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Coniothyrium minitans strain CON/M/91-08 - CONTANS® WG (EPA Reg. No. 72444-1) 9/01

New York State Department of Environmental Conservation
Division of Solid & Hazardous Materials
Bureau of Pesticides Management
Pesticide Product Registration Section
625 Broadway, Albany, New York 12233-7257
Phone 518-402-8768     FAX 518-402-9024
Website: http://www.dec.state.ny.us/website/dshm
E-Mail: ppr@gw.dec.state.ny.us


September 14, 2001

CERTIFIED MAIL
RETURN RECEIPT REQUESTED


Ms Oleta Melnicoe
Prophyta Biologischer Pflanzenschutz GmbH
c/o Encore Technologies LLC
111 Cheshire Lane, Suite 500
Minnetonka, MN 55305

Dear Ms Melnicoe,

Re: Registration of CONTANS® WG (EPA Reg. No. 72444-1) containing the New Active Ingredient: Coniothyrium minitans strain CON/M/91-08.

    The New York State Department of Environmental Conservation (the Department) has reviewed your application, received April 11, 2001, to register the above mentioned product in New York State. CONTANS® WG contains the active ingredient Coniothyrium minitans strain CON/M/91-08 and is labeled for the reduction/control of Sclerotinia sclerotiorum and Sclerotinia minor in agricultural soils.

    The application was deemed complete for purposes of review on May 31, 2001 and a registration decision date was set for October 26, 2001.

    CONTANS® WG is applied on agricultural soils as a preplant treatment, three to four months prior to planting, or as a post harvest treatment to control the common plant pathogens Sclerotinia sclerotiorum and Sclerotinia minor which cause white mold, pink rot, and water soft rot. It is applied as a spray diluted in water with ground based equipment at a rate of one to four pounds, 0.053 to 0.212 pounds active ingredient, per acre. The treated soil is then thoroughly mixed to a depth of one to two inches.
    Coniothyrium minitans strain CON/M/91-08 is a naturally occurring, nonpathogenic, mycoparasitic soil fungi classified as Coelomycetes, subdivision Deuteromycotina. It targets sclerotia of Ascomycotina and Deuteromycotina. Coniothyrium minitans requires a host to be in the vegetative state. The optimum temperature range for Coniothyrium minitans germination and growth is 25 to 30O C. No spore germination occurs above 30O C, no mycelium growth occurs above 33O C.
    The Department has received the following technical reviews with regard to the registration of CONTANS® WG for impacts to human health, non-target organisms, and the environment. An exemption from tolerance for residues on all food commodities has been issued for Coniothyrium minitans strain CON/M/91-08 (Federal Register Vol. 66, March 28, 2001).

    The New York State Department of Health (DOH) stated that Coniothyrium minitans is a naturally occurring soil microorganism commonly found in the environment. Coniothyrium minitans strain CON/M/91-08 is not known to be a human pathogen and it has not been implicated in human disease. A search of the toxicological literature did not find any information on adverse effects from exposure to Coniothyrium minitans.

    CONTANS® WG is a biological pesticide and the United States Environmental Protection Agency (USEPA) required only limited toxicological data for its federal registration. The oral, dermal, intraperitoneal and inhalation acute toxicity data, as well as eye and skin irritation and skin sensitivity data on Coniothyrium minitans strain CON/M/91-08 required for federal registration indicate that this active ingredient was not very toxic, pathogenic or irritating to laboratory animals by these noted routes of exposure. The USEPA waived the requirement for these tests on CONTANS® WG since "the formulated product only contains added ingredient(s) of no expected toxicity." The USEPA waived the requirement for both subchronic and chronic toxicity studies on the active ingredient "because of the low acute toxicity of the microbial pesticide, and no indications of infectivity or pathogenicity, in mammals." The USEPA based its conclusion that Conithyrium minitans strain CON/M/91-08 is not pathogenic to humans, in part, on the observation that this microorganism does not germinate at 30 degrees Celsius or above, and does not grow at 33 degrees Celsius or above (both temperatures are lower than the normal human body temperature of about 37_ Celsius). In addition, Technology Sciences Group Inc. has indicated (see correspondence from O. Melnicoe to F. Hegener, June 26, 2001), that "To our knowledge there have been no adverse reactions that have occurred in humans during the manufacture and/or use of CONTANS® WG in Europe or the United States." Based on the low toxicity/pathogenicity potential of Coniothyrium minitans strain CON/M91-08, the USEPA granted an exemption from the requirement of a tolerance for residues of this microbial pesticide when used in or on all food commodities.

    The potential for significant risks to public health from the labeled use of CONTANS® WG appears minimal. Given the above, the DOH does not object to registration of this pesticide product in New York State.     The Department's Division of Fish, Wildlife & Marine Resources' Bureau of Habitat (BOH) stated that the submitted study results show Coniothyrium minitans strain CON/M/91-08 to be nontoxic to rats via oral, dermal, inhalation, and intraperitoneal injection exposures.

    The aquatic organism studies submitted were conducted according to European, OECD, guidelines which differ significantly from USEPA guidelines. They show strain CON/M/91-08 to be nonlethal to the golden ide, Leuciscus idus melanatus, Daphnia magna STRAUS, and the algae Scenedesmus subspicatus at concentrations as high as 100 mg spore dry weight per liter. Although the submitted aquatic studies were inadequate to assess pathogenicity and were, by United States standards, also deficient in measuring signs of toxicity other than mortality, no further testing was required.

    All avian, non-target plant, and non-target insect toxicity/pathogenicity study requirements were waived by the USEPA.

    Coniothyrium minitans is a naturally occurring parasitic soil fungi that is likely to be a poor competitor as a free living organism. In the absence of its host fungi it probably persists only at relatively low levels, if at all, for more than a few years.

    Coniothyrium minitans has been examined as a potential biocontrol agent for sclerotia producing fungi of the genus Sclerotinia for over 20 years. It was first reported from the United States in 1947 and has since been found in at least 29 countries in most parts of the world. Almost all isolations have been from sclerotia of susceptible fungal species, with a low percentage of isolations from soil. There is no evidence that it grows in other environments, although it does grow well in artificial media.

    Although the non-mammalian toxicity/pathogenicity studies conducted and submitted with this application range from substandard to nonexistent, it can be concluded with a reasonable degree of confidence when the following study results and biological characteristics are considered:
    Therefore, BOH concluded that labeled use of CONTANS® WG poses little risk to non-target fish or wildlife resources.
    The Bureau's environmental fate reviewer stated the Environmental Assessment Branch of the USEPA does not perform an environmental exposure assessment on biological active ingredients unless the Toxicology Branch has a problem with the information presented by the registrant. Several Tier I study requirements were waived, indicating a low level of concern for this active ingredient. According to the USEPA OPP BPPD Biopesticides Fact Sheet dated 3/7/01: "Available studies show that no adverse environmental effects are expected when products containing Coniothyrium minitans strain CON/M/91-08 are used in accordance with label instructions."

    Environmental fate data were not required. Since environmental fate data were not necessary, there is no impact to the groundwater to be assessed. As such, staff have no objection from a groundwater perspective to the registration of this product as labeled.

    Therefore, the Department hereby accepts the registration of the pesticide product CONTANS® WG (EPA Reg. No. 72444-1) for use in New York State as labeled.

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

    If you have any questions, please contact Ms. Cyndi Crowley, of my staff, at (518) 402-8768.

Sincerely,

Maureen P. Serafini
Director
Bureau of Pesticides Management

Enclosures

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