Fludioxonil - Registration of Maxim 4FS Fungicide (EPA Reg. No. l00-758) 3/96
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
March 28, 1996
Mr. Jerry Harrison
State Registration & Regulatory Support
Ciba Crop Protection
P.O. Box 18300
Greensboro, NC 274l9-8300
Dear Mr. Harrison:
Re: Registration of the Pesticide Product Maxim 4FS Fungicide
(EPA Reg. No. l00-758) Containing the New Active Ingredient
The New York State Department of Environmental Conservation (NYSDEC) has
accepted your application for the registration of the new active
ingredient, f ludioxonil, contained in thepesticide product Maxim 4FS
(EPA Reg. No. 100-758), in New York State. Maxim 4FS is a new, non-
systemic contact fungicide which was developed ash a seed treatment for
control of certain diseases of corn, sweet corn, and sorghum. Maxim 4FS
contains 40.3% fludioxonil and is applied to corn and sorghum at a rate
of 0.16 fluid oz. per l00 lbs. of seed. Assuming a seeding rate of 20
lbs./A for corn and 5 lbs./A for sorghum, fludioxonil is applied at a
rate of 0. 00l lbs./A and 0.00025 lbs./A, respectively.
Maxim provides high-level, broad-spectrum activity against a wide range
of seed-borne and soil-borne diseases caused by Ascomycetes,
Deuteromycetes, and Basidiomycetes. On corn it is highly active against
fungi of the genera Fusarium, Rhizoctonia, and Helminthosporium and
weakly pathogenic fungi of the genera Penicillium and Aspergillus. On
June 16, 1994, the Environmental Protection Agency (EPA) assigned this
product the favorable classification of "Reduced Risk Pesticide. "
The key reasons for this reduced risk classification werethe low order
of acute toxicity by oral, dermal and inhalationexposure routes, low
application rate on a per-acre basis, and the seed treatment use pattern
which inherently minimizes worker and environmental exposure.
The data package for this product was reviewed by the Division of Fish &
Wildlife (DF&W), the Geotechnical Support Section (GTS), and the New
York State Department of Health (NYSDOH)
The DF&W Bureau of Environmental Protection (BEP) did not object to
registration of the pesticide product Maxim 4FS. According to BEPs
aquatic and terrestrial models, fludioxonil is not toxic to fish,
invertebrates, aquatic plants, mammals, birds, or nontarget insects.
Due to its low toxicity, low application rates, and seed treatment use
pattern, labeled uses of Maxim 4FS should not adversely impact the fish
and wildlife resources of New York State.
The NYSDOH stated in their review that the registration package provided
did not contain USEPA DERs for the mammalian toxicity and genotoxicity
studies; however, NYSDOH stated in their completeness letter that they
did not need to review these DERs for the proposed use pattern. If the
registrant applies for registration of other uses for fludioxonil in the
future, these reviews must be provided.
Fludioxonil may have some oncogenic potential. It caused increased
incidence of liver tumors in female rats exposed over their lifetimes.
Lymphomas were reported in female mice in one study, but these findings
were not replicated in a second mouse study using a broader range of
doses. The USEPA Registration-Eligibility Decision document states that
no additional uses of fludioxonil should be registered until the
Carcinogenicity Peer Review Committee has evaluated fludioxonil's
There are no chemical-specific federal or State drinking water/
groundwater standards for fludioxonil. Based on its chemical structure,
fludioxonil falls under the 50 microgram per liter general New York
State drinking water standard for an "unspecified organic contaminant"
(10 NYCRR Part 5-Public Water Systems). If the Carcinogenicity Peer
Review Committee classifies fludioxonil as a Group C (possible Human)
carcinogen, a potential federal and State drinking water standard of 21
micrograms per liter for fludioxonil would be derived using the
reference dose for fludioxonil (0.03 milligrams per kilogram body weight
per day) and the USEPA procedures for determining maximum contaminant
levels for Group C carcinogens (Federal Reaister, 55:30374-30375, July
25, 1990.) This value (21 micrograms per liter) should also be
considered a potential State groundwater standard.
Maxim is labeled for application to seeds in standard slurry seed
treatment equipment and is not to be used on agricultural establishments
in seed-treatment applications at or immediately before planting. These
conditions should not result in significant exposure to applicators. In
addition, Maxim's loading rate to planted fields is very low (about 0.45
grams active ingredient per acre for treated seeds applied at about 20
lbs. per acre) and pesticide residues are expected to be non-detectable
in corn and sorghum raw agricultural and processed commodities.
Registration of Maxim 4FS Fungicide as a seed treatment is not likely to
result in significant exposure or risks to the public of New York State.
The GTS stated in their review, dated December 15, 1995, that they had
no objection to the registration of fludioxonil as labeled but should
Ciba-Geigy apply to use Maxim 4 FS for any other than seed-only
treatment, a complete environmental fate study would need to be provided
The only study necessary for a "Reduced Risk Pesticide" is hydrolysis.
USEPA states that "...this is needed because most chemicals, during
their lifetime, will come into contact with water. The hydrolysis study
provided in the application showed that "Parent CGA 173505 (fludioxonil)
accounted for more than 97% of the radioactivity in the test solutions
at all times for the pH 5, 7 and 9 solutions; no discrete degradation
products were detected. Therefore, CGA 173506 is hydrolytically stable
in solution at 25°C and 70°C at pH 5, 7, and 9." The solutions were
incubated for 30 days at 25°C and 70°C.
After consideration of the reviews by NYSDOH, FEW, and by GTS, the
Department accepted for registration the pesticide product Maxim 4FS
(EPA Reg. No. 100-758) containing fludioxonil for use in New York State
as labeled. As a condition of registration, Ciba Crop Protection must
submit the Carcinogenicity Peer Review Committee report along with study
summaries and/or reviews of the mammalian studies and genotoxicity
studies as soon as they are available.
Enclosed for your records are the stamped-accepted label and the
certificate of registration for the above product.
If you have any questions on this matter, please contact Maureen
Serafini, Supervisor of our Pesticide Product Registration Section, at
Norman H. Nosenchuck, P.E.
Division of Solid & Hazardous Materials
cc: w/enc. - D. Rutz/W. Smith, Cornell University
N. Rudgers, NYS Dept. of Ag. & Mkts.
N. Kim/A. Grey, NYS Dept. of Health