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bacillus subtilis MBI 600 (Subtilex) NYS DEC Letter - Major Change in Labeling 8/03

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

Bureau of Pesticides Management, 9th Floor
625 Broadway, Albany, New York 12233-7254
Phone: (518) 402-8788     FAX: (518) 402-9024

August 14, 2003


Ms. Catherine Rice
Regulatory Specialist
Becker Underwood, Incorporated
801 Dayton Avenue, P.O. Box 667 Ames, Iowa 50010

Dear Ms. Rice:

Re: Subtilex Biological Fungicide (EPA Reg. No. 71840-1) Major Change in Labeling - New Use for Bacillus subtilis, MBI 600; for in-furrow Application and Other Various Uses

    The New York State Department of Environmental Conservation (Department) has reviewed the application, received March 14, 2003, from Becker Underwood, Incorporated, to register the above-mentioned product in New York State. The application was deemed complete for purposes of review on May 12, 2003 and a registration decision is due by October 9, 2003.

    Subtilex Biological Fungicide contains the active ingredient Bacillus subtilis MBI 600 and is used to suppress disease organisms that invade root systems including Fusarium, Rhizoctonia alternaria, and Aspergillus. It is labeled for formulating into registered end-use products and for use as a seed treatment (cotton, peanuts, seed and pod vegetables, soybeans, alfalfa, forage and turf grasses, wheat, barley and corn), in-furrow application, or incorporation into peat moss or growing media. Bacillus subtilis MBI 600 is currently registered in New York State for use as a biological fungicide seed treatment on soybeans, and dry and snap beans.


    When Bacillus subtilis MBI 600 was initially reviewed, very limited toxicological data were required for federal registration of Subtilex Biological Fungicide. The data available indicates that Bacillus subtilis MBI 600 did not cause toxicological effects and was not pathogenic or infective following oral, dermal, inhalation or intravenous exposure. However, some dermal sensitization and transient dermal and eye irritation were reported. Search of the toxicological literature found no additional data on the toxicity, pathogenicity or infectivity of Bacillus subtilis MBI 600. Based on the ubiquitous natural occurrence of Bacillus subtilis and the absence of toxicological or pathogenic effects, the United States Environmental Protection Agency (USEPA) established an exemption from the requirement of a tolerance for residues of Bacillus subtilis MBI 600 in or on all raw agricultural commodities when applied as a seed treatment for growing agricultural crops.

    Subtilex Biological Fungicide is somewhat irritating to the eyes and skin and may cause skin sensitization upon direct contact. To mitigate the potential for these effects, this product's label requires the use of the following personal protective equipment (PPE): long-sleeved shirt and long pants, shoes plus socks, waterproof gloves, and a NIOSH-approved dust/mist filtering respirator.


    The Department's Division of Fish, Wildlife & Marine Resources' Bureau of Habitat (BOH) stated the following:

    The BOH has reviewed the materials submitted in support of Subtilex Biological Fungicide and has no objection to its registration. The Subtilex use pattern is nearly identical to that of HiStick N/T Fungicide, reviewed by BOH in September 2000, which also contained the MBI 600 strain as an active ingredient. As with HiStick N/T, no adverse effects to fish or wildlife resources are anticipated from labeled use of Subtilex.


    The Department's groundwater staff stated the following:

    Subtilex Biological Fungicide contains 2.75% Bacillus subtilis MBI 600 (or a minimum of 5.5 X 10' viable spores per gram). The application rate for seed treatment is from 0.05 to 1.0 ounce per 1001b. of seed and is labeled for use on seed and pod vegetables, peanuts, soybeans, alfalfa, forage and turf grasses, wheat and barley and corn for suppressing Rhizoctonia, Fusarium, Aspergillus and Pythium diseases. It can be used as an in-furrow treatment for cotton, seed and pod vegetables, peanuts, soybeans, alfalfa, forage and turf grasses, wheat and barley and corn at the rate of 0.125 to 0.5 ounces per acre. It can be incorporated into peat moss or growing media at the rate of 0.53 to 5.3 ounces per 100 cubic yards of potting soil. It is for use only on nonbearing non-fruiting plant use in protected growing environments (e.g., glasshouse or greenhouse) and is not for use in non-protected environments (e.g., non-contained nurseries or slat houses). It cannot be applied by chemigation. The inerts do not appear to be solvent carriers.

    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. Since environmental fate data were not necessary, there is no impact to the groundwater to be assessed.

    Subtilex Biological Fungicide should not have an adverse effect on the health of workers or the general public, the fish and wildlife resources, or the ground and surface water of New York State when used as labeled.

    Based on the above-mentioned information, the Department accepts for general use registration in New York State Subtilex Biological Fungicide (EPA Reg. No.71840-1), which contains the new active ingredient Bacillus subtilis MBI 600.

    Enclosed is your Certificate of Registration and New York State stamped "ACCEPTED" label.

    Becker Underwood, Incorporated, is reminded that if New York State registration is requested for this product or for any other product which contains Bacillus subtilis MBI 600, 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.


Maureen P. Serafini
Bureau of Pesticides Management

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