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Trichoderma harzianum (T-22G, F-Stop) - Registration as New Active Ingredient 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 24, 2001

CERTIFIED MAIL
RETURN RECEIPT REQUESTED


Mr. William J. Foster
BioWorks, Inc.
122 N. Genesee Street
Geneva, NY 14456

Dear Mr. Foster:

Re: Major Change in Labeled Use Application for T-22 Planter Box Biological Fungicide (EPA Reg. No. 68539-4) containing the active ingredient Trichoderma harzianum Rifai strain KRL-AG2.

    The New York State Department of Environmental Conservation (The Department) has reviewed the above referenced application for T-22 Planter Box Biological Fungicide (EPA Reg. No. 68539-4) requesting approval from New York State for use of the product on wheat crops. The product is currently registered in New York State for use on several listed crops as an in-furrow soil treatment, seed treatment, and as a cutting or bare-rooted transplant treatment.

    T-22 Planter Box is a biological fungicide for control of plant diseases. The active ingredient is a beneficial microbe, Trichoderma harzianum strain T-22 (KRL-AG2) which grows on the outside of the plant root to provide prolonged protection against plant root pathogens such as Pythium, Rhizoctonia, Fusarium, Cylindrocladium and Thielaviopsis. The active ingredient is applied at a single application rate of 0.023 lbs./acre as an in-furrow soil treatment or in a slurry to coat seeds, tree seedlings, and cut potatoes for seed.

    The Department conducted the following technical reviews with regard to the registration of T-22 Planter Box Biological Fungicide, for impacts to human health, non-target organisms, and the environment. The human health review determined that the active ingredient, Trichoderma harzianum Rifai strain KRL-AG2, does not appear to be very toxic or pathogenic in laboratory animals and the uses allowed on the product label, including the addition of wheat, should not significantly increase exposure of the general public to Trichoderma harzianum Rifai strain KRL-AG2 nor pose significant risk to workers, particularly if personal protective equipment requirements are followed.
    The United States Environmental Protection Agency (USEPA) exempted Trichoderma harzianum Rifai strain KRL-AG2 from the requirements of a tolerance for residues on foods. The decision to exempt this material was based on a lack of acute toxicity and pathogenicity of the organism as well as its ubiquitous natural occurrence. The use as a seed treatment on wheat is unlikely to significantly increase dietary exposure to Trichoderma harzianum Rifai strain KRL-AG2 from food sources.

    Non-target organism reviews, conducted on the Trichoderma harzianum Rifai strain KRL-AG2, indicate that it is not toxic or pathogenic to mammals or birds on an acute basis. The USEPA waived all other data requirements for this product, including freshwater and saltwater fish and invertebrates, aquatic plants, non-target insects, and environmental fate, due to its non-toxic nature and use pattern. Labeled uses of T-22 Planter Box Biological Fungicide should not adversely impact the fish and wildlife resources of New York State.

    Environmental Fate reviews conducted by the Department were limited due to the fact that the Environmental Assessment Branch of the USEPA does not perform an environmental exposure assessment on biologically active ingredients unless the Toxicology Branch has a problem with the information presented by the registrant. In this case, no problem was noted, therefore no environmental fate data were required. The impact to groundwater was not assessed. The inert ingredients do not appear to be solvent carriers.

Summary:

    Enclosed for your record is a copy of the stamped accepted label for T-22 Planter Box Biological Fungicide (EPA Reg. No. 68539-4). Please note that a proposal by BioWorks, Inc. or any other registrant, to register a product that contains Trichoderma harzianum Rifai strain KRL-AG2, and whose labeled uses are likely to increase the potential for significant impact to humans, non-target organisms, 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 our Pesticide Product Registration Section, at (518) 402-8768 if you have any questions.

Sincerely,
MPS
Maureen Serafini
Director
Bureau of Pesticides Management

Enclosure

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