoints from aquatic studies with water column animals (freshwater and estuarine/marine fish and invertebrates), as well as benthic invertebrates, were used to quantitatively characterize potential risk resulting from exposure to spray drift and runoff / erosion.  However, toxicity endpoints from studies on aquatic organisms (fish and invertebrates) with the typical end use product (TEP) are used quantitatively to estimate risk resulting from exposure to spray drift only. See additional discussion in the Description of Assumptions, Limitations, Uncertainties, Strengths and Data Gaps  section of this document.

An additional consideration to note is that the reported solubility of fluopyram is 16 ppm or (mg a.i./L). Many of the submitted aquatic toxicity tests for fluopyram technical report a lower test chemical solubility under test conditions, and therefore the highest concentrations tested in some of the submitted aquatic studies are not up to the level of solubility reported in the available fate information for fluopyram. The formulated product appears to have a higher level of solubility based on the submitted toxicity studies. See additional discussion in the Description of Assumptions, Limitations, Uncertainties, Strengths and Data Gaps  section of this document.

 Only one study was submitted to the US EPA that examined the toxicity of fluopyram degradates to any non-target aquatic organism. An algal study with fluopyram-lactame has been submitted and is summarized below.

 Table 15. Toxicity reference values for aquatic organisms exposed to fluopyram technical or formulated fluopyram (Fluopyram SC 500A, 41.5% active ingredient).
                               Exposure Scenario
                              % Active Ingredient
                                    Species
                               Exposure Duration
                            Toxicity Reference Value
                                     Effect
                                   Reference
                                (Classification)
 Freshwater Fish
                                                                          Acute
                                      TGAI
                                     94.7%
 Rainbow Trout
 Oncorhynchus mykiss
                                    96 hours
 LC50>1.78 mg a.i./L
 NOAEC=1.78 mg a.i./L
 The reported limit of solubility for fluopyram TGAI under these test conditions is 2.0 mg/L, the nominal concentration for this limit test. No mortality or sublethal effects were observed at 1.78 mg a.i./L (mean-measured).
                                 MRID 47372328
                                   Acceptable

                                      TEP
                                     41.5%
 Rainbow Trout
 Oncorhynchus mykiss
                                    96 hours
 LC50 >46.4 mg a.i./L[b]
 NOAEC=1.31 mg a.i./L
 Sublethal effects included fish lying on the bottom of the test chamber, dark coloration, labored respiration, mucous secretion from intestine, surfacing, and lying on side/back.
                                 MRID 47372333
                                  Supplemental
                                                                        Chronic
                                      TGAI
                                     94.7%
 Fathead minnow Pimephales promelas
                                    33 days
 NOAEC = 0.135 mg a.i./L
 LOAEC = 0.269 mg a.i./L
 Treatment-related signs of toxicity were observed at the >=0.269 mg ai/L levels, including deformed mouth, ventral hematoma, labored respiration, surfacing, dark coloration, swollen belly, loss of equilibrium and lordosis.
 Compared to the negative controls, a statistically-significant reduction in post-hatch survival and the growth of surviving fry occurred at the two highest treatment levels (0.560 and 1.05 mg a.i./L).

                                 MRID 47372336
                                   Acceptable

 Freshwater Invertebrates
                                                                          Acute
                                      TGAI
                                     94.7%
 Water flea
 Daphnia magna
                                    48 hours
 EC50>17 mg a.i./L
 NOAEC=17 mg a.i./L
 No immobilization or sublethal effects were observed at any treatment level.
                                 MRID 47372324
                                  (Acceptable)

                                      TEP
                                     41.5%
 Water flea
 Daphnia magna
                                    48 hours
 EC50>38.2 mg a.i./L
 NOAEC=11.6 mg a.i./L
 Immobilization occurred at 20.4 mg a.i./L (13%) and 38.2 mg a.i./L (20%).

 No other sublethal effects were reported.
                                 MRID 47372325
                                  (Acceptable)
                                                                        Chronic
                                      TGAI
                                     94.7%
 Water flea
 Daphnia magna
                                    21 days
 NOAEC = 1214 ug a.i./L
 LOAEC = 2996 ug a.i./L
 Offspring production was affected at the highest treatment level, 2996 ug a.i./L. Of the 836 total offspring produced at the 2996 μg ai/L level, 225 neonates were dead, and 49 of the 611 living offspring (8.0%) showed unspecified sublethal signs of toxicity. Mean body lengths of the parent daphnia were also affected at 2996 ug a.i./L.
                                 MRID 47372334
                                  (Acceptable)
 Estuarine/Marine Fish
                                                                          Acute
                                      TGAI
                                     94.7%
 Sheepshead minnow
 Cyprinodon variegatus
                                    96 hours
 LC50 >0.98 mg a.i./L[a]
 NOAEC=0.98 mg a.i./L
 No mortality or sublethal effects were observed at any treatment level.
 MRID 47372330
 (Acceptable)
                                                                        Chronic

                                    Data Gap
 Estuarine/Marine Invertebrates
                                                                          Acute
                                      TGAI
                                     94.7%
 Saltwater mysid Americamysis bahia
                                    96 hours
 EC50>0.51 mg a.i./L
 NOAEC=0.27 mg a.i./L
 Two mysids were reportedly missing from the highest treatment group, and were therefore considered dead.

 No other sublethal effects were reported.