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Agrobacterium radiobacter strain K1026 - New Active Ingredient Registration in NOGALL 8/00

New York State Department of Environmental Conservation
Division of Solid & Hazardous Materials
Bureau of Pesticides Management, Room 498
Pesticide Product Registration Section

50 Wolf Road, Albany, New York 12233-7254
Phone: (518) 457-0300FAX: (518) 485-8836
Website: www.dec.state.ny.us/website/dshm/pesticid/pesticid.htm


August 15, 2000

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Ms. Oleta Melnicoe
Agent for Bio-Care Technology Pty Ltd
Technology Sciences Group, Inc.
712 5th Street, Suite A
Davis, CA 95616

Dear Ms. Melnicoe:

Re: Registration of the New Active Ingredient Agrobacterium radiobacter Strain K1026, Contained in the Pesticide Product NOGALL (EPA Reg. 62388-1)

    The New York State Department of Environmental Conservation has completed its review of the application and supporting data received from Bio-Care Technology Pty Ltd., on October 19, 1999, for the above mentioned pesticide product. NOGALL contains 0.25 % of the new active ingredient Agrobacterium radiobacter Strain K1026 and is labeled for biological control for prevention of crown gall in non-food and non-bearing plants only. NOGALL is a living culture that is used to dip or spray germinating seeds or roots and stems of non-bearing gall-free cherry, peach, nectarine, apricot, plum, almond, pecan, caneberry, euonymous and rose stock to prevent infection by many virulent strains of Agrobacterium tumifaciens and A. rhizogenes.

    NOGALL is supplied in packs of either 100 grams or 500 grams of concentrated, moist peat bacterial cultures. There are at least 1,000 million colony forming units (cfu) of Agrobacterium radiobacter strain K1026 per gram of product. 100 Grams of NOGALL is added to one gallon of water and this solution is applied to germinating seeds by dipping 15 pounds of seeds into one gallon of solution. Root and stems application to seedlings and application to cuttings are treated at the rate of 1000 plants per one gallon of solution.

    Agrobacterium radiobacter is a naturally occurring bacterium that is widespread in soil and found near plant roots. Agrobacterium radiobacter strain K1026 is similar to a currently registered active ingredient Agrobacterium radiobacter strain K84 which has been registered by the United States Environmental Protection Agency (USEPA) and New York State since 1982 without causing any adverse effects or reactions. Strains K1026 and K84 are microbial pesticides that produce a toxic compound that prevents certain other Agrobacterium species from causing crown gall disease. Strain K1026 is the result of genetic alteration of Strain K84, deleting a small portion of DNA and thereby preventing the transfer of resistance from K1026 to other strains.

    The USEPA issued a Notice of Pesticide Registration for NOGALL on September 28, 1999. The registration was conditional based on the submission of the following studies within one year:
  1. Repeat growth temperature studies to determine the maximum growth temperature of Agrobacterium radiobacter strain K1026 at temperatures ranging from 29°C to 37°C.

  2. Substrate utilization studies (ribose, cellobiose, melibiose, xylitol, B-gentiobiose, D-turanose, D-fucose and L-fucose) using both strains K84 and K1026.
    These studies are due to be submitted to the USEPA on or before September 28, 2000.

    On January 27, 2000 your application was determined to be incomplete for purposes of review. On March 23, 2000 additional information was received in support of your application and on May 18, 2000 the application was determined to be complete with the registration decision date set at on/or before October 22, 2000.

HEALTH EFFECTS:

    The submitted acute toxicity data on the NOGALL product (eye and dermal irritation studies) and on the active ingredient, Agrobacterium radiobacter, strain K1026, (oral toxicity/pathogenicity studies) indicated that the formulated product was not very irritating to the skin, but was moderately irritating to the eyes; the active ingredient was not toxic, pathogenic or infective to laboratory animals by the above noted routes of exposure. The USEPA did not require additional acute, subchronic, chronic, reproductive or developmental toxicity studies. A search of the toxicological literature did not find any information on adverse reactions from exposure to Agrobacterium radiobacter. Based on the available information, the labeled use of NOGALL does not appear to pose significant risks to public health.

ECOLOGICAL EFFECTS:

    Given the seed/root/cutting dip use pattern, absence of reported adverse non-target effects over twenty years of K84 use, and the waiver of all the USEPA Ecotoxicity testing, there are no fish or wildlife issues that need to be addressed.

ENVIRONMENTAL FATE AND GROUNDWATER IMPACTS:

    According to the draft Registration Eligibility Decision (RED) for Agrobacterium radiobacter strain K1026, no Environmental Fate studies were performed because the Tier I Ecotoxicity studies were waived. The Ecotoxicity studies were waived based on the derivation of Agrobacterium radiobacter strain K1026 from strain K84, minimal exposure to non-target organisms, and no evidence of any unintended effects on non-target species by strain K84. Based on this evaluation the USEPA has determined that Agrobacterium radiobacter strain K1026 is likely to pose only minimal risk to the environment.

CONCLUSION:

    The USEPA stated in the RED for Agrobacterium radiobacter strain K1026 that it believes that registration of this new active ingredient would be in the public interest because of its efficacy and additional safety as compared to other registered alternatives. Agrobacterium radiobacter strain K1026 is intended for formulation into end-use products for control of crown gall disease. There are no effective registered alternatives for the control of crown gall disease except strain K84. Strain K1026 is better than strain K84 because it is genetically modified to greatly reduce the chance of genetic exchange between strain K1026 and the pathogenic Agrobacterium spp. in soil, thus stopping any immunity buildup of the crown gall disease-causing bacteria.

    Therefore, the Department accepts NOGALL (EPA Reg. No. 62388-1) for registration in New York State as labeled. However, even though Agrobacterium radiobacter, strain K1026, is not known to cause any infectious diseases in humans, the USEPA is requiring growth temperature variation measurements to determine whether this strain can grow at human body temperatures. The USEPA is also requiring substrate utilization tests with both strains K1026 and K84 to alleviate discrepancies in previously submitted tests and to confirm the lineage of K1026. Therefore, until these studies are completed and the topics are resolved, NOGALL will be a conditional registration in New York State. Bio-Care Technology Pty Ltd., as a condition of this registration, must provide the Department with a copy of the additional studies required by the USEPA as a condition of Federal registration and copies of any subsequent reviews provided by the USEPA as soon as they become available but not later than September 30, 2001.

    Enclosed are the Certificate of Registration and a stamped accepted copy of the product label for your records. If you have any questions, please contact Frank Hegener, Chief of our Pesticide Product Registration Section, at (518) 457-7446.

Sincerely,

Maureen P. Serafini
Director
Bureau of Pesticides Management

Enclosure

cc: w/enc.- G. Good/W. Smith, Cornell PMEP
R. Zimmerman/R. Mungari, NYS Dept. of Ag & Mkts.
N. Kim/D. Luttinger, NYS Dept. of Health

bcc: w/enc.- F. Hegener
S. Sanford
SPCS I, Reg. 1
PCS II's -Regions 2-7 & 9
D. Rollins, Reg. 8
B. Seeley
Product File
Chemical File
Active File

bcc: w/o enc.- M. Serafini
T. Lynch
J. Leach
T. Martin
L. Whitbeck
Daybook

BS:scy
(betty\nogall.mps)