February 13, Via UPS (Co. No ) Ms. Christina Swick Cheminova, Inc. c/o Lewis & Harrison 122 C Street, NW Suite 740 Washington, DC 20001

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1 New York State Department of Environmental Conservation Division of Materials Management Bureau of Pest Management Product Registration & Pest Management Alternatives Section 625 Broadway, Albany, New York Phone: (518) Fax: (518) Website: Joe Martens Commissioner February 13, 2012 Via UPS (Co. No ) Ms. Christina Swick Cheminova, Inc. c/o Lewis & Harrison 122 C Street, NW Suite 740 Washington, DC Dear Ms. Swick: Re: Registration of the New Active Ingredient Flutriafol as Contained in Topguard Fungicide (For Use on Soybeans) (EPA Reg. No ) and Topguard Fungicide (For Use on Apples) (EPA Reg. No ) (Active Ingredient Code ) The New York State Department of Environmental Conservation (Department) has evaluated your application, received January 13, 2011, and supplemental materials received to date in support of the registration of the above-referenced pesticide products. Topguard Fungicide contains 11.8% of the active ingredient flutriafol and is formulated as a liquid concentrate. It is labeled for control of rust and other fungal diseases on soybeans and apples. It is to be applied as a broadcast foliar spray using ground or aircraft spray equipment. The maximum single application rate is 14 ounces of Topguard Fungicide (0.114 pounds of flutriafol) per acre per application for soybeans and 13 ounces of Topguard Fungicide (0.106 pounds of flutriafol) per acre per application for apples. The maximum seasonal use rate is 28 ounces of Topguard Fungicide (0.228 pounds of flutriafol) per acre per season for soybeans and 52 ounces of Topguard Fungicide (0.422 pounds of flutriafol) per acre per season for apples. The application package was deemed complete for purposes of technical review on March 14, Pursuant to the review time frame specified in Environmental Conservation Law , a registration decision date of August 11, 2011 was established. However, the decision date was waived on August 9, 2011 to allow Cheminova, Inc. time to respond to technical issues presented by the Department.

2 Ms. Christina Swick 2. Technical reviews of the proposed uses included on the Topguard Fungicide labels have been performed by the Department and the New York State Department of Health. These reviews encompassed the expected impacts of labeled use of the subject products with respect to human health, ecological effects, and environmental fate. The technical reviews are shown below. HUMAN HEALTH ASSESSMENT: The following assessment was prepared by staff within the Bureau of Toxic Substance Assessment at the New York State Department of Health (DOH). On an acute basis, flutriafol and Topguard Fungicide were not very toxic through the oral and inhalation routes of exposure in laboratory animal studies. The formulated product was only slightly toxic through the dermal route; however, the registrant did not submit an acceptable acute dermal toxicity study for the active ingredient. In lieu of an acceptable acute dermal study, the U.S. Environmental Protection Agency (U.S. EPA) reviewed a subchronic dermal toxicity study in rats. Dermal effects were not observed in this study up to 1,000 milligrams flutriafol per kilogram body weight per day (mg/kg/day), the highest dose tested. Based on these results, the U.S. EPA classified flutriafol as moderately toxic for the acute dermal exposures because doses higher than 1,000 mg/kg/day were not tested. Flutriafol and Topguard Fungicide were slight eye irritants, but not skin irritants (tested on rabbits). In addition, the end product was a skin sensitizer whereas the active ingredient was not (tested on guinea pigs). Flutriafol caused similar toxic effects in mice, rats and dogs in chronic feeding studies with the liver being identified as the primary target organ of toxicity. Increased fatty change in the liver was observed in mice at 24 mg/kg/day in males and 31 mg/kg/day in females; the respective noobserved-effect-levels (NOELs) were 5.9 mg/kg/day and 7.4 mg/kg/day. Increased liver weight, fatty change, bile duct proliferation/cholangiolarfibrosis, hemosiderin accumulation in Kupffer cells, and centrilobular hypertrophy was observed in rats at 102 mg/kg/day and 122 mg/kg/day in males and females, respectively. The NOELs were 10 mg/kg/day in males and 12.2 mg/kg/day in females. In the dog study, adverse liver effects and clinical chemistry findings (increases in liver weight, centrilobular hepatocyte lipids, alkaline phosphatase, albumin, and triglycerides) were observed in both sexes at 20 mg/kg/day; the NOEL was 5 mg/kg/day. Additionally, increased adrenal cortical vacuolation of the zona fasciculata, marked hemosiderin pigmentation in the liver and spleen as well as mild anemia was observed in males and increased adrenal weight and decreased body weight and body weight gains were observed in females at the 20 mg/kg/day dose level. The U.S. EPA, Office of Pesticide Programs (OPP) established a chronic reference dose (crfd) of 0.05 mg/kg/day for flutriafol based on the NOEL of 5 mg/kg/day from the chronic toxicity study in dogs and an uncertainty factor of 100. This RfD has not yet been adopted by the U.S. EPA s Integrated Risk Information System (IRIS). Flutriafol did not cause oncogenic effects in the rat or mouse combined chronic feeding/carcinogenicity studies. This compound was also negative in a number of genotoxicity studies. The U.S. EPA classified flutriafol as not likely to be carcinogenic to humans based on the absence of significant tumor increases in two adequate rodent carcinogenicity studies.

3 Ms. Christina Swick 3. Flutriafol caused developmental and reproductive toxicity in laboratory animal studies (exposed through gavage) at doses that also elicited maternal toxicity. Increases in late resorptions, decreased fetal weight, skeletal variations in the hyoid, maxilla and mandible, rudimentary and long cervical ribs, pelvic girdle, radius and ulna as well as skeletal retardation were reported in rats at a dose of 75 mg/kg/day; the NOEL was 10 mg/kg/day. Maternal toxicity was characterized by decreases in body weight gain and food consumption at 75 mg/kg/day; the NOEL was 10 mg/kg/day. In a rabbit study, decreased live fetuses, complete litter resorptions and increased postimplantation loss were reported at 15 mg/kg/day; the NOEL was 7.5 mg/kg/day. Maternal toxicity was characterized by decreased body weight gain and food consumption at 15 mg/kg/day; the NOEL was 7.5 mg/kg/day. Although the developmental effects seen in these studies occurred at doses that also caused maternal toxicity, the U.S. EPA considered the developmental effects to be more severe. In a multi-generation reproductive toxicity study in rats, offspring effects included decreased live birth index and litter size, as well as liver effects (increased fatty change and vacuolation) at 88.7 mg/kg/day in males and 103 mg/kg/day in females; the respective NOELs were 20.6 mg/kg/day and 21.9 mg/kg/day. The U.S. EPA attributed these effects in the offspring to the decreased body weight and food consumption of the parents. Parental toxicity characterized by decreased body weight gain and food consumption as well as liver effects (increased liver weight, centrilobular hypertrophy, and fatty change) occurred at 88.7 mg/kg/day in males and 103 mg/kg/day in females; the respective NOELs were 20.6 mg/kg/day and 21.9 mg/kg/day. The U.S. EPA OPP established an acute reference dose (arfd) for flutriafol in females aged years of mg/kg/day based on the NOEL of 7.5 mg/kg/day from the developmental toxicity study in the rabbit and an uncertainty factor of 100. Acute and subchronic neurotoxicity studies were conducted on flutriafol in rats. In the acute study, flutriafol caused decreased body weight, body weight gain and food consumption as well as clinical signs of toxicity, indicative of a moribund condition, in both sexes at 750 mg/kg; the NOEL was 250 mg/kg. Effects observed in the subchronic study included decreased body weight gain, food consumption and hindlimb grip strength (in males only) at in males and 185 mg/kg/day in females; the respective NOELs were 84.3 mg/kg/day and 97.6 mg/kg/day. To account for potential acute toxicity effects, the U.S. EPA OPP established an arfd for flutriafol for the general population of 2.5 mg/kg/day based on the NOEL of 250 mg/kg from the acute neurotoxicity study in rats and an uncertainty factor of 100. The U.S. EPA established tolerances for flutriafol residues in or on soybean (seed) at 0.35 parts per million (ppm), apple at 0.2 ppm, grain (aspirated fractions) at 2.2 ppm, and liver commodities of various animals (cattle, goat, hog, horse and sheep) at 0.02 ppm. The U.S. EPA established acute population adjusted doses (apad) of 2.5 mg/kg/day for the general population and mg/kg/day for females years of age. These apads have the same basis as the arfds for these population groups. The U.S. EPA estimated that the acute dietary exposure to flutriafol residues from all crops for which there are tolerances, and from drinking water, would be <1.0 percent of the apad for the general U.S. population and 3.7 percent of the apad for females years old, the most highly exposed population subgroup. The chronic population adjusted dose (cpad) for flutriafol for the general public and all population subgroups is 0.05 mg/kg/day and has the same basis as the crfd. The U.S. EPA estimated that the chronic dietary exposure to flutriafol residues in food and drinking water from all registered uses would be 1.0 percent of the cpad for the general population and 4.6 percent for children 1 2 years old, the most highly

4 Ms. Christina Swick 4. exposed subgroup. These exposure analyses are based on the conservative assumptions that 100 percent of the crops are treated and that these treated crops contain tolerance level residues. The U.S. EPA conducted an occupational risk assessment for short-term combined dermal and inhalation exposures to flutriafol from aerial, groundboom and airblast applications to soybeans and apples. For this risk assessment, dermal absorption was assumed to be 21 percent based on the results from an in vivo rat dermal-absorption study and inhalation absorption was assumed to be 100 percent. For determining margins of exposure (MOEs), the U.S. EPA compared estimated short-term combined dermal and inhalation exposures to a NOEL of 7.5 mg/kg/day from the developmental toxicity study in rabbits (decreased number of live fetuses, complete litter resorptions and increased post-implantation loss). The U.S. EPA considered the estimates of risk for short-term exposures to be protective of those for intermediate-term exposure since the shortand intermediate-term toxicological endpoints are the same; long-term exposures are not expected. For mixer/loaders, the MOEs for short-term combined exposures were 570, 3,400 and 17,000 for aerial, groundboom and airblast applications, respectively. For applicators, the MOEs for aerial, groundboom and airblast applications were 3,000, 5,600 and 1,300, respectively. The MOE for flaggers supporting aerial applications was 4,400. These estimates assumed workers wore a longsleeve shirt and long pants, shoes plus socks and chemical resistant gloves as per label requirements, except for aerial applicators and flaggers which were assumed to not wear gloves. The U.S. EPA estimated post-application occupational risks for short- and intermediate-term dermal exposures to flutriafol from various activities to soybeans and apples. Since flutriafol is applied only in outdoor settings and has a low vapor pressure (5.33 x mm Hg), postapplication inhalation exposures and risks were not assessed. For determining post-application dermal MOEs, the U.S. EPA compared estimated short-term exposures to the NOEL of 7.5 mg/kg/day from the developmental toxicity study in rabbits, which is assumed to be similarly protective of intermediate-term exposures. The post-application, short-term dermal MOEs for exposure to flutriafol on the day of application to apples were 360 for high exposure activities (thinning), 720 for medium exposure activities (hand harvesting) and 1,100 for low exposure activities (scouting). The MOEs for post-application dermal exposures on the day of application to soybeans were 720 for high exposure activities (scouting and irrigating) and 11,000 for low exposure activities (scouting and hand weeding). The U.S. EPA considered MOEs of 100-fold or greater to provide adequate worker protection from flutriafol. Flutriafol has common metabolites (1,2,4-triazole, triazole alanine, triazole acetic acid) with a number of other triazole fungicides, including triticonazole, tebuconazole and tetraconazole, which have been recently reviewed for registration in the state on a variety of field crops and turf sites. Therefore, the potential exists for the additional uses of Topguard Fungicide to increase exposure to these metabolites, which have some toxic properties. In order to assess aggregate risks from all uses of registered triazole fungicides, the U.S. Triazole Task Force conducted a risk assessment for the common metabolites. This risk assessment did not include the uses of flutriafol because it was not registered for use at the time. However, the U.S. EPA concluded in its Registration Decision for Flutriafol document that revising the risk assessment to include flutriafol is not necessary because incorporation of its uses (at an annual application rate less than 200 grams per acre per season) would result in negligible changes to the metabolite residue and exposure estimates. The Task Force risk assessment concluded that, although the triazole

5 Ms. Christina Swick 5. metabolites have the potential to cause some toxicity, the MOEs for aggregate exposure (food, water and residential) are within the range that was considered acceptable (100-fold or greater for acute and short-term exposures, 900-fold or greater for chronic exposures). There are no chemical specific federal or New York State drinking water/groundwater standards for flutriafol. Based on its chemical structure, this chemical falls under the 50 micrograms per liter New York State drinking water standard for unspecified organic contaminants (10 NYCRR Part 5, Public Water Systems). The available information on flutriafol and the Topguard Fungicide product indicates that they are not very acutely toxic in laboratory animal studies, except for the active ingredient being classified as moderately toxic via dermal exposure. Although flutriafol and Topguard are not irritating to the skin, the formulated product is considered a dermal sensitizer. This risk should be mitigated by the label statement Prolonged or frequently repeated skin contact may cause allergic reactions in some individuals and label requirements for all handlers to wear long-sleeved shirt and long pants, shoes plus socks and chemical resistant gloves. Flutriafol was classified as not likely to be carcinogenic to humans, but caused liver toxicity in multiple species in subchronic and chronic animal feeding studies and developmental toxicity at doses which also induced maternal toxicity. The available information indicates that both the dietary and occupational risks associated with the labeled use of flutriafol are within the range that is generally considered acceptable. Given the above, the DOH does not object to the registration of Topguard Fungicide in the state on the basis of direct health risks from dietary and worker exposure. ECOLOGICAL EFFECTS ASSESSMENT: The Department s Bureau of Habitat (BOH) evaluated the proposed use of flutriafol as contained in Topguard Fungicide. Shown below is the assessment. Material Identification and Purpose: Active Ingredient: Flutriafol, CASRN: Target pests: Fungal plant pathogens Mode of action: Sterol biosynthesis inhibitor, SBI Product % Active Topguard Fungicide 11.8 Formulation Applied to: Application Rate, lbs/acre Soluble Concentrate Apples and Soybeans Apples Soybean Multiple application scenario used for worst case exposure modeling: No of Apps 4 Interval (days) 14 Max Seasonal app rate, lbs/acre.423

6 Ms. Christina Swick 6. Chemical Characteristics: Molecular wt. Solubility Log K ow K oc Vapor Pressure Mean=292 3x10-9 mmhg Toxicity/Mutagenicity/Genotoxicity Summary: Flutriafol has relatively low toxicity to all nontarget test organisms. All mutagenicity and related trials yielded negative results. Environmental Fate Summary: 1) Terrestrial - Highly persistent, expected to be moderately mobile post-application. 2) Aquatic - Highly persistent. 3) Metabolite concerns - Degrades so slowly only minor metabolites were produced over the course of the submitted studies. Longer term, major metabolites may be produced. Flutriafol use will add to environmental loading of 1,2,4-triazole a persistent degradate common to all -azole fungicides. Exposure Modeling: Flutriafol was evaluated using standard BOH screening level terrestrial and aquatic exposure modeling. No toxicity threshold was exceeded by residues resulting from a single application at the highest label rate. Application of the seasonal maximum rate results in one chronic feeding NOEC threshold being exceeded for both birds and mammals. Risk Assessment: Current pesticide testing requirements and understanding of the toxicity of mixtures of parent compounds and degradation products as they occur in the environment are both inadequate to assess the risks of compounds as persistent as flutriafol. It is one of, if not the most, persistent compounds reviewed by BOH. The persistence and mixture toxicity concern applies primarily to aquatic systems, virtually all of which now contain measurable pesticides and metabolites thereof. A single season of Topguard use is not likely to adversely impact fish or wildlife resources. The slightly exceeded terrestrial food item thresholds for birds and mammals flagged in the model output aren t likely to have a significant impact. The persistence of flutriafol in the environment ensures that once use begins it will be present in increasing amounts virtually in perpetuity. There are no preregistration testing requirements that evaluate the effects of the mixtures of compounds and degradates as they occur in the environment. With less persistent chemicals, if one of them proves to be problematic in an unexpected way, stopping use removes it from the mix over a relatively short period. With compounds that take decades to degrade there is no such remedy. Current methodology suggests that flutriafol, evaluated as though it was the only contaminant present, should not pose undue risks to non-target resources. As such, BOH has no basis to object to this registration. We do, however, recommend that the Product Registration Section not register products that are this persistent due to the unknown consequences of this type of environmental loading.

7 Ms. Christina Swick 7. ENVIRONMENTAL FATE ASSESSMENT: The following technical review was produced by the Department s Engineering Geology staff within the Bureau of Pest Management: Solubility: Flutriafol has a solubility of 130 mg/l. Hydrolysis: (MRID ) In an acceptable study, flutriafol was stable at phs 5, 7, 9. Aqueous Photolysis: (MRID ) In an acceptable study, flutriafol was stable in a sterile aqueous buffer solution at ph 7 in both the irradiated sample and the dark control. (MRID ) In an acceptable study, flutriafol was stable in a sterile pond water in both the irradiated sample and the dark control. Quantum Yield in Water: (MRID ) The half-life in water was not determined. Aerobic Aquatic Metabolism: (MRID ) In a supplemental study, in a stream water-sand sediment from the UK, the linear half-life in water was 42.6 days, and half-life was not determined in the sediment or total system. The non-linear half-life was 27.9 days, and half-life was not determined in the sediment or total system. The observed half-life in water was about 20 days, and was >100 days in the sediment and the total system. No major transformation products were isolated. In a river water-silt loam sediment from the UK, the linear half-life in water was 36.3 days, and half-life was not determined in the sediment or total system. The non-linear half-life was 28.4 days, and half-life was not determined in the sediment or total system. The observed half-life in water was about 18 days, and was >100 days in the sediment and the total system. No major transformation products were isolated. Soil Photolysis: (MRID ) In a supplemental study, in a sandy loam soil from England, meaningful half-lives for flutriafol could not be determined because of inadequate sampling intervals. (MRID ) In a supplemental study, in a sandy loam soil (ph 7.6, % OM 1.8) from North Dakota, the linear and non-linear half-lives were 6,932 days, and the observed half-live was >365 days. No major transformation products were isolated. Aerobic Soil Metabolism: (MRID ) supplemental: Soil ph % Linear Non-linear T Observed T Degradates OM T ½ weeks ½ weeks ½ weeks Clay loam >36 None Coarse sandy loam >36 None Sandy clay loam >18 None Sandy loam >18 None

8 Ms. Christina Swick 8. Clay >18 None Sandy clay loam >18 None Aerobic Soil Metabolism: (MRID ) supplemental: Soil ph % OM Linear Non-linear Observed T Degradates T ½ weeks T ½ weeks ½ weeks Sand Stable >52 Not determined Sand >52 Not determined Loamy sand >52 Not determined Anaerobic Aquatic Metabolism: (MRID ) In an acceptable study in a pond water (ph 7.9)-sandy clay loam sediment (ph 7.3, % OM 9.0) from California, the linear and non- linear halflives in water, soil and the total system were not determined. The observed half-life in water was <1 day, and was >365 days in the sediment and the total system. No major transformation products were isolated. Adsorption/Desorption Studies: (MRID ) Supplemental Soil ph % OM K oc Adsorption K oc Desorption Sandy loam Not reported Clay loam Not reported (MRID ) Supplemental Soil ph % OM K oc Adsorption K oc Desorption Loamy sand Not reported Clay loam Not reported (MRID ) Supplemental Soil ph % OM K oc Adsorption K oc Desorption Loamy sand Silt loam Loam Adsorption Studies: (MRID ) The non-guideline study designed to evaluate the effect of time on the adsorption properties of flutriafol in 16 European soils was not classified as to acceptability under Subdivision N Guidelines. Values were not determined. Field Dissipation: (MRID ) In a supplemental study in a sandy loam soil in the UK bare ground plot (ph 6.8, % OM 4.9), the linear half-life was 15.1 weeks, the non-linear half-life was 17.0 weeks, and the observed half-life was about 18 weeks. In a clay loam soil in the UK cropped plot (ph 7.7, % OM 4.3), the linear half-life was 142 weeks, the non-linear half-life was 49.5 weeks, and the observed half-life was not determined. In a sandy clay loam soil in the UK cropped plot, (ph 6.4, % OM 3.7) the linear half-life was 42.2 weeks, the non-linear half-life was 32.4

9 Ms. Christina Swick 9. weeks, and the observed half-life was not determined. EPA felt the half-lives from this study were of limited value. (MRID ) In a supplemental study done on six German soils (soil types not reported), the half-lives were 1155 days, 866 days, 770 days, 866 days, 1155 days, and 1386 days. Samples were not analyzed for transformation products. (MRID ) In a supplemental study in a sandy clay loam (ph 6.0, % OM 1.3) from France, the half-life was 990 days. In a clay soil from France (ph 6.5, % OM 1.23) the half-life was 408 days. In a silty clay soil from France (ph 6.1, % OM 1.09) the half-life was 1733 days. Samples were not analyzed for transformation products. (MRID ) In a supplemental study done on six German soils (soil type not reported), the half-lives could not be determined. Samples were not analyzed for transformation products. (MRID ) In a supplemental study done on four French soils, the half-lives could not be determined. Samples were not analyzed for transformation products. (MRID ) In a supplemental study done on six United Kingdom soils, the half-lives could not be determined. Samples were not analyzed for transformation products. (MRID ) In a supplemental study in the Horsley sandy loam soil (ph 6.5, % OM 1.0), the half-life was 1155 days. In the Boxford clay soil (ph 8.1, % OM 1.9), the half-life was 3466 days. In the Chalgrove sandy clay loam soil (ph 6.9, % OM 2.2), the half-life was 2310 days. None of the samples were analyzed for transformation products. EPA Comments: In the January 20, 2010 Revised Baseline Ecological Risk Assessment for the Registration of Flutriafol, the EPA stated on page 2 Since multiple ground water models predict that flutriafol 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 Agency, EFED is recommending that a Small Scale prospective Ground Water Monitoring study (EPA Guideline ) be conducted to evaluate the potential for flutriafol to contaminate ground water. Label Statements: The following statements appear on the label: Ground Water Advisory -- Flutriafol has properties and characteristics associated with chemicals detected in ground water. This chemical may leach into ground water if used in areas where soils are permeable, particularly where the water table is shallow. Surface Water Advisory -- This product may impact surface water quality due to runoff of rain water. This is especially true for poorly draining soils and soils with shallow ground water. This product is classified as having a high potential for reaching surface water via runoff for several months or more after application.

10 Ms. Christina Swick 10. Prospective Ground Water Monitoring (PGW) Study: The registrant submitted information to the Department on the German PGW. The study is being conducted in a sandy loam with a ph of 5.9 to 6.5 and a percent organic matter of 0.9%, similar to Long Island soils. Flutriafol is applied each year at 0.22 lb ai/a. The study will continue until The data show no clear pattern of accumulation in well GWM2. Well Date ppb GWM2 2/25/ ppb GWM2 4/30/ GWM2 5/22/ GWM2 7/23/ GWM2 10/23/ GWM2 1/21/ GWM2 4/23/ GWM3 10/23/ U.S. EPA allowed the registrant 5 years from the date of registration (April 29, 2010) or until April 29, 2015 to submit a PGW done in the US. The U.S. EPA subsequently indicated in a letter dated August 4, 2011 that the German PGW may be acceptable and a US study may not be required; however, U.S. EPA is waiting for the conclusion of the German study before making a decision. Computer Modeling: Using a Riverhead soil profile, a K oc of 1048, a half-life of 1106 days and the apple rate of lb ai/a/season (4 apps of lb ai), the model projected accumulation, reaching about 1.8 ppb at the end of the 10 year modeling. Changing to the soybean rate of lb ai/a/season (3 apps of to lb/ai), the model predicted steady accumulation, reaching 1.0 ppb at the end of the 10 year modeling. Summary: EPA placed ground and surface water advisory statements on the label based on the characteristics found in the laboratory studies. Computer modeling by the Department for apples at the maximum application rate, using the most conservative parameters (bare ground model), indicated that the product would accumulate and eventually leach into groundwater at up to 1.8 ppb. Because of the method of application to apples and that the vegetation under the trees will intercept any dripping product, the Department does not believe that the product will impact groundwater from labeled use on apples. For soybean use, the application rate is lower, and the application method is different. Modeling using the maximum application rate and conservative parameters (bare ground) projected accumulation, with leaching into the groundwater at up to 1 ppb. However, the PGW study performed at the yearly maximum soybean rate provided data indicating that the product was found in groundwater at the part per trillion levels, with no clear pattern of accumulation. Staff does not believe that use on soybeans will have any significant impact on groundwater when used as labeled. Therefore, staff does not object to the registration of these products as labeled in NYS.

11 Ms. Christina Swick 11. REGISTRATION DECISION Groundwater modeling predicted that flutriafol could be persistent in the environment due to its long half-life in many soil types. The Department has general concerns regarding pesticidal active ingredients that are expected to persist. Therefore, the Department requested additional information from Cheminova relating to a Prospective Groundwater Study currently being performed in Germany. This study provided the Department with valuable real-world data, which is more beneficial to registration decisions than computer modeling. The results of this study indicated that the leaching potential of flutriafol is significantly less than the results derived from computer modeling. In addition, Cheminova, Inc. has voluntarily indicated their intent to prohibit the sale, use, and distribution of Topguard Fungicide in Nassau and Suffolk Counties of New York State. The Department concludes that the use of Topguard Fungicide should not have an adverse effect on the health of applicators or the general public, the fish and wildlife resources, or the ground and surface water of New York State when used as labeled. Therefore, the Department hereby registers Topguard Fungicide (For Use on Soybeans) (EPA Reg. No ) and Topguard Fungicide (For Use on Apples) (EPA Reg. No ) in New York State. Enclosed for your record are copies of the Certificate of Pesticide Registration and stamped Accepted for Registration labels. It is noted that Cheminova retains the right to pursue use of flutriafol-containing products in Nassau and Suffolk Counties at a later date. Such an application would require an in-depth review by the Department and would necessitate the submission of up-to-date groundwater monitoring study results. Please note that a proposal by Cheminova, Inc. or any other registrant to register a product that contains flutriafol, and whose labeled uses are likely to increase the potential for significant impact on humans, nontarget organisms, or the environment, would constitute a major change in labeling. Such an application must be accompanied by a new application fee and meet the requirements listed in Appendix 1.B. of New York State Pesticide Product Registration Procedures (April 2009). Such information, as well as forms, can be accessed at our website as listed in our letterhead. letter. Please contact Shaun Peterson, at , if you have any questions regarding this Sincerely, Scott Menrath Enclosures Scott Menrath, P.E. Director Bureau of Pest Management