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Trifloxystrobin - New Active Ingredient Registration 3/00

New York State Department of Environmental Conservation
Division of Solid & Hazardous Materials
50 Wolf Road, Albany, New York 12233-7254
Phone: (518) 457-6934 FAX: (518) 457-0629


March 15, 2000

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Mr. Jerry Harrison
Manager, State Registration and Regulatory Support
Novartis Crop Protection, Inc.
PO Box 18300
Greensboro, NC 27419-8300

Dear Mr. Harrison:

Re: Registration of Two New Pesticide Products, FLINT (EPA Reg. No. 100-919) and Compass (EPA Reg. No. 100-920), which Contain the New Active Ingredient Trifloxystrobin

    The New York State Department of Environmental Conservation (the Department) has reviewed your application received on October 1, 1999 for the registration of FLINT (EPA Reg. No. 100-919) and Compass (EPA Reg. No. 100-920) in New York State. The products contain the new active ingredient trifloxystrobin. The application was deemed complete on November 30, 1999 and a registration decision, which was due March 1, 2000, was waived until March 15, 2000. The two-week waiver was granted in order to allow Novartis Crop Protection time to change their federal label with the United States Environmental Protection Agency (USEPA), at our request, to prohibit aerial application of the products in New York State.

    A registration decision would be due to Novartis Crop Protection, Inc. for FLINT and Compass by April 28, 2000 (150 days from the date of completeness). However, Novartis Crop Protection, Inc. had requested that the Department review the registration application for FLINT and Compass before two other pending non-routine Novartis registrations, Proclaim Insecticide and Action Herbicide. Proclaim Insecticide (EPA Reg. No. 100-904) was deemed complete on September 21, 1999 and a registration decision was due to Novartis on February 18, 2000. Action Herbicide (EPA Reg. No. 100-806) was deemed complete on September 8, 1999 and a registration decision was due to Novartis by February 5, 2000.

    The Novartis Crop Protection, Inc. has agreed to the following revised registration decision schedule:

PRODUCT NAME REGISTRATION DECISION DATE
FLINT (EPA Reg. No. 100-919) and
Compass (EPA Reg. No. 100-920)
March 1, 2000
Proclaim Insecticide (EPA Reg. No. 100-904) April 1, 2000
Action Herbicide (EPA Reg. No. 100-806) July 1, 2000


    FLINT is labeled for control of certain diseases in pome fruits, grapes, and cucurbit vegetables. The maximum application rate on grapes is 1.5 pounds of product per acre per year (six total applications) or 0.75 pound active ingredient per acre per year. The maximum application rate on cucurbits is 1.0 pound of product per acre per year (four total applications) or 0.5 pound active ingredient per acre per year. The maximum application on pome fruit is 0.69 pound of product per acre per year (five total applications) or 0.345 pound active ingredient per acre per year.

    Compass is labeled "For Professional Use Only" for the control of certain foliar, stem, and root diseases of turfgrass (including golf courses and residential lawns) and ornamentals grown in interiorscapes, field nursery plantings, forest nurseries, residential and commercial landscapes, greenhouses, lath and shadehouses, containers, and other enclosed structures. The maximum application rate for Compass on turf is 2.16 pounds of product per year or 1.08 pounds active ingredient per acre per year. The applications range from 0.006 to 0.25 pounds active ingredient per 1000 square foot per application. The maximum rate for seedlings and plants grown in greenhouses, containers and other enclosed structures is 7.5 pounds of product per acre per year (3.75 pounds active ingredient per acre per year). Compass treats both foliar and soil borne diseases, and is applied with enough water to reach the root zone.

    The Department has reviewed the information supplied to date in support of the pesticide product registration application for FLINT and Compass.

    The groundwater modeling conducted by Department staff projected no leachate from the parent compound and breakthrough for the major degradate at about 1.5 years, with a maximum peak of 0.016 ppb. The model did not project accumulation.

    The products have the following short groundwater advisory on the label:

"Several trifloxystrobin degradates have properties and characteristics associated with chemicals detected in ground water. The use of this chemical in areas where soils are permeable, particularly where the table is shallow, may result in ground water contamination."

    Trifloxystrobin has low mobility and rapid photolysis. Even though the label contains the short groundwater advisory, based on the environmental fate parameters, it appears that FLINT (EPA Reg. No. 100-919) and Compass (EPA Reg. No. 100-920) will not cause an impact to groundwater in New York State when used according to label directions.

    There are no chemical-specific federal or State drinking water/groundwater standards for trifloxystrobin or its principal degradates. Based on their chemical structures these compounds fall under the 50 micrograms per liter (μg/L) New York State drinking water standard for "unspecified organic contaminants" (10 NYCRR Part 5 - Public Water Systems). The New York State drinking water standard for the sum of "unspecified organic contaminants" and "principal organic contaminants" is 100 μg/L.     Ground based applications are not likely to result in adverse effects to fish or wildlife resources, aerial application, however, poses an unacceptable level of risk to aquatic organisms. Trifloxystrobin is very highly toxic to aquatic organisms and is a fast acting fish toxin. Virtually all freshwater fish mortality observed in laboratory acute toxicity tests occurred within the first twenty-four hours of exposure. Signs of toxicity were exhibited within two to four hours of exposure initiation. The level of risk associated with aerial trifloxystrobin application significantly exceeds current Department protective standards.

    Therefore, the Department hereby accepts for registration FLINT (EPA Reg. No. 100-919) and Compass (EPA Reg. No. 100-920). The products are approved for ground application only. Aerial application of FLINT and Compass is not allowed in New York State. Also, Compass (EPA Reg. No. 100-920) is labeled "For Professional Use Only" and is, therefore, classified as restricted use in New York State in accordance with rules and regulations 6NYCRR 326.2 (copy enclosed).

    As such the product, Compass (EPA Reg. No. 100-920), is restricted in its purchase, distribution, sale, use, and possession in New York State. Furthermore, the product may only be purchased and used by a certified applicator in New York State.

    According to the New York State Department of Environmental Conservation Regulations 6NYCRR 326.3 (a):

"It shall be unlawful for any person to distribute, sell, offer for sale, purchase for the purpose of resale, or possess for the purpose of resale, any restricted pesticide unless said person shall have applied for, and been issued a commercial permit."

    Should you require information concerning commercial permits, please contact the Pesticide Certification Section, at (518) 457-7482.

    Enclosed are your New York State stamped "ACCEPTED" labels and a copy of the Certificate of Registration.

    If you have any questions, please contact Maureen P. Serafini, Chief of our Pesticide Product Registration Section, at (518) 457-7446.

Sincerely,

Stephen Hammond, P.E.
Director
Division of Solid & Hazardous Materials

Enclosures

cc: w/enc. - N. Kim/D. Luttinger - NYS Dept. of Health
J. Leach/J. Kaplan - NYS Dept. of Health
R. Zimmerman/R. Mungari - NYS Dept. of Ag. & Markets
G. Good/W. Smith - Cornell University, PMEP
bcc: w/enc. - S. Hammond (2)
E. Dassatti
J. Colquhoun
L. Whitbeck
SPCS I, Reg. 1
PCS II's - Regions 2-7 & 9
D. Rollins, Reg. 8
J. Broughel (2)
Chemical File
Active File
Product File

bcc: w/o enc. - D. O'Toole
T. Lynch
M. Serafini
B. Seeley
Daybook

JMB:scy
(jeanine\TRIFLOXY.REG) Mr. Jerry Harrison