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sucrose octanoate NYS DEC Letter - Registration of New Pesticide Product, Sucrocide 7/04

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

July 30, 2004

CERTIFIED MAIL
RETURN RECEIPT REQUESTED


Mr. Anthony Barrington
Dadant & Sons, Inc.
c/o AVA Chemical Ventures, L.L.C.,
80 Rochester Ave., Suite 214
Portsmouth, New Hampshire 03801

Dear Mr. Barrington:

Re: Registration of One New Pesticide Product, Sucrocide (EPA Reg. No. 70950-2-2205), Which Contains the New Active Ingredients Sucrose Octanoate Esters

    The New York State Department of Environmental Conservation (Department) has reviewed your application and supporting data received January 8, 2004 and March 11, 2004, to register the pesticide product Sucrocide (EPA Reg. No. 70950-2-2205) in New York State. This product contains as the new active ingredients sucrose octanoate esters [(a-D-glucopyranosyl-[3-D-fructofuranosyl-octanoate), mono-, di-, and tri-esters of sucrose octanoate] (chemical code 035300). The application was deemed complete for purposes of review on April 15, 2004 and a registration decision is due by September 10, 2004.

    Sucrocide is labeled as a biochemical miticide for use against Varroa mites on honeybees. This product is packaged as a liquid containing 40% active ingredient. The application rate of this product (0.625% v/v or eight ounces in ten gallons of water) is 1.5 fluid ounces of mix on each full depth frame of bees, which indicates a typical 18 frame two-story colony will receive 27 fluid ounces of mix. The mixed solution is applied with a garden type hand-held or backpack sprayer. Up to three applications may be applied per infestation of mites.

    The Department has reviewed the information submitted to date in support of the application for registration of Sucrocide (EPA Reg. No. 70950-2-2205).

    Based on their similarity to naturally occurring sucrose fatty acid esters, the United States Environmental Protection Agency (USEPA) granted a biochemical pesticide designation to sucrose octanoate esters. Accordingly, the USEPA required limited data for federal registration of Sucrocide. Although the USEPA typically requires registrants of pesticide products to conduct a battery of acute toxicity studies (oral, dermal and inhalation toxicity, eye and dermal irritation and dermal sensitization) on both the active ingredient(s) and formulated product, the only new studies required for federal registration of the Sucrocide product were eye and dermal irritation. These studies showed that both Sucrocide and sucrose octanoate esters caused moderate to severe eye irritation, but neither was very irritating to the skin (tested on rabbits). The USEPA accepted data from the open technical literature to support the data requirements for acute oral, dermal and inhalation toxicity. These data indicate that the sucrose octanoate esters (and presumably also the formulated product which is approximately a 50 percent water dilution of these active ingredients) are not very toxic by the oral, dermal or inhalation routes of exposure. In addition, no hypersensitivity incidents have been reported for workers regularly exposed to sucrose esters for up to six years. Finally, submitted data/information showed sucrose fatty acid esters to be negative in genotoxicity studies.

    The USEPA waived the requirement for all subchronic, chronic/carcinogenicity, developmental/reproductive toxicity and genotoxicity studies for federal registration of Sucrocide. The USEPA also issued an exemption from the requirement of a tolerance for the sucrose octanoate esters in Sucrocide on all food commodities when applied and used in accordance with good agricultural practices.

    There are no chemical specific federal or State drinking water/groundwater standards for the subject sucrose octanoate esters. Based on their chemical structure, each of these chemicals falls under the 50 microgram per liter 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 micrograms per liter.

    The limited toxicity data required to support the registration of Sucrocide indicate that this product is not very toxic following acute exposures. Although there are no data available for longer-term exposure, significant risks to workers or the general public are not expected based on the lack of toxicity in acute studies and that the components of the sucrose octanoate esters are chemicals that are a regular part of the human diet. While both the formulated product and active ingredients can cause moderate to severe eye irritation, this potential adverse effect for workers should be mitigated by following the product's statements which include the use of protective eyewear (goggles or face shield).

    The nontoxic mode of action and very limited use pattern of Sucrocide, make significant adverse non-target organism effects, or even exposures, highly unlikely.

    The USEPA has exempted this product from food tolerances, and therefore the need for environmental fate and groundwater data (Tier II, (40CFR Section 158.690(d)(2)(vii through xv)) were not triggered because Tier I studies are waived on products that are exempt from food tolerances. Since environmental fate data were not necessary, there is no impact to the groundwater to be assessed.

    Sucrocide should not have an adverse effect on the health of workers or the general public, the fish and wildlife resources, or the ground and surface water of New York State when used as labeled.

    Therefore, the Department hereby accepts for general use registration in New York State, Sucrocide (EPA Reg. No. 70950-2-2205) which contains the new active ingredients sucrose octanoate esters.

    Enclosed are your Certificate of Pesticide Registration and New York State stamped "ACCEPTED" label.

    If you have any questions, please contact Mr. Samuel Jackling, Chief of our Pesticide Product Registration Section, at (518) 402-8768.

Sincerely,

Maureen P. Serafini
Director
Bureau of Pesticides Management

Enclosures
cc: w/enc. - N. Kim/D. Luttinger - NYS Dept. of Health
R. Zimmerman/ R. Mungari - NYS Dept. of Ag. & Markets
W. Smith - Cornell University, PMEP