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Fludioxonil - Registration of a Major Change in Use for Medallion 10/97

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

50 Wolf Road, Albany, New York 12233-7250
Phone 518-457-6934   FAX 518-457-0629

CERTIFIED MAIL
RETURN RECEIPT REQUESTED


Mr. Jerry Harrison
State Registration
Novartis Crop Protection, Inc.
P.O. Box 18300
Greensboro, NC 27419



Dear Mr. Harrison:

Re: Registration of a Major Change in Use for Fludioxonil Contained in Medallion M Fungicide (EPA Reg. No. 100-769)

Novartis Crop Protection, Inc. submitted an application and supporting documentation on March 27, 1997 for the registration of Medallion Fungicide (EPA Reg. No. 100-769), containing the active ingredient fludioxonil, for use to control certain foliar and soil-borne diseases in ornamental plants grown in containers, greenhouses and other enclosed structures.

Fludioxonil is currently registered in New York State in the pesticide product Maxim 4FS (EPA Reg. No. 100-758) for use as a seed treatment to control certain fungal diseases in field and sweet corn, popcorn and sorghum. The Department determined that the proposed use of Medallion on ornamentals in enclosed structures represents a major change in label for fludioxonil.

Medallion is a protectant fungicide containing 50% fludioxonil [4-(2,2-difluoro-1,3-benzdioxol-4-yl)-1H-pyrrole-3-carbonitrile, a pyrrolnitrin derivative] which can be applied through irrigation and by either soil drench or foliar spray methods. Medallion controls damping-off and root and stem rot disease caused by Rhizoctonia spp. Medallion may be used as a soil drench on ornamentals at the time of seeding or transplanting, or on established plants. Medallion is also used as a foliar spray for control of Botrytis spp., foliar Rhizoctonia spp., and Alternaria spp. on ornamentals. Medallion is mixed at the rate of one eight-ounce packet per 100 gal. water and is applied at the rate of up to one pt/sq. ft using one application for seedlings. Medallion is used on transplants and cuttings using two to four eight-ounce packets/100 gal. of water. This application may be repeated in 21-28 days if needed. Medallion is mixed at the rate of 4-16 packets/100 gal. of water when used as a foliar spray and this application may be repeated at 7-14 day intervals.

The Department has completed its review of the subject product. The findings and conclusions are discussed below, broken down by Ecological, Human Health and Groundwater impacts.

Ecological Effects:

Minimal exposure to fish and wildlife is expected from the use of fludioxonil in greenhouses and other enclosed structures.

Human Health Effects:

While fludioxonil has been previously evaluated as to human health effects, the Medallion registration package contained some additional toxicity information as well as acute toxicity data for the Medallion product. The acute toxicity data for Medallion indicate that it is not very toxic, irritating or a sensitizer.

It has been noted that fludioxonil caused an increased incidence of heptacellular tumors in female rats and a positive dose-related trend for total lymphomas in females in one mouse oncogenicity study. A second study in mice, which included higher dose levels, did not report an increased tumor incidence in either sex. At the time of the first review, the United States Environmental Protection Agency (USEPA) had not yet classified fludioxonil as to its oncogenic potential, and the USEPA Registration Eligibility Decision document states that no additional uses (other than seed treatment) of this compound should be registered until the Carcinogenicity Peer Review Committee has evaluated the carcinogenicity data. The Committee has now classified fludioxonil as a Group D (not classifiable as to human carcinogenicity) compound.

The USEPA estimated exposure and risks to mixer/loader/applicators of medallion from soil drench treatment and foliar spray treatment were estimated to be 0.2995 milligrams/kilogram body weight/day (mg/kg/day) and 0.0477 mg/kg/day, respectively. Medallion can be applied repeatedly at certain intervals, but chronic daily use by workers is not expected. To evaluate worker risks, the USEPA compared estimated exposures to a no-observed-effects level (NOEL) from an oral subchronic dog study (50 mg/kg/day) and calculated margins of exposure of 167 and 1,048 for soil drench and foliar spray treatments, respectively. In a rat developmental toxicity study, an increased incidence of dilated renal, pelvis and ureter in offspring was reported at a dose level of 1,000 mg/kg/day, with a NOEL of 100 mg/kg/day. Margins of exposure for soil drench and foliar spray are 334 and 2,096, respectively, based on comparison of exposure estimates to this NOEL.

Medallion is labeled for use on ornamental plants grown in containers, greenhouses and other enclosed structures. Given this use, exposure of the general public to fludioxonil from Medallion use should be minimal. In addition, risk estimates for workers handling Medallion are at levels generally accepted as adequate for occupational exposures.

Groundwater Impacts:

The Department did not review this indoor use as they had previously reviewed fludioxonil for outdoor use as a seed treatment and had no objection to its registration.

Registration Action:

Therefore, based on the above reviews, the Department accepts for registration in New York State the pesticide product Medallion Fungicide (EPA Reg. No. 100-769) for use as federally labeled. Enclosed for your records are the stamped-accepted label and the Certificate of Registration for the above pesticide product.

If you have any questions on this matter, please contact Maureen Serafini, Supervisor of our Pesticide Product Registration Section, at (518) 457-7446.

Sincerely,

Norman H. Nosenchuck, P.E.
Director
Division of Solid & Hazardous Materials

Enclosures
cc: w/enc. - D. Rutz/W. Smith, Cornell University
N. Rudgers, NYS Dept. of Ag & Mkts.
N. Kim/D. Luttinger, NYS Dept. of Health