|New York State Department of Environmental
Division of Solid & Hazardous Materials
Bureau of Pesticides Management, Room 498
Pesticide Product Registration Section
50 Wolf Road, Albany, New York 12233-7254
Phone: (518) 457-7446 FAX: (518) 485-8990
|January 6, 2001|
RETURN RECEIPT REQUESTED
Mr. Desmond Byrne
Tomen Agro, Inc.
100 First Street, Suite 1700
San Francisco, CA 94105
Dear Mr. Byrne:
Re: Registration of Elevate 50 WDG Fungicide (EPA Reg. No. 66330-35) containing the active ingredient Fenhexamid for additional labeled use on almonds and stone fruit.
The New York State Department of Environmental Conservation (the Department) has approved the above referenced pesticide product for registration in New York State. The Department received the application on June 30, 2000 from Tomen Agro, Inc. to register Elevate 50 WDG (EPA Reg. No. 66330-35) for additional use on almonds and stone fruit, this constitutes a major change in labeled use(MCL). The active ingredient fenhexamid was initially registered in New York State on May 5, 2000 under the same product name for control of Botrytis cinerea diseases of strawberries and grapes. Your application was deemed complete for purposes of technical review on August 9, 2000. Pursuant to the review time frame specified in ECL ß33-0704.2, a registration decision date of January 6, 2000 was established.
Elevate 50 WDG fungicide contains 50.0% fenhexamid. The product is labeled for use as a spray for control of Botrytis cinerea diseases of grapes and strawberries, and control of Monilinia diseases of almonds and stone fruit, in agricultural settings. The product is not labeled for homeowner use. It is a water dispersable granule applied by ground equipment only. Fenhexamid is a "protectant" fungicide, in that it does not directly kill the target fungus when applied but binds to the surface of vegetation. When the fungus is exposed, the fenhexamid interferes with germ tube and hyphae development. Without hyphae, the fungus dies from lack of nutrients.
The labeled use of this product would determine the maximum annual use rate for the active ingredient, fenhexamid to be four applications of 0.75 pounds per acre at intervals of 7 to 14 days apart. The label recommends that not more than two consecutive applications be made before switching to an alternative product with a different mode of action for at least two applications, to avoid the development of resistance and to preserve the usefulness of fenhexamid. The maximum annual application rate is 3.0 pounds per acre. The half-life of fenhexamid when bound to foliage is 28.6 days.
The Department has conducted toxicological, ecological effects and environmental fate risk assessments for fenhexamid and the Elevate 50 WDG formulation. The Departmentís toxicological review found that the fenhexamid and the formulated product Elevate 50 WDG Fungicide was not very acutely toxic in laboratory animal studies. Although data from chronic studies on fenhexamid showed that this chemical has the potential to cause certain hemotological and other effects, the major change in labeling of this active ingredient to add use on almonds and stone fruit, in addition to its labeled use on grapes and strawberries, should not pose a significant risk to the general public or to workers.
The Departmentís ecological effects review determined that fenhexamid, when modeled for potential impacts to non-target organisms, exceeded no toxicity thresholds in any of the risk assessment models. The direct application of Elevate 50 WDG Fungicide at the labeled rate to an acre of water six inches deep did not exceed the toxicity threshold for any fish or freshwater invertebrate species. Therefore, the use of Elevate 50 WDG Fungicide as labeled is not likely to cause any harm to fish, wildlife, or estuarine/marine species.
The environmental fate review was performed by the Environmental Assessment Division of the Pest Management Regulatory Agency of Health Canada. The Health Canada review stated that fenhexamid is stable to hydrolysis at pHs 5,7,and 9 and hydrolysis is not considered a major route of transformation in the environment. Fenhexamid is soluble in water at 20 mg/l and has a photolysis half-life (DT50) in water of about one hour. Photolysis is considered a major route of transformation for fenhexamid.
Fenhexamid is non-persistent in surface water and slightly persistent in sediment under aerobic conditions. Fenhexamid is slightly persistent in anaerobic sediment and bound residue formation is a major process. The sediment half-life did not follow major order kinetics, but the DT50 was 39.9 days. Adsorption/Desorption studies showed that fenhexamid is classified as a medium to low mobility compound with KOC values ranging from 450 to 1025 in loamy sands and clay loam, and with its KOCís not dependent on clay and organic matter content.
The Canadian terrestrial field dissipation studies have to be repeated (the new study is due June 30, 2001) because the dissipation pathways of fenhexamid were inadequately characterized. However, the first study, done in a silty loam, showed a DT50 of one day. No compound was found below 15 cm for this study and negligible amounts of compound were found at 0-15 cm after one week. The mobility of fenhexamid was also tested in a second study done on bare ground using lysimeters in a sandy loam soil. The DT50 was 44 days with a negligible amount of fenhexamid found below six inches. However, this second study was considered supplemental because typical end use product was not used and replicate samples were not taken to assess experimental error.
Our computer groundwater modeling, using conservative parameters, predicted that there would be no fenhexamid in leachate. Because of its short half-life, fenhexamid is not expected to cause an impact to groundwater when used as labeled.
Enclosed for your records are a copy of the stamped accepted label and the certificate of registration for Elevate 50 WDG (EPA Reg. No. 66330-35). Please note that a proposal by Tomen Agro, Inc., or any other registrant, to register a product that contains fenhexamid and whose labeled uses are likely to increase the potential for significant impact to humans, property, or the environment, would constitute a major change in labeled(MCL) use pattern. 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" (August 1996). Such information as well as forms can be accessed at our website as listed in our letterhead.
Please contact Frank Hegener, Chief of our Pesticide Product Registration Section, at (518) 457-7446 if you have any questions.
Bureau of Pesticides Management
cc: w/enc. - N. Kim/D. Luttinger - NYS Dept. of Health
R. Zimmerman/ R. Mungari - NYS Dept. of Ag. & Markets
G. Good/W. Smith - Cornell University, PMEP