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bacillus subtilis NYSDEC-Conditional Registration 4/01



April 9, 2001


CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Mr. Ralph L. Riggs
Manager, State Registrations
AgraQuest, Inc.
1530 Drew Avenue
Davis, CA 95616-6320

Dear Mr. Riggs:

Re: Conditional Registration of Serenade® Biofungicide Wettable Powder (EPA Reg. No. 69592-4) containing the new active ingredient Bacillus subtilis, strain QST 713

    The New York State Department of Environmental Conservation (the Department) has approved the above referenced pesticide product for registration in New York State. The Department will require that AgraQuest submit U.S. EPA data evaluation records for all of the outstanding confirmatory studies listed in the "Ecological Effects Data Required" section of the June 20, 2000 EPA Notice of Conditional Registration, as a condition of registration in New York State.

    The Department received the above application on August 23, 2000 from Agra Quest, Inc. (the Applicant) to register Serenade® Biofungicide Wettable Powder (EPA Reg. No. 69592-4) as a broad spectrum fungicide for the control of many plant diseases, including molds and mildews. Serenade® Biofungicide Wettable Powder contains 10% of the active ingredient Bacillus subtilis strain QST713 and is applied as a foliar spray to cucurbits, leafy vegetables (except brassica), peppers, potatoes, tomatoes, grapes and walnuts. The maximum application rate is ten lbs/product per acre at seven to ten day intervals for walnuts, and six lbs product per acre at five to seven day intervals or eight lbs product per acre at seven to ten day intervals for other listed crops. No maximum number of applications per growing season is specified.

    The product is a water dispersable powder labeled for use as a foliar spray, to be applied by ground equipment only. No aerial application or use of irrigation equipment is permitted in the labeled use of this product. The product is labeled for agricultural use only and includes worker protection standard (WPS) labeling. Product labeling supports integrated pest management (IPM) programs and the Bacillus subtilis strain QST713 has been exempted from the requirement of a tolerance for it's residues in or on all raw agricultural commodities (40CFR Part 180). The product is not labeled for homeowner use.

    The Bacillus subtilis strain QST713 inhibits plant pathogen spore germination, disrupts germ tube growth, and interferes with the attachment of the pathogen to the plant. It is also reported to induce systemic acquired resistance (SAR) in treated plants against bacterial pathogens. Bacillus subtilis is a ubiquitous naturally occurring saprophytic bacteria which is commonly recovered from soil, water, air, and decomposing plant material. Under most conditions, however, it is not biologically active and is present in the spore form. The Bacillus subtilis strain QST713 is a naturally occurring strain that was isolated in 1995 by AgraQuest Inc. from soil in a California peach orchard. The QST713 strain is not a genetically manipulated organism.

    The Application to register Serenade® Biofungicide Wettable Powder in New York State was deemed conditionally complete for purposes of technical review on December 15, 2000. AgraQuest was required to submit a completed 30-day grass shrimp toxicity study prior to the completion of the Department's technical review of the product. AgraQuest submitted the required study on March 14, 2001. Pursuant to the review time frame specified in ECL §33-0704.2, a registration decision date of May 15, 2001 was established.

    The Department has conducted technical reviews for potential impacts to human health, non-target organisms, and the environment and found the Serenade® Biofungicide product, when used in accordance with the New York State stamped "accepted" labeling, to be protective of human health and the natural resources of New York State.

    In terms of human health, reviewers found the Bacillus subtilis bacteria to be relatively benign. It is not known to be a human pathogen and it has not been implicated in causing human disease. Bacillus subtilis is known to produce the enzyme subtilisin, which has been reported to cause dermal allergic or hypersensitivity reactions in individuals repeatedly exposed to this enzyme in industrial settings. The oral, dermal and pulmonary acute toxicity data, as well as eye and skin irritation data on the active ingredient and/or the formulated product, indicate that neither the Bacillus subtilis strain QST713 nor the Serenade Biofungicide product was very toxic, irritating, pathogenic, or infective to laboratory animals by the above noted routes of exposure.

    The Serenade Biofungicide product elicited a mild contact hypersensitivity response (tested on guinea pigs) indicating that it is a potential skin sensitizer. However, the use of personal protective equipment (long-sleeved shirt and long pants, gloves, shoes plus socks, dust/mist filtering respirator) required by the product's label for applicators and other handlers, should mitigate this risk. In addition, the label contains a warning statement that prolonged or frequent skin contact may cause allergic reactions in some individuals. The Department believes that the label instructions are sufficiently protective of workers and the general public but would not consider this product appropriate for registration as a homeowner use product.

    The Department's evaluation of non-target organisms found the Serenade Biofungicide product to be practically non-toxic to mammals and birds. Label instructions are adequate to protect aquatic organisms and bees. Modeling of maximum use rate applications did not exceed toxicity thresholds for birds, mammals, or aquatic organisms. However, the Department requests that AgraQuest submit U.S. EPA data evaluation records for all of the outstanding confirmatory studies listed in the "Ecological Effects Data Required" section of the June 20, 2000 EPA Notice of Conditional Registration, as a condition of registration in New York State.

    The Department did not evaluate impacts to groundwater and overall environmental fate in keeping with the views of the Environmental Assessment Branch of the EPA which 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. In this case, no problem was noted, therefore no environmental fate data were required.

    Enclosed for your record is a copy of the stamped accepted label and the certificate of registration for Serenade Biofungicide Wettable Powder (EPA Reg. No. 69592-4). Please note that a proposal by AgraQuest, Inc., or any other registrant, to register a product that contains Bacillus subtilis strain QST 173 and whose labeled uses are likely to increase the potential for significant impact to humans, property, 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 Frank Hegener, Chief of our Pesticide Product Registration Section, at (518) 457-7446 if you have any questions.

Sincerely,

Maureen Serafini
Director
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