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Fludioxonil - Registration of Scholar and Major Change in Labeling 4/03

New York State Department of Environmental Conservation
Division of Solid and Hazardous Materials

Bureau of Pesticides Management
Pesticide Product Registration Section
625 Broadway, Albany, New York 12233-7254
Phone: (518) 402-8788     FAX: (518) 402-9024
Website: www.dec.state.ny.us/website/dshm
E-Mail: ppr@gw.dec.state.ny.us

April 22, 2003

CERTIFIED MAIL
RETURN RECEIPT REQUESTED


John D. Abbott, Ph.D.
State Regulatory Affairs Team Leader
Syngenta Crop Protection, Inc.
P.O. Box 18300
Greensboro, North Carolina 27419-8300

Dear Dr. Abbott:

Re: Registration of the New Product Scholar Fungicide (EPA Reg. No. 100-969) Which Represents a Major Change in Labeling for the Active Ingredient Fludioxonil

    The New York State Department of Environmental Conservation (Department) has reviewed your application, received October 28, 2002, to register the new product Scholar Fungicide (EPA Reg. No. 100-969) in New York State. The product is labeled for post-harvest application to control certain diseases of stone fruit and represents a major change in labeling for the active ingredient fludioxonil (chemical code 071503).

    The application was deemed complete for purposes of review on December 12, 2002 and a registration decision is due by May 9, 2003.

    Fludioxonil is currently registered for use in New York State on ornamental plants grown in containers, greenhouses, and other enclosed structures, on turf grass and field-grown and landscape ornamentals, on onions and strawberries, and as a seed treatment to control diseases in agricultural crops.

    The Department has reviewed the information supplied to date in support of registration of the new product Scholar Fungicide (EPA Reg. No. 100-969).

    The New York State Department of Health (DOH) stated that the end-use Scholar Fungicide product, which is identical in formulation to Medallion Fungicide, was not very toxic in acute oral, dermal, or inhalation toxicity studies in laboratory animals. While the technical active ingredient fludioxonil also was not very acutely toxic, this chemical caused some subchronic and chronic effects in animal studies. In addition, it caused some developmental effects in the offspring of pregnant rats, but not rabbits at doses that also caused maternal toxicity. Fludioxonil caused some limited increase in liver tumors in female rats, but did not cause a tumorigenic response in male rats or in mice of either sex. Fludioxonil was negative in a number of genotoxicity studies. Based on these data, the United States Environmental Protection Agency (USEPA) denoted fludioxonil as a Group D carcinogen- "not classifiable as to human carcinogenicity." The USEPA Office of Pesticide Programs established a reference dose (RfD) of 0.03 mg/kg/day for fludioxonil based on a No Observed Effect Level (NOEL) of 3.3 mg/kg/day in a one-year dog feeding study and an uncertainty factor of 100. This RfD has not yet been adopted by the USEPA's Integrated Risk Information System (IRIS).

    The USEPA established tolerances for the residues of fludioxonil in or on stone fruit at 5.0 parts per million (ppm). The USEPA estimated that chronic dietary exposure to these and other crop residues would be less than 6.6 percent of the chronic population adjusted dose (cPAD) of 0.03 mg/kg/day for the general U.S. population, less than 16.3 percent for children one to six years old, and less than 32 percent for infants under one year of age. These chronic exposure analyses are based on the assumption that 100 percent of crops are treated and contain tolerance level residues. Actual residues and resulting exposure levels are expected to be less than these assessments estimate.

    The USEPA reported the results of an occupational risk assessment for short- and intermediate-term dermal and inhalation exposures to fludioxonil from post-harvest application to stone fruit. The application rate for cherries (the highest application rate, 0.5 pounds fludioxonil per 25,000 pounds) was used for this assessment. The assessment assumed that handlers wore a long-sleeved shirt, long pants and gloves as per label requirements. For determining margins of exposure (MOEs), the USEPA compared estimated combined dermal and inhalation exposures to a NOEL of 64 mg/kg/day from a 90-day rat feeding study. For an individual mixer/loader, the short-term inhalation MOE was estimated to be 320,000 and the intermediate-term combined dermal and inhalation MOE was estimated to be 9,100. The post-application occupational exposure of most concern was considered to be sorting/culling or packing fruit by hand. The highest average field trial residue (for plums) was used for this assessment and it was assumed that workers did not wear gloves. The MOE for this dermal exposure was estimated to be 670. Generally, the USEPA considers MOEs of 100-fold or greater to provide adequate worker protection.

    There are no chemical-specific federal or State drinking water/groundwater standards for fludioxonil or its major degradates. Based on their chemical structures, these compounds fall under the 50 microgram per liter (_g/L) New York State drinking water standard for "unspecified organic contaminants" (10 NYCRR Part 5, Public Water Systems). The New York State drinking water standard for the sum of "unspecified organic contaminants" is 100 _g/L.

    Fludioxonil and the formulated product Scholar Fungicide were not very acutely toxic or irritating to laboratory animals. While fludioxonil caused some subchronic, chronic and developmental effects in laboratory animals, dietary and occupational risk assessments indicate that risks would be low to both workers and the general population. Fludioxonil also has some limited oncogenic potential, and generally the Department does not support registration of oncogenic compounds for use on food crops unless the needs are significant or it replaces other chemicals that pose greater risks. However, the Department previously resolved issues regarding fludioxonil's oncogenicity during the evaluation of other products containing this compound. Also, the apparent leaching properties and groundwater/drinking water contamination potential of fludioxonil should not be an issue for Scholar Fungicide either as the labeled use of this product is for post-harvest application at fruit processing facilities.

    The Department concludes that Scholar Fungicide should not have an adverse effect on the health of workers or the general public, or the ground and surface water of New York State when used as labeled.

    Therefore, the Department hereby accepts for registration the new product Scholar Fungicide (EPA Reg. No. 100-969) in New York State.

    Enclosed are your New York State stamped "ACCEPTED" label and a copy of the Certificate of Registration.

    Syngenta Crop Protection, Inc. is reminded that if New York State registration is requested for this product or for any other product which contains fludioxonil with an increased application rate and/or expanded use sites, the product will be considered a Major Change in Labeling and the Department will require an extensive review.

    If you have any questions, please contact Samuel Jackling, Chief of our Pesticide Product Registration Section, at (518) 402-8768.

Sincerely,

MPS
Maureen P. Serafini
Director
Bureau of Pesticides Management

Enclosures
cc: w/enc. - N. Kim/D. Luttinger - NYS Dept. of Health
G. Good/W. Smith - Cornell University, PMEP