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.
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:
The battery of acute toxicity studies (oral, dermal and inhalation toxicity, dermal
and eye irritation and dermal sensitization);
90-day mouse and dog feeding studies; o chronic dog feeding study;
rabbit developmental toxicity study;
21-day dermal toxicity study (MRID #42212701) referred to in the USEPA memorandum of
April 1997 (Subject: The revised HED Chapter of the Reregistration Eligibility Decision
Document (RED) for Triclopyr; page 19);
genotoxicity studies on gene mutations and structural chromosomal aberrations; and
environmental fate studies pertaining to hydrolysis and photodegradation (water).
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.
Samuel J. Jackling
Pesticide Product Registration Section
cc: N. Kim/D. Luttinger, NYSDOH
W. Smith, Cornell University, PSUR