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lysophosphatidylethanolamine (LPE)
NYS DEC Letter - Product(s) Registration For Use on Grapes 1/03

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

January 6, 2003

CERTIFIED MAIL
RETURN RECEIPT REQUESTED


Ms. Oleta Melnicoe
Nutra-Park, Inc.
c/o Technology Sciences Group, Inc.
Sacramento: State Affairs Division
712 Fifth Street, Suite A
Davis, California 95616

Dear Ms. Melnicoe:

Re: Registration of Three Products: Nutra-Park, Inc. LPE-94 10% Aqueous Growth Regulator (EPA Reg. No. 70515-1), NPI 105 For Grapes (EPA Reg. No. 70515-1), and NPI 116 For Tomatoes (EPA Reg. No. 70515-1) Containing the New Active Ingredient Lysophosphatidylethanolamine.

    The New York State Department of Environmental Conservation (Department) has evaluated the application and data package submitted on 07/12/02, by Nutra-Park, in support of the registration of the formulated product LPE-94 10% Aqueous Growth Regulator (EPA Reg. No. 70515-1) and the alternate brand name products NPI 105 for Grapes (EPA Reg. No. 70515-1) and NPI 116 for Tomatoes (EPA Reg. No. 70515-1) each containing the new active ingredient Lysophosphatidylethanolamine (LPE) at 10% by weight.

    LPE is the breakdown product of a class of phospholipids found in membranes and known as phosphatidylethanolamine. LPE speeds up ripening and delays aging in plants by two different mechanisms. The active ingredient is ubiquitous in nature and has been evaluated by the United States Environmental Protection Agency (USEPA) as a bio-pesticide. The product formulation contains 10% LPE and is applied at a maximum strength of 400 ppm or 0.334 lbs. of active ingredient in 100 gallons of water. The diluted product is applied with a conventional ground sprayer to completely wet fruit clusters on the following crops: grapes, cranberries, tomatoes, apples, blueberries, and strawberries to speed up ripening. The product can also be applied to tomatoes, cranberries, and cut flowers as a post-harvest application at a maximum strength of 100 ppm or 0.084 lbs. of active ingredient per 100 gallons of water, to extend shelf life.

    The Department received the new active ingredient (NAI) application for LPE-94, NPI 105, and NPI 116 on 07/12/02. The Department reviewed the application for completeness and determined the initial submission to be complete on 08/30/02. Pursuant to the review time frame specified in ECL 33-0704.2, a registration decision date of January 27, 2003 was established. The Department conducted the following technical reviews with regard to the registration of LPE-94, NPI 105, and NPI 116, for impacts to human health, non-target organisms, and the environment. Review summaries are provided below:

Human Health Review:
    The active ingredient LPE is a breakdown product of a major phospholipid (phosphatidylethanolamine) that is present in the membranes of all living things. LPE itself is also present in membranes as well as in cow's milk and human breast milk and in high concentrations in egg yolks and meats. Because LPE is considered to be a biopesticide by the USEPA, only acute toxicity testing of the technical active ingredient and the formulated product was required for federal registration of LPE-94 10% Aqueous Growth Regulator. For acute toxicity testing of the product, a 35 percent LPE formulation was used. Because the LPE-94 10% Aqueous Growth Regulator product is essentially a water dilution of the 35 percent formulation tested, USEPA allowed this more concentrated material to serve as a surrogate. Neither LPE nor the formulated product was very toxic in acute oral, dermal or inhalation toxicity studies in laboratory animals, nor were they irritating to the skin of rabbits. The formulated product was not irritating to the eyes, whereas LPE was minimally irritating (tested on rabbits). Both LPE and the formulated product were shown to be strong dermal sensitizers (tested on guinea pigs).

    The USEPA waived all subchronic, chronic, developmental/reproductive toxicity and genotoxicity studies for registration of LPE-94 10% Aqueous Growth Regulator. The study waivers were granted on the basis of the low toxicity that LPE demonstrated in the acute toxicity studies and the fact that it is a biochemical that is ubiquitous in nature. The USEPA also exempted the requirement of a tolerance for LPE because they believe that LPE is unlikely to be carcinogenic or to have other long-term toxic effects and is already present in many foods. A search of the toxicological literature did not find any additional significant information on the toxicity of LPE.

    Worker exposure to LPE could be a concern due to the dermal sensitizing nature of the active ingredient and the formulated product. However, this risk to applicators should be mitigated by the product label directions which require workers to wear long-sleeved shirt and long pants, waterproof gloves and shoes plus socks. In addition, the label for LPE-94 10% Aqueous Growth Regulator, as well as the labels for the identically formulated products NPI 105 for Grapes and NPI 116 for Tomatoes, caution that "Prolonged or frequently repeated skin contact may cause allergic reactions in some individuals."

    There are no chemical specific federal or State drinking water/groundwater standards for LPE. Based on its chemical structure, LPE falls under the 50 microgram per liter New York State drinking water standard for "unspecified organic contaminants" (10 NYCRR Part 5, Public Water Systems).

    Neither the formulated product nor the active ingredient LPE was very acutely toxic by the oral, dermal and inhalation routes of exposure. Although both the formulated product and active ingredient showed skin sensitizing properties, this potential adverse effect should be mitigated by following the product's precautionary statements which include the use of personal protective equipment. Based on the information available, the labeled use of LPE is not expected to pose a significant health risk to either workers or the general public.

Non-Target Organism Review:
    LPE is a major breakdown product of one of the major cell membrane phospholipids and is found in all living organisms. Fish and wildlife are exposed to it via multiple routes on a daily basis. Any additional exposure from use as an agricultural ripening aid is likely to be a minor component of their overall exposure. All ecotoxicity and environmental fate data requirements were waived for federal registration. In view of these factors, the Department believes that any adverse impacts to fish and wildlife are highly unlikely.

Environmental Fate (Groundwater) Review:
    The active ingredient LPE, is ubiquitous in nature and has been evaluated by the USEPA as a biopesticide. In the Biopesticides Registration Action Document, the USEPA states on page 19 that "The need for environmental fate and groundwater data (Tier II, (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.

Summary:
    Enclosed for your records are a copy of the stamped accepted labeling and the Certificate of Registration for LPE-94 10% Aqueous Growth Regulator (EPA Reg. No. 70515-1) and the alternate brand name products NPI 105 for Grapes (EPA Reg. No. 70515-1) and NPI 116 for Tomatoes (EPA Reg. No. 70515-1). Please note that a proposal by Nutra-Park, Inc. or any other registrant, to register a product that contains LPE, and whose labeled uses are likely to increase the potential for significant impact to humans, non-target organisms, or the environment, would constitute a major change in labeled (MCL) use pattern. Such an application must be accompanied by a new application fee and meet the requirements listed in Appendix 1.B. of "New York State Pesticide Product Registration Procedures" (August 1996). Such information as well as forms can be accessed at our website as listed in our letterhead.

    Please contact our Pesticide Product Registration Section, at (518) 402-8768 if you have any questions.

Sincerely,

Maureen 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