RETURN RECEIPT REQUESTED
Mr. Steve Cockreham
Se PRO Corporation
11550 N. Meridian Street
Carmel, IN 46032
Dear Mr. Cockreham:
Re: Registration of Decree (EPA Reg. No. 66330-35-67690) containing the active ingredient Fenhexamid, for use on greenhouse and field grown ornamentals.
The New York State Department of Environmental Conservation (the Department) has approved the above referenced pesticide product for registration in New York State.
The above application was received by the Department on October 18, 2000 from SePRO Corporation (the Applicant) to register Decree 50 WDG (EPA Reg. No. 66330-35-67690) for use on greenhouse and field grown ornamentals. The active ingredient fenhexamid, was initially registered in New York State on May 5, 2000 under the product name Elevate 50 WDG, for the control of Botrytis cinerea diseases on strawberries and grapes. The Department reviewed the Elevate 50 WDG fungicide product for a major change in labeled use and approved the use of the Elevate product for the control of Monilinia diseases for almonds and stone fruit on January 5, 2001. Both the Decree 50 WDG and the Elevate 50 WDG product contain 50.0% fenhexamid. The Elevate 50 WDG Fungicide is registered under Tomen Agro, Inc., the basic registrant.
The Decree 50 WDG Fungicide 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 instead, 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 use instructions and application rates for Decree are consistent with the previous two reviews that were conducted on Elevate for grapes, strawberries, almonds, and stone fruit. The Decree product however, will be used in greenhouses, therefore the technical review focused on worker exposure concerns.
The Department conducted a technical review of information provided by the Applicant for exposure of workers to fenhexamid based on the labeled use of Decree 50 WDG Fungicide for application on greenhouse-grown ornamentals. For mixer/loader/applicators, margins of exposure (MOEs) for short-term (subchronic) dermal and inhalation exposures were estimated to be 13,000 and 27,000, respectively. For long-term (chronic) dermal and inhalation exposures (assumed 20 days of applications per year for 40 years), the estimated respective MOEs were 210,000 and 450,000. These estimates assume that the workers wore long-sleeved shirts, long pants, and gloves, which are required on the label. The no-observed-effect-levels (NOELs) used for estimating the subchronic and chronic MOEs were about 34 and 17 milligrams per kilogram body weight per day, respectively. Absorption of the active ingredient via the dermal route was assumed to be 10%, whereas via the inhalation route, it was assumed to be 100%. The United States Environmental Protection Agency (USEPA) also estimated MOEs for workers involved in post-application activities (details of this analysis were not presented) related to indoor and outdoor ornamental production. The estimated MOEs were 450. Generally, the USEPA considers MOEs of a 100-fold or greater to provide adequate worker protection. Based on the above assessment, the Department has determined that the labeled use of Decree 50 WDG Fungicide on greenhouse and field grown ornamentals is protective to workers and the general public.
Enclosed for your record is a copy of the stamped accepted label and the certificate of registration for Decree 50 WDG Fungicide (EPA Reg. No. 66330-35-67690). Please note that a proposal by SePRO Corporation, 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