**UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460**  **OFFICE OF C**  **H EM** **ICAL SAF E**  **TY AND**  **POLLUTION PREVENTION** 

# Environmental Fate **and Ecological Risk Assessment for**  **Fluopyram Registration** 

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

**Prepared by: Mohammed A. Ruhm**  **an, Ph.D. Am**  **anda Solliday, M.S. Reviewed by:**  **Keith Sappington, M.S. Mah Sham** **im , 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. 2046 0 

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# O N

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# Clii



### Table of Contents **I. Executive Summary** 
................................ ................................ ................................ ................................ ............. 1 **A. Nature of Chem ical 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. Physicochem ical, 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 Eff**

**ects** ................................ ................................ ................................ ................................ .......... 11 **a. Aquatic Effects**
................................ ................................ ................................ ................................ .......... 13 **b. Terrestrial Effects**
................................ ................................ ................................ ................................ ..... 13 **2. Ecos ystems 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. Measu res of Effect** 
................................ ................................ ................................ ................................ ..... 20 **c. Measures of Ecosystem and Receptor Characteristics** 
................................ ................................ ........... 20 **III. Analysis** 
................................ ................................ ................................ ................................ ........................... 22 **A. Use Characteri zation** 
................................ ................................ ................................ ................................ ....... 22 **B. Exposure Characterization**
................................ ................................ ................................ ............................. 24 **1. Environm ental Fate and Transport Characterization** 
................................ ................................ .............. 24 **a. Abiotic Degradation**
................................ ................................ ................................ ................................ .... 25 **b. Biotic Degradation**
................................ ................................ ................................ ................................ ...... 26 **c. Tranformation Profile**
................................ ................................ ................................ ................................ . 28 **d. Mobility**
................................ ................................ ................................ ................................ ....................... 30 **2. Measures of Aqua tic 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 Expos ure Monitoring (Field Data**  **)**
................................ ................................ ............................... 37 **3. Terrestrial Exposure Assessment**
................................ ................................ ................................ ................ 37 **a. Terrestrial Animal Exposure Modeling -**  **Spray Applications**
................................ ................................ 38iii **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 Colum n Exposure: Acute and Chronic Risk to Anim**  **als** ................................ ............................ 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 Mamm als**  ................................ ................................ ....... 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 Effect s**  ................................ ................................ ....................... 68 **1. Risks to Aquatic Organisms**
................................ ................................ ................................ ......................... 68 **a. Aquatic Anim als 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 Governm ent Reports**  ................................ ................................ ................................ ... 96iv



### VI. Appendices **A. Environmental Fate and Transport Data**  **Summaries B.**  **Aquatic Exposure PRZM/EXAMS Modeling and Ground Water Modeling**  **C. T**  **errestrial Residue E X** **posure (T -**  **REX ; V**  **ersion 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 Requirement s** **1**



### I. **Executive Summary A. Nature of Chemical Stressor**  Fluopy ram (N - [2
- [3
- chloro
- 5 - (trifluoromethyl)
- 2
- py ridinyl]ethyl]
- 2(trifluoromethyl)benzamide; fluopy ram; CAS 658066
- 35
- 4, PC code 080302 ) represents a new group of fungicide chemi stry , py ridinyl
- ethylbenzamides . The biochemical mode of action of this chemi cal involves the inhibition of the enzy

me succinate dehydrogenase within the fungal mitochondrial respiratory chain, thus blocking electron transport. Other fungicides that share the same target site, or succin ate dehydrogenase inhibitors ( SDHI s) , include boscalid and carboxin, among others (FRAC, 2009). The registrant reported that fluopy ram is a fungicide with penetrative and trans
- laminar properties. The active substance is also trans
- located by the x yl em vascular system. Current formulations for fluopy ram include suspension concentrates for the chemical alone (41.5% a.i), or with other fungicides including: tebuconazole (17.6% with 17.6% fluopy ram), trifloxystrobin (21.4% with 21.4% fluopy ram), py rimethanil (33.8% with 11.3% fluopy ram), or pro thioconazole (17.4% with 17.4% fluopy ram). Fluopy

ram and /or its mixtures is proposed for agricultural uses on apples, watermelons , selected dry beans, gr apes (wine), peanuts, potatoes, strawberries, sugerbeet, and tree nuts. Fluopy ram is stable to hydrolysis and soil photolysis and highl y persistent in both aerobic and anaerobic aquatic s ys tems. 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 s ys tems, then these compounds may reach these s ys tems via run
- off at low concentrations base d on the level of formation in laboratory

aerobic soil studies. Limited ecological effects data show low comparative toxicity of degradates compared to parent . O ne algal study with fluopy

ram - lactame and one dietary rat study with fluopy

ram - PCA have been submitted and no treatment
- related effects were observed in either study
. Therefore, based on the high persistence of fluopy ram, the low occurrence of degradates and the low comparative toxicity of degradates , onl y the parent compound (fluopy ram) was consi dered of concern in aquatic and terrestrial ecos ys tems. Fluopy ram is stable to hydrolysis and soil photolysis and highl y persistent in both aerobic and anaerobic aquatic s ys tems. Based on the high persistence of fluopy ram, the low occurrence of degradates and the low comparative toxicity of degradates, onl y the parent compound (fluopy ram) is considered of concern in aquatic and terrestrial ecos ys tems. **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 fluop yram . **Tables 1** and **2 2** 

summarize the major conclusions and uncertainties of this assessment for aquatic and terrestrial receptors, respectivel y. 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 no**  **n -**  **target ma**  **mmals, birds, reptiles and terrestrial -**  **phase amphibians based on modeled exposure resulting from spray applications of fluopyram**  **.** Low acut e risk concerns exist for mammals , birds, reptiles and terrestrial
-phase amphibians . F luopy ram shows low acute toxicity to terrestrial invertebrates on a mortality basis and some reproductive effects to this taxon were observed at high levels of fluopy ram exposure . Overall risk to terrestrial plant species is low, but some uncertainty exists with the effects of fluop yram on the seedling emergence of one dicot species, buckwheat. The u se of the fluop yr am 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 e stimated environmental exposure concentrations of the fluop yram only product are assumed to be equal or greater than the EECs of the proposed products containing fluop yr am and another active ingreadient, based on the application rates in the proposed l abels. Overall, the coformulations for all fluopy ram 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 p yrimethanil and prothioconazole coformulations. From the available toxicity data, it appears as if use of the fluopy

ram co - formulated products with tebuconazole, trifloxystrobin, py rimethanil, and prothioconazole have a higher potential to adversel y impact aquatic ecos ys tems than use of the proposed fluop yr am - only product. **Table 1. Summary of Environm**  **ental Risk Conclusions for Aquatic Organisms E**  **xposed to Fluopyram**  **Risk Conclusion Summarized Risk Characterization and Major**  **Uncertainties 3** 

**Table 1. Summary of Environm**  **ental Risk Conclusions for Aquatic Organisms E**  **xposed to Fluopyram**  **Risk Conclusion Summarized Risk Characterization and Major**  **Uncertainties Low**  **a cute and**  **chronic risk for**  **freshwater and e**  **stuarine/marine fish**  **and i nvertebrates**  **(water colum n)**  For acute risk to freshwater and estuarine/marine fish species, risk quotients were not calculated because the available toxicity endpoints were non - definitive (LC 50 > highest test concentration). T he peak estimated exposure concentration for aquatic organisms is mo re than two orders of magnitude less than the highest tested fluopyram technical concentratio ns in acute toxicity tests which caus ed 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 (LC 50 > highest test conce ntration). However, the peak estimated exposure concentration for aquatic organisms is two orders of magnitude less than the lowest level at which immobility was obs erved in any aquatic inv ertebrate 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 mo deled 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 whi ch effects were observed in the submitted aquatic organism toxicity tests.**4**

**Table 1. Summary of Environm**  **ental Risk Conclusions for Aquatic Organisms E**  **xposed to Fluopyram**  **Risk Conclusion Summarized Risk Characterization and Major**  **Uncertainties Low**  **a cute**  **and chronic**  **r isk**  **for freshwater and**  **e stuarine/marine**  **b enthic**  **i nvertebrates**  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 leve ls of fluopyram exposure. Estimate d 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 (L OCs) were exceeded for these taxa.

--------------------------------------------------------------------------------------------------------- A short
- term

10
- day study with freshwater benthic invertebrates was not submitted for fluopyram. D ue to the low estimated aquatic exposure concentrati ons 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 r**  **isk for**  **aquatic vascular and non**  **** **vascular p lants**  **.** 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 e xceeded for aquatic vascular or non - vascular plant species
.

---------------------------------------------------------------------------------------------------------

**Table 2. Summary of Environm**  **ental Risk Conclusions for Terrestrial Organisms E**  **xposed to Fluopyram**  **Risk Conclusion Summarized Risk Characterization and Major Uncertainties** **5**

**Table 2. Summary of Environm**  **ental Risk Conclusions for Terrestrial Organisms E**  **xposed to Fluopyram**  **Risk Conclusion Summarized Risk Characterization and Major Uncertainties**  **Low a**  **cute r**  **isk for**  **b irds**  Risk quotients were not calculated for acute risk to birds based on the non - definitive endpoints in the submitted acute and dietary studies (LD 50 > 2000 mg ai/kg bw ; LC 50 > 4785 mg ai/kg bw). Less than 50% mo rtality occurred at the highest treatment level in all submitted avian acute oral and dietary studies. As a conservative assum ption to approximate risk, the highest levels tested in acute oral and dietary studies were co mp ared to the maximum acute dose and dietary
-based EECs. All calculated ratios were < 0.1, the level
- of

- concern for listed species. M ortality and sublethal effects , such as soft excrement, fluffed feathers and a decrease in food consumption, were note d at all treatment levels in the mo st sensitive acute oral test with bobwhite quail
. The lowest treatment level at which o bservations 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 mo deling
. 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 wa s 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 mo rtality occurs in a limit test ( OCSP P 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 LD 50 endpoint was established as only 4 0% mortality occurred at the highest treatment level (2000 mg ai/kg bw). In the two submitted dietary studies with mallard duck and bobw hite quail, no mortalities were observed ( LC 50 > 4604 mg ai/kg diet and LC 50 > 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
- mo rtem examinations
. Body

weight reduction occurred in the highest treatment l evel 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. O bservati ons 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 o r sublethal effects would occur. B ased on the available information, risk to listed birds from acute exposure to fluopyram is not expected. A definitive acute LD 50 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.**6**

**Table 2. Summary of Environm**  **ental Risk Conclusions for Terrestrial Organisms E**  **xposed to Fluopyram**  **Risk Conclusion Summarized Risk Characterization and Major Uncertainties**  **Chronic r**  **isk concerns**  **exist for b**  **irds .**  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 a**  **cute r**  **isk for**  **m am**  **mals** Results of oral, dermal and inhalation toxicity studies on rats show that fluopyram TGAI is practically non
- toxic to mammals on an acute basis (LD 50 > 2000 mg a.i./kg bw for both oral and dermal exposure routes and acute 4
- hour LC 50 > 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 mo st 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 r**  **isk concerns**  **exist for m**  **am mals**  **.** 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 bro adleaf 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 coul d 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.

----------------------------------------------------------------------------------------------------------**7**

**Table 2. Summary of Environm**  **ental Risk Conclusions for Terrestrial Organisms E**  **xposed to Fluopyram**  **Risk Conclusion Summarized Risk Characterization and Major Uncertainties**  **R isk concerns exist**  **for t**  **errestrial p**  **lants .**  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 maxim um application rate) in the seedling emergence test, a Tier II was conducted with this species
. T his test resulted in highly variable results for the most sensitive endpoint , biomass, and an EC 25 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 n on**  **- target**  **i nsects**  **and other**  **terrestrial invertebrates. Som**  **e reproductive effects**  **observed at high ex** **posure 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% mo rtality or more in any of the toxicity tests (at levels greater than >83.2 μg a.i./bee , the maximum application rate, or o bserved 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 conducte d 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.**8**

**C . Conclusions**  **- Exposure Characterization**  Fluopy ram has low vapor pressure/Henry ’s Law constant (2.33x10 - 8 torr/2.94 x 10 - 10 atm m3 mole - 1 ) and its solubility

in water is 16 ppm. F luopy ram is stable to hydrolysis and soil photolysis; highl y persistent in aerobic/anaerobic aquatic s ys tems (90 th % t1⁄2 ranges from 1,360 to 1,757 days); relativel y stable to aqueous photolysis (t1⁄2= 57 days), and persistence under aerobic soil conditions (90 th percentile t1⁄2= 464 days). In field studies, fluopy ram has shown similar persistence in three out of five terrestrial field dissipation studies on bare
- ground plots ( dissipation half

- lives ranged from 24 to 8 3 days in two studies in GA and ND and 163 to 539 days in three studies in WA, CA, and NY). For mobility, fluop yr am appears to have medium absorption a ffinity 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 fluopy ram are bio
- transformation s in aerobic s ys tems. The high persistent and moderate mobility of fluopy ram suggests that it may cause contaminat e ground water. Furthermore, fluopy ram can reach surface water through erosion, drift and/or run
- off events. **E . Conclusions**  **- Effects Characterization**  C hronic effects w ere observed at environmentall y - 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 LD 50 . Low acute toxicity was ob served in the submitted studies for mammals and terrestrial invertebrates. For terrestrial plants, s ome 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 fluopy ram may cause adverse effects to some species of plants. Acute and chronic toxicity of fluopy ram to fish and aquatic water- column and benthic organisms is low. Acute toxicity to non - vascular and vascular aquatic plants is low. Fluopy ram 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 fluopy ram has been conducted with only limited environmental fate and transport data gaps. The assessment would have been strengthened if**9**

hydrol ys is and aerobic soil studies were conducted on at least two of fluopyram degradates, namely Fluop yram - 7 - hydrox y and fluop yr am py ridyl
- carbox yl ic acid (Fluopy ram - PCA). This would have confirmed the sugge sted degradation pathway for fluopy

ram and collec ted data necessary for confirmin g conclusions on the degree of persistence for these degradates. **2. Ecological Effects** The screening level risk assessment for fluopy r am 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 fluop yram . **II. Problem**  **Formulation A. Stressor Source and Distribution**  **1. Source and Intensity** Fluopy ram is formulated as a suspension concentrate (SC) alone and mixed with four other fungicides: tebuconazole, trifloxystrobin, py rimethanil, and prothioconazole. These formulations are proposed to be applied as liquid spray to foliage using ground, airblast o r aerial spray equipments. The rate of application for fluop yram formulations ranges from a maximum single rate of 0.0 92 lb a.i/A to 0.222 lb a.i/A with a maximum rate of 0.44 5 lb a.i/A/crop cycle and a range of 5 to 14 days between applications. The range of application rates for fluop yram in mixtures is from a maximum single rate of 0.09 1 lb a.i/A to 0.22 2 lb a.i/A with a maximum rate of 0.44 5 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 differentl y than formulations containing fluop yr am alone. The maximum numbers of applications were mostly not specified but were calculated from allowed maximum crop cycle rate and the maximum single rate. Fluopy ram 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 fluopy ram. 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 fluop yr am products that are co
- formulated with tebuconazole,**10**

trifloxystrobin, py

rimethanil, and prothioconazole are documented in the effects characterization of this risk assessment . **2. Physicochemical, Fate, and Transport Properties**  Fluopy ram is characterized by

a water solubility of 16 ppm in acidic and alkaline conditions. The chemical has a low potential for volatil ization from dry and wet surfaces (vapor pressure= 2.33 x 10 - 8 torr and Henry’s Law constant= 2.94 x 10 - 10 atm m3 mole - 1 , respectivel y at 25 °C). Therefore fluop yr am has low potential to partition into the atmosphere. In the laboratory , fluopy

ram was stab le to hydrol ysis and photolysis and showed high per sistence to photolysis in water . The same high persistence was observed in aerobic/anaerobic soil sy stems (90 th percentile t1⁄2= 464 days in aerobic s ys tems and stable in anaerobic s ystems) and in aerobic/anaerobic water/sediment systems (extrapolated t1⁄2 ranged from 648 to 5,240 days). Due to persistence, degradation products observed in all sy stems 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, an d 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%, respectivel y) 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** F luopy ram represents a new group of fungicide chemistry (py ridinyl
- ethylbenzamides ). The biochemical mode of action involves the inhibition of the enzy me 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 SDHI s) include bo scalid and carboxin , among others (FRAC, 2009). As reported b y the registrant, at the fungal cell level, fluop yr am 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** Fluopy ram is a new pesticide that is proposed to be used in the United S tates to prevent and/or control certain fungal diseases on some major crops and therefore is expected to be applied in most agri cultural areas of the US. Fluopy ram is formulated as a suspension concentrate (SC) alone and mixed with four other fungicides: tebuconazole, trifloxystrobin, py rimethanil, and prothioconazole. Formulations are proposed to be applied by ground, airblast, and aerial spray into foliage (leaves, stems, and shoots), flowers and fruits.**11**

**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 e cological effects in this screening level risk assessment. Within each of these very broad taxonomic groups, an acute and/or chronic endpoint is selecte d 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 ( Le pomis 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 My sid ( 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 rye grass, (

Lolium perenne ), barley (Hordeum vulgare ) and onion (

Allium cepa ) Dicots

– soy

bean ( Glycine max) , sugarbeet (Beta vulgaris ), oilseed rape (Brassica napus ), cucumber ( Cucumis sativus ), buckwheat (Fagopyrum esculentum ) and sunflower (Helianthus annuus )**12**

**Table 3. Taxonomic groups and test species evaluated for ecological effects in this screening -**  **level risk assessment.**  **Taxonomic group**  **Representative species** 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 endpo ints presented in **Table 4** are used as inputs to the risk q uotient (RQ) method for expressing risk (US EPA, 2004). The designation of “l isted species ” refers to either federally threatened or endangered species. **Table 4. Toxicity endpoints used in risk quotient calculations**  **Taxonomic group Representative species**  Aquatic Animals Ac ute assessment
Chronic assessment Lo west tested EC 50 or LC 50 fo r freshwater fish and invertebrates and estuarine/marine fish and invertebrates acute toxicity tests. Lo west no - observed
- adverse
- effects
- concentration (NOAEC) for freshwater fish and invertebrates and estuarine/marine fish and invertebrates early lif

e - stage or full life
- cycle tests. Terrestrial Animals Ac ute avian assessment Chronic avian assessment Ac ute mammalian assessment Chronic mammalian assessment Lo west LD 50 (single oral dose) and LC 50 (subacute dietary). Lo west NOAEC for 21
- we ek avian reproduction test. Lo west LD 50 from single oral dose test. Lo west NOAEC for two - generation reproduction test or chronic dietary study**13**

**Table 4. Toxicity endpoints used in risk quotient calculations**  **Taxonomic group Representative species**  Plants Terrestrial non
- listed species Aquatic vascular and algae Terrestrial listed species Lo west EC 25 values from both seedling emergence and vegetative vigor for both monocots and dicots. Lo west EC 50 for both vascular and algae. Lo west EC 5 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 fluopy ram provide information regarding lethality , as well as sublethal measures of effect. Data are available on both the technical grade active ingredient ( TGAI) and the ty pical 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 fluopy ram technical are available for acute, subacute, and chronic exposure to birds, and acute and chronic exposure to mammals. Additional ecological effects data for fluopy ram are available for honey bees ( Apis mellifera ) and other nontarget terrestrial invertebrates. D ata are available on the toxicity of fluopyram formulations to the vegetative vigor and seedling emergence of terrestrial plants
. **2. Ecosystems at Risk** Ecosystems potentiall y atrisk reflect a potential concern b y 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 14** 

This risk assessment considers the maximum application rate of fluopy ram , the maximum number of applications , and the minimum application intervals as stated in the proposed label s to estimate exposure concentrations as a result of its proposed use . This assessment is not intended to represent a site or time
- specific anal ys is. Instead, this assessment is intended to represent high
- end exposures at a national level. Likewise, the most sensitive toxicity endpoints are used from surrog ate 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 surv ival 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 fluopy ram to cause adverse effects, to determine whether further testing is required, and to determine the need for precautionary label statements to minimize the po tential adverse effects to non
- target animals and plants (40 CFR §158.202, 2002 ). **D. Conceptual Model 1. Risk Hypotheses**  For fluop yr am, the following ecological risk hy pothesis is being emplo ye d for this risk assessment: Given the uses of fluop yr am 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, fluop yr am 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 biologicall y 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**15**

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, especial ly 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 fo r constituents, and the determination of potential exposure routes (e.g., ingestion, inhalation, and dermal absorption). Ecological receptors that may potentiall y be exposed to fluopy ram 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. A quatic receptors (e.g., freshwater and estuarine/marine fish and invertebrates, and amphibians) may also be exposed as a result of po tential migration of fluopy ram 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 fluopy ram . **2. Diagram** Based on the preliminary iterative process of examining fate , transport and effects data, the conceptual model or the risk hy pothesis 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) likel y 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 g iven the persistence of parent fluopy ram.**16**

**Figure 1 a**  The aquatic conceptual model for spray application of fluopy

ram to agricultural crops (dotted lines indicate unlikely routes of chemical dissipation)
.**17**

**Figure 1b** The terrestrial conceptual model for spray application of fluopy

ram to agricultural crops (dotted line s 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 s creening
- 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 LD 50 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 mo re certain the potential risks. However, the risk quotients are not necessarily a true estimate of risk since there**18**

is no estimated probability of effect. Risk presumptions, al ong with the corresponding RQs and LOCs , are summarized in **Appendix E**  . Generation of robust risk quotient s is dependent on the quality of data from both fate and toxicological studies. The adequacy of the submitted data i s 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 fluopy ram . For the ecological effects, **Table G -**  **1** (**Appendix G**) lists the status of ecological data requirements for fluop yr am. An additional Tier II seedling emergence study is requeste d for buckwheat (Fagopyrum esculentum ). For fate and transport, **Table G -**  **2** (**Appendix G** ) lists the status of fate and transport data requirements for fluop yr am . The adequacy of the submitted data was evaluated relative to Agency guidelines. In this respec t, it is noted that there were no hydrolysis and aerobic soil studies for two of the fluopy ram degradates, namely Fluop yram - 7 - hydroxy and fluopy

ram py ridyl
- carbox yl ic acid (Fluopy ram - PCA). None e xistence of th e s e 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 onl y, 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 use d 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 b y 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 (v2.98.4.6, 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 model s can be found at http://www.epa.gov/oppefed1/models/water/index.htm
.**19**

Measures of exposure for terrestrial mammals, birds, reptiles and amphibians similarly incorporate maximum proposed use rates but rel y less on fate properties. Terrestrial exposures were estimated using a number of methods. For fluopy ram , 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 di ssipation half
- life of the chemical. Inthe absence of data, a default half

- life of 35 days is used. In this assessment, the T
- REX model was run for fluopy ram use s (watermelon and strawberries) with the maximum proposed application rate (0.222 lb a.i./A), a maximum o f 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 b y the registrant regarding the fol iar 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 presente d in the model T
- REX Version 1.4.1 (October 2008 )
. F or more details see **Appendix C**  and the Exposure Characteri zation section of this document
. TerrPlant is used b y 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 s emi
- 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, p ecan, 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 e ach chemical, application method and rate and then compares these exposure estimates to avian and mammalian toxicity

data. The model estimates avian
- inhalation toxicity v alues, 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 v alues to**20**

account for differences in avian and mammalian inhalation toxicity
. The Screening Imbibition Program (SIP, version 1.0, July 2 010) was used to upper-bound drinking water exposure potential using fluopy

ram’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 ty pically 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 ecos ys tems. 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 LD 50 , LC 50 , or EC 50 ) 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 betwe en these effects and higher
- order processes is highl y uncertain . The latter can reflect changes seen in mortality , reproduction, or growth. In general, for a given assessment endpoint , the lowest relevant measure of effe ct 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 recepto rs to include birds, mammals, reptiles, amphibian, fish, terrestrial and aquatic invertebrates and terrestrial and aquatic plants. The response of these receptors to fluopy ram 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 calcul ate risk to accommodate for some of this inherent uncertainty. The ecos ys tems selected for modeling using PRZM/EXAMS aquatic assessment and T
- REX for the terrestrial animal assessment are intended to be generall y representative of any aquatic or**21**

terrestrial ecos ys tem associated with area s where fluopy ram is used. The receptors addressed b y the aquatic and terrestrial risk assessments for fluopy ram are summarized in **Table 3** . For aquatic assessments, generall y 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/se eds/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 terre strial 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 toxi city data available for these various classes of aquatic and terrestrial receptors is provided in the Ecological Effects Characterization section and in **Appendix D**  .**22**

**III. Analysis**  **A. Use Characterization** Fluopy ram is proposed to be widel y 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. Fluopy

ram is formulated as a suspension concentrate (SC) alone and mixed with four other fungicides: tebuconazole, trifloxystrobin, py rimethanil, and prothioconazole. Formulations are proposed to be applie d 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 fluopy ram and/or its mixtures. Table III - 1 Crops included in the proposed crop group use patterns for fluopy ram 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 Soy beans) 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, mo th 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 Straw berries Straw

berries Sugerbeet Sugerbeet
Tree Nuts Almonds, Pecan, Pistachio , Beech nut, Brazil nut, Butternut, Cashe w, 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 fluop yram and its four premixed formulation including labeled application parameters**23**

**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**

Al mond **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 Py rimethanil= FLU+PYM; and With Prothioconazole= FLU+PTZ. **2 Num**  **ber 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**24**

**B. Exposure Characterization 1. Environmental Fate and Transport Characterization**  **Physical and chemical properties** The physical and chemical properties of fluopy ram are summarized in **Table 5**  . The chemical is characterized b y a water solubility of 16 ppm in acidic and alkaline conditions. The chemical has a low potential for volatilization from dry and wet surfaces (v apor pressure= 2.33 x 10 - 8 torr and Henry ’s Law constant= 2.94 x 10 - 10 atm m3 mole - 1 , respectivel y at 25 °C). Therefore relativel y 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 Form ula C 16 H 11 Cl F 6 N2 O CAS number 658066
- 35
- 4 PC code 080302 Molecular Weight (g/mol) 396.72
Solubility (@ 20 ̊ C) pH 4 → **15 m g/L** 

pH 6.7 & 7.0 → **16 m g/L**  pH 9 → **15 m g/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 Solv e nts 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 m3 mole - 1 Calculated from VP at 25°C Kow **2,060** (Log Kow = 3.3 14 ) MRID 47372245**25**

The n
- octanol water partition coefficient (Kow) of fluopy ram (2,060) suggests a moderate potential for bioaccumulation in aquatic organisms such as fish. **Fate and Transport Properties** The fate and transport behaviour of fluop yr am has been investigated in a series of laboratory and field studies. The laboratory studies were all conducted with 14 C
- labelled active substance uniformly labelled in one of the two rings: the phenyl and the p yridylrings ( **Figure 3**  ).

N H O N

Cl C F 3 C F 3

* * denotes position of radiolabel, uniformly labelled in

the phenyl ring N H O N

Cl C F 3 C F 3
* *
* denotes position of radiolabel, labelled in the 2
- and

6
-position of the pyridyl ring **[phenyl -**  **UL**   ** 14** **C] Fluopyram [pyridyl** **- 2,6**  **- 14**  **C] Fluopyram Figure**  **3** Positions of radiolabels for fluopy ram used in fate and transport studies **a. Abiotic Degradation**  Fluopy ram labeled at both the [phenyl
- UL 14 C] and the [py rrdyl
- 2,6 14 C] was used in conducting hydrol ys is and photol ys is studies. In the hydrolysis study , the chemical was shown to be practicall y stable in acidic/neutral/alkaline aqueous buffered solutions (pHs 4, 7 and 9; MRIDs 47372 3
- 03/04). The chemical was also shown to degrade relativel y slowl y by aqueous photolysis (t1⁄2= 57 days; MRID 473723
- 07) and was practically stable by photolysis on soil surfaces subjected to sunlight (t1⁄2= 54 days, MRID 473723
- 06). Results indicate that hydrol ys is and aqueous and on soil photolysis are not important in fluopy ram dissipation in the natural environment. The fate properties of fluop yr am in abiotic systems are summarized in **Table 6** 
. **Table 6** F ate properties of fluopy ram in abiotic s ystems **Prop erty**  **Description or Value Reference**  * Hydroly sis half

- life **Stable** 473723
- 03**26**

**Prop erty**  **Description or Value Reference**  * Aqueous photolysis half
- lives (two labels) **57 days (m ean value) i** n aqueous buffered solution at pH 7 **

**87 days (m ean value) i** n sterile natural water from the Rhine River 473723
- 04 And 473723
- 0 5 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 fluopy ram in biotic systems are summarized in **Table 7**  . **Table 7** F ate and transport properties of fluopy ram 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**27**

**Property Description or Value**  **Reference** *

Aerobic aquatic Half
- lives (two labels, two systems) **Pond water/sedim ent 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 (**  [Py ridyl label) in the total system (extrapolated beyond the study duration of 120 days) **(Note: the chem ical dissipated from** **the water into the sediment with a**  **half -**  **life of 17 & 14 days, respectively**  ) **Pond water/sedim ent sy**  **stem from Ger**  **ma ny: 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 **Non e**  473723
- 11 Anaerobic aquatic half
- lives (two Labels/one system) **Pond water/sedim ent 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 transf ormation products, Fluopyram
benzamide and Fluopyram
- PCA with maximum concentrations of 9.8 μg/kg (equivalent to 19% of 0
- day parent) and 10.2 μg/kg (16%), respectively, at 6 DAT Minor Degradation products: one minor transformation product, Fluopyram
7 - hydroxy

with a maximum concentration of 3.0 μg/kg (3% of 0
- day parent equivalent) were observed at the CA site 475670
- 01 475670
- 02 475670
- 03 475670
- 04 and 475670
- 05**28**

**Property Description or Value**  **Reference** *

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 wa s 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 (i somer 1), Fluopyram
- 8
- OH
- GA (isomer 2) and Fluopyram
- py ridyl 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 the se studies is included in **Appendix A**
. **c. Tranformation Profile**  The primary

metabolic pathway for fluop yram in soil is hydroxylation in the 7
-position of the molecule to form the hydrox yl ated metabolite, Fluopy ram - 7 - hydrox y. Fluopy

ram - 7 - hydrox y 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 nearl y constant low concentration of this degradate suggests that it is a transient species. It appears that the transient Fluopy ram - 7 - hydrox y is cleaved to form, in most cases, minor quantities of the metabolites Fluopy ram - PCA (py

ridyl
- carbox yl ic acid) and Fluopy ram benzamide. Further degradation of the py ridyl
- Fluop yram - PCA appear to result in the formation of the degradate methyl
- sulfoxide. In addition the expected very limited aquatic photo
- degradation of fluopy ram results in the degradate lactam in quantities ranging from 1 to 13% ( **Figure 4**  ).**29** C F 3 O N

H N C F 3 Cl

C F 3 O **N H**  **2 O**  **H** N C F 3 Cl
**O**

O H N C F 3 **S**
**O O**  **C H**  **3** C F 3 O N

H N C F 3 Cl
**O H**  **Figure 4**  Environmental degradation pathways for fluopyram

**Fluopyram Parent** 

N C F 3 N H O F 3 C **Molecular Cleavage**

**Lactam 7**  **- Hydroxy**  **Cleavage**

**Benzam ide**  **PCA**

**Me thyl Sulfoxide**  Limited aerobic soil degradation ( Parent hydroxylation) Very limited aqueous p hotolysis**30**

**Che mical Names (Molecular Formula** 
**– Weight; No CAS number reported)**  **Lactam :**  2,9
-bis(trifluoromethyl)
- 6,7
- dihydropy rido[2,3
- e][2]benza
- zocin
- 8(5H)
- one [ C 16 H 10 F 6N 2 O
- 360.26 g mol - 1 ] **7 -**  **Hydroxy:** N - {2
- [3
- chloro
- 5 - (trifluoromethyl)pyridin
- 2
- yl]
- 2
- hydroxyethyl}
- 2
- (trifluoromethyl)benzamide [ C 16 H 11 Cl F 6N 2 O 2 - 412.72 g mol - 1 ] **Benzam ide:**  2
- (trifluoromethyl)benzamide [ C 8 H 6 F 3 NO
- 189.14 g mol - 1 ] **PCA:** 3
- chloro
- 5 - (trifluoromethyl)pyridine
- 2
- carboxylic acid [ C 7 H 3 Cl F 3 NO 2 - 225.26 g mol - 1 ] **Me thyl Sulfox** **ide:** 3
- (methylsulfinyl)
- 5 - (trifluoromethyl)pyridine
- 2
- carboxylic acid [ C 8 H 6 F 3 N O 3 S
- 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 san d and clay

loam soils, respectivel y. 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 0.86 3) indicating that the concentration of the test item affected the adsorption behavior
. Based on Kfoc values, mobility

of fluopy ram in the tested soils is classified as moderate in accordance to the FAO mobility

classification. Additionally , the adsorpti on/desorption behavior of the degradate [py

ridine
- 2,6
- 14 C] Fluopy

ram - 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, respectivel y. 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 fluopy

ram in the tested soils is classified as high to moderate in accordance to the FAO mobility classification. For the parent desorp tion 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, respectivel y. 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 Fluopy ram - 7 - hydrox y 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
- hydrox y 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**31**

**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** Fluopy ram has a low vapor pressure (9x10 - 9 torr) and its solubility in water is 16 ppm. F luopy ram is highly persistence under all other abiotic/biotic conditions tested in the laboratory
. The chemical is stab le to aqueous hydrol ys is 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, fluopy ram has shown similar persistence especiall y 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, fluop yr am 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 f rom 316 to 591 L/Kg). The major routes of dissipation for fluopy ram in important compartments of the natural environment appear to be the slight bio
transformation in aerobic systems. The relative high persistent, and mobility of fluopy ram 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. Fluopy ram can also reach surface water through erosion, drift and/or run
- off events. Based on fate and transport properties and the degradation profile of fluopy ram, environmental**32**

exposure of aquatic systems may o ccur from parent and two main degradates, namel y: m ethyl sulfoxide and benzamide in addition to limited quantities of lactam in shallow clear wat er systems. Examination of the soil metabolism data suggests that a limited quantity o f 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
. Onl y one study w as submitted for degradate toxicity which suggest parent is more toxic than degradate. Inthis respect, the Global Residues of Concern Knowledgebase Subcommittee (Global ROCKS) decided that only p arent 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. A**  **pplication Methods** Fluopy ram is formulated as suspension concentrates alone or admixed with other fungicides and applied as liquid sprays or through drip irrigation (watermelon s 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 applicatio n rates. Exposure was evaluate d for all crops and all application methods
. **b. Label Application Rates and Intervals** Fluopy ram labels may

be categorized into two ty pes: labels for manufacturing uses (including technical grade fluop yr am) and its formulated products or end
- use products. While technical products, which contain fluopy ram of high purity , are not used directl y 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 legall y 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 fluopy ram 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**33**

**Crop Scenario**  ***** **Single Application Rate Number of**  **Applications Date of 1**  **st**

**Application (DD/MM)** ****** **lb a.i./A Kg a.i./ha** 

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; Ai r**  **blast 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**34**

**Crop Scenario**  ***** **Single Application Rate Number of**  **Applications Date of 1**  **st**

**Application (DD/MM)** ****** **lb a.i./A Kg a.i./ha**  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 Straw berries, Drip only FLstraw berry _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 Legge d Frog scenario; and OP= organo phosphate 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 fluop yram 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 ratio s 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 ca

pacity , 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 onl y short periods of time and are then carried downstream.**35**

**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
- m 3 mo l - 1 @ 20 o C ) **2.94E -**  **10** Solubility in Water(mg/L) **16** Photolysis in Water (t1⁄2 in days @ pH 7) **57** Aerobic Soil Metabolism (90 th % t1⁄2 in days for 6 soils x two labels ) **464** Hydroly sis (t1⁄2 in days @ pH 7) **Stable** Aerobic Aquatic Metabolism ( 90 th % t1⁄2 in days whole system t1⁄2 in days for two systems x two labels ) **1,360** Anaero bic Aquatic Metabolism (90 th % t1⁄2 in days whole system t1⁄2 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 concentra** **tions varied from 0.01 to 5.47 μ g a.i./L.**  **Table 11**  Surface water 1
- in
- 10 Year EECs (μg/L) for fluopy ram use patterns applied by aerial and ground equipment **Crop Scenario**  **Peak 21**  **- day**  **60 -** **day Aerial** **36**

**Crop Scenario**  **Peak 21**  **- day**  **60 -** **day** 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 37** 

**Crop Scenario**  **Peak 21**  **- day**  **60 -** **day**

WApotatoNMC **1.70 0.250**  **0.088** MEpotatoSTD **1.68 0.380**  **0.150** Straw berries, Drip only FLstraw

berry _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 highes t and lowest surface water EECs. The s e data are summarized in **Table 12** 
. **Table 12**  Sediment (μg/Kg) and p ore 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 38** 

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. Appl ication methods of fluopy ram 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 ir

rigation 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 Application**  **s** 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 insect s when foraging in the treated fields for nesting material or food. Therefore, for fluop yr am 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). Specificall y, 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) b y a value specific to each food item
. These values (termed the Hoerger
- Kenaga estimates) along with a more detailed discussion of the methodo logy

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 immediatel y 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 fluopy ram are summarized in **Table 8**
. Inthe 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 additi onal anal ys is of available submitted foliar dissipation data ( see the **Description of Assumptions, Limitations, Uncertainties, Strengths and Data Gaps** section). In this respect, the EECs for fluop yram may be an overestimation of actual concentrations, if the half
- life under field conditions is lower than the default value.**39**

Risks could also be overestimated if the actual application rate, frequency of application or number of applic ations 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 appl ication 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 c oncentrations in the environment. Although the label stated that fluopy ram 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 fluopy ram 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 ye ar, exposure estimates and risk to terrestrial organisms could be signific antly underestimated. **Table 13 . Input**  **parameters used in T -**  **REX v1.4.1 to determine terrestrial EE**  **Cs for the m axim**  **um fluopyram**  **spray application scenario. a**  **Input Variable Param**  **eter Value Source**  Maximum application rate 0.222 lb s 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 dail y oral dose based on the fraction of body weight consumed daily as estimated through mammalian allometric relationships. The screening
- level risk assessment for fluopy ram considers upper-bound predicted resid

ues as the measure of exposure. Summaries of the predicted upper
-boun d and mean residues of fluop yr am 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 applicati on scenario, acut e concentrations on f oliar surfaces ranged from 6.35 to 101.54 ppm f or upper-bound residues and 2.96 to 35.96 ppm for mean residues. **Table 14 . Upper**  **- bound and m**  **ean terrestrial dietary**  **EECs estimat ed for the m**  **aximum fluopyram spray**  **applicat ion scenario**  **(Kenaga values) .**  **a**

**Forage Type Upper**  **- bound Residues (ppm)**  **Me an Residues (ppm)** **40**

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)**  Fluopy ram is a new chemical, therefore no data are available on terrestrial monitoring for fluopy ram . **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 application s , 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 fluop yr am can produce in aquatic or terrestrial organism s . As fluopy ram 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. Onl y 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 usuall y 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 L C 50 and EC 50 values or limit of solubility ), mammals (based on LD 50 values), avian species (based on and LD 50 and L C 50**41**

values), and non
- target insects (based on LD 50 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 fluopy ram are summarized in **Table 1 5**  **.** 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 fluopy ram applications is given in **Appendix E**
. F or fluop yr am , all fluop yram technical toxicity end points 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, toxi city endpoints from studies on aquatic organisms ( fish and invertebrates) with the ty pical 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 fluopy ram is 16 ppm or (mg a.i./L). Many

of the submitted aquatic toxicity tests for fluopy

ram 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 fluop yr am . The formulated product appears to have a higher level of solubility based on the submitte d toxicity studies. S ee 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 fluopy ram degradates to any non - target aquatic organism. An algal study with fluopy ram - lactame has been submitted and is summarized below. **Table 1 5**  **. Toxicity reference values for**  **aquatic organisms exposed to fluopyram technical or form** **ulated 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 LC 50 >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**42**

**Table 1 5**  **. Toxicity reference values for**  **aquatic organisms exposed to fluopyram technical or form** **ulated fluopyram** **( Fluopyram SC 500A, 41.5% active ingredient)**  **. Exposure**  **Scenario % Active** 

**Ingredient Species**  **Exposure Duration**  **Toxicity**

**Reference Value**  **Effect Reference**  **(Classification)** TEP 41.5% Rainbow Trout

Oncorhynchus mykiss 96 hours LC 50 >46.4 mg a.i./Lb 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. C ompared 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 EC 50>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 EC 50>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 μg a.i./L LOAEC = 2996 μg a.i./L Offspring production was affected

at the highest treatment level, 2996 μg 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 μg a.i./L. MRID 47372334 (Acceptable)

**Estuarine/Marine Fish 43** 

**Table 1 5**  **. Toxicity reference values for**  **aquatic organisms exposed to fluopyram technical or form** **ulated fluopyram** **( Fluopyram SC 500A, 41.5% active ingredient)**  **. Exposure**  **Scenario % Active** 

**Ingredient Species**  **Exposure Duration**  **Toxicity**

**Reference Value**  **Effect Reference**  **(Classification) Acute**  TGAI

94.7% Sheepshead minnow

Cyprinodon variegatus 96 hours LC 50 >0.98 mg a.i./La 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 EC 50>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. MRID 47372327 (Acceptable)

**Chronic** Data Gap **Freshwater Benthic Invertebrates Acute**  Data Gap
**Chronic** TGAI

94.7% Midge

Chironomus tentans 54 days Sediment concentrations NOAEC = 26 mg a.i./kg sediment LOAEC = 48 mg a.i./kg sediment Pore water concentrations NOAEC = 3.8 mg a.i./L pore water LOAEC = 8.8 mg a.i./L pore water The most sensitive endpoints

were larval survival (assessed on day 20) and percent emergence. These endpoints were statistically
- reduced at the 48 and 96 mg TRR/kg sediment levels. Midge growth (assessed on day 20) and development rate for both sexes were statistically
- reduced at the 96 mg TRR/kg sediment level. MRID 47372339 (Supplemental)

**Estuarine/Marine Benthic Invertebrates 44** 

**Table 1 5**  **. Toxicity reference values for**  **aquatic organisms exposed to fluopyram technical or form** **ulated fluopyram** **( Fluopyram SC 500A, 41.5% active ingredient)**  **. Exposure**  **Scenario % Active** 

**Ingredient Species**  **Exposure Duration**  **Toxicity**

**Reference Value**  **Effect Reference**  **(Classification) Acute**  TGAI

94.7% Saltwater amphipod

Leptocheirus plumulosus 10 days Sediment value: LC 50 > 100 mg a.i./kg sediment NOAEC=100 mg a.i./kg sediment Pore water value : LC 50 > 7.5 mg a.i./L pore water NOAEC = 7.5 mg a.i./L pore water Mortality was 1, 5, 6, 3 and 2% in

the 5.8, 14, 26, 51 and 100 mg 14 C
- AEC656948 equivalents/kg dry sediment treatment groups, respectively. No sublethal effects observed. MRID 47372338 (Acceptable)

**Chronic** TGAI

94.7% Saltwater amphipod

Leptocheirus plumulosus 28 days Sediment concentrations NOAEC = 36 mg TRR/kg sediment LOAEC = 92 mg TRR/kg sediment Pore water concentrations NOAEC = 2.5 mg TRR/L pore water LOAEC = 5.9 mg TRR/L pore water The reviewer’s analysis detected a

significant difference between the negative and solvent control groups for this endpoint, with significantly fewer (25%) offspring produced in the solvent control group. The dose
- response for reproduction was poor. MRID 47372335 (Supplemental)

**Aquatic Plants 45** 

**Table 1 5**  **. Toxicity reference values for**  **aquatic organisms exposed to fluopyram technical or form** **ulated fluopyram** **( Fluopyram SC 500A, 41.5% active ingredient)**  **. Exposure**  **Scenario % Active** 

**Ingredient Species**  **Exposure Duration**  **Toxicity**

**Reference Value**  **Effect Reference**  **(Classification)**

**Algae Acute** TGAI

94.7% Pseudokirchneriella

subcapitata 96 hours EC 50 = 4.3 mg a.i./L NOAEC = 1.46 mg a.i./L (biomass) Biomass was the most sensitive

endpoint. Compared to the control, the percent inhibition ranged from 10
- 99% for cell density, 9
- 99% for biomass and 2
- 95% for growth rate. Mean
measured concentrations were <0.005 (<LOQ; controls), 0.093, 0.241, 0.584, 1.46, 3.78, and 9.53 mg a.i./L. No cell abnormalities were reported. MRID 47372403 (Acceptable)

TEP 41.5% Pseudokirchneriella

subcapitata 72 hours EC 50 = 3.4 mg a.i./L NOAEC = 1.17 mg a.i./L (cell density) Cell density was the most

sensitive endpoint. Compared to the control, the percent inhibition ranged from
- 18
- 99% for cell density and
- 3.4
- 110% for growth rate. Mean - measured concentrations were <0.002 (<LOQ; controls), 0.379, 1.17, 3.84, 12.5, and 38.65 mg a.i./L. No cell abnormalities were reported. MRID 47372407 (Acceptable)

Fluopyram
lactame (metabolite) 94% Pseudokirchneriella

subcapitata 7 2 hours EC 50 >8.87 mg a.i./L NOAEC = 8.87 mg a.i./L (for both cell density and growth rate) No treatment - related effects were

observed at the highest level tested for either cell density or growth rate. MRID 47372418 (Acceptable)**46**

**Table 1 5**  **. Toxicity reference values for**  **aquatic organisms exposed to fluopyram technical or form** **ulated fluopyram** **( Fluopyram SC 500A, 41.5% active ingredient)**  **. Exposure**  **Scenario % Active** 

**Ingredient Species**  **Exposure Duration**  **Toxicity**

**Reference Value**  **Effect Reference**  **(Classification)**

**Macrophyte Acute**  TGAI

94.7% Duckweed

Lemna gibba 7 days EC 50 = 2.6 mg a.i./L NOAEC = 0.2 8 mg a.i./L (frond number based on yield) Frond number based on yield was

the most sensitive endpoint. There were no phytotoxic effects in the first three treatment levels. S mall fronds and slight chlorosis were observed in the 4.04 mg a.i./L te st concentration, while single fronds and slight to medium chlorosis were observed in the highest test concentration (8.88 mg a.i./L). Based on frond number, the percent inhibition in the treated samples as compared to the negative control ranged from 1.2 to 92.9%. Based on frond area, the percent inhibition in the treated samples as compared to the negative control ranged from
- 3.8 to 90%. MRID 47372401 (Acceptable)

TEP 41.6% Duckweed

Lemna gibba 7 days EC 50 = 2.9 mg a.i./L NOAEC = 1.04 mg a.i./L (frond number based on yield) The most sensitive endpoint was

frond number based on yield. There were no phytotoxic effects in the first two treatment levels. Small fronds, medium necrosis, and slight chlorosis were observed in the 4.34 mg a.i./L te st concentration. S ingle fronds, sm all fronds, and medium necrosis were observed in the 8.42 mg a.i./L

treatment level. Small fronds, medium necrosis, single fronds, and strong necrosis were observed in the highest test concentration (15.9 mg a.i./L). Based on frond number, the percent inhibition in the treated samples as compared to the negative control ranged from 3.9 to 94.5%. Based on frond area, the percent inhibition in the treated samples as compared to the negative control ranged from 9.7 to 92.2%. MRID 47372402 (Acceptable)

**a** These values were used for evaluation of risk via spray drift only
. Freshwater Fish Acute freshwater fish studies with technical
- grade fluopy ram were conducted up to the limit s of solubility determined under the specific test conditions , which ranged from ~ 2 to 5 mg a.i./L
. No**47**

mortality or sublethal effects were observed at the solubility limit (1.78 mg a.i./L , mean measured) in a 96
- hour study with rainbow trout ( Oncorhynchus mykiss) and fluopy ram TGAI
. Similar results were observed in other 96
- hour studies with freshwater fish. In the acute toxicity test with bluegill sunfish ( Lepomis macrochirus ) , no mortality or sublethal effects were observed at any treatment level ( LC 50 > 5.17 mg a.i./L and NOAEC = 5.17 mg a.i./L). In an acute toxicity test with fathead minnow ( Pimephales promelas ) , the LC 50 was greater than 4.95 mg ai/L and NOAEC was 4.95 mg ai/L, based on no observations of mortality or sublethal effects. All three of these acute tests are considered acceptable. One additional acute test was submitted for a freshwater fish species, the common carp ( Cyprinus carpio ). However, this study is considered unacceptable (invalid) due to the presence of undissolved test material at all test levels and high variability

in measured concentrations. Based on the results of submitted toxicity studies, fluopy ram is considered to have little or no toxicity to freshwater fish up to the reported limit s of solubility
. A study with the formulated fluopy ram end
- use product (Fluop yr am SC 500; 41.5% active ingredient) was also conducted with the rainbow trout and the 96
- hour LC 50 was greater than 46 .4 mg a.i./L. The calculated L C 50 is based on time
- weighted average concentrations. Some sublethal effects were observed and the EC 50 and NOAEC values, based on sublethal effects, were 3.71 and 1.31 mg ai/L , respectivel y. Sublethal e ffects observ ed throughout the test included inactivity

or abnormally

low activity , labored respiration, remaining on the bottom of the test vessel, dark coloration, surfacing, l ying on their side or back, loss of equilibrium with lateral deviation from their normal orientation and displaying mucous excretions from the intestine. Undissolved test material was observed at the three highest treatment levels in this study
. The mean of the measured test concentrations are within 88 to 98% of the nominal, implying that the undissolved test material was included in the chemical analyses. However, the bioavailability

of the undissolved test material is uncertain, and therefore the study is classified as supplemental
. An earl y- life stage study

with fluopy

ram technical was also submitted for freshwater fish. Fertilized fathead minnow ( Pimephales promelas ) eggs/embryos (<24 hours old) were exposed to fluopy ram technical for 33
- days . In this study , t ime to hatch and hatching success were unaffected b y exposure. Statistically signi ficant larval mortality (5%) was observed at the highest treatment level (1.05 mg ai/L) onl y. Hatched larval survival was 100% at all other control and treatment levels on day

5 (prior to thinning). Reduction in post
- hatch survival also occurred at the two highest treatment levels compared to the negative control. In addition, the growth of surviving fry

was adversely

affected by

exposure. Mean length and weight of the surviving fry were reduced comp ared to the negative control at the two highest treatment levels (0.560 and 1.05 mg ai/L). Treatment - related signs of toxicity were observed at the three highest treatment levels (≥0.269 mg ai/L) from days 20 to 33. These abnormalities included deformed mouth, ventral hematoma, labored respiration, remaining at the water surface, dark coloration, swollen belly , loss of equilibrium (with lateral deviation from normal orientation), and/or lordosis. This study was determined to be acceptable, with a NOAEC was determined to be 0.135 mg a.i./Lfor this study, with a LOAEC of 0.269 mg a.i./L based on observed sublethal effects
.**48**

Freshwater Invertebrates Toxicity tests that evaluated the effects of both technical grade fluopy ram and formulated fluopy ram (Fluopy

ram SC 500 G) to freshwater invertebrates were submitted and were found to be acceptable
. Technical grade fluopy ram caused no mortality

or sublethal effects at any treatment level in a 48
- hour test with water fleas (Daphnia magna ; EC 50 >17 mg a.i./L and NOAEC=17 mg a.i./L). Dimethylformamide (100 μ g/1000 ml test water) was used as a solvent in this test. The 48
- hour acute toxicity endpoints of the fluopy

ram end
- use product to Daphnia magna were EC 50 > 38.2 mg a.i./L and NOAEC =11.6 mg a.i./L, based on imm obility
. Immobility

was observed at the two highest treatment levels (20.4 and 38.2 mg a.i./L) in 13 and 20 percent of the test organisms , respectivel y . Based on the results of these studies, fluopy ram technical would be classified as practicall y nontoxic to freshwater invertebrates and formulated fluopy ram is classified as no more than slightl y toxic to Daphnia magna on an acute toxicity basis. In a 96
- hour shell deposition test with the eastern oyster ( Crassostrea virginica ), there was no mortality or inhibition of shell growth. Shell growth was promoted in all treatment levels, relative to the negative control group. The EC 50 was >0.43 mg ai/L and the NOAEC was 0.43 mg ai/L. A solvent (DMF, 0.1 mL/L) was used in this study, so it is unclear why the t est concentrations of fluop yr am in the study are considerabl y lower than the reported solubility of the chemical. Based on an acceptable 21
- day chronic life cycle study with Daphnia magna , the chronic NOAEC of fluop yr am technical i s 1 .214 m g ai/L
. Treatment - related effects on offspring production and terminal body lengths of surviving females were observed at the highest treatment level ( LOAEC = 2 .996 m g ai/L)
. The 21
- day EC 50 for adult immobility (mortality) was >2 .996 m g ai/L
. A non - guideline sub
- chronic study with benthic freshwater invertebrates was also submitted
. The 28
- day toxicity of technical
- grade fluop yr am to the freshwater dipteran Chironomus riparius was studied under static conditions with aeration. First instar larvae were exposed to f luopy ram via spiked water. E ffects on emergence were observed at the two highest treatment levels (overl ying water concentrations of 1.63 mg ai/L and 6.76 mg ai/L) and effects on development rate occurred at the highest treatment level (6.76 mg ai/L)
. The 28
- day EC 50 exceeded the highest concentration level for emergence ratio and development rate ( EC 50 > 5.52 mg ai/L) . However, the reviewer was unable to calculate emergence ratio or discern replicate data to conduct an independent verification of th e results because raw data was not submitted
. Therefore, this study is currentl y uncategorized , pending the submission and review of the requested data. The chronic toxicity

of fluopy ram to the freshwater midge Chironomus tentans was studied during 54
- day

life
- cycle test. The total radioactive residues (TRR) were measured in this test and include both the parent compound and any degradates. As fluopy

ram appears to be resistant to degradation, the TRR are considered to be approaching the actual parent compound**49**

concentrations. The NOAEC was 26 mg total radioactive residue ( TRR) /kg dry sediment (corresponding with 3.8 mg TRR/Lpore water), based upon statistically
- significant reductions in larval survival on day

20 (17
- 40% reduction) and percent emergence on day 5 4 ( 26
- 28% reduction) compared to the negative control
. These endpoints were statistically
- reduced at the 48 and 96 mg TRR/kg sediment levels. Midge growth on day 20 ( 26% reduction) and development rate for both sexes ( 25% reduction) were statistically
- red uced at th e 96 mg TRR/kg sediment level. No treatment - related effect on time to death for mated adults, number of eggs per female, or percent hatch of egg masses were indicated. This study is considered supplemental because it is a non
- guideline study , but it provides adequate information to assess chronic risk to freshwater benthic invertebrates. Estuarine/marine Fish An acute toxicity

study for fluopy

ram technical was conducted on sheepshead minnow ( Cyprinodon variegates ). No mortality or sublethal effects were observed at any treatment level ( LC 50 > 0.98 mg a.i./L and NOAEC=0.98 mg a.i./L). Based on the results of this acceptable study , fluop yr am technical is practicall y nontoxic to estuarine/marine fish. No studies were submitted to examine fluopy ram chronic effects on estuarine/marine fish. Estuarine/marine Invertebrates An acute 96
- hour study

with the saltwater mys id , there was 10% mortality in the highest treatment group (0.51 mg ai/L) and no mortality was detected in the lower treatment levels or controls ( LC 50 : >0.51 mg ai/L, NOAEC = 0.27 mg ai/L). No studies were submitted to examine fluopy ram chronic effects on estuarine/marine invertebrates in the water column. A short
- term 10
- day

s tudy w as submitted for sediment - dwelling estuarine/marine invertebrates. No treatment - related effect on survival of the marine amphipod Leptocheirus plumulosus was observed. The data for the marine amphipod Leptocheirus plumulosus suggest that fluop yr am is practicall y non - toxic to benthic saltwater invertebrates, as no treatment - related effect on survival were observed ( LC 50 >100 mg TRR/kg dw sediment and > 7.5 mg TRR/L pore water).**50**

Chronic data were also submitted for estuarine/marine benthic invertebrates. Ina 28
- day test with the estuarine amphipod Leptocheirus plumulosus , neonates were exposed to fluopy ram spiked sediment. The 28
- day NOAEC was 36 mg TRR/kg sediment (corresponding with 2.5 mg TRR/Lpore water), based upon a statistically
- significant reduction in dry w eight (X %) compared to the negative control at the 92 mg TRR/kg sediment level (corresponding with 5.9 mg TRR/Lpore water). An effect detected in reproduction at 6.3 mg TRR/kg sediment is not considered to be treatment related due to a very poor dose
- response for this endpoint. For all test levels, no treatment
- related effects on survival were observed. Offspring production was reduced at all levels (6 to 41%) and significantl y s o (p<0.05) at the second lowest treatment level (6.3 mg TRR/kg). The averag e number of offspring per amphipod ranged from 5 to 9 for all levels. However, the dose
- response for this endpoint is considered very poor as the offspring survival increased at higher concentrations and there was a high degree of variability in response
. In addition, a significant difference was detected between the negative and solvent control for the reproduction endpoint, with significantl y fewer offspring produced in the solvent control. The potential effect of the solvent on reproduction confounded th e effect observed for this endpoint, so interpretation of these results should be made with caution. This study is considered supplemental information due to potential solvent effects on reproduction and the lack of statistical power for this endpoint ( onl y effects 38 % or above, relative to controls, would be statistically

significant). Aquatic Plants Five algal toxicity

studies were submitted for fluopy ram technical
. The results of these studies varied among species. For two species, no adverse effects were observed in the submitted toxicity studies. Specifically , in a 96
- hour acute toxicity study with the saltwater diatom Skeletonema costatum , the NOAEC and EC 50 values for all three endpoints (cell density, biomass and growth rate) were 1.13 and >1.13 mg a.i./L , respectivel y. The results for blue
- green algae Anabaena flos
- aquae were similar, as no endpoint was affected b y fluopyram technical at any test level (NOAEC = 9.69 mg a.i./L and EC 50 >9.69 mg a.i./L). Other species exhibited negative effects on cell density, biomass and growth rate following exposure to fluopy

ram technical. In a 96
- hour acute toxicity study with the freshwater diatom Navicula pelliculosa , the most sensitive endpoint was biomass, with NO AEC and EC 50 values of 2.47 and 6.1 mg a.i./L , respectively
. Two studies were conducted with the freshwater green algae Pseudokirchneriella subcapitata

– one study with the fluopyram technical and another study with the fluopy

ram formulated product (SC 50 0 G). Ina 96
- hour acute toxicity study , cultures of the freshwater green algae Pseudokirchneriella subcapitata were exposed to AE C656948 (Fluop yram ) Technical. The most sensitive endpoint was biomass, with NOAEC and EC50 values of 1.46 and 4.3 mg a.i./L , respectivel y. In a 72
- hour acute toxicity study , cultures of Pseudokirchneriella subcapitata were exposed to the fluopy

ram formulated product . The more sensitive endpoint was cell density, with NOAEC and EC 50 values of 1.17 and 3.4 mg a.i./L, respectivel y . Based on the results of these**51**

studies, fluopy

ram appears to have effect s on algal growth at similar levels , whether the exposure occurs in the form of the active ingredient alone or the as the formulated product. However, the duration of exposure was shorter for the study with the formulated product and the study with the formulated product was conducted with a higher light intensity than the study

with the technical product (5620
- 7090 lux compared to 4300 lux). The s e factors may have influenced the results. One algal study with Pseudokirchneriella subcapitata was submitted for the degradate fluopy ram lactame, and no treatment
- related effects were observed ( EC 50 >8.87 mg/L and NOAEC = 8.87 mg/L). Two aquatic vascular plant studies were submitted for fluop yram, one study with the technical product and another with the formulated product ( Fluopy ram SC 500A). Ina 7 - day acute toxicity study , the freshwater macrophy te, duckweed (

Lemna gibba ) , was exposed to fluopy ram technical. The most sensitive endpoint was frond number based on yi eld, with NOAEC and EC 50 values of 0.278 and 2.6 mg a.i./L, respectivel y. There were no phytotoxic effects in the first three treatment levels. Small fronds and slight chlorosis were observed in the second highest treatment level (4.04 mg a.i./L), while single fronds and slight to medium chlorosis were observed in the highest test concentration (8.88 mg a.i./L). In another 7 - day acute toxicity

study , freshwater duckweed (

Lemna gib ba ), was exposed to the formulated fluop yram product. Small fronds, necrosis and chlorosis were observed at the three highest treatment levels (4.34, 8.42, and 15.9 mg a.i./L). The most sensitive endpoint was frond number based on yi eld, with NOAEC and EC 5 0 values of 1.04 and 2.9 mg a.i./L, respectivel y. **2. Terrestrial Effects** The acute and chronic toxicity references valu es associated with fluopy ram exposure to terrestrial animals are summarized in **Table 1 6** 
. **Table 16 . Toxicity reference values for terrestrial organisms exposed to fluopyram**  **technical or form ulated**  **fluopyram (**  **Fluopyram SC 500A, 41.5% active ingredient) .**  **Exposure Scenario**  **% Active**

**Ingredient Species**  **Exposure Duration**  **Toxicity**

**Reference Value Effect**  **Reference Mam**  **mals Acute**  TGAI (94.7% a.i.) Laboratory

Rat ( Rattus norvegicus ) Single oral

dose LD 50 > 2000 mg a.i./kg

bw No mortalities observed at 2000 mg/kg. No effects on weight or other gross pathological findings were reported. MRID 47372430 Acceptable **Chronic** TGAI

(94.7% a.i.) Laboratory

Rat ( Rattus norvegicus ) 90
- day

dietary study NOAEL = 13 mg

a.i./kg bw/day LOAEL = 61 mg a.i./kg bw/day Decreased body weight and food consumption observed at the two highest treatment levels (61 and 204 mg a.i./kg/day for male rats, 70 and 230 mg a.i./kg day for female rats). MRID 47372441 Acceptable **Birds 52** 

**Table 16 . Toxicity reference values for terrestrial organisms exposed to fluopyram**  **technical or form ulated**  **fluopyram (**  **Fluopyram SC 500A, 41.5% active ingredient) .**  **Exposure Scenario**  **% Active**

**Ingredient Species**  **Exposure Duration**  **Toxicity**

**Reference Value Effect**  **Reference Acute**  TGAI (94.5% a.i. [bobwhite] and 94.7% a.i [zebra finch]). Northern

bobwhite quail ( Colinus virginianus ) and zebra finch ( Taeniopygia guttata ) Single oral

dose LD 50 >2000 mg a.i./kg

bw Bobwhite quail: Cumulative mortality was 0/9, 1/10, 1/10, and 4/10 birds from the control, 500, 1000, and 2000 mg ai/kg bw nominal treatment levels, respectively. Treatment - related signs of toxicity were observed at all dose levels, including diarrhea, soft excrement, ptosis, fluffed feathers, red excrements, and reduced vigilance. Necropsy of birds that died during the study indicated severe emaciation, reduction in organ size (bre ast muscle, liver, spleen, heart, and/or liver) and discoloration of organs (gizzard, intestines, and/or pancreas). Therefore, the NOAEL <500 mg a.i./kg bw. Zebra finch : Two limit tests were conducted with the zebra finch. Six birds were exposed in each individual test. Inthe first test, one mortality occurred
. A second test was conducted and no mortalities occurred. Pilorection, ataxia, lethargy, wing droop and uncoordination were observed in the single treatment level. Therefore , the NOAEL is <2000 mg a.i./kg bw. MRID s 47372341 Acceptable and 47567007 Supplemental

**Acute** TGAI (9 5 .0 % a.i.) Northern

bobwhite quail ( Colinus virginianus ) 5 - Day

dietary LC 50 >4785 mg a.i./kg

diet Based upon treatment - related reductions (24 to 64% of control) in food consumption at all treatment levels on day 7, the reviewer determined the NOAEC to be <27 9 mg ai/kg diet. There was a statistically
- significant reduction in body weight in birds from the 4785 mg ai/kg diet level during the exposure period. No mortality, clinical signs of toxicity, or post
mortem findings were observed. MRID 47372343 Acceptable**53**

**Table 16 . Toxicity reference values for terrestrial organisms exposed to fluopyram**  **technical or form ulated**  **fluopyram (**  **Fluopyram SC 500A, 41.5% active ingredient) .**  **Exposure Scenario**  **% Active**

**Ingredient Species**  **Exposure Duration**  **Toxicity**

**Reference Value Effect**  **Reference Chronic**  TGAI

(94.7% a.i.) Bobwhite

quail ( Colinus Virginianus ) and Mallard duck ( Anas platyrhyncho s ) Avian

reproduction study (dietary exposure, one generation) NOAEC = 46.7 mg

a.i./kg diet **a** LOAEC = 75.7 mg a.i./kg diet **a** The NOAEC value is based on a treatment - related reduction in 14
- day survivor body weight for bobwhite quail chicks (mean
- measured concentrations) (MRID 47372344). In this study, reductions in hatchling body weight and percentage of 14
- day survivors/number of hatchlings were also observed at 175 mg a.i./kg diet. Other studies showed additional reproductive effects such as reductions in adult female body weight gain, reduced number of eggs laid, increased numbers of cracked or defective eggs, increased embryonic mortality, reductions in egg shell strength & thickness, and reductions in the number of hatchlings and 14
- day chick survivors at higher treatment levels. MRIDs 47372344 Acceptable 47372345 Supplemental 47372346 Acceptable

**Terrestrial Insects Acute**  TGAI (95.5% a.i.) Honey bee

(Apis mellifera ) 96
- Hour

acute contact and oral toxicity test Contact toxicity

LD 50 >100 μg test material/bee Oral toxicity LC 50 >102.3 μg test material/bee No mortalities or sublethal effects were observed in the controls or treatment groups for either test. MRID 47372347 Contact toxicity test: Acceptable Note : No guideline available for acute oral toxicity to honey bees. **Acute** TEP (41.6% a.i.) Honey bee

(Apis mellifera ) 96
- Hour

acute contact and oral toxicity test Contact toxicity

LD 50 > 83.2 μg a.i./bee Oral toxicity LC 50 > 89 μg a.i./bee Contact toxicity 1/50 mortality in the 83.2 μg a.i./bee level and no mortality in the control (5 reps of 10 bees). Oral toxicity 1/50 mortality in the 89 μg a.i./bee level and no mortality in the control (5 reps of 10 bees). No sublethal effects were observed in the controls or treatment groups for either test. MRID 47372348 Contact toxicity test: Acceptable Note : No guideline available for acute oral toxicity to honey bees. **Plants -**  **Tier I seedling emergence 54** 

**Table 16 . Toxicity reference values for terrestrial organisms exposed to fluopyram**  **technical or form ulated**  **fluopyram (**  **Fluopyram SC 500A, 41.5% active ingredient) .**  **Exposure Scenario**  **% Active**

**Ingredient Species**  **Exposure Duration**  **Toxicity**

**Reference Value Effect**  **Reference**
**Monocot** TEP

(41% a.i.) **Oat** (

Avena sativa ), **perennial r** **yegrass** ( Lolium perenne ), **barley** ( Hordeum vulgare ) and **corn** (Zea mays ) Single

application at test initiation EC 25 >0.444 lbs a.i./A

NOAEC = 0.444 lbs a.i./A No detrimental effects ≥25% were observed for any test species. The highest reduction in seedling emergence for monocots was 6.3% in barley (not statistically significant) at the 0.444 lb a.i./A treatment level. The highest reduction in dry weight for monocots was 9.9% in ryegrass (not statistically significant) at the 0.444 lb a.i./A treatment level. MRID 47372349 Acceptable

**Dicot** TEP (41% a.i.) **Sugarbeet**

( Beta vulgaris ), **oilseed rape** ( Brassica napus ), **soybean** ( Glycine max), **cucumber** ( Cucumis sativus ), **buck wheat**  ( Fagopyrum esculentum ) and **sunflower** ( Helianthus annuus ) Single

application at test initiation EC 25 <0.444 lbs a.i./A

NOAEC <0.444 lbs a.i./A Buckwheat was the most sensitive dicot species. A significant reduction (50.4%) was observed in buckwheat dry weight at the 0.444 lbs a.i./A treatment level. Mild inhibition in height occurred across treatments, with soybean having the highest level of inhibition of 12.1% in comparison to the control (statistically significant) at the 0.444 lbs a.i./A treatment level. Soybeans also had a statistically significant reduction in dr y weight, 14.1% in comparison to the control. MRID 47372349 Acceptable

**Plants -**  **Tier II seedling emergence Dicot**  TEP (41% a.i.) **Buck**

**wheat** ( Fagopyrum esculentum ) Single

application at test initiation No acceptable

endpoints available The most sensitive endpoint was biomass
. N o clear dose
- dependent pattern for effects on biomass was observed due to high variance. Compared to the negative control, reductions in biomass were 12.3, 1.6, 21.3, 40.1 and 6.2% at nominal concentrations of 0.028, 0.056, 0.111, 0.222, and 0.444 lbs a.i./acre respectively. Inhibition in height was very mild across all test concentrations. No other phytotoxic effects were reported
. MRID 47372349 Supplemental

**Plants -**  **Tier I vegetative vigor 55** 

**Table 16 . Toxicity reference values for terrestrial organisms exposed to fluopyram**  **technical or form ulated**  **fluopyram (**  **Fluopyram SC 500A, 41.5% active ingredient) .**  **Exposure Scenario**  **% Active**

**Ingredient Species**  **Exposure Duration**  **Toxicity**

**Reference Value Effect**  **Reference**
**Monocot** TEP

(41% a.i.) **Onion**

( Allium cepa ), **oat** ( Avena sativa ), **perennial r** **yegrass** ( Lolium perenne ) and **corn** (Zea mays ) Single

application at test initiation EC 25 >0.222 lbs a.i./A

NOAEC = 0.222 lbs a.i./A There were no detrimental effects ≥25% for any test species and no species or endpoint exhibited a significant reduction in survival, dry weight or height compared to the controls. Corn showed the highest reduction in dry weight in comparison to the control (6.1%) at 0.222 lbs a.i./A, but this difference was not statistically significant. Inhibition in height was very mild across all treatments, with no species exhibiting inhibitions of  5% in comparison to the negative control. MRID 47372350 Acceptable

**Dicot** TEP (41% a.i.) **sugarbeet**

( Beta vulgaris ), **oilseed rape** ( Brassica napus ), **cucumber** ( Cucumis sativus ), **buck wheat**  ( Fagopyrum esculentum ), **soybean** ( Glycine max) and **sunflower** ( Helianthus annuus ) Single

application at test initiation EC 25 >0.222 lbs a.i./A

NOAEC = 0.222 lbs a.i./A For dry weight, sugarbeet had the highest level of inhibition of 20.2% in comparison to the negative control. Howe ver, a t -test was not able to detect a si gnificant difference between this treatment group and the control. Inhibition in height was very mild across all treatments, with no species exhibiting inhibitions of  5% in comparison to the negative control. M RID 47372350 Acceptable

Mammals For terrestrial mammals, one acute oral toxicity study , one acute dermal study and two acute inhalation studies were conducted with laboratory rats exposed to fluopy ram TGAI (MRIDs 47372430, 47372432, 47372434 and 47372435). Several subchronic and chronic mammalian studies with fluopy

ram TGAI were submitted, including a 90
- day dietary rat study , a 1
- ye ar dietary canine study , a chronic feeding/carcinogenicity rat study and a 2
- generation reproduction rat study (MRID s 47372441, 47372449, 47372501 and 47372447 )
. A subchronic dietary rat study was also submitted for fluop yram - PCA (MRID 47372521). No additional information was submitted for the f

ormulated product fluop yr am 500 SC ( s ee **Appendix D** for full mammalian toxicology

p rofile). Results of oral , dermal and inhalation toxicity studies on rats show that fluopy ram TGAI is practicall y non - toxic to mammals on an acute basis. The acute 4
- hour L C 50 was determined to be greater than 2.091 mg/Land 5.1 mg/L in the tw o rat inhalation studies submitted for fluopy ram ,**56**

which indicates low toxicity via inhalation exposure
. No mortality was observed in any of the studies, but sublethal effects observed in the inhalation study included slow and labored breathing, piloerectio n, ungroomed hair
- coat, reduced motility , high
- legged gait and limpness. The LD 50 is greater than 2000 mg a.i./kg bw for both oral and dermal exposure routes. There were no effects on body weight gain in any of the acute studies. Based on the non - definitiv e endpoints available from these toxicity studies risk quotients will not be calculated. However, predicted exposures will be compared to the highest concentrations tested to qualitatively assess risk to these species. Chronic and reproductive studies with rats and dogs indicate that fluop yram TGAI can affect both parents and offspring at levels as low as 61 mg/kg/day
. Toxicity was observed at similar levels in a chronic 1
- year dietary study with dogs and a 2
- generation reproduction study with rats. In the chronic dog study , decreased weight and food consumption occurred at the 66 mg/kg bw/day treatment level (NOAEL=13 mg/kg bw/day). In a 90
- day rat dietary

study with fluopy ram, decreased body

weight and food consumption were observed at 61 mg/kg bw/day (NOAEL=13 mg/kg/day). Effects observed in the 2
- generation rat reproduction study included decreased body weight in the offspring (NOAEL = 15 mg/kg bw/day ; LOAEL= 83 mg/kg bw/day)
. To assess chronic risk to mammal s, EFED will use the NOAEL of 13 mg a.i./kg bw/day based on reductions in body weight and food consumption in the submitted 90
- day rat dietary study
. In a chronic dietary

carcinogenicity

study with mice , effects were observed at lower levels of exposure than the dietary and 2
- generation studies with rats. The NOAEL for systemic toxicity = 4 mg/kg/day

and the LOAELfor s ys temic toxicity = 21 mg/kg/day**,** based on treatment
- related follicular cell hyperplasia in the thy roid gland, centrilobular to panlobular hy pertrophy and hepatocellular single cell degeneration /necrosis in the liver. Because these parameters are not clearl y linked to the typical ecologic al endpoints of survival, growth and reproduction, these endpoints were not selected for risk estimation. Fluopy ram - PCA, a metabolite of fluopy ram, showed much lower toxicity than the parent compound based on a single 28
- day dietary rat toxicity study
. In the subchronic study with fluopy ram - PCA, no treatment
- related effects were observed at the highest level tested (NOAEL=1574 mg/kg/day). In similary subchronic 28
- day rat and mouse dietary studies conducted with the parent compound fluopy ram , treatment - re lated effects including decreased body weight gain and increased liver weight were observed at levels as low as 162 mg/kg/day (MRIDs 47372516 and 47372517 ). Birds All toxicity

reference values used to assess the potential acute and chronic risks of fluopy ram exposure to birds were obtained from studies using fluop yr am TGAI.**57**

The results of a two oral toxicity studies with fluopy

ram indicate that the chemical is practically nontoxic to avian species on an acute basis , based on mortality effects . The incidence of mortalities did not occur at a level high enough to establish an LD 50 in either study (bobwhite quail LD 50 > 2000 mg a.i./kg bw, MRID 47372341; zebra finch LD 50 > 2000 mg a.i./kg bw, MRID 47567007 ). In the study conducted with bobwhite quail, mortality occurred at all treatment levels (4 out of 10 test birds died at the highest treatment level [ 2000 mg ai/kg bw level ] , while 1 out of 10 birds died in the other two lower treatments [ 500 mg a.i./kg bw and 1000 mg a.i./kg bw ] ). Slight to severe treatment
- related effects on food consumption were observed at all dose levels. Body weight losses were observed in test birds at the 2000 mg ai/kg bw level. Two limit tests were conducted with the zebra finch. Six birds were exposed in each individual test. In the first test, one mortality occur red. A second test was conducted and no mortalities occurred. Pilorection, ataxia, lethargy , wing droop and uncoordination were observed in the single treatment level. Therefore , the NOAELis <2000 mg a.i./kg bw. Because the low mortality (<50%) in submitted acute avian tests, which did not allow determination of an LD 50 , acute risk quotients will not be calculated. Nonetheless, the observed mortality and sublethal effects of fluopy ram and comparison to expected environmental exposure concentrations will be discussed in the risk characterization section of this document. Two submitted 5 - day dietary toxi city studies are available for fluop yr am. In a study with mallard duck , there were no treatment
- related effects on mortality , clinical signs of toxicity, body weight, or food consumption to the tested species, mallard duck
. The acute dietary L C 50 was >4604 mg ai/kg diet. Based upon a notable increase in the incidences of red pancreases in surviving birds at the 4604 mg ai/kg diet level, the NOAEC was 2307 mg ai/kg diet. The acute dietary toxicity fluopy ram technical to 9
- day

old northern bobwhite quail was also assessed. The acute dietary LC 50 was >4785 mg ai/kg diet. Based upon treatment
- related reductions (24 to 64% of control) in food consumption at all treatment levels on day 7, the reviewer determined the NOAEC to be <279 mg ai/kg diet. Furthermore, there was a statistically
- significant reduction in body weight in birds from the 4785 mg ai/kg diet level during the exposure period. No mortality , additional clinical signs of toxicity , or post - mortem findings were observed. Because these studies resulted in a non - definitive LC 50 endpoint , risk quotients will not be calculated. However, predicted exposure s will be compared to the levels at which mortality and sublethal effects were observ ed to qualitatively

assess dietary risk to these species. Results of avian reproduction studies show that there is concern for exposure to fluop yram TGAI with effects seen in both parents and hatchlings. The NOAEC value for birds is 46.7 mg a.i./kg diet based on a treatment
- related reduction in 14
- day survivor bo dy

weight for bobwhite quail chicks in a one
- generation reproductive toxicity test, with corresponding LOAEC of 75.7 mg a.i./kg diet (based on mean
- measured concentrations) (MRID 47372344). In this study , reductions in hatchling body weight and percentage of 14
- day survivors/number of hatchlings were also observed at 175 mg a.i./kg diet. Other studies showed additional reproductive effects such as reductions in adult female body weight gain, reduced number of eggs laid, increased numb ers of cracked or defective eggs, increased embryonic mortality , reductions in egg shell**58**

strength & thickness, and reductions in the number of hatchlings and 14
- day chick survivors at higher treatment levels (MRIDs 47372345 and 47372346)
. To assess chronic risk to birds, the chronic NOAEC of 46 .7 mg a.i./kg diet (MRID 47372344) will be used to calculate risk quotients
. Terrestrial Invertebrates Results of acute contact toxicity studies with honey

bee s demonstrate that fluopy ram TGAI is practicall y non - tox ic to beneficial insects. Two acute oral toxicity tests conducted with fluopy ram showed the TGAI having an LD 50 > 97.7 μg a.i./bee ( 102.3 μg test material/bee ) and fo rmulated fluop yr am having an LD 50 > 89 μg a.i./bee. The acute contact tests showed an LC 50 > 95.5 μg a.i./bee (100 μg test material/bee) for the TGAI and an L C 50 > 83.2 μg a.i./bee for the fluopy ram formulation. No definitive endpoints were given in any of the acute toxicity tests with honey bees, due to lack of mortality
. Additional studies with fluopy ram technical and the end
- use product (Fluopy ram SC 500, 41.8% active ingredient) were submitted for other nontarget terrestrial invertebrates, including predatory mite ( Typhlodromus pyri), rove beetle ( Aleochara bilineata, springtail ( Folsomia candida ), soil mite (

Hypoaspis aculeifer) and earthworm ( Eisenia fetida ). None of these studies resulted in an LC 50 or EC 50 , as 50% mortality did not occur at the highest treatment level in any of the tests (L C 50 s ranged from >20.31 mg a.i./kg dw soil to > 1000 mg a.i./kg dw soil for earthworms; LD 50 > 801.8 mLa.i./ha for rove beetles; LC 5 0 >415 mg a.i./kg dw soil for soil mites and springtails ; LC 50 >825.9 mLa.i./ha for parasitic wasp; LC 50 >834.2 mLa.i./ha for predatory mite). The highest single application rate of 0.222 lbs a.i./acre (6.84 fl oz product/acre) is equivalent to 207 mLa.i./ha. In two 14
- day toxicity

studies , s tatistically

significant w eight loss (10
- 23 %) was observed in earthworms exposed to fluopy ram at treatment levels > 131 mg a.i./kg dw of soil
. No adverse effects on mortality

or growth were observed in a 28
- day subchronic study with earthworms exposed to lower levels of the end
- use product (1.85 to 20.31 mg a.i./kg dw soil) , but a reduced number of surviving juveniles occurred at the highest treatment levels ( 8
- 2 3 % reduction compared to the control, NOAEC = 3.27 mg a. i./kg dw soil)
. In the 28
- day reproduction test conducted with the springtail, the test organisms were exposed to nominal application rates of 26.1 to 415 mg a.i./kg dw soil
. After 28 days, significant mortality occurred (29.5
- 45.5%) and the number of juveniles was significantly reduced ( 36.5
- 36.9 %) at the two highest treatment levels ( 207.5 and 415 mg a.i./kg dw soil)
. The Agency

does not currently

assess quantitative risk to non
- target terrestrial invertebrates. H owever, these toxicity data will be used for a qualitative evaluation in the risk characterization section
. Terrestrial Plants**59**

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 in the seedling emergence test (MRIDs 47372349 and 47372350)
. In the vegetative vigor study , sugarbeet had the highest level of inhibition in dry weight, a 20.2% reduction in comparison to the negative control at a fluopy ram application rate of 0.222 lbs a.i./A
. Because this is a Tier I study and a 25% or greater adverse effect did not occur, a Tier II study is not requested. However, a t - test was not able to detect a significant difference between this treatment group and the control. The rate applied in the Tier I seedling emergence test , 0.444 lbs a.i./A , was greater than the maximum applic ation rate of 0.222 lbs a.i./A
. Because buckwheat showed a 50.4% reduction in dry weight at 0.444 lbs a.i./A in the seedling emergence test, a Tier II test was conducted (MRID 47372349)
. The most sensitive endpoint was biomass. No clear dose
- dependent pattern for effects on biomass was observed due to high variance. Compared to the negative control, reductions in biomass were 12.3, 1.6, 21.3, 40.1 and 6.2% at nominal concentrations of 0.028, 0.056, 0.111, 0.222, and 0.444 lbs a.i./acre respectively
. A non
- guideline terrestrial plant study that evaluated the pre
-plant incorporated biological effects of fluopy ram 500 SC was also submitted. There were no effects on plant emergence across species, except for oat and ryegrass, which experienced effects at the first two treatment levels. Due to promotion of growth at the highest treatment level, a dose
- response relationship cannot be inferred. There was no additional crop damage in any species, and there was no effect of the treatment on fresh weight across all species (EC 25 >0.44 lbs a.i ./A, NOAEC = 0.44 lbs a.i./A)
. **Fluopyram co -**  **formulation toxicity data** Some toxicity

data were submitted for the fluopy ram products that are co
- formulated with the fungicides tebuconazole, trifloxystrobin, py rimethanil, and prothioconazole. A complete li sting of the currently

available ecological toxicity studies is located in **Appendix D**
. For the fluop yr am/tebuconazole SC 400 product, eight studies were submitted that examined the effects of the co
- formulation on freshwater fish, freshwater invertebrates, algae, rats, honey bees and terrestrial plants. In all aquatic studies, the fluopy ram/tebuconazole product was more toxic than fluopy

ram technical or formulated fluopy ram. This increase in toxicity appears to be tebuconazole’s greater toxicity to these organisms, compared to fluop yr am. For the terrestrial organisms, none of the submitted studies with fluopy ram/tebuconazole resulted in definitive endpoints, either due to lack of 50% mortality for rat and honey

bees or lack of a 25% adverse eff ect for terrestrial plants. Therefore, both fluop yram and the fluop yr am/tebuconazole co
formulated product appear to have low overall toxicity to terrestrial organisms. However, no avian data was submitted.**60**

Seven toxicity

tests were submitted for the fluopy ram/trifloxystrobin 500 SC product. Three aquatic studies were submitted. Based on the results of tests with freshwater fish, freshwater invertebrates and algae, the fluopy ram/trifloxystrobin co
- formulation has greater toxicity to these species. Like tebuconazole, this increase in toxicity appears to be due to trifloxystrobin’s greater toxicity to these organisms compared to fluop yr am . Also similar to tebuconazole, none of the submitted terrestrial studies with fluopy ram/trifloxystrobin resulted in def initive endpoints, either due to lack of 50% mortality for rat and honey

bees or lack of a 25% adverse effect for terrestrial plants. No avian data was submitted. Both fluopy ram and the fluop yr am/trifloxystrobin co
formulated product appear to have low overall toxicity to terrestrial organisms. Only limited toxicity

data were available for the fluopy ram/p yrimethanil 500 SC and the fluopy ram/prothioconazole SC 400 products. Rat acute oral studies were submitted for both co
formulations. Based on these studies, the fluop yram/pyrimethanil and fluopy ram/prothioconazole products show low toxicity to mammals, similar to fluopy ram technical. No other toxicity studies were submitted for these products.**61**

**IV. Risk**  **Characterization** Risk characterization is the integration of exposure and effects characterization to determine the ecological ri sk from the use of fluopy ram and the likelihood of effects on aquatic life, wildlife, and plants based on varying pesticide
- use scenarios. The risk characterization provides estimation and a description of the risk; articulates risk assessment assumptions, limitations, and uncertainties; s ynthesizes an overall conclusion; and provides the risk managers with information to make regulatory

decisions. **A. Risk Estimation -**  **Integration of Exposure and Effects Data** Results of the exposure and toxicity effects data are used to evaluate the likelihood of adverse ecological effec ts on non - target species. For the assessment of fluopy ram risks, the risk quotient (RQ) method is used to compare exposure and measured toxicity values (refer to **Appendix F** ). Estimated environmental concentrations (EECs) are divided by the most sensitive acute and chronic toxicity

values. The RQs are then compared to the Agen cy ’s levels of concern (LOCs). These LOCs, summarized in **Appendix F** , are the Agency ’s interpretive policy and are used to anal yz e potential risk to non
- target organisms and the need to consider regulatory action. These criteria are used to indicate when a pesticide’s use as directed on the label has the potential to cause adverse effects on non
- target organisms. Details of all RQs are provided in **Appendix G**
. **1. Non -**  **target Aquatic Animals and Plants**  To assess risk of fluop yr am to no n - target aquatic animals ( fish and invertebrates) and plants (macrophyt es and algae ), surface water, pore water and sediment EECs for fluopy ram we re obtained from the Tier 2 model PRZM/EXAMS based on the label
- recommended usage scenarios ( **Table 5** )
. In all instances, this risk assessment used the highest peak (instantaneous) concentration in surface water (for water column dwellers), benthic sediment (for benthic organisms), and benthic pore water (for benthic organisms) generated from the PRZM/EXAMS model to represent acute exposure to aquatic organisms
. For chronic risk, the 21
- day EECs for fluopy ram were compared to available aquatic toxicity data. **a. Water Column Exposure**  **: Acute and Chronic Risk to Animals**  Fish For acute risk to freshwater and estuarine/marine fish species , risk quotients were not calculated because the available toxicity endpoints were not definitive (L C 50 > highest test concentration). For freshwater fish , the chronic risk quotient = 0.001 ( **Table 1 7**  ). InEFED risk assessments, endpoints which are considered to be ecologicall y significant are likel y to lead to reductions in survival, growth and/or reproduction of fish. For the submitted earl y- life stage study with fathead**62**

minnow, although sublethal effects including deformed mouth, ventral hematoma, labored respiration, surfacing, dark coloration, swollen belly , loss of equilibrium and lordosis occurred at the third highest treatment level and above ( >0.269 mg a.i./L), reductions in survival and growth oc curred at onl y the two highest treatment levels (0.560 and 1.05 mg ai/L). Therefore, 0.269 mg ai/L will be used as the functional NOAEC for chronic risk quotient calculations for freshwater fish. A chronic risk quotient was not calculated for estuarine/m arine fish, because no chronic toxicity data were submitted for this taxon and appropriate acute
- to - chronic ratios could not be determined due to non
- definitive acute endpoints for all aquatic taxa
. **Table 17 . Acute and chronic**  **risk q uotients (RQs) for evaluating toxic risk of**  **fluopyram exposure to**  **freshwater and estuarine/m arine fish**  **. Organis**  **m LC**  **50**

**(μg a.i./L )**  **NOAEC**

**(μg a.i./L )**  **EEC c** 

**Peak (μg a.i./L**  **) EEC**  **d**

**60 -**  **Day (μg a.i./L**  **) Acute** 

**RQ (EEC/LC**  **50 )**  **Chronic**

**RQ (EEC/NOAEC)**  Freshwater fish a > 1780 269 7.31 0.2 86 Not calculated 0.00 1 Estuarine/marine fish b > 980 Not available 7.31 0. 286 Not calculated Not calculated
**a** Acute toxicity value is based on rainbow trout ( Oncorhynchus mykiss ) ( LC 50 > 1.78 mg a.i./L) and chronic toxicity value is based on an early life stage study with f athead minnow (

Pimephales promelas ) (NOAEC = 0.135 mg a.i./L)
. **b** Acute toxicity value is based on sheepshead minnow ( Cyprinodon variegates ) LC 50 > 0.9 8 mg a.i./L
. Chronic toxicity data were not submitted for estuarine/marine fish. **c** EEC values are generated from PRZM/EXAMS and represent the most conservative level of acute exposure based on proposed label rates (watermelons , spray and drip irrigation [same EECs for each] , STXmelonNMC scenario)
. d EEC values are generated from PRZM/EXAMS and represent the most conservative level of chronic exposure based on proposed label rates (watermelons, drip irrigation, Florida cucumber scenario ). Aquatic Invertebrates For acute risk to freshwater and estuarine/marine invertebrate species, risk quotients were not calculated because the available toxicity endpoints were non
- definitive (LC 50 > highest test concentration). A chronic risk quotient was calculated for freshwater invertebrates (RQ = 0.0006 ; **Table 1 8**  ). A chronic risk quotient was not calculated for estuarine/marine invertebrates , because no chronic toxicity

data were submitted for this taxon and appropriate acute
- to - chronic ratios could not be determined due to the lack of definitive acute toxicity endpoints
. **Table 18**  **. Acute and chronic risk quotients (RQs) for evaluating toxic risk of fluopyram exposure to freshwater and estuarine/m**  **arine aquatic invertebrates**  **.**
**Organis m**  **LC 50** 

**(μg a.i./L) NOAEC** 

**(μg a.i./L) EEC**  **c**

**Peak (μg a.i./L)**  **EEC c** 

**21 -**  **Day (μg a.i./L)**  **Acute**

**RQ (** **peak EEC/LC**  **50 )**  **Chronic**

**RQ (** **21 -**  **day EEC/NOAEC)** **63**

**Table 18**  **. Acute and chronic risk quotients (RQs) for evaluating toxic risk of fluopyram exposure to freshwater and estuarine/m**  **arine aquatic invertebrates**  **.**
**Organis m**  **LC 50** 

**(μg a.i./L) NOAEC** 

**(μg a.i./L) EEC**  **c**

**Peak (μg a.i./L)**  **EEC c** 

**21 -**  **Day (μg a.i./L)**  **Acute**

**RQ (** **peak EEC/LC**  **50 )**  **Chronic**

**RQ (** **21 -**  **day EEC/NOAEC)**  Freshwater invertebrates a > 17 ,000 1214 7.31 0. 712 Not calculated 0.000 6 Estuarine/marine invertebrates b > 510 Not available 7.31 0. 712 Not calculated Not calculated
**a** Acute and chronic toxicity value s are based on studies with the water flea (Daphnia magna)

– acute E C 50 > 17 mg a.i./L and chronic toxicity NOAEC = 1214 μg a.i./L
. **b** Acute toxicity value is based on saltwater mysid Americamysis bahia LC 50 > 0. 51 mg a.i./L. Chronic water column toxicity data were not submitted fo r estuarine/marine invertebrates
. **c** EEC values are generated from PRZM/EXAMS and represent the most conservative level of acute exposure based on proposed label rates (watermelons, spray and drip irrigation [same EECs for each], STXmelonNMC scenario ). d EEC values are generated from PRZM/EXAMS and represent the most conservative level of chronic exposure based on proposed label rates (watermelons, drip irrigation, Florida cucumber scenario ). **b. Sediment Exposure**  **: Acute**  **and Chronic Risk to Benthic**  **Invertebrates** Comparisons of EECs and sediment toxicity endpoints are provided below to supplement risk estimation to water column organisms. The evaluation of toxic risk to the benthic organisms was approached by

a ssuming equilibrium partitioning of a high Koc compound like fluop yr am between the sediment and the pore water (the water found between particulates in the sediment). Risk to benthic organisms was assessed using two approaches: (1) EECs for sediment were model
- generated (PRZM/EXAMS) and compared to the toxicity v alue as reported for sediment exposure (EC 50/L C 50/NOAEC) in the sediment toxicity t ests (normalized to organic carbon) and (2) EECs for pore water were model
- generated (PRZM/EXAMS) and compared to the toxi city value as reported for pore water (EC 50/L C 50/NOAEC) in the sediment toxicity tests. No acute risk quotient s were derived for freshwater or estuarine/marine benthic invertebrates via sediment and pore water fluopy ram exposure ( **Table 1 9**  ). Short
- term toxicity data were not provided for freshwater benthic invertebrates and the LC 50 endpoint was undefined as no treatment

–

related mortality

occurred at the highest test concentration (> 2,700,000 μg a.i./kg OC; > 2500 μg a.i./L pore water) of the submitted study with estuarine/marine invertebrates.
**Table 19 . Acute risk quotients (RQs) for evaluating toxic risk of fluopyram** **exposure to freshwater and estuarine/marine benthic invertebrates.** 

**Organis m**  **LC 50**  **a, b, d,**  **f**

**(μg a.i./kg OC)**  **LC 50** 

**(μg a.i./L pore water)**  **Peak**

**Sediment EEC**  **c, d, e**  **(μg a.i./ kg OC)**  **Peak Pore** 

**Water EEC**  **(μg a.i./L pore wa** **ter) c**  **Acute**

**sedi me**  **nt RQ**  **(peak EEC/LC**  **50 )**  **Acute**

**pore water RQ**  **(peak EEC/**  **LC 50** **) 64** 

**Table 19 . Acute risk quotients (RQs) for evaluating toxic risk of fluopyram** **exposure to freshwater and estuarine/marine benthic invertebrates.** 

**Organis m**  **LC 50**  **a, b, d,**  **f**

**(μg a.i./kg OC)**  **LC 50** 

**(μg a.i./L pore water)**  **Peak**

**Sediment EEC**  **c, d, e**  **(μg a.i./ kg OC)**  **Peak Pore** 

**Water EEC**  **(μg a.i./L pore wa** **ter) c**  **Acute**

**sedi me**  **nt RQ**  **(peak EEC/LC**  **50 )**  **Acute**

**pore water RQ**  **(peak EEC/**  **LC 50** **)** Freshwater invertebrates a Not

available Not

available 63.8 0.142 Not calculated Not calculated Estuarine/marine invertebrates b > 2,700,000 > 2500 63.8 0.142 Not calculated Not calculated

a No short
- term freshwater sediment toxicity studies were submitted for fluopyram. b Acute toxicity value is based on the marine amphipod Leptocheirus plumulosus 10
- day LC 50 > 100 mg TRR/kg sediment and > 2.5 mg TRR/L pore water. c EEC values are generated from PRZM/EXAMS and represent the most conservative level of exposure based on proposed label rates (watermelons , STXmelonNMC scenario). d Sediment concentrations and toxicity endpoints were normalized to organic carbon (OC) content based on the following equation: mg/kg OC = mg/kg dry weight sediment kg TOC/kg dry weight sediment e The default organic carbon content in PRZM/EXAMS is 4% (0.04 kg TOC/kg dry weight sediment):

2.55 μg /kg dry weight sediment = 63.8 μg a.i./kg OC 0.04 kg TOC/kg dry weight sediment f The sediment in the 10
- day test with Leptocheirus plumulosus contained 3.7% organic carbon (0.037 kg TOC/kg dry weight sediment) :

100,000 μg /kg dry weight sediment = 2,700,000 μg a.i./kg OC 0 .037 kg TOC/kg dry weight sediment Chronic risk quotients were derived for both freshwater and estuarine/marine benthic invertebrates via sediment and pore water fluop yr am exposure ( **Table 20**  ).
**Table 20 .**  **Chronic risk quotients (RQs) for evaluating toxic risk of fluopyram exposure to freshwater and**  **estuarine/marine benthic invertebrates.**

**Organis m**  **NOAEC a,**  **b, d,**  **f (μg a.i./kg**  **OC) NOAEC** 

**(μg a.i./L pore water)**  **21 -**  **day**

**Sediment EEC**  **c, d, f (μg a.i./ kg**  **OC) 21**  **- day**  **Pore**

**Water EEC**  **(μg a.i./L pore wa** **ter) c**  **Chronic**

**sedi me**  **nt RQ**  **( 21**  **- day**  **EEC /**  **NOAEC )**  **Chronic**

**pore water RQ**  **( 21**  **- day**  **EEC/NOAEC)** Freshwater invertebrates a 1,180,000 3800 12.2 0.027 0.00001 0.000007 Estuarine/marine invertebrates b 643,000 2500 12.2 0.027 0.0000 2 0.00001**65**

**Table 20 .**  **Chronic risk quotients (RQs) for evaluating toxic risk of fluopyram exposure to freshwater and**  **estuarine/marine benthic invertebrates.**

**Organis m**  **NOAEC a,**  **b, d,**  **f (μg a.i./kg**  **OC) NOAEC** 

**(μg a.i./L pore water)**  **21 -**  **day**

**Sediment EEC**  **c, d, f (μg a.i./ kg**  **OC) 21**  **- day**  **Pore**

**Water EEC**  **(μg a.i./L pore wa** **ter) c**  **Chronic**

**sedi me**  **nt RQ**  **( 21**  **- day**  **EEC /**  **NOAEC )**  **Chronic**

**pore water RQ**  **( 21**  **- day**  **EEC/NOAEC)** a The chronic toxicity value for freshwater benthic invertebrates is based on the midge ( Chironomus tentans ) 54
- day NOAEC = 26 mg TRR/kg sediment and 3.8 mg TRR/L pore water. b The chronic toxicity value for estuarine/marine benthic invertebrates is based on the amphipod Leptocheirus plumulosus 28
- day NOAEC = 36 mg TRR/kg sediment and 2.5 mg TRR/L pore water. c EEC values are generated from PRZM/EXAMS and represent the most con servative level of exposure based on proposed label rates ( Florida potato scenario). d Sediment concentrations and toxicity endpoints were normalized to organic carbon (OC) content based on the following equation: mg/kg OC = mg/kg dry weight sediment kg TOC/kg dry weight sediment e The default organic carbon content in PRZM/EXAMS is 4% (0.04 kg TOC/kg dry weight sediment).

0.487 μg /kg dry weight sediment = 12.2 μg a.i./kg OC 0.04 kg TOC/kg dry weight sediment f The sediment in the 54
- day test with Chironomus tentans contained 2.2 % organic carbon (0.0 22 kg TOC/kg dry weight sediment) : 26,000 μg /kg dry weight sediment = 1,180 ,000 μg a.i./kg OC 0.0 22 kg TOC/kg dry weight sediment The sediment in the 28
- day test with Leptocheirus plumulosus contained 5.6 % organic carbon (0.0 56 kg TOC/kg dry weight sediment) : 36,000 μg /kg dry weight sediment = 643 ,000 μg a.i./kg OC 0.0 56 kg TOC/kg dry weight sediment **c. Aquatic Plants** Acute risk quotients for listed and non - listed vascular and non - vascular aquatic were calculated for the modeled crop use with the highest estimated exposure values (watermelon) for aquatic ecos ys tems ( **Table 21**  ). **Table 21 . Acute RQs for non**  **- vascular and vascular aquatic plants exposed to fluopyram.** 

**Plant Type EC**  **50**

**(μg a.i./L) NOAEC or** 

**EC 05**  **(μg a.i./L) Peak Water** 

**Column EEC (μg a.i./L)**  **RQ**

**endangered s pecies**  **(Peak EEC/EC 50** **) c**  **RQs o**  **ther non -**  **target plants**  **(Peak EEC/NOAEC or**  **EC 05**  **) d**  Non - vascular plants a 3400 1170 7.31 0.00215 0.006 Vascular plants b 2600 278 7.31 0.00281 0.026**66**

**Table 21 . Acute RQs for non**  **- vascular and vascular aquatic plants exposed to fluopyram.** 

**a** For freshwater green algae ( Pseudokirchneriella subcapitata ) the EC 50 = 3.4 mg a.i./L and NOAEC = 1.17 mg a.i./L based on a study with the formulated fluopyram product (41.5% active ingredient). The most sensitive endpoint was cell density. b For duckweed (

Lemna gibba ), the EC 50 = 2.6 mg a.i./L and NOAEC = 0.278 mg a.i./L based on a study with fluopyram technical. The most sensitive endpoint was frond number based on yield. c Endangered species LOC > 0.05 d Acute toxicity LOC > 0.5 **2. Non -**  **target Terrestrial Animals** The EFED terrestrial exposure model T
- REX was used to estimate exposure and risks in conservative scenarios to avian and mammalian species for four forage food ty pes with spr ay applications of fluop yram as described in the Exposure Characterization. For this risk assessment, terrestrial EECs as a result of fluop yr am spray applications were estimated using the maximum proposed application rate (0.222 lb a.i./A), the m aximum number of applications with this rate (2 ), and the minimum application interval (5 days ) . Risk quotients were calculated using upper-bound EECs. All toxicity

reference values for terrestrial animals that are used for calculating risk quotients (RQs) are based on exposure to fluopy ram TGAI and are summarized in **Table 1 6** 
. Dietary
based and dose
-based and chronic RQs for mammals based on a maximum spray application scenario are listed in **Table 2**  **2** and **Table 2**  **3** , respectively
. . Dietary
-based chronic RQs for avian species based on a maximum spray application scenario are summarized in **Table 24**
. All chronic terrestrial RQs can be found in **Appendix F**  .

**a. Spray Applications: Acute Risk to Birds and Mammals** Mammal s A cute dose
-based RQ values for mammalian receptors were not calculated because the results of the definitive submitted acute oral toxicity studies on mammals did not allow calculation of a definitive LD 50 values
. Birds Acute dose
- or dietary
- based RQs for birds were not calculated because definitive LD 50 and L C 50 values were not available.

**b. Spray Applications: Chronic Risk to Birds and Mammals**  Mammals Dietary
-based RQs were calculated using EECs expressed in terms of residue concentration for the various forage categories, and the toxicity value (NOAEC) is expressed in units of dietary concentration. Dose
-based RQs were calculated using EECs expressed in terms of a dose**67**

concentration for the various forage categories and the estimated toxicity value (NOAEL). The dose
-based EECs are calculated by using the estimated dietary concentrations and assuming the laboratory

rat consumes 5% of its body weight dail y. Three weight categories (or sizes) were considered for dose
-based risk calculations ( **Tables 22 and**  **23** )
. **Table 22 . Dietary**  **- based chronic RQs for**  **ma mmals exposed to fluopyram**  **based on upper -**  **bound residues on short grass, tall grass, broadleaf plants/**  **sm all insects, and fruits/pods/seeds/large insects as calculated by**  **T -**  **REX Mam**  **malian Chronic Risk Quotients** ***** **Short Grass Tall Grass**  **Broadleaf Plants/ Sm**  **all Insects Fruits/Pods/Seeds/**  **Large Insects** 7.58 3. 58 4.39 0
. 4 9
* These values were calculated using the maximum application rate (0.222 lb a.i./A), the maximum number of applications (2), the minimum application interval (5 day s), and a chronic NOAEC = 13 mg a.i./kg diet in rats and a default chemical foliar half
- life of 35 days
. **Table 23 . Dose**  **- based chronic RQs for small (15g), intermediate (35g), and large (1,000g) m**  **ammals exposed to fluopyram**  **based on upper -**  **bound residues on short grass, tall grass, broadleaf plants/sm all insects,**  **fruits/pods/large insects and seeds as calculated by T -**  **REX Mam**  **malian Chronic Risk Quotient** ***** **Body Weight (g)**  **Short Grass Tall Grass**  **Broadleaf Plants/**  **Sm all**  **Insects Fruits/Pods/** 

**Large Insects Seeds** 
15 **67.76 31.06**  **3 8.12**  **4.24** 0. 94 35 **5 7.88**  **2 6.53**  **32.56 3.**  **62** 0. 80 1000 **31.03 1**  **4.22 1**  **7.45 1.**  **94** 0. 43 * These values were calculated using the maximum application rate (0.222 lb a.i./A), the maximum number of applications (2), the minimum application interval (5 days), and an estimated chronic NOAEL = 0.75 mg a.i./kg body weight/day in rats based on the chronic dietary NOAEC = 13 mg ai/kg diet and a default chemical foliar half
life of 35 days
. Birds For birds, chronic RQs were derived using a dietary
- based chronic toxicity value. Dietary
- based RQs were calculated using EECs expressed in terms of residue concentration for the various forage categories, and the toxicity value (NOAEC) is expressed in units of dietary concentration ( **Table 24**  )
.**68**

**Table 24 . Dietary**  **- based chronic RQs for birds exposed to**  **fluopyram based on upper**  **- bound residues on**  **short grass, tall grass, broadleaf p lants/small insects, and fruits/pods/seeds/large insects as calculated by T**  **** **REX Avian Chronic Risk Quotients**  **a Short Grass**  **Tall Grass Broadleaf Plants/**  **Sm all Insects**  **Fruits/Pods/Seeds/ Large Insects**  **2.17 1**  **.00 1**  **.22** 0.14

a These values were calculated using th e maximum application rate (0.222 lb a.i./A), the m aximum number of applications (2 ), the mi nimum application interval (5 day s), and a chronic NOAEC = 46.70 mg a.i./kg diet in bobwhite quail and a default chemical foliar half
- life of 35 days
. **3. Non -**  **target Terrestrial and Semi -** **Aquatic Plants** A preliminary

run of TERR
- PLANT was conducted using the maximum application scenario s for ground application (labeled use rates for watermelon s) and aerial application (labeled use rates for almond, pecan, pistachios and tree nuts). All EEC s 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
. Compared to the avai lable toxicity studies, in the vegetative vigor study , sugarbeet had the highest level of inhibition in dry weight, a 20.2% reduction in compari son to the negative control at a fluop yram application rate of 0.222 lbs a.i./A. The rate applied in the Tier I seedling emergence test, 0.444 lbs a.i./A, was greater than the maximum application rate of 0.222 lbs a.i./A. Because buckwheat showed a 50.4% reduction in dry weight at 0.444 lbs a.i./A in the seedling emergence test, a Tier II test was conducted (MRID 47372349). The most sensitive endpoint was biomass. No clear dose
- dependent pattern for effects on biomass was observed due to high variance. Comp ared to the negative control, reductions in biomass were 12.3, 1.6, 21.3, 40.1 and 6.2% at nominal concentrations of 0.028, 0.056, 0.111, 0.222, and 0.444 lbs a.i./acre respectivel y. **B. Risk Description -**  **Interpretation of Direct Effects** The purpose of the risk description is to characterize risk and incorporate other lines of evidence including non - standard methods and data. **1 . Risks to Aquatic Organisms** **69 a. Aquatic Animals**  **and Plants :**  **Water Column Exposure** Acute Risk to Fish and Aquatic
- phase Amphibians For acute risk to freshwater and estuarine/marine fish species (and aquatic
- phase amphibians using the surrogate species approach) , risk quotients were not calculated because the available toxicity endpoints were non
- definitive (LC 50 > highest test concentration). However, as shown in **Table 13** , the peak estimated exposure concentration for aquatic organisms ( 7.31 μg a.i./L) is more than two orders of magnitude less than the highest tested fluop yr am technical concentrations in acute toxicity tests that caused no adverse effects to freshwater and estuarine/marine fis h species ( LC 50 > 0.98 mg a.i./L and NOAEC = 0.98 mg a.i./L for sheepshead minnow; LC 50 >1.78 mg a.i./L and NOAEC = 1.78 mg a.i./L for rainbow trout) . No mortality or sublethal effects were observed in acute fish studies with the fluopy ram active ingredient. In studies with the formulated product (fluopy ram 500 SC , 41.5% active ingredient), sublethal effects at the 8.27
- 46.4 mg ai/Ltreatment groups included fish lying on the bottom of the test chamber, dark coloration, labored respiration, mucous secretio n from intestine, surfacing, and lying on side/back (NOAEC =1.31 mg a.i./L). However, these effects were observed at much higher concentrations than is expected to occur in the environment. A cute risk to freshwater and saltwater fish from fluopy ram use is expected to be low. Chronic Risk to Fish and Aquatic
- phase Amphibians The level
- of

- concern for chronic risk to aquatic organisms (LOC > 1.0) was not exceeded for freshwater fish (and aquatic
-phase amphibians using the surrogate species approach) (RQ = 0.001 ; **Table 1 7**  ). 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
. C hronic risk to fish species resulting from the proposed uses of fluop yr am appears to be low. Because the expected exposure concentration of fluopy ram (60
- day

EEC = 0.286 μg a.i./L) is much lower than the levels at which adverse chronic effects to fish are expected to occur (NOAEC = 0.135 mg a.i./L and LOAEC = 0.269 mg a.i./L for fathead minnow) , the submission of a fish full life cycle test or additional chronic testing with estuarine/marine fish is not expected to greatly influence the overall risk picture for fluopy ram. Acute Risk to Aquatic Invertebrates For acute risk to freshwater and estuarine/marine invertebrate species, risk quotients were not calculated because the available toxicity endpoints were non
- definitive (LC 50 > highest test concentration). However, as shown in **Table 1 8**  , the peak estimated exposure concentration for aquatic organisms ( 7.31 μg a.i./L or 0.00731 mg a.i./L) is at least two orders of magnitude l ess than the high est tested fluopy ram concentrations in the available acute toxicity tests , ranging**70**

from 0.51 mg a.i./L to 38.2 mg a.i./L , in which no EC 50 values were definitively calculated due to low mortality
. N o immobility

(assumed to be equivalent to death) or sublethal effects were observed in tests with technical grade fluopy ram and water flea (

Daphnia magna ; EC 50 >17 mg a.i./L and NOAEC=17 mg a.i./L). However, immobility was observed at the two highest treatment levels (20.4 and 38.2 mg a.i./L) in a Daphnia magna test with fluopy ram end
- use product (EC 50 > 38.2 mg a.i./L and NOAEC =11.6 mg a.i./L). In addition, the submitted acute study with the saltwater mysid resulted in 10% mortality in the highest treatment group, 0.51 mg ai/L ( LC 50 : >0.51 mg ai/L , NOAEC = 0.27 mg ai/L). Nonetheless, the peak estimated exposure concentration for aquatic organisms (7.31 μg a.i./L or 0.00731 mg a.i./L ; **Table 13** ) is still two orders of magnitude less than the level at which immobility was observed in the these aquatic invertebrate test s . Therefore, based on currentl y available information, acute risk to aquatic invertebrate species due to water column exposure appears to be low following application of fluopy ram from the propos ed uses. Chronic Risk to Aquatic Invertebrates The level
- of

- concern for chronic risk to aquatic organisms (LOC > 1.0) was not exceeded for freshwater invertebrates (RQ = 0.0006 ; **Table 1 7**  ). A chronic risk quotient was not calculated for estuarine/marine invertebrates, because no chronic toxicity data were submitted for this taxon and appropriate acute
- to - chronic ratios could not be determined due to the lack of definitive acute toxicity endpoints for any

aquatic species
. One additional way

to approximate to xicity

to this taxon is to use the available chronic estuarine/marine benthic invertebrate toxicity endpoint based on pore water concentrations and compare this chronic exposure concentrations in the water column. This approach assumes that equal toxicity

exists for water column and benthic invertebrates
. This assumption is employed in the equilibrium partitioning (EqP) approach (Di Toro et al, 1991) when deriving sediment benchmarks when onl y data for water column species is available (US EPA, 2005 and US EPA, 2002 ). Chronic data on fluopy ram were submitted for estuarine/marine benthic invertebrates. The EEC is 0. 712 μg a.i./L for the use scenario with the highest 21
- day water c olumn estimated exposure (watermelon) ( **Table 11**  ). Ina 28
- day test with the estuarine amphipod Leptocheirus plumulosus , the NOAEC was 2.5 mg TRR/L pore water ( or 2500 μg a.i./L) , and the total toxic residues are assumed to be predominantl y the parent chemical fluopy ram . The highest chronic water column EEC ( **Table 12** ) is approximately four orders of magnitude less than the estuarine/marine benthic invertebrate NOAEC based on pore water concentrations. Some uncertainty are inherent in this comparison , due to differences in exposure routes of the toxicity tests, water- column only

exposure vs. sediment ingestion in combination with pore water , as well as the life histories of the organisms. Inaddition, the study was considered supplemental due to the lack of a clear dose
- response for reproductive endpoints. However, in the ab sen ce of additional data, this is considered the best available approximation for chronic risk to estuarine/marine invertebrates.**71**

Based on these lines of evidence, low chronic risk is presumed for aquatic invertebrates in the water column
. Aquatic 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 s) ( **Table 21**  ). Risk quotient s ranged from 0.00215 to 0.02 63. The most sensitive endpoints for vascular and nonvascular plants were similar. Two of the four algal species in toxicity studies submitted for fluopy ram technical showed no adverse effects were observed at any test level (Skeletonema costatum , NOAEC=1.13 and EC 50 >1.13 mg a.i./L ; Anabaena flos
- aquae , NOAEC = 9.69 mg a.i./L and EC 50 >9.69 mg a.i./L). Other species exhibited negative effects on cell density, biomass and growth rate following exposure to fluopy

ram technical (

Navicula pelliculosa , the NOAEC = 2.47 and EC 50 = 6 .1 mg a.i./L ; Pseudokirchneriella subcapitata NOAEC = 1.46 and EC 50 = 4.3 mg a.i./L)
. In addition to studies with fluopy ram technical, Pseudokirchneriella subcapitata was exposed to the fluopy

ram formulated product (NOAEC = 1 .17 mg a.i./L and EC 50 = 3.4 mg a.i./L) . Based on the results of these studies with the same species, fluopy ram appears to have effects on algal growth at similar levels, whether the exposure occurs in the form of the active ingredient alone or the as the formulated product. However, the duration of exposure was shorter for the study with the formulated p roduct , 72 hours compared to the 96 hour duration of the test with fluopy ram technical . In addition, the test with the formulated product was conducted with a higher light intensity , 5620
- 7090 lux compared to 4300 lux in the test with fluopy ram technical
. The higher light intensity likely did not change the chemical concentrations, as fluopy ram degrades relativel y slowly b y aqueous photolysis (t1⁄2= 57 day s; MRID 47372307) . In addition, Time 0 measured concentrations yielded recoveries of 93 to 98% of the nom inal test concentrations, and day

4 measured concentrations yielded recoveries of 88 to 95% of nominal, which indicate that fluopyram technical was relatively stable under the test conditions. However, the higher light intensity may have created difference s in the rate of algal growth between the tests . B oth study

duration and light intensity are factors that create sources of uncertainty in directly comparing the results of the two tests
. Both a study with the technical product and the formulated product ( Fluopy ram SC 500A) were submitted for freshwater duckweed ( Lemna gibba ). In the acute study with fluopy

ram technical, the NOAEC = 0.278 mg a.i./Land EC 50 = 2.6 mg a.i./L , respectivel y. In another acute toxicity study with freshwater duckweed exposed to the formulated fluop yram product , the endpoints were similar to those observed in the study with the technical product, with a NOAEC = 1.04 and EC 50 = 2.9 mg a.i./L , respectivel y . Small fronds, necrosis and chlorosis were observed in both studies, at high er treatment levels ranging from 4.04 to 15.9 mg a.i./L.**72**

In addition to studies conducted on the parent compound, o ne algal study with Pseudokirchneriella subcapitata was submitted for the degradate fluop yr am lactame which showed low toxicity

of this degradates to nonvascular plant species ( EC 50 >8.87 mg/L and NOAEC = 8.87 mg/L).

**b. Aquatic Animals :**  **Sediment Exposure** Fluopy ram shows the potential to bind to particulate and organic carbon (with a high l og Kow = 3.314 , although the log Koc = 439 is not particularly high), which increases the likelihood of occurrence of this chemical in sediment. Expos ure to this sediment can result in a direct impact to aquatic life through respiration, ingestion, dermal contact, as well as indirect impact through alterations of the food chain. Coupled with fluopy ram ’s expected persistence in aerobic and anaerobic environments, sediment
-bound fluopy ram could present a toxicity risk for benthic and epibenthic aquatic life, and aquatic ecos ys tems in general. Therefore, risk to benthic organisms was considered in addition to risk to water
- column dwelling organisms
. No acute risk quotients were derived for freshwater or estuarine/marine benthic invertebrates via sediment and pore water fluopy ram exposure ( **Table 19**  ). Short
- term toxicity data was not provided for freshwater benthic invertebrates and the LC 50 endpoint was undefined (> 2,700,000 μg a.i./kg OC; > 2500 μg a.i./Lpore water) in the submitted study with estuarine/marine invertebrates. Based on information in the available, the predicted environmental concentrations for the modeled crop use with the highest peak aquatic EEC value (watermelon s) are more than four orders of magnitude lower than the highest fluopy ram levels tested that did not elicit adverse effects on the survival of estuarine/marine benthic invertebrates. T he EqP approach, as described above in the water column exposure section, was also used to approximate acute risk to freshwater benthic invertebrates , as no toxicity studies were submitted for this taxon
. The levels at which no adverse effects were observed acute water column toxicity tests with f reshwater invertebrate (EC 50 >17 mg a.i./L) is 5 orders of magnitude greater than the predicted maximum peak pore water concentrations (0.142 μg a.i./L pore water)
. Therefore, overall acute risk to freshwater and estuarine/marine benthic organisms is expected to be low. Inaddition, n o chronic levels
- of

- concern were exceeded and chronic risk to freshwater or estuarine/marine benthic invertebrates is not expected from current proposed uses of fluop yr am ( **Table 20** )
. **3 . Risks to Terrestrial Organisms**  **a. Spray Applications: Acute and Chronic Risk to Birds and Mammals** Acute Risk to Birds, Reptiles and Terrestrial
- phase Amphibians Risk quotients were not calculated for acute risk to birds (and reptiles and terrestrial
-phase amphibians using the surrogate species approach) based on the nondefinitive endpoints in the**73**

submitted acute and dietary s tudies (LD 50 > 2000 mg ai/kg bw; LC 50 > 4785 mg ai/kg bw)
. However, mortality

and sublethal effects were noted. In the acute oral study with bobwhite quail , mortalities were observed in all treatm ent levels, ranging from 1/10 birds at 500 mg ai/kg bw (lowest treatment level ) and 4/10 birds at the 2000 mg ai/kg bw (highest treatment level
. In addition, One mortality

w as also observed in the limit test with zebra finch (1/6 birds). A second test was conducted and no mortality o ccurred. However, sublethal clinical effects such as ataxia, piloerection, wing droop and uncoordination were observed in the limit test. In the dietary

tests, there were no treatment - related effects on mortality , clinical sign s of toxicity , body w eight, or food consumption to the tested species, mallard duck (dietary L C 50 >4604 mg ai/kg diet). However, based upon a notable increase in the incidences of red pancreases in surviving birds at the 4604 mg ai/kg diet level, the NOAEC was 2307 mgai/kg diet (note that this effect does not appear to be directly linked to the ty

pical US EPA ecological risk assessment endpoints of survival, growth or reproduction of an organism)
. Inas tudy with northern bobwhite, exposure to fluopy ram te chnical resulted in a dietary L C 50 >4785 mgai/kg diet. Based upon treatment
- related reductions in food consumption at all treatment levels, the NOAEC <279 mg ai/kg diet. A statistically
- significant reduction in body w eight also occurred in birds from the 4785 mg ai/kg diet lev el during the exposure period. For the highest use scenario (watermelons and strawberries), the most conservative acute dose
based and dietary

E ECs for birds would be 101.54 ppm (short grass) and 115.64 ppm (15
- gram bird, short grass) , respectivel y (assuming the default 35
- day h alf
- life)
. Therefore, the se observations of mortality and sublethal effects occurred at levels that are approximately 2.7 to 4.3 times higher than the upper bound EECs of the highes t fluop yram use scenario
. Some uncertainty exists in defining the lowest level at which mortality or sublethal effects would occur, since no NOAEC was established in the most sensitive acute oral and dietary s tudies. Therefore, acute risk to avian species cannot be entirely precluded. Chronic Risk to Birds, Reptiles and Terrestrial
- phase Amphibians The dietary
-based chronic RQs for avian species (and reptiles and terrestrial
-phase amphibians using the surrogate species approach) exceed the chronic risk LOC (EEC/NOAEC ≥ 1) for three of the four dietary

i tems (short grass, tall grass and broadleaf plants/small insects). The dietary
based chronic avian RQs for the fruits/pods/seeds/large insects dietary c ategory did not exceed the chronic risk level of concern (RQ range = 0.14 to 2.17; **Table 24**  ). Therefore, chronic risk concerns exist for avian species. Potential chronic effects to avian species, such as reduction in 14
- day s urvivor body

w eight for chicks , could occur at environmental ly
- relevant exposure concentrations of fluop yr am following proposed label use rates
. Exceedances of the chronic levels
- of
- concern for this taxa occurred for all crops on the proposed label, with the exception of cherry (see detailed risk quotients in **Appendix F** ).**74**

Acute Risk to Mammals Results of oral toxicity

s tudy c onducted on rats show that fluopy ram TGAIi s practicall y non toxic to mammals on an acute basis ( LD 50 > 2000 mg a.i./kg b w). No mortality or sublethal effects were observed in this study
. For the highest use scenario (watermelons and strawberries), the most conservative acute dose
based EEC for mammals is 96.81 ppm ( 15
- gram mammal , short grass), assuming the default 35
- day half
- life
. The highest fluopy

ram concentration in the acute oral s tudy with rats did not result in any m ortality o r sublethal effects and is approximately 2 0 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. Chronic Risk to Mammals For the maximum application scenario considered in this risk assessment (watermelon s and strawberries), dietary
-based RQs for chronic risk to mammalian species are above the chronic risk level
- of

- concern (EEC/NOAEC ≥ 1) for three of the four dietary items (short grass, tall grass and broadleaf plants/small insects). The dietary
-based chronic mammalian RQs for the fruits/pods/seeds/large insects dietary c ategory did not exceed the chronic risk level of concern (RQ range = 0.49 to 7.81 ; **Table 22**  ). Dose -based RQs for chronic risk to mammalian species exceed the chronic LOC for all dietary routes of exposure with the exception o f seeds (overall RQ range = 0.43 to 67.76 ; **Table 23**  ). Specificall y, chronic RQs exceed the LOC for all size classes of mammals feeding on short grass (RQ range = 31.03 to 67.76 ), tall grass (RQ range = 14.22 to 31.06 ), broadleaf plants/small insects (RQ range = 17.45 to 38.12 ) and fruits/pods/large insect s (RQ range = 1.94 to 4.24 ). The chronic LOC is not exceeded for mammals of any size feeding on seeds (RQ range = 0.43 to 0.94 ). Exceedances of the chronic levels
- of
- concern for this taxa occurred for all crops on the proposed label (see detailed risk quo tients in **Appendix F** ). Based on this analysis, the potential for chronic adverse affects to mammalian species could occur at environmentall y - relevant exposure concentrations. These potential effects include decreased body weight in adults and offspring, a s well as reduced food consumption
.

**b . Non**  **- target Terrestrial Invertebrates**  US EPA does not evaluate the potential exposure of terrestrial insects to pesticides or quantitatively

evaluate risk to this taxonomic group in new chemical screening level assessments . The risk characterization for terrestrial insects and mites that follows below is based solely on available toxicity

data.**75**

Results of the submitted acute toxicity studies demonstrate that fluopy ram TGAI and the fluopy ram formulated product show little toxicity to honey bees on an acute contact or oral basis ( acute oral : LD 50 > 97.7 μg a.i./bee for fluop yr am TGAI and LD 50 > 89 μg a.i./bee for formulated fluop yr am ; acute co ntact : LC 50 > 95.5 μg a.i./bee for fluop yr am TGAI and an LC 50 > 83.2 μg a.i./bee for formulated fluopy ram)
. Additional studies with fluopy ram technical and the end
- use product (Fluopy ram SC 500, 41.8% active ingredient) were submitted for other nontarget terrestrial invertebrates, including predatory mite ( Typhlodromus pyri), rove beetle ( Aleochara bilineata, springtail ( Folsomia candida ), soil mite (

Hypoaspis aculeifer) and earthworm ( Eisenia fetida ). None of these studies resulted in an LC 50 or EC 50 , as 50% mortality did not occur at the highest treatment level in any of the tests (L C 50 s ranged from >20.31 mg a.i./kg dw soil to >1000 mg a.i./kg dw soil for earthworms; LD 50 > 801.8 mLa.i./ha for rove beetles; L C 50 >415 mg a.i./kg dw soil for soil mites and springtails; LC 50 >825.9 mLa.i./ha for parasitic wasp; LC 50 >834.2 mLa.i./ha for predatory mite). The highest single application rate of 0.222 lbs a.i./acre (6.84 fl oz product/acre) i s equivalent to 207 mLa.i./ha, which is lower than the highest levels tested in comparable units. Therefore, acute toxicity to these additional nontarget terrestrial invertebrates appears to be low. In two 14
- day

toxicity studies, statistically

significant weight loss (10
- 23%) was observed in earthworms exposed to fluopy ram at treatment levels >131 mg a.i./kg dw of soil. No adverse effects on mortality

or growth were observed in a 28
- day subchronic study

with earthworms exposed to lower levels of the end
- use product (1.85 to 20.31 mg a.i./kg dw soil), but a reduced numb er of surviving juveniles occurred at the highest treatment levels (8
- 23% reduction compared to the control, NOAEC = 3.27 mg a.i./kg dw soil). In the 28
- day reproduction test conducted with the springtail, the test organisms were exposed to nominal application rates of 26.1 to 415 mg a.i./kg dw soil . After 28 days, significant mortality occurred (29.5
- 45.5%) and the number of juveniles was significantly reduced (36.5
- 36.9%) at the two highest treatment levels ( 207.5 and 415 mg a.i./kg dw soil)
. Based on sub mitted ter restrial field dissipation studies , the maximum soil concentration following fluop yram application at 0.446 lb a.i/A (twice the maximum label rate ) is 286 μg a.i./kg soil (MRIDs 47567001, 47567002, 47567003, 47567004 and 47567005)
. This maximum empirical soil concentration is approximately 1
- 3 orders of magnitude less than the exposure concentrations that caused adverse reproductive effects in the studies with earthworms and springtails. Therefore, the potential for adverse effects to soil
dwelling invertebrates following fluop yram application appears to be low, based on the currentl y available information.

**c . Terrestrial Plants**  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**76**

for aerial application. Compared to the available toxicity studie s, in the vegetative vigor study , sugarbeet had the highest level of inhibition in dry weight, a 20.2% reduction in comparison to the negative control at a fluopy ram application rate of 0.222 lbs a.i./A. Therefore, it does not appear as if fluop yr am spray applications will have any direct phy

to to xic effects on the height or weight of exposed monocot or dicot species at these proposed label rates. The rate applied in the Tier I seedling emergence test, 0.444 lbs a.i./A, was greater than the maximum application rate of 0.222 lbs a.i./A. Because buckwheat showed a 50.4% reduction in dry weight at 0.444 lbs a.i./A in the seedling emergence test, a Tier II test was conducted (MRID 47372349). The most sensitive endpoint was biomass. No clear dose
- dependent pattern for effects on biomass was observed due to high variance. Compared to the negative control, reductions in biomass were 12.3, 1.6, 21.3, 40.1 an d 6.2% at nominal concentrations of 0.028, 0.056, 0.111, 0.222, and 0.444 lbs a.i./acre respectively . Therefore, it appears as if some reduction in biomass following seedling emergence of certain dicot species, such as buckwheat, may occur at environmental ly relevant concentrations of fluopy ram exposure following the proposed spray

application rates
. **4. Review of Incident Data** Because fluop yram has not been previously a pproved for use in the United States, there are no incident reports for this chemical. **5 . Threatened and Endangered Species Concerns**  For listed species assessment purposes, the action area is considered to be the area affected directly or indirectl y b y the Federal action and not merel y the immediate area involved in the action. At the initial screening
- level, the risk assessment considers broadl y described taxonomic groups and so conservatively assumes that list species within those broad groups are collocated within the pesticide treatment area. This means that terrestrial plants and wildlife are assumed to be located on or adjacent to the treated site and aquatic organisms are assumed to be located in a surface water body adjacent to the treated site. The assessment also assumes that the listed species are located within an assumed area which has the relativel y highest potential exposure to the pesticide, and that exposures are likely to decrease with distance from the treated area. If the assumptions associated with the screening
- level action area result in RQs that are below the listed species LOCs, “no effect,” determination conclu sion may be made with respect to listed species in that taxa (for direct effects), and no further refinement of the action is necessary . Furthermore, RQs below the listed species LOCs for a given taxonomic group indicate no concern for indirect effects up on listed species that depend upon the taxonomic group as a resource. However, in situations where the screening assumptions lead to RQs in excess of the listed species LOCs for a given taxonomic group, a potential “may affect,” conclusion exists and**77**

may be associated with direct effects on listed species belonging to that taxonomic group or may extend to indirect effects upon listed species that depend on that taxonomic group as a resource. In such cases, additional information on the biology of the list ed species, the locations of these species, and the locations of use sites could be considered along with available information on the fate and transport properties of the pesticide to determine the extent to which screening assumptions regarding an action area appl y to a particular listed organism. These subsequent refinement steps could consider how this information would impact the action area for a particular listed organism and may potentially

include areas of exposure that are downwind and downstream of the pesticide use site. In conducting a screen for indirect effects, direct effects LOCs for each taxonomic group are used to make inferences concerning the potential for indirect effects upon listed species that rel y upon non - listed organisms in the se taxonomic groups as resources critical to their c ycle. Pesticide use scenarios resulting in RQs that are below all direct effect listed species LOCs for all taxonomic groups assessed are considered of no concern for risks to listed species either b y direct or indirect effects. For fluop yr am , the potential direct effects to listed species should they co - occur with application sites are indicated for mammals and birds (based on consumption of short grass, tall grass and broadleaf plants/small insects). Screening
- level chronic RQs for avian and mammalian species exceed the chronic endangered species risk LOC s . In addition, acute risk to avian species could not be discounted. Li sted species LOCs are not exceeded for any other taxonomic group assessed (aquatic animals, terrestrial or aquatic plants, nontarget invertebrates). For the maximum proposed fluopyram application rates , there may be a potential concern for direct effects to the following groups of organisms:

• Birds
• Mammals
• Terrestrial
-phase reptiles
• Terrestrial
-phase amphibians
• Terrestrial plants A spatial co
- occurrence analysis would be necessary to delineate the action area. **C. Description of Assumptions, Limitations, Uncertainties, Strengths and Data Gaps 1. Exposure**  **f**

**or All Taxa** There are a number of areas of uncertainty in the aquatic and terrestrial risk assessments. The toxicity a ssessment for terrestrial and aquatic plants and animals is limited by the number of species tested in the available toxicity s tudies. U se of toxicity data on representative species**78**

does not provide information on the potential variability in susceptibility

to acute and chronic exposures. For each proposed use , the risk assessment is based on the maximum application rate on the proposed label. The frequency at which actual uses appro ach these maximum scenarios is dependent on the resistance to the pesticide, the timing of applications, and market forces. Exposure and risks could be overestimated if the actual application rates, frequency o f application, or number of applications are lower than the input parameters used for the conservative exposure scenario that was modeled. H owever , i f there are conditions under which there is more than one growing season for a crop within a single ye ar, exposure estimates and risk to aquatic and terrestrial organisms could be significantl y underestimated. **2. Exposure f** 

**or Aquatic Species** This Tier II risk assessment relies on best available estimates of environmental fate and physicochemical properties, maximum application rate of fluop yram , maximum number of applications, and the shortest interval between applications. H owever, several uncertainties and model limitations are noted and should be considered in interpreting the results of this aquatic risk assessment.

• The frequen cy

at which actual fluopy

ram uses approach the use estimates modeled is dependent on resistance to the insecticide, timing of applications, and market forces. In general, model output values represent the upper- bound estimates of concentrations that might be observed in surface water due to the application of fluopy ram , given available data and model limitations.

• Although there are uncertainties associated with using the standard PRZM/EXAMS runoff scenario (10 ha field draining into 20,000 m 3 pond with no outlet) for an aquatic exposure assessment, it is designed to represent pestic ide exposure from an agricultural watershed impacting a vulnerable aquatic environment. Extrapolating the risk conclusions from this standard pond scenario may e ither underestimate or overestimate the potential risks.

• Major uncertainties associated with the standard runoff scenario include the physical construct of the watershed and representation of vulnerable aquatic environments for different geographic regions. The physicochemical properties (pH, redox conditions, etc.) of the standard farm pond ar e based on a Georgia farm pond. These properties are likely to be regionally specific because of local hydrogeological conditions. Any alteration in water quality p arameters may

impact the environmental behavior of a pesticide. The farm pond represents a well mixed, static water body
. B ecause the farm pond is a static water body (no flow through), it does not account for pesticide removal through flow through or water releases. The lack of flow through the farm pond provides an environmental condition for accumulation of persistent pesticides. The assumption of**79**

uniform mixing does not account for stratification due to thermoclines ( e.g. , seasonal stratification in deep water bodies). A dditionall y, the dimensions of the standard runoff scenario assume a watershed area to water body v olume ratio of 10 ha: 20,000m 3

. This ratio is recommended to maintain a sustainable constructed pond in the Southeastern United States. The use of higher watershed area to water body v olume ratios (as recommended for sustainable ponds in drier regions of the United States) may l ead to higher pesticide concentrations when compared to the standard watershed area to water body volume ratio.

• The standard runoff scenario assumes uniform soils and agronomic management practice s across the standard 10 hectare field. S oils can vary s ubstantially

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

• For an acute risk assessment, there is no averaging time for exposure. Ap eak concentration, with a 1 in 10 ye ar return frequency , is assumed. The use of the peak concentration in the calculation of risk quotients assumes that exposure is sufficient to elicit acute effects comparable to those observed over more protract ed exposure periods tested in the laboratory , ty pically 4 8 to 96 hours. In the absence of data regarding time
to - toxic event anal ys es and latent responses to peak exposure, the degree to which risk is overestimated cannot be quantified. **3. Exposure f** 

**or Terrestrial Species**  This risk assessment relies on the best available estimates of environmental fate and physicochemical properties, maximum application rate of fluop yram , maximum number of applications, and the shortest interval between applications. H owever, several uncertainties and model limitations are noted and should be considered in interpreting the results of this terre strial risk assessment. Choice of Half

- life Value Used in Terrestrial Exposure Modeling One source of uncertainty f or the terrestrial risk assessment relates to the magnitude of the estimated exposure concentrations representing terrestrial exposure to fluopy ram is based on a 35
- day f oliar dissipation half

- life. When data are absent, US EPA assumes a 35
- day f oliar dissipation half

- life as an input to T - REX model. The use of the 35
- day h alf
- life is based on the highest reported value (36.9 days) on the fo liar dissipation rate of a wide range of pesticides, as reported in Willis and McDowell (1987).**80**

Some data were submitted by the registrant regarding the foliar dissipation half
- life. These magnitude of residue studies were conducted on different crops than those on the proposed label. Residue decline trials were conducted on corn, sorghum, wheat, cabbage, mustard greens, lettuce, spinach, radish, sugar beet, turnip, so ybean, Bermuda grass and timothy grass (MRIDs 47372606, 47567010, 47567011, 47567014, 47 567015, 47567016, 47567025 and 47567026). Because the tested crops differ from the crops on the proposed label, these studies were not submitted to or reviewed by the Health Effects Division , as is ty pical for foliar dissipation studies . A summary

of the data (MRID 47567008) and the individual study reports were preliminarily

reviewed by

the Environmental Fate and Effects Division. The residue trials report fluopy ram concentrations following a single foliar application of fluopy ram 500 SC at the maximum all owable rate (reported to be 0.223 lbs a.i./A which is slightly higher than the 0.222 lbs a.i/A used for modeling, presumabl y due to rounding differences). Fluopy ram concentrations were anal yz ed in the homogenized above
- ground foliage, and extracted residue s were quantified using high performance liquid chromatography- electrospray ionization/tandem mass spectrometry . Sampling occurred at day 0 and four additional time points until day 10
- 28 post
application, depending on the study . All residue trials were co nducted in typical growing areas for the examined crop. Half
- lives were calculated assuming a first
- order decay rate. One potential concern exists for using the empirical half
- lives from the trials. Rainfall and/or sprinkler irrigation occurred in all of the trials to varying degrees, ranging from 0.1 to 11.5 inches rainfall and 0.99 to 2.50 inches of irrigation water. When precipitation occurs, this can reduce the residues present on plant surfaces. Regardless, an additional analysis was conducted to explore how changes in the half
- life used in terrestrial exposure modeling may affect risk conclusions. Based on this information, it appears that the foliar dissipation half
- life could be lower than the default value of 35 days, and the terrestrial EECs may b e overestimated to some degree. The range of half

- lives calculated from the field trials ranged from 0.76 to 9.27 days, with the exception of an estimated half
- life of 45.6 days in one trial with corn. In addition to appearing to be an outlier in the data set, the concentrations in this corn trial were highly variable and suggest that the results are questionable. From the available data in the 15 other field trials, excluding the suspect corn trial, the 90 th percentile of the mean half
- life values was calculated. This alternate half
- life value for fluop yram is 7.37 days ( Note: I f the 45.6 half

- life value from the corn trial is added to the data set, the 90 th percentile of the mean changes slightly to a half
- life value of 8.45 days )
. This differs slightly f rom the suggested value in the summary report, 4.08 days, which is based on the overall mean of the 15 trials. The highest use scenario, the lowest use scenario, and the scenario with the greatest number of applications were run again in T - REX using 7.37
- day dissipation half

- life, in addition to the 35
- day h alf
- life used to calculate risk quotients. The highest and lowest use scenarios were used to bound potential exposure and risk estimates. When multiple applications are modeled, residue concentrati ons resulting from the final application and remaining residue from previous**81**

applications are summed. The maximum concentration calculated (out of the 365 days) is the EEC used to estimate potential risk to birds and mammals. Therefore, the number of appli cations is an important consideration for comparing estimated exposure based on potential differences in the half
- life of a chemical. To account for the influence, the scenario with the highest number of applications was also included in this comparison. Based on this exploratory anal ys es, EECs are reduced by a pproximately

15% of those calculated using a 35
- day

h alf
- life when a 7.37
- day

h alf
- life is used for the maximum and minimum use scenario. For the use scenario with the highest number of applications , EECs are reduced by about 25 % when a 7.37
- day h alf
- life is used instead of the default 35 days. Despite these reductions in EECs, using a 7.37
- day h alf
- life would still result in chronic dietary
-based exceedances for birds (RQs range from 0.05 to 1.85) and mammals (RQs range from 0.15 to 6.77) ( **Table 25**  **- 27**  )
. This comparison suggests that even if the foliar dissipation half
- life for fluopy ram is the lower value reported in the residue decline trials, the chronic risks to birds and mammals as a result fluo py ram exposure would remain similar. **Table 25 . Terrestrial EECs (ppm) estimated for fluopyram** **use scenarios with 35 -**  **day and 7.37 -**  **day foliar dissipation half** 

**- lives using upper**  **- bound Kenaga values** 

**Waterm elon**  **s and Strawberries**  **max exposure scenario a**  **Cherries min exposure**  **scenario b**  **Potatoes**

**scenario with highest number of**  **applications c**  **Forage Type 35**  **- day**  **half -**  **life 7.37**  **- day**  **half -**  **life 35**  **- day**  **half -**  **life 7.37**  **- day**  **half -**  **life 35**  **- day**  **half -**  **life 7.37**  **- day**  **half -**  **life short grass**  101.54 86.57 42.08 35.88 60.19 44.50 **tall grass** 46.54 39.68 19.29 16.44 27.59 20.39 **broadleaf plants and small**

**insects** 57.11 48.70 23.67 20.18 33.86 25.03 **fruits/pods/large insects** 6.35 5.41 2.63 2.24 3.76 2.78 a The maximum application rate for watermelons and straw berries is 0.222 lbs a.i./A, with a 5 - day application interval and 2 applications. b The maximum application rate for cherries is 0.092 lbs a.i./A, with a 5 - day application interval and 2 applications. This scenario for cherries results in the lowest EECs from any of proposed application rates for any crop on the Fluopyram 500 SC label. All scenarios for terrestrial mo deling use the maximum application rate for any given use pattern. Therefore, these numbers represent the exposure from the maximum application rate for the crop with the lowest proposed use rates of fluopyram. c The maximum aerial application rate for potatoes is 0.092 lbs a.i./A, with 5 - day application interval and 3 applications. The aerial scenario for p otatoes has the highest num ber of applications for any crop on the Fluopyram 500 SC label.**82**

**Table 26 . Chronic avian dietary RQs estimated for fluopyram** **use scenarios with 35 -**  **day and 7.37 -**  **day foliar dissipation half** 

**- lives using upper**  **- bound Kenaga values** 

**Waterm elon**  **s and Strawberries**  **max exposure scenario**  **a Cherries**  **min exposure scenario**  **b Potatoes** 

**scenario with highest number of**  **applications c**  **Forage Type 35**  **- day**  **half -**  **life 7.37**  **- day**  **half -**  **life 35**  **- day**  **half -**  **life 7.37**  **- day**  **half -**  **life 35**  **- day**  **half -**  **life 7.37**  **- day**  **half -**  **life short grass**  **2.17 1.85**  0.90 0.77 **1. 29**  0.95 **tall grass 1.00**  0.85 0.41 0.35 0. 59 0 .44 **broadleaf plants and small**

**insects 1.22**  **1.04** 0.51 0.43 0. 73 0. 54 **fruits/pods/large insects** 0.14 0.12 0.06 0.05 0. 08 0. 06 a The maximum application rate for watermelon s and straw berries is 0.222 lbs a.i./A, with a 5 - day application interval and 2 applications. b The maximum application rate for cherries is 0.092 lbs a.i./A, with a 5 - day application interval and 2 applications. This scenario for cherries results in the lowest EECs from any of proposed application rates for any crop on the Fluopyram 500 SC label. All scenarios for terrestrial mo deling use the maximum application rate for any given use pattern. Therefore, these numbers represent the exposure from the maximum application rate for the crop with the lowest proposed use rates of fluopyram. c The maximum aerial application rate for potatoes is 0.092 lbs a.i./A, with 5 - day application interval and 3 applications. The aerial scenario for potatoes has the highest num ber of applications for any crop on the Fluopyram 500 SC label. **Bolded values represent LOC exceedances (RQ ≥1).** 
**Table 27 . Chronic m**  **ammalian dietary RQs estimated for fluopyram use scenarios with 35**  **- day and**  **7.37 -**  **day foliar dissipation half -**  **lives using upper -**  **bound Kenaga values Waterm**  **elon s and**  **Strawberries max exposure scenario**  **a Cherries**  **min exposure scenario**  **b Potatoes** 

**scenario with highest number of**  **applications c**  **Forage Type 35**  **- day**  **half -**  **life 7.37**  **- day**  **half -**  **life 35**  **- day**  **half -**  **life 7.37**  **- day**  **half -**  **life 35**  **- day**  **half -**  **life 7.37**  **- day**  **half -**  **life short grass**  **7.81 6.66**  **3.24 2.76**  **4. 63**  **3.42 tall grass**  **3.58 3.05**  **1.48 1.26**  **2.12 1.**  **57 broadleaf plants and small** 

**insects 4.39**  **3.75 1.82**  **1.55 2.**  **60 1.**  **93 fruits/pods/large insects**  0.4 9 0. 42 0. 20 0.1 7 0 .2 9 0. 21**83** a The maximum application rate for watermelon s and straw berries is 0.222 lbs a.i./A, with a 5 - day application interval and 2 applications. b The maximum application rate for cherries is 0.092 lbs a.i./A, with a 5 - day application interval and 2 applications. This scenario for cherries result s in the lowest EECs from any of proposed application rates for any crop on the Fluopyram 500 SC label. All scenarios for terrestrial mo deling use the maximum application rate for any given use pattern. Therefore, these numbers represent the exposure from the maximum application rate for the crop with the lowest proposed use rates of fluopyram. c The maximum aerial application rate for potatoes is 0.092 lbs a.i./A, with 5 - day application interval and 3 applications. The aerial scenario for potatoes has the highest num ber of applications for any crop on the Fluopyram 500 SC label. **Bolded values represent LOC exceedances (RQ ≥1).** 

**a. Location of Wildlife Species** For screening terrestrial risk assessments, a generic bird or mammal is assumed to occupy e ither the treated field or adjacent areas receiving the pesticide at a rate equivalent with the treatment rate on the target field. This assumption may l ead to an o verestimation of exposure to species that do not occup y the treated field. The actual habitat requirements of any p articular terrestrial species are not considered, and it is assumed that species occup y, exclusively and permanently , the treated area being modeled. This assumption leads to a maximum level of exposure in the risk assessment.

**b. Routes of Exposure Dietary Exposure**  Screening
- level risk assessments for spray a pplications of pesticides assume that 100% of the diet is relegated to single food ty pes foraged only

f rom treated fields. These assumptions are likely to be conservative for many species and will tend to overestimate potential risks. The assumption of 100% diet from a treated area may be realistic for acute exposures, but long
- term exposures modeled as single food ty pes composed entirel y of material from a treated field is uncertain. **Inhalation Exposure** The screening risk assessment also considered acute inhalation exposure from spray m aterial in droplet form at the time of application and vapor phase pesticide volatilizing from treated surfaces. Inputs for the STIR tool (version 1.0) included fluop yr am’s molecular weight (396.72 g/mole), vapor pressure ( 2.33 x 10 - 8 mm Hg) , maximu m application rate (0.222 lbs a.i./acre), as well as available avian and mammalian toxicity information
. Because no definitive endpoints were available for acute oral mammalian or avian studies, the highest concentration tested was used as an upper-bound e stimate of acute toxicity ( 2000 mg a.i./kg bw for both mammals and birds). A 4
- hour rat inhalation study w as submitted for fluopy ram (L C 50 = 2.091 mg a.i./L). Due to the chemical’s low vapor pressure, low acute oral toxicity to mammals and birds and low inhalation toxicity

to mammals , acute inhalation exposure at the time of fluopyram application is not an appreciable route of exposure for mammals or birds.**84**

**Dermal Exposure** The screening assessment doe s not consider fluopy ram dermal exposure to terrestrial organisms. The Agency

i s actively

p ursuing modeling techniques to account for dermal exposure via direct application of spray

and by incidental contact with contaminated vegetation , soil and water
. **Drinking Water Exposure** Drinking water exposure to a pesticide active ingredient may b e the result of consumption of surface water or consumption of the pesticide in dew or other water on the surfaces of treated vegetation. F or pesticide active ingredient s with a potential to dissolve in runoff, puddles on the treated f ield may c ontain the chemical. The SIP tool (version 1.0) was used to assess the potential for exposure concerns to birds and mammals via drinking water alone
. F luopy ram ’s solubility in wate r (16 mg/L) and toxicity to avian and mammalian species are inputs for the potential upper-bound drinking water calculations. Because no definitive endpoints were available for acute oral mammalian or avian studies, the highest concentration tested was use d as an upper-bound estimate of acute toxicity ( 2000 mg a.i./kg bw for both mammals and birds). Chronic NOAEL/NOAEC toxicity v alues were 15 mg a.i./kg bw for mammals and 46.7 mg a.i./kg diet for birds. Based on this information , fluopy ram e xposure through drinking water alone does not present an acute concern for mammals or birds or chronic concern for mammals. There is a potential chronic concern from drinking water exposure for birds
.

**c. Incidental Pesticide Releases Associated with Use** This risk assessment is based on the assumption that the entire treatment area is subject to fluopy ram application at the rates specified on the label. In reality , there is the potential for uneven application of fluopy ram through such plausible incidents as changes in calibration of application equipment, spillage, and localized releases at specific areas of the treated field that are associated with specifics of the type of a pplication equipment. **d. Residue Levels Selection** As discussed earlier in the exposure section of this document, the Agency r elies on the work of Kenaga and Fletcher et al
. (1994) for setting the assumed pesticide residues in wildlife dietary items. The Agency

believes that these residue assumptions reflect a realistic upper
-bound residue estimate for pesticides , with the assumption that these residues reflect a chemical
- specific e stimate for fluop yr am . **4. Effects Assessment** The data available to support the terrestrial and aquatic e ffects assessment for fluopy ram is incomplete. Data gaps, uncertainties and limitations are summarized as follows:**85**

 Non
- definitive acute avian endpoints : Risk quotients were not calculated for acute risk to birds base d on the non - definitive endpoints in the submitted acute and dietary s tudies (LD 50 > 2000 mg ai/kg bw; LC 50 > 4785 mg ai/kg bw). However, mortality and sublethal effects were noted at the lowest concentrations tested
. The lowest treatment level at which observations of mortality and sublethal effects occurred (mortality o ccurred in 1/10 birds; 500 mg ai/kg bw) is approximately 4to 71 times higher than the peak upper bound EECs of the highest fluopy ram use scenario (0.4 1

– 116 mgai/kg bw), depending on the dietary

i tem and using the smallest size of the bird (most conservative) in the terrestrial exposure modeling. Some uncertainty exists in defining the lowest level at which mortality

o r subleth al effects would occur, since a NOAEC was not established in the most sensitive acute oral and dietary s tudies. All submitted acute oral and dietary studies with birds were determined to be acceptable and meet US EPA guideline requirements, with the exception of the limit test co nduct with a passerine specie s (zebra finch, supplemental). Because overall acute risk to avian species appears to be low, an additional pa sserine study is not requested at this time
.
 Chronic effects to estuarine/marine fish and estuarine/marine invertebrates : No chronic data were submitted for estuarine/marine fish or es tuarine/marine invertebrates
. An acute
to - chronic ratio could not be calculated due to lack of available data on definitive acute toxicity endpoints for any aquatic taxa. The expected chronic exposure of fluopy ram to aquatic organisms is low (60
- day E EC = 0.286 μg a.i./L). The level
- of
- concern for chronic risk to aquatic organisms was not exceeded for freshwater fish or freshwater aquatic invertebrates ( LOC > 1.0; freshwater fish chronic RQ = 0.001, **Table 17**  ; freshwater invertebrate chronic RQ = 0.0006 , **Table 18**  )
. On an acute basis, both freshwater and estuarine/marine fish showed low sensitivity to fluopy ram exposure (L C 50 > 0.98 mg a.i./Land NOAEC = 0.98 mg a.i./Lf or sheepshead minnow; LC 50 >1.78 mg a.i./Land NOAEC = 1.78 mg a.i./L for rainbow trout ; **Table 15**  ). Freshwater and estuarine/marine invertebrates also showed low sensitivity o n an acute basis ( E C 50 > 17 mg a.i./L and NOAEC = 17 mg a.i./L for Daphnia magna ; E C 50 >0.51 mg a.i./L and NOAEC = 0.98 mg a.i./Lf or saltwater mysid ; **Table 15**  ). Inaddition, the maximum chronic predicted exposure concentration in the water column is approximately f our orders of magnitude less than the available chronic estuarine/marine benthic invertebrate toxicity endpoint (NOAEC) based on pore water concentrations. Based on these lines of evidence , chronic testing with estuarine/marine fish or estuarine/marine invertebrates is not requested at this time
.  Differences in TGAI vs. TEP : Inthis risk assessment, ecological effects studies with the fluopy ram technical grade active ingredient were compared to predicted exposure concentrations based on movement of the chemical via runoff /erosion and spray drift
. However, in EFED risk assessments, toxicity endpoints from studies with water column dwelling animals and the ty pical end use product (TEP) are used quantitatively to estimate risk resulting from exposure to spray drift only
. Formulated products containing**86**

fluopy ram are expected to be directly d eposited to aquatic systems via spray drift. Therefore, to provide a realistic representation of the expected effects and risk to aquatic animals associated with spray drift, toxicity

endpoints based on concentrations of the active ingredient in laboratory s tudies with the formulated product are compared to estimated exposure concentrations from expected concentrations of the active ingredient to aquatic environments via drift onl y. Because the spray drift is only

a f raction of the total aquatic E ECs, and the TEP does not show greatly enhanced toxicity

compared to the TGAI (see **Table 15**  ) , the risk quotients calculated with the spray drift + runoff

/erosion EECs and fluop yr am technical toxicity endpoints are expected to be a more conservative estimate of risk than estimates with spray drift only

and fluop yramT EP toxicity endpoints. However, the solubility o f the TEP may

b e greater than that of the TGAI, whi ch can result in increased bioavailability in the environment (see discussion of solubility in aquatic tests below).

 Solubility in aquatic tests : According to the submitted fate information, fluopy ram is characterized by

a w ater solubility

r anging from 1 5 to 16 mg a.i./L in acidic to alkaline conditions. However, acute f ish studies with technical
- grade fluop yram were conducted up to the limits of solubility d etermined under the specific test conditions, which ranged from 1 to 6 mga .i./L. Inthe TEP toxic ity s tudy , treatment levels were up to fluop yram concentrations of 46.4 mg ai/L for freshwater fish. Inthe submitted acute study f or mysid , a solvent was used without adverse impacts on the solvent control test organisms (0.1 mL/LD MF). However, the solub ility o f the test material was also low in this study, as fluopy ram levels were only

t ested up to 0.51 mg ai/L. In acute studies with Daphnia magna , studies were conducted up to the limit of solubility that was determined to be 17 mg a.i./L for the technic al product and 38.2 for the formulated fluop yr am 500 SC, under the specific test conditions. O ne submitted aquatic study with the formulated product noted the presence of undissolved test material (highest three treatment levels that were nominal ly 8.72 to 49.8 mg ai/L , acute test with rainbow trout, MRID 473723333 ). In another test with the technical product , the presence of undissolved test material was observed at all treatment levels (nominal concentrations of 11.8 to 189 mg ai/L , acute test with carp, MRID 47372332). No undissolved test material was noted in any o ther submitted studies with the formulated or technical product. Iti s unclear why the solubility o f fluop yr am technical would be much lower in the test conditions of some of the aquatic toxicity

tests. The higher solubility

of the formulated product in some toxicity s tudies indicates that the solubility o f fluopy

ram in the environment may b e higher than the concentrations of active ingredient that were tested. However, the TEP showed low solubility in a study with rainbow trout. The maximum potential for exposure to aquatic ecos ystems , utilizing the value for water solubility ( 16 mga .i./L) 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 (see **Risk Characterization** section)
.**87**

 Terrestrial plant toxicity studies : No acceptable Tier II study i s available for buckwheat, which showed a 50% reduction in biomass in the acceptable Tier I study. The submitted Tier II study did not allow reliable calculation of an EC 25 or NOAEC.
 Fluopyram co -

formulations : Based on the toxicity d ata submitted for the fluopy ram coformulations with tebuconazole and trifloxystrobin, these products are more toxic to aquatic organisms than fluopy ram only
. This increase in toxicity a ppears to be attributable to the presence of the non
- fluop yr am active ingredients, which are more toxic to aquatic taxa. Although no data were submitted for the coformulated products, b oth py rimethanil and prothioconazole are more toxic to aquatic organisms than fluop yram, with the potential exception of py rimethanil effects to freshwater fish
. Therefore, it appears as if use of the fluop yr am co - formulated pro ducts with tebuconazole, trifloxystrobin, py

rimethanil, and prothioconazole have a higher potential to adversel y impact aquatic ecosystems than use of the proposed fluopy ram - only p roduct. Overall, the coformulations for all fluopy ram 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 . However, only rat acute oral studies were submitted for py rimethanil and prothioconazole coformulations. Although th ese studies indicate that the products show low acute toxicity

to mammals, there is uncertainty regarding the effects of these products on other terrestrial taxa. All four fungicides in the coformulation have different modes
- of
- action than fluopy

ram (FRAC , 2009). Fluop yr am is a succinate dehydrogenase inhibitor that alters cellular respiration. Tebuconazole and prothioconazole are demethyl ation inhibitor s that affect sterol biosy

nthesis in membranes. Triflox ys trobin is the most similar to fluop yram, as quinine outside inhibitor that also affects respiration. Py rimethanil is an aniline
py rimidine that impacts amino acid and protein sy nthesis
. This indicates that these chemicals should act independentl y within an exposed organism , with the potential exception of triflox ys trobin
. **a. Age Class and Sensitivity of Effects Thresholds** It is generall y recognized that test organism age may h ave a significant impact on the observed sensitivity

to a toxicant. The screening risk assessment acute toxicity d ata for fish are collected on juvenile fish and aquatic invertebrate acute testing is performed on recommended immature age classes
. Similarly , acute dietary t esting with birds is also performed on juveniles, with mallard being 5
- 10 days old and quail at 10
- 14 days of age. Testing of juveniles may o verestimate the toxicity o f direct acting pesticides in adults. As juvenile organisms do not have fully d eveloped metabolic systems, they m ay n ot possess the ability to transform and detoxify x enobiotics equivalent to the older/ad ult organism. The screening risk assessment has no current provisions for a generall y applied method that accounts**88**

for this uncertainty
. In so far as the available toxicity data may

p rovide ranges of sensitivity information with respect to age class, the risk assessment uses the most sensitive life
- stage information as the conservative screening endpoint.

**b. Lack of Effects Data for Amphibians and Reptiles** Currently , toxicity

s tudies on amphibians and reptiles are not required for pesticide registration. Since these data are lacking, the Agency uses fish as surrogates for aquatic phase amphibians and birds as surrogates for terrestrial phase amphibians and reptiles. If other species are more or less sensitive to fluopy

ram than the surrogates, risks may b e under
- or overestimated, respectivel y. The Agency

i s not limited to a base set of surrogate toxicity information in establishing risk assessment conclusions. The Agency also considers toxicity

data on non - standard test species when available. Further research is needed to determine whether, in general, reptiles and terrestrial
-phase amphibians are suitably represented by

b ird species in a ssessing risks for fluopy ram and fish are an appropriate surrogate for aquatic
-phase amphibians
. **c. Use of the Most Sensitive Species Tested** Although the screening risk assessment relies on a selected toxicity endpoint from the mos t sensitive species tested, it does not necessaril y mean that the selected toxicity endpoints reflect sensitivity

of the most sensitive species existing in a given environment. The relative position of the most sensitive species tested in the distribution of all possible species is a function of the overall variability

among species to a particular chemical. The relationship between the sensitivity

o f the most sensitive tested species versus wild species (including listed species) is unknown and a source of significant uncertainty . In addition, in the case of listed species, there is uncertainty regarding the relationship of the listed species' sensitivity and the most sensitive species tested.**89**



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kal, H. (2008) 1st Amendment to Report No. 20050612.01: AE C656948; Substance, Pure: AE C656948 00 1B99 0001: Vapour Pressure A.4. (OECD 104). Project Number: 20050612/01. Unpublished study prepared by

Siemens Axiva GmbH & Co. KG. 19 p. 47372245 Ey

rich, U.; Bogdoll, B. (2006) Partition Coefficients 1
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4, 7 and 9. Project Number: CX/06/015, M/282473/01/2. Unpublished study prepared b y Battelle UK, Ltd. 69 p. 47372304 Oddy , A.; Brett, R. (2008) [Carbon 14]
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at pH 7. Project Number: CX/06/016, M/297180/02/2. Unpublished study prepared by Battelle UK, Ltd. 121 p. 47372305 Stupp, H.; Koehn, D. (2007) [Phenyl
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Metabolism/Degradation and Time
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47372309 Meyer, B. (2008) [Phenyl
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47567004 Xu, T. (2008) Terrestrial Field Dissipation of AE C656948 in a Georgia Soil, 2006.

Project Number: MEGMP086, M/306814/01/2, 01023. Unpublished study prepared by Bayer CropScience, Agvise Laboratories and Ag Research Associates. 234 p. 47567005 Lembrich, D.; Rapp, V.; Neumann, B.; et al. (2008) Terrestrial Field Dissipation of

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in/on Soil after Spraying of AE C656948 (250 SC) in the Field in Germany, United Kingdom, Sweden, France, Spain and Ital y EU study No MRID Heinemann, O.; Telscher, M. (2007) Interim Report: Determination of the Residues

of AE C656948 in/on Soil after Spraying of AE C656948 (250 SC) in Germany and France **B. Ecological Effects Studies Submitted to EPA** MRID Author(s) Year Title 47372349 Bach, F.; Nguyen, D.

H. 2008 AE C656948 SC 500A G effect on seedling emergence and seedling growth test of ten species of non
- target terrestrial plants (Tier 1 and 2) SE07/037 BCS 47372350 Bach, F.; Nguyen, D.

H. 2008 AE C656948 SC 500A G
- Effect on the vegetative vigour of ten species of non
- target terrestrial plants (Tier 1) VV07/038 BCS 47372403 Banman, C. S.; Lam,

C. V. 2007 Toxicity of AE C656948 technical to the green alga Pseudokirchneriella subcapitata EBGMP048 BCS 47372406 Banman, C. S.; Lam,

C. V. 2007 Toxicity of AE C656948 technical to the freshwater diatom Navicula pelliculosa EBGMP040 BCS 47372404 Banman, C. S.; Lam,

C. V. 2007 Toxicity of AE C656948 technical to the blue
- green algae Anabaena flos
- aquae EBGMP049 BCS**92**

MRID Author(s) Year Title 47372330 Banman, C. S.; Lam,

C. V. 2006 Ac ute toxicity of AE C656948 technical to the sheepshead minnow ( Cyprinodon variegatus ) under static conditions EBGMP053 BCS 47372405 Banman, C. S.; Lam,

C. V. 2007 Toxicity of AE C656948 technical to the saltwater diatom Skeletonema costatum EBGMP050 BCS 47372341 Barfknecht, R. 2008 Ac ute oral toxicity for bobwhite quail ( Colinus vir ginianus ) with AE C656948 technical BAR/LD 074 BCS 47372343 Barfknecht, R. 2007 AE C656948 technical 5 - day
- dietary LC 50 for bobwhite quail ( Colinus virginianus ) BAR/LC 023 BCS 47372342 Barfknecht, R. 2007 AE C656948 technical 5 - day
- dietary LC 50 mallard duck ( Anas platyrhynchos ) BAR/LC 020 BCS 47372324 Bruns, E. 2007 Ac ute toxicity of AE C656948 (tech.) to the waterflea Daphnia magna in a static laboratory test system EBGMP046 BCS 47372334 Bruns, E. 2008 Influence of AE C656948 (tech.) on development and reproductive output of the waterflea Daphnia magna in a static renewal laboratory test system EBGMP047 BCS 47372325 Bruns, E. 2008 Ac ute toxicity of AE C656948 SC 500A G to the waterflea Daphnia magna in a static laboratory test system EBGMP067 BCS GLP: Y , published: N 1783598 / 47372337 Bruns, E.; Weber, E. 2008 [pyridyl
- 2,6
- 14C]
- fluopyram bioconcentration and biotrans formation in fish ( Lepomis macrochirus ) EBGMP116 BCS 47372346 Christ, M.T.; Lam, C.

V. 2008 Effect of AE C656948 technical on reproduction of the mallard duck (

Anas platyrhynchos ) EBGMP041 BCS**93**

MRID Author(s) Year Title 47567008 Desmarteau, D.;

Sabbagh,G. 2008 Foliar half
- life calculation for AE C656948 in grass forage and hay EBGMP158 BCS 47372418 Dorgerloh, M. 2008 Pseudokirchneriella subcapitata grow th inhibition test with fluopyram
- lactame EBGMP155 BCS 47372340 Dorgerloh, M. 2008 Chironomus riparius 28
- day chronic toxicity test with fluopyram (tech.) in a water
- sediment system using spiked water EBGMP121 BCS 47372401 Dorgerloh, M. 2007 Lemna gibba G3
- Growth inhibition test with AE C656948 under static conditions EBGMP051 BCS 47372333 Dorgerloh, M. 2008 Ac ute toxicity of fluopyram SC 500 G to fish ( Oncorhynchus mykiss ) under static conditions EBGMP066 BCS 47372407 Dorgerloh, M. 2008 Pseudokirchneriella subcapitata grow th inhibition test with fluopyram SC 500 EBGMP068 BCS 47372402 Dorgerloh, M. 2008 Lemna gibba G3 grow th inhibition test with fluopyram SC 500A G under static conditions EBGMP151 BCS 47372432 Eiben, R. 2005 AE C656948 SC 500
- Acute toxicity in the rat after dermal application AT 02500 BCS 47372435 Folkerts, Andree 2007 AE C656948 SC 500
- Acute inhalation toxicity in rats AT 03663 BCS 47372434 Folkerts, Andree 2006 AE C656948 SC 500
- Acute inhalation toxicity in rats AT 03464 BCS 47372344 Frey, L. T.; Martin,

K. H.; Beavers, J. B.; Jaber, M. 2008 AE C656948: A reproduction study with the Northern bobwhite EBGMP152 BCS**94**

MRID Author(s) Year Title 47372426 Frommholz, U. 2007 AE C656948 SC 500A G: Influence on the reproduction of the collembola species Folsomia candida tested in artificial soil with 5 % peat FRM - COLL
- 50/07 BCS 47372409 Heimbach, F. 2008 AE C656948 SC 500: Effects on survival, growth and reproduction on the earthworm Eisenia fetida tested in artifical soil with 5 percent peat LKC
- RG
- R- 20/06 BCS 47372418 Hills, M. 2008 Evaluation of the pre
- emergence (PPI) biological activity of AE C656948 SC 500 PPI - 07002 BCS 47372441 Kennel, P. 2005 AE C656948 90
- day toxicity study in the rat by dietary administration SA04048 BCS 47372425 Kratz, M. A. 2007 Fluopyram SC 500: Influence on mortality and reproduction on the soil mite species Hypoaspis aculeifer tested in artificial soil with 5 % peat KRA
- HR - 3/07 BCS 47372408 Lechelt
- Kunze, C. 2005 AE C656948: Acute toxicity to earthworms (Eisenia fetida ) tested in artificial soil with 5 percent peat LKC/RG
- A
- 57/05 BCS 47372410 Leicher, T. 2006 AE C656948 SC 500: acute toxicity to earthworms (Eisenia fetida ) tested in artificial soil with 5 percent peat LRT/RG
- A
- 78/06 BCS 47372331 Matlock, D.; Lam, C.

V. 2008 Ac ute toxicity of AE C656948 technical to the fathead minnow (Pimephales promelas ) under static conditions EBGMP237 BCS 47372328 Nieden, D. 2008 Ac ute toxicity of AE C656948 (tech.) to fish ( Oncorhynchus mykiss ) under static conditions EBGMP017 BCS 47372329 Nieden, D. 2008 Ac ute toxicity of AE C656948 (tech.) to fish ( Lepomis macrochirus ) under static conditions EBGMP052 BCS**95**

MRID Author(s) Year Title 47372332 Nieden, D. 2008 Ac ute toxicity of AE C656948 (tech.) to fish ( Cyprinus carpio ) under static conditions EBGMP020 BCS 47372336 Nieden, D. 2007 Early
- life stage toxicity of AE C656948 (tech.) to fish Pimephales promelas ) EBGMP054 BCS 47372327 Palmer, S. J.;

Kendall, T. Z.; Krueger, H. O. 2007 AE C656948: A 96
- hour flow
- through acute toxicity test with the saltwater mysid ( Americamysis bahia ) EBGMP043 BCS 47372326 Palmer, S. J.;

Sutherland, C. A.; Kendall, T. Z.; Krueger, H. O. 2006 AE C656948: A 96
- hour shell deposition test with the eastern oyster ( Crassostrea virginica ) EBGMP045 BCS 47372338 Putt, A. E. 2008 AE C656948
- Toxicity to marine amphipods ( Leptocheirus plumulosus ) during a 10
- day sediment exposure EBGMP119 BCS 47372339 Putt, A. E. 2008 AE C656948
- Life
- cycle toxicity test exposing midges ( Chironomus tentans ) to a test substance applied to sediment under static
- rene wal conditions following EPA test methods EBGMP128 BCS 47372335 Putt, A. E. 2008 AE C656948
- Toxicity to estuarine amphipods ( Leptocheirus plumulosus ) during a 28
- day sediment exposure EBGMP153 BCS 4 7372427 Roehlig, U. 2007 Dose - response toxicity (LR50) of AE C656948 SC 500 to the parasitic wasp Aphidius rhopalosiphi under laboratory conditions 06 10 48 187 BCS 47372428 Roehlig, U. 2007 Dose - response toxicity (LR50) of AE C656948 SC 500 to the predatory mite Typhlodromus pyri under laboratory conditions 06 10 48 188 BCS**96**

MRID Author(s) Year Title 47372424 Roehlig, U. 2007 Chronic dose
- response toxicity (ER50) of AE C656948 SC 500 to the rove beetle Aleochara bilineata under extended laboratory conditions 07 10 48 018 A BCS 47372347 Schmitzer, S. 2007 Effects of AE C656948 (acute contact and oral) on honey bees ( Apis mellifera L.) in the laboratory 24851035 BCS 47372348 Schmitzer, S. 2008 Effects of AE C656948 SC 500A G (acute contact and oral) on honey bees (

Apis mellifera L.) in the laboratory 34481035 BCS 47372430 Schuengel, M. 2008 AE C656948 SC 500
- Acute toxicity in the rat after oral administration AT 03603 BCS 47567007 Stafford, J. M. 2008 AE C656948
- Ac ute oral toxicity test (LD50) with the zebra finch ( Taeniopygia guttata ) following OECD draft guideline 223 EBGMP117
- 1 BCS 47372345 Stoughton, T. L.;

Lam, C. V. 2008 Effect of AE C656948 technical on reproduction of the northern bobwhite quail EBGMP004
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