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Isomate-LPTB - NYS DEC Letter: Registration of Active Ingredient 5/03

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

Bureau of Pesticides Management, 9th Floor
625 Broadway, Albany, New York 12233-7254
Phone: (518) 402-8788     FAX: (518) 402-9024
Website: www.dec.state.ny.us

May 30, 2003

CERTIFIED MAIL
RETURN RECEIPT REQUESTED


Ms. Kathy A. Bolan
Registration Agent
Pacific Biocontrol Corporation
PO Box 1551
Healdsburg, CA 95448

Dear Ms. Bolan:

RE: Registration of Isomate-LPTB Pheromone (EPA Reg. No. 53575-23) Which Contains the New Active Ingredients (E-Z)-3-13- Octadecadien-1-yl Acetate and (Z-Z)-3-13-Octadecadien-1-yl Acetate

    The New York State Department of Environmental Conservation (Department) has reviewed your application, received July 15, 2002, and additional information, received November 7, 2002 and May 8, 2003, to register Isomate-LPTB Pheromone (EPA Reg. No. 53575-23) containing the new active ingredients (E-Z)-3-13-Octadecadien-1-yl Acetate and (Z-Z)-3-13-Octadecadien-1-yl Acetate.

    The application was deemed complete for purposes of review on January 6, 2003.

    Isomate-LPTB Pheromone is a synthetic replica of the pheromone which disrupts the mating of the lesser peachtree borer and the greater peachtree borer on peach, almond, nectarine, cherry, prune, plum and apricot crops. The active ingredients are specific to the lesser peachtree borer and the greater peachtree borer and do not impact beneficial non-target species. Isomate-LPTB dispensers contain a mixture of 60.5% (E,Z)-3,13 Octadecadien-l-yl acetate and 22.7% (Z,Z)-3,13 Octadecadien-l-yl acetate as the active ingredient. The application rate is a minimum of 100 dispensers per acre (0.2 ounces ai per dispenser) to a maximum of 250 dispensers per acre (0.5 ounces ai per dispenser). Dispensers are attached to lateral branches above the midpoint of the tree. Dispensers release active ingredient for 100-120 days, depending on air temperature. The Department has reviewed the information supplied to date in support of registration of Isomate-LPTB Pheromone (EPA Reg. No. 53575-23) in New York State.

    The New York State Department of Health (DOH) stated that the U.S. Environmental Protection Agency (U.S. EPA) required limited data for federal registration of Isomate-LPTB Pheromone. The U.S. EPA accepted the acute toxicity studies of another product, Isomate-P Pheromone, to support the registration of Isomate-LPTB since "[B]oth products contain identical active ingredients." The data from these acute toxicity studies indicate that Isomate-LPTB Pheromone would not be very toxic via the oral, dermal or inhalation routes of exposure. In addition, this product would not be very irritating to the skin or eyes and would not be a skin sensitizer. A search of the toxicological literature did not find any additional significant information either on the toxicity of Isomate-LPTB Pheromone or its active ingredients.

    The U.S. EPA waived all subchronic, chronic, genotoxicity, developmental/reproductive toxicity and oncogenicity studies for federal registration of Isomate-LPTB Pheromone. Because of the expected low acute toxicity of Isomate-LPTB Pheromone and the minimal post-application exposure potential, the U.S. EPA exempted Isomate-LPTB Pheromone from the requirement of a tolerance when this product is used on crops at a rate not to exceed 150 grams active ingredient per acre per year (the maximum labeled annual application rate). The U.S. EPA apparently also did not require a worker risk exposure assessment for the labeled uses of the active ingredients (E,Z)-3,13-Octadecadien-1-yl acetate and (Z,Z)-3,13-Octadecadien-1-yl acetate.

    There are no chemical specific federal or State drinking water/groundwater standards for either (E,Z)-3,13-Octadecadien-1-yl acetate or (Z,Z)-3,13-Octadecadien-1-yl acetate. Based on their chemical structures, 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 limited toxicity data required to support the registration of Isomate-LPTB Pheromone 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. The use rate for Isomate-LPTB Pheromone is quite low (5.5 to 13.8 grams active ingredient per acre per application, with an annual maximum of 150 grams active ingredient per acre) and the formulation is contained within a polyethylene dispenser tube, which should reduce dermal contact by workers. Given the above, the NYSDOH does not object to the registration of Isomate-LPTB Pheromone in New York State.

    The Department's groundwater staff stated that for biorational crop protectants, the need for environmental fate and groundwater data (Tier 11, (40CFR Section 158.690(d)(2)(vii through xv)) was not triggered because the Tier I studies were waived. Risk is minimal due to the lack of exposure, low toxicity, use pattern and application methods.

    Since environmental fate data were not necessary, there is no impact to the groundwater to be assessed. Therefore, groundwater staff have no objection to the registration of Isomate-LPTB Pheromone in New York State.

    The Department's Division of Fish, Wildlife & Marine Resources' Bureau of Habitat (BOH) indicated that the federal testing requirements for Lepidopteran pheromone products are much reduced compared to those required for typical pesticides. Due in part to the low mammalian toxicity of the compounds in question, the U.S. EPA published a Final Rule in the August 30, 1995 Federal Register establishing an exemption from the requirement for a food tolerance for residues of certain Lepidopteran pheromones in all raw agricultural commodities regardless of the formulation, mode of application, or physical form or shape, as long as the annual application rate was limited to 150 grams active ingredient, ai per acre per season or less. For the purposes of the exemption a Lepidopteran pheromone was defined as "a naturally occurring compound, or identical or substantially similar synthetic compound, designated by the unbranched aliphatics (with a chain between 9 and 18 carbons) ending in an alcohol, aldehyde, or acetate functional group and containing up to three double bonds in the aliphatic backbone." The two active ingredients in Isomate-LPTB, two isomers of an acetate with 18 carbon aliphatic backbones, meet these criteria.

    Isomate-LPTB dispensers contain a mixture of 60.5% (E,Z)-3,13 Octadecadien-l-yl acetate and 22.7% (Z,Z)-3,13 Ocatdecadien-1-yl acetate as the active ingredient. All of this group of compounds are either insoluble or have very low water solubility, and all are highly volatile. Little other chemical information was provided. The ai slowly volatilizes from the dispensers creating a continuous plume of synthetic female LPTB pheromone which makes it difficult for male LPTB to find females for mating. Numbers of larvae are reduced in subsequent generations thereby reducing crop damage.

    Very limited toxicity data was submitted for this product. The Isomate-LPTB ai is practically non-toxic to birds, mammals, and freshwater fish. However, it is highly toxic to freshwater invertebrates.

    Virtually no environmental fate information was provided in any of the submitted sources. The only fate information reported is given in a list of physical and chemical properties which states that the ai is "stable against sunlight and hydrolysis...."

    Since the combination of very low toxicity, low application rates, and the application method will result in little to no risk to birds, mammals, or aquatic organisms, no exposure modeling was completed.

    Labeled use of Isomate-LPTB will not result in direct toxic effects to fish or wildlife resources.

    The major environmental fate data gap is not unique to Isomate-LPTB but rather extends to all products that utilize synthetic aliphatic lepidopteran pheromones as active ingredients. Even the comprehensive EPA Reregistration Eligibility Documents for several families of aliphatic synthetic pheromones only describe the fate of these volatile compounds as "lost to the atmosphere." To date, an adequate description of the environmental fate of synthetic aliphatic lepidopteran pheromones has not been submitted to the Department.

    The BOH does not object to the registration of Isomate-LPTB.

    The Department, therefore, concludes that Isomate-LPTB Pheromone 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 registration the new product Isomate-LPTB Pheromone (EPA Reg. No. 53575-23) in New York State.

    Enclosed are your New York State stamped "ACCEPTED" label and a copy of the Certificate of Registration.

    Pacific Biocontrol Corporation is reminded that if New York State registration is requested for this product or for any other product which contains (E-Z)-3-13-Octadecadien-l-yl Acetate or Z-Z)-3-13-Octadecadien-1-yl Acetate with an increased application rate and/or expanded use sites, the product will be considered a Major Change in Labeling and the Department will require an extensive review.

    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 G. Good/W. Smith - Cornell University, PMEP