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Triclopyr - Denial of Major Change in Labeling for Garlon 3A 4/04

New York State Department of Environmental Conservation
Division of Solid & Hazardous Materials

Bureau of Pesticides Management
Pesticide Product Registration Section
625 Broadway, Albany, New York 12233-7257
Phone 518-402-8768     FAX 518-402-9024
Website: http://www.dec.state.ny.us/website/dshm/pesticid/pesticid.htm
E-Mail: ppr@gw.dec.state.ny.us

April 15, 2004

CERTIFIED MAIL
RETURN RECEIPT REQUESTED


Raymond S. Brinkmeyer, Ph.D.
State Regulatory Leader
Dow AgroSciences, LLC
9330 Zionsville Road
Indianapolis, Indiana 46268-1054

Dear Dr. Brinkmeyer:

Re: Denial of Application to Register a Major Change in Labeled Use Pattern (MCL) for the Active Ingredient Triclopyr, Triethylamine (TEA) Salt Contained in the Pesticide Product Garlon 3A (EPA Reg. No. 62719-37)

The New York State Department of Environmental Conservation (Department) has reviewed your application, received July 30, 2003, and supplemental information (received November 10, 2003) submitted to date regarding registration of the referenced pesticide product. Garlon 3A (EPA Reg. No. 62719-37) contains 44.4% of the active ingredient triclopyr, triethylamine (TEA) salt.

Garlon 3A is labeled for control of woody plants, broadleaf weeds and vines in forests and industrial non-crop areas, including manufacturing and storage sites, rights-of-way such as electrical power lines, communication lines pipelines roadsides railroads fence rows, nonirrigation ditch banks, and around farm buildings; including application to grazed areas, and establishment and maintenance of wildlife openings on these sites, and in Christmas tree plantations. Use within production forests and industrial non-crop sites may include applications to control target vegetation in and around standing water sites such as marshes wetlands and - the banks of ponds and lakes. The underlined text represents proposed additional uses in New York State for the Garlon 3A label since the Department's last stamped "Accepted" label (February 12, 1998). The new uses represent a major change in labeled use pattern (MCL) for the active ingredient triclopyr, TEA salt.

In a letter dated September 25, 2003, the Department notified Dow AgroSciences, LLC (Dow Agro), that the MCL application was incomplete. Following review of the information submitted by Dow Agro on November 7, 2003, the Department issued another notice of incompleteness on December 23, 2003. This second incompleteness letter discussed the reasons why your application remained incomplete and allowed 45 days from date of receipt to submit the required information. Pursuant to your February 13, 2004 letter requesting a 45-day extension to complete the acquisition of the required information, a new response date of March 29, 2004 was established. As of the date of this letter, the Department has not received the required information.

Since the Department is required to operate under legislatively mandated time frames, and there has been no indication as to when the required information will be available, the review process has been terminated and the subject MCL application denied.

Please be reminded that the application fee is nonrefundable. If you wish to reapply, you must submit a new application for registration of a MCL, application fee and application requirements specified in 6 NYCRR Part 326.17. The application should only be resubmitted when the following United States Environmental Protection Agency (USEPA) Data Evaluation Record reports (DERs) for the active ingredient are available: Please be aware that the Garlon 3A label (coded LlA/Garlon 3A/PKG FPL/01-21-03) bearing the new uses may not be sold, offered for sale, distributed, or used in New York State. The only Garlon 3A (EPA Reg. No. 62719-37) label available for legal sale, use or distribution in New York State is the label stamped "Accepted" on February 12, 1998.

If you have any questions on this matter, please contact me, at (518) 402-8768.

Sincerely,

Samuel J. Jackling
Chief
Pesticide Product Registration Section

cc: N. Kim/D. Luttinger, NYSDOH
W. Smith, Cornell University, PSUR