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

OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES


### PC Code: 128940 Chemical: Flutriafol DP Barcode: D356830

January 20, 2010

MEMORANDUM

SUBJECT: Revised Baseline Ecological Ri sk Assessment for the Registration of Flutriafol

FROM: Stephen Carey, Biologist Stephanie Syslo, Environmental Scientist/RAPL Mary Frankenberry, Senior Statistician James Hetrick, Ph.D., Senior Advisor Environmental Risk Branch 3

THRU: Dana Spatz, Chief Environmental Risk Branch 3 Environmental Fate a nd Effects Division (7507P)

TO: Mary Waller, Risk Manager Tamue Gibson, Risk Manager Reviewer Registration Division (7505P)

The Environmental Fate and Effects Division (E FED) has revised the en vironmental fate and ecological risk assessment for flutriafol (versi on dated December 12, 2008) in support of the new active ingredient, flutriafol (CAS Registry Number: 76674-21-0) and its End Use Product – TOPGUARD TM 

### - a soluble concentrate containing 11.8% active ingredient [EPA Reg. No. 67760-TL], for use to control fungal diseases on apples and soybeans. Based on communications with the Registration Division, the maximum number of applications to apples that was assessed was decreased from six to four; EECs associated with the apple use were remodeled accordingly and new Risk Quotients (RQs) were calculate d. Also, environmental fate and ecotoxicology studies submitted by the registrant since the original 2008 assessment have been reviewed and the results incorporated into the revised docum ent. Conclusions regarding the environmental fate, ecological effects, and ecological risks associated with the proposed us es in agricultural areas can be found in the Executive Su mmary of the attached document.

### The combination of field observations of leach ing from registrant-submitted studies and EFED modeling predictions indicate a pot ential for flutriafol to contam inate ground water. Results from non-guideline fi eld dissipation studies showed that following multiple applications over a number of years, flutriafol residues were found in the soil to the maximum depth sampled. PRZM modeling conducted by EFED predicted th at the dominant route of dissipation for flutriafol is leaching below the root zone.

In addition, the Draft Assessment Report on flutri afol prepared by the UK for submission to the European Commission to enable a decision to be made on the inclusion of flutriafol on Annex I of the Directive 91/414/EEC (draft dated May 2006: Flutriafol_DAR_01_Vol-1_public .pdf 

### ) predicted annual average concentrations of flutriaf ol in leachate leaving the top 1 m soil layers would exceed 0.1 μg/L 80% of the time (peak concentration of 4.259 μg/L as modeled using FOCUS model).

Since multiple ground water models predict that flut riafol will leach out of the surface layer of soil and since no field data quantifying the maximum depth of leaching under actual use conditions have been provided to the Agenc y, EFED is recommending that a Small Scale Prospective Ground Water Monitoring study (EPA Guideline 835.7100) be conducted to evaluate the potential for flutri afol to contaminate ground water

Considering the ecotoxicity data along with exposure estimate s, EFED concludes that for terrestrial species, there is an i ndication of acute and chronic risks to birds, reptiles, terrestrialphase amphibians and mammals when exposed to flutriafol.

There is no indication of risk to freshwater or estuarine/marine species through acute or chronic exposure to the active ingredient. Risk is minima l for listed terrestrial monocots and dicots and listed aquatic vascular and non-vascular plant sp ecies. Precautionary labeling for honeybees is not required since flutriafol and its formulated product are practically nontoxic to bees.

Ecotoxicity profile

Levels of concern were exceeded for listed birds (acute RQs ≤ 0.25; chronic RQs ≤ 2.21), terrestrial-phase amphibians (based on surrogate species), reptiles (based on surrogate species), and mammals (acute RQs ≤ 0.43; chronic RQs ≤ 1.83). Therefore, there is potential for indirect effects to all taxa dependant on birds, mammals, reptiles, and terrestrial-phase amphibians for habitat, feeding, cover requirements, for survival, growth, or reproduction, and as pollinators, seed dispersers, or burrowers. Direct effect s LOCs were not exceeded for birds and mammals feeding on large insects and seeds, freshwater an d estuarine/marine fish and invertebrates, aquatic-phase amphibians (based on surrogate sp ecies), terrestrial m onocots and dicots, and aquatic vascular and non-vascular plants.

Acute toxicity data for aquatic sp ecies indicate that technical grade flutriafol is slightly toxic to freshwater species and no more than slightly toxi city to estuarine/marine species. Chronic data with the technical grade active ingredient (TGAI) for estuarine/marine animals are not available and the toxicity to these taxa is estimated by an acute to chronic ratio approach. Based on acute toxicity data, flutriafol is slightly toxic to practically non-toxic to upland game birds and

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### waterfowl via oral and dietary rout es. There are no acute oral toxic ity data with a passerine bird; therefore, the toxicity to thes e birds is uncertain. Chronic stud ies with flutriafol indicate numerous reproductive effects to upland game bi rds and waterfowl at levels as low as 95 mg ai/kg-diet. Flutriafol technical is classified as moderately to slightly toxic to mammals and reproductive effects were observed as a result of chronic exposure as low as 1000 ppm (88.7 mg ai/kg-diet/day in parental rat males).

Toxicity data for freshwater fi sh and invertebrates, mammals, a nd terrestrial and aquatic plants with the formulated product, Flutriafol 125 g/L SC, are available. A comparison of the available formulated product (TOPGUARD fungicide) and technical grad e toxicity data shows the formulated product, when results are expres sed in terms of the active ingredient, is approximately 30 to 50-fold more toxic than techni cal grade flutriafol in an aquatic environment. Formulation blank data suggest the greater toxic ity of the formulated product is not due to synergistic effects of the combina tion of the active ingredient and in erts, but is due to the toxicity of one or more of the inert ingr edients. A change in the iner t ingredients for TOPGUARD could mitigate the toxicity to aquatic organisms and plants.

Data Gaps

The fate laboratory data set for flutriafol is mostly complete for the parent compound and is adequate for the proposed use pattern. Howeve r, EFED is recommending that a Small Scale Prospective Ground Water Monitoring study (EPA Guideline 835.7100) be conducted to evaluate the potential for flut riafol to contaminate ground wate r. Environmental chemistry methods used to generate data associated with this study must include re sults of a successful confirmatory method trial by an independent la boratory. Test standards and procedures for independent laboratory validati on are available as addenda to the guideline for this test requirement. Agency approval of a protocol is necessary prior to in itiation of the study.

The ecological data set for flutriaf ol is mostly complete except for passerine birds. No toxicity data are available for the degrad ation products of flutriafol and they are uncertain; however, in the drinking water assessment for flutriafol, th ere was no concern about residues less than 10% of parent equivalents. In addition, the st ructure analysis relati onship model (ECOSAR) estimated the toxicity of the degr adates, based on individual chemi cal structures, to be less toxic to aquatic animals than the parent compound. Ther efore, concern about the degradates in the environment, from a toxicological perspective, is minimal. An exception to this is the minor degradate 1,2,4-triazole. This de gradate is a common degradate to other conazole fungicides and its fate properties and toxicity will be addressed by the Agency in a separate assessment.

No acute oral toxicity data with a passerine bi rd are available. The risk to passerine birds exposed to flutriafol applicati on is uncertain. A risk assessment for acute exposure to passerine birds is needed based on the use pattern of flutriafol in agricultural fields.

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### Table A.1. identifies the status of environmental fate and transport study requirements and Table A.2. identifies the status of ecologi cal effects study requirements.

Table A.1. Environmental Fate and Transpor t Data Requirements for Flutriafol and its Formulated Product
Study Type Study Classification Are Additional Data Needed at This Time? MRID

Hydrolysis (161-1) A cceptable No 47090416

Acceptable 47090417 Aqueous Photolysis (161-2) supplemental No
47090418 Soil Photolysis (161-3) supplemental No 47418401

Supplemental 47090421
Supplemental 47090422 Aerobic Soil Metabolism (162-1)

Supplemental No

47090423

Anaerobic Soil / Aquatic Metabolism (162-2, 162-3) Acceptable No 47090424

Aerobic Aquatic Metabolism (162-4) Supplemental No 47090419

Supplemental 47090425

Supplemental 47090426 Supplemental 47090427 Supplemental No

47090428 Adsorption / Desorption ( 163-1)

Ancillary No 47345401
Bioaccumulation in Fi sh (165-4) Acceptable No 47090437

Supplemental 47090429

Supplemental 47090431 Supplemental 47090432 Supplemental 47115502 Supplemental 47090433 Supplemental 47090434 Terrestrial Field Dissipation (164-1)

Supplemental No

47090435



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### Table A.1. Environmental Fate and Transpor t Data Requirements for Flutriafol and its Formulated Product Small scale Prospective Ground Water Monitoring No data Yes No data

Non-Guideline – Calculation of first order DT 50 and DT 90 values by nonlinear regression analysis. Supplemental not required 47090436



### Table A.2. Ecological Toxicity Data Requirement s for Flutriafol and its Formulation Product

Are more data needed? OPPTS Guideline # Data Requirement MRID # Classification Flutriafol

850.2100 Avian acute oral LD 50 (bobwhite quail) (mallard duck) (red-legged partridge) (passerine bird) 47471301 47090318 47090319 No data Acceptable Acceptable Supplemental 1 No data No No No Yes

850.2200 Avian subacute dietary LC 50 (bobwhite quail) (mallard duck) 47090321 47090320 Acceptable Acceptable No No

850.2300 Avian reproduction (bobwhite quail) (mallard duck) 47090323 47090322 Supplemental 2 Acceptable No No

850.1075 Freshwater fish acute LC 50 (bluegill sunfish ) (rainbow trout) 47090310 47090311 Acceptable Acceptable No No

850.1010 Freshwater invertebrate acute EC 50 (daphnia) 47090304 Acceptable No

850.1075 Estuarine/marine fish acute LC 50 (sheepshead minnow) 47090308 Acceptable No
850.1025 and

850.1035 Estuarine/marine invertebrate acute EC 50 (eastern oyster) (mysid) 47090306 47090307 Acceptable Acceptable No No

850.1400 Freshwater fish early life stage (fathead minnow) 47090317 Acceptable No

850.1300 Freshwater invertebrate life cycle (daphnia) 47090314 47090315 Acceptable Supplemental 3 No

850.1400 Estuarine/marine fish early life stage (sheepshead minnow) No data Not applicable No

850.1350 Estuarine/marine invertebrate life cycle (mysid) No data Not applicable No
850.1500 Freshwater fish full life cycle No data Not applicable No

870.1100 Acute mammalian oral LD 50 (rat or mice) 47090335 Acceptable No

870.3800 Mammalian Reproduction (rat) 47090351 Acceptable No

850.4100 Seedling Emergence – Tier I 47090328 Acceptable No

850.4150 Vegetative Vigor - Tier I 47090329 Acceptable No

850.4225 Seedling Emergence – Tier II No data Not required No

850.4250 Vegetative Vigor - Tier II 47689801 Acceptable No



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### 6 850.5400 Aquatic plant algae (green algae) (blue-green cyanobacteria) (freshwater diatom) (estuarine/marine diatom) 47090333 47090334 47090332 47090331 Supplemental 4 Supplemental 4 Supplemental 4 Supplemental 4 No No No No

850.4400 Aquatic plant acute EC 50 (duckweed) 47090330 Supplemental 4 No
850.3020 Acute honey bee contact LD 50 47090326 Acceptable No
Non-guideline Acute honey bee oral LD 50 47090326 Supplemental No

850.3030 Honey Bee Residue on Foliage No data Not applicable No

850.3040 Honey Bee Field Testing for Pollinator No data Not applicable No

1 >5% mortality occurred during acclimation
2 Significant effects were observed at all treatment levels, a NOAE C could not be determined. The study needs to establish an NO AEC with lower concentrations.
3 Only the test solutions of the biologicall y relevant levels were analyzed in this study. Guideline requires all treatment leve ls including the biologically relevant levels be analyzed
4 Data were not available to establish a dose- response curve for the formulation inerts.