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Sulfuryl Fluoride - Denial of Application to Register a Major Change in Labeled (MCL) Use Pattern Contained in ProFume™ 1/05

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

January 31, 2005

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 (MCL) Use Pattern for the Active Ingredient Sulfuryl Fluoride Contained in the Pesticide Product ProFume™ (EPA Reg. No. 62719-376)

    The New York State Department of Environmental Conservation (Department) has reviewed the application and data package submitted by Dow AgroSciences, LLC (Dow Agro) in support of the application to register ProFumeTM (EPA Reg. No. 62719-376) containing the active ingredient sulfuryl fluoride.

    ProFume™ (99.8% sulfuryl fluoride) is a pressurized fumigant labeled for control of postharvest insect and rodent pests in or on certain stored commodities. Fumigation sites include nonresidential structures (for the food commodities listed on the label) such as mills, warehouses, stationary transportation vehicles (railcars, trucks, etc., excluding aircraft and passenger railcars), temporary and permanent fumigation chambers, and storage structures.

    One product containing sulfuryl fluoride is currently registered in New York State for fumigation of structures for control of termites under the brand name Vikane™ (EPA Reg. No. 62719-4). The use on stored food commodities represents a major change in labeled (MCL) use pattern for sulfuryl fluoride. The Department has not previously conducted a toxicological and health effects evaluation of this active ingredient.

    In a letter dated August 12, 2004 (copy enclosed), the Department notified Dow Agro that the major change in labeled (MCL) use pattern application was incomplete and allowed 45 days from receipt of the letter for submission of the requested information. Per your request, two extensions of 45 days and 60 days were granted. The most recent due date was January 25, 2005. As of the date of this letter, the Department has not received the information required to proceed with a technical review of the subject application.

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

Please note that the application fee is nonrefundable. If you wish to reapply, a new MCL application, application fee and information specified in 6 NYCRR Part 326.17 must be submitted. The application should be resubmitted only when the information requested in the Department's August 12, 2004 incompleteness letter is available.

    Please be aware that ProFume™ (EPA Reg. No. 62719-376) may not be sold, offered for sale, distributed, or used in New York State.

    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: w/enc. - N. Kim/D. Luttinger, NYSDOH
W. Smith, Cornell University, PSUR