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Imidacloprid - Pesticide Product Registration 3/95

New York State Department of Environmental Conservation
50 Wolf Road, Albany, New York 12233-7257
518-457-6934 FAX 518-457-0629

CERTIFIED MAIL
RETURN RECEIPT REQUESTED


March 24, 1995

Dr. Douglas A. Spilker
Regulatory Affairs Specialist
Registrations Department
Bayer Corporation
P. O. Box 4913
Kansas City, MO 64120-0013

Dear Dr. Spilker:

Re: Registration of Five New Pesticide Products Containing the New Active Ingredient Imidacloprid: Merit 75 WSP Insecticide (EPA Reg. No. 3125-439) Merit 75 WP Insecticide (EPA Reg. No. 3125-421) Merit 0.5 G Insecticide (EPA Reg. No. 3125-451) Admire 2 Flowable Insecticide (EPA Reg. No. 3125-422) Provado 1.6 Flowable Insecticide (EPA Reg. No. 3125-457)

   Bayer Corporation (formerly known as Miles Inc.) applied for New York State registration for the above-mentioned five products which contain the new active ingredient imidacloprid.

   Merit 75 WSP Insecticide (EPA Reg. No. 3125-439) is a 75% active ingredient wettable powder packaged in water soluble packets. Merit 75 WP (EPA Reg. No. 3125-421) is a 75% active ingredient wettable powder. Both products are labeled for foliar and systemic insect control in turfgrass, landscape ornamentals and interior plantscapes and will be used by commercial applicators in commercial settings. Merit 0.5 G Insecticide (EPA Reg. No. 3125-451) is a 0.5°s granular formulation and is labeled for systemic control in turfgrass and landscape ornamentals. Merit 0.5 G Insecticide is. labeled for use by homeowners. Applications for all three Merit products cannot exceed a total of 0.4 lb. of active ingredient per acre per year.

   Admire 2 Flowable Insecticide contains two pounds of imidacloprid per gallon and is labeled for control of certain insects infesting cotton and potatoes. Admire 2 Flowable Insecticide is labeled for soil application only. Provado 1.6 Flowable Insecticide contains 1.6 pounds of imidacloprid per gallon and is labeled for control of certain insects infesting apples, cotton and potatoes. Provado 1.6 Flowable Insecticide is labeled for foliar application only.

   The maximum amount of imidacloprid that can be applied to potatoes, regardless of formulation or method of application, is 0.31 lb. imidacloprid per acre per season. The maximum amount of imidacloprid that can be applied foliarly to potatoes is 0.2 lb. active ingredient per acre per season.

   The amount of imidacloprid that can be applied to apples as a foliar treatment is 0.1 lb. active ingredient per acre per application and cannot exceed a total of 0.5 lb. active ingredient per acre per year.

   The product labels for Admire 2 Flowable and Provado 1.6 Flowable contain exposure mitigation measures for endangered species, which are grouped by state and county. The Counties with special restrictions in New York State are Saratoga and Schenectady, and the endangered species of concern for both products is the Karner Blue Butterfly.

   The product labels bear statements which restrict the use of Admire 2 Flowable Insecticide and Provado 1.6 Flowable Insecticide on potatoes to soil application only in Saratoga and Schenectady Counties. Therefore, Provado 1.6 Flowable Insecticide, which is labeled for foliar application only, cannot be used on any potatoes in Saratoga or Schenectady County. Provado 1.6 Flowable Insecticide also contains language regarding the timing of applications for apples in Saratoga and Schenectady Counties. Therefore, foliar applications of Provado 1.6 Flowable Insecticide to apples should be avoided during the flowering period, when butterflies may be present.

   The New York State Department of Environmental Conservation (the "Department") has completed the review of the information supplied to date in support of the pesticide product registration applications for Merit 75 WSP, Merit 75 WP, Merit 0.5 G, Admire 2 Flowable and Provado 1.6 Flowable which contain the new active ingredient imidacloprid.

The Department has concerns regarding the long-term environmental fate and environmental persistence of the active ingredient imidacloprid when used in vulnerable aquifers. The Department is especially concerned about the use of imidacloprid on Long Island (Nassau and Suffolk Counties) which has been identified as a vulnerable sole-source aquifer. Groundwater monitoring studies to be performed by Bayer Corporation in compliance with United States Environmental Protection Agency ("EPA") requirements may shed some light on the environmental fate of imidacloprid in the future. However, no groundwater data exists within the time frames in which the Department is required to make a registration decision.

   Therefore, Bayer Corporation, in correspondence dated March 8, 1995, has agreed to conditions of registration in order for the Department to grant full registration of the five above mentioned imidacloprid containing products and any future imidacloprid containing products. We have been informed by the EPA that additional labels and use patterns for imidacloprid are forthcoming.

   Bayer Corporation has agreed to the following:

      1. Establish appropriate monitoring wells on Long Island on typical use sites;

      2. A total of ten wells will be established, six wells in turf use sites and four wells in potato use sites;

      3. Sites are to be mutually acceptable to the Department and Bayer Corporation;

      4. Site selection will be determined in 1995 with initial sampling to begin in 1996;

      5. Use patterns are to be consistent with the label directions for turf and potatoes;

      6. Sampling frequency will be once per year, approximately four to six weeks after application. An initial background sample prior to yearly application and a sample after application will be collected during the first year of sampling;

      7. Bayer Corporation will pay for the initial installation of the monitoring wells and sample analyses;

      8. The Department intends to take over sampling and analysis within three years;

      9. Samples are to be analyzed for parent compound and metabolites, unless Bayer Corporation can demonstrate that the metabolites will not leach to groundwater above 50°s of a calculated standard (reference Chapter I, State Sanitary Code Subpart 5-1, Public Water Systems);

      10. The Department intends to develop a Memorandum of Understanding between the Department and the cooperator (landowner), which will release the landowner from any enforcement liability associated with positive detects from analysis of samples collected from these monitoring wells;

      11. The cooperators (landowners) must be willing to allow Bayer Corporation and/or Department representatives to enter their property for sample collection from the monitoring wells (notification of sampling will always be provided to the property owner by the Department prior to the sample collection after the Department takes ownership of the monitoring wells) ;

      12. Bayer Corporation will provide the Department with the quarterly and final reports of the groundwater studies required by the United States Environmental Protection Agency;

      13. Bayer Corporation will provide the Department with a copy of the gas chromatography-mass spectrometry ("GC-MS") analytical method for water when available; and

      14. Bayer Corporation will provide the Department with the appropriate analytical standards upon request of the Department.

   The Department hereby conditionally registers the five products, Merit 75 WSP (EPA Reg. No. 3125-439), Merit 75 WP (EPA Reg. No. 3125-421), Merit 0.5 G (EPA Reg. No. 3125-451), Admire 2 Flowable (EPA Reg. No. 3125-422) and Provado 1.6 Flowable (EPA Reg. No. 3125-457), as general use pesticide products provided that Bayer Corporation complies with the aforementioned 14 requirements.

   The continued registration of all imidacloprid products within New York State will be dependent upon the annual review of groundwater monitoring data collected within the Long Island aquifer. Enclosed are a New York State stamped "ACCEPTED" label for each of the five new pesticide products and a copy of the Certificate of Registration.

   Please contact Ms. Maureen Serafini, of my staff, at (518) 457-7446, if you have any questions.

Sincerely,

Norman H. Nosenchuck, P.E.
Director
Division of Hazardous Substances Regulation

Enclosures
cc: w/o enc.
N. Kim - NYS Dept. of Health
A. Grey - NYS Dept. of Health
D. Dodge - NYS Dept. of Agriculture and Markets
D. Rutz - Cornell University
J. Gergela - Long Island Farm Bureau