|New York State Department of Environmental
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
|September 25, 2000|
RETURN RECEIPT REQUESTED
Ms. Julia Newsom
Helena Chemical Company
6075 Poplar Avenue, Suite 500
Memphis, TN 38119
Dear Ms. Newsom:
Re: Registration of the New Active Ingredient - Bacillus subtilis MBI 600 Contained in the Pesticide Product - HiStick N/T Fungicide (EPA Reg. 5905-530)
The New York State Department of Environmental Conservation (The Department) has completed its review of the application and supporting data received from Helena Chemical Company, on January 26, 2000, for the above mentioned pesticide product. HiStick N/T, which was accepted by the United States Environmental Protection Agency (USEPA) for registration on November 12, 1999, contains 0.001% of the active ingredient Bacilius subtilis Strain MBI 600, an active ingredient never before registered for use in New York State. HiStick N/T, which also contains nitrogen fixing bacteria, is a ready to use product labeled for use as a seed treatment for soybeans and dry and snap beans. The seeds are coated with HiStick N/T to suppress fungal root disease organisms such as Fusarium, Rhizoctonia and Aspergillus. The MBI 600 bacteria extend along the developing root system, promoting more effective modulation by its nitrogen fixing partner, resulting in a more uniform stand with greater yield potential.
Both Bacilis subtilis and Bradyrhizobium japonicum (the naturally occurring nitrogen fixing bacteria used) are ubiquitous in the environment, the microbes used in this combination product are not genetically modified, and this combination has been used in the past by farmers with no reports of negative impacts on crops. The USEPA required limited toxicological data and established an exemption from tolerance for residues of Bacillus subtilis in or on all raw agricultural commodities when applied as a seed treatment for growing agricultural crops.
Because this application was submitted as a routine registration, we did not determine that it was a new active ingredient until review as a routine new product registration. On April 4, 2000 your Company was notified that the application was incomplete. Following review of the supporting data received (April 20, 2000) from Helena Chemical Company the subject application and data package were deemed complete for purposes of technical review on June 12, 2000. Pursuant to the review timeframe specified in Environmental Conservation Law (ECL) §33-0704.2, a registration decision date of November 14, 2000 was established.
No toxicological effects were reported for Bacillus subtilis MBI 600 following oral or dermal inhalation studies and no infectivity or pathogenicity was observed. HiStick N/T (based on data for the surrogate product EPIC) may be somewhat irritating to eyes and skin and may cause skin reactions from direct contact. However, the HiStick N/T label requires applicators and other handlers to use a NIOSH/MSHA approved dust respirator, waterproof gloves, a long-sleeved shirt and long pants, shoes plus socks, and protective eyewear.
USEPA Biopesticides and Pollution Prevention Division documents indicate that Bacillus subtilis MBI 600 is non-toxic/pathogenic to birds or insects and no aquatic exposures are anticipated. No adverse effects to fish or wildlife resources are likely through labeled use of this product and no impact to groundwater is anticipated.
Therefore, the Department accepts HiStick N/T Fungicide (EPA Reg. No. 5905-530) for registration in New York State as labeled.
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.
Maureen P. Serafini
Bureau of Pesticides Management
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
SPCS I, Reg. 1
PCS II’s -Regions 2-7 & 9
D. Rollins, Reg. 8
bcc: w/o enc.- M. Serafini