February 2, 2006 CERTIFIED MAIL RETURN RECEIPT REQUESTED

Transcription

1 New York State Department of Environmental Conservation Division of Solid and Hazardous Materials Bureau of Pesticides Management, 11th Floor 625 Broadway, Albany, New York Phone: (518) FAX: (518) Website: February 2, 2006 CERTIFIED MAIL RETURN RECEIPT REQUESTED Ms. Oleta A. Melnicoe Agent for Jeneil Biosurfactant Company Technology Sciences Group, Inc. 712 Fifth Street, Suite A Davis, California Dear Ms. Melnicoe: Re: Registration of the New Active Ingredient Rhamnolipid Biosurfactant as Contained in the New Pesticide Product BLI-NIX (EPA Reg. No ) The New York State Department of Environmental Conservation (Department) has reviewed your application, received June 1, 2005, submitted by Technology Sciences Group on behalf of Jeneil Biosurfactant Company to register BLI-NIX_ in New York State. The product contains the new active ingredient rhamnolipid biosurfactant (chemical code ). The application was deemed complete for purposes of review on September 30, 2005 and a registration decision is due by February 27, BLI-NIX_ contains the new active ingredient rhamnolipid biosurfactant (decanoic acid, 3- [[6-deoxy-2-O-(6-deoxy-_-L-mannopyranosyl)-_-L-mannopyranosyl]oxy]-, 1- (carboxymethyl)octyl ester, mixture with 1-(carboxymethyl)octyl 3-[(6-deoxy-_-Lmannopyranosyl)oxy]decanoate) and is labeled for the prevention and control of plant pathogenic fungi on root, bulb, tuber and cane crops. The formulated product BLI-NIX_, which is a (water) diluted form of the active ingredient rhamnolipid biosurfactant, was not very acutely toxic to laboratory animals by the oral, dermal or inhalation routes of exposure. Although it was slightly irritating to the skin, it was a severe/corrosive eye irritant (tested on rabbits). Because of lack of significant dermal irritation and lack of reported hypersensitivity effects in users of products containing rhamnolipid biosurfactants, the United States Environmental Protection Agency (USEPA) granted a waiver for dermal sensitization testing. The USEPA waived the requirements for all subchronic, chronic, developmental/reproductive, genotoxicity and oncogenicity studies. The study waivers [W]ere granted based on the physical mode of action of the product, the demonstrated lack of oral, dermal and inhalation

2 2. toxicity, and the innocuous nature of the potential breakdown products. In addition, the carbohydrate moiety of rhamnolipid biosurfactant, rhamnose sugar, is approved by the U.S. Food and Drug Administration (FDA) as a food additive, and rhamnolipid biosurfactant products are currently in use as emulsifiers, dispersants, wetting agents and agricultural adjuvants. Finally, there have been no reports of adverse effects from any of these uses documented by the USEPA, and our search of the current toxicological literature did not find any additional significant information on rhamnolipid biosurfactant. Based on the above facts and observations, the USEPA established an exemption from the requirement of a tolerance for residues of rhamnolipid biosurfactant in or on all agricultural commodities when applied or used in accordance with product label directions. There are no chemical specific federal or New York State drinking/groundwater standards for the rhamnolipid molecules. Based on their chemical structures, these compounds fall under the 50 microgram per liter (_g/l) 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 _g/l. The available information indicates that the potential for significant risks to workers or the general public from use of BLI-NIX appears minimal. Furthermore, homeowners would not be expected to use this pesticide product due to the label statement For agricultural use and because of the large package sizes ranging from 15 to 400 gallons. While this product was a severe eye irritant, the BLI-NIX label contains the precautionary statement DANGER: Corrosive. Causes irreversible eye damage. Also, the potential for this effect among workers using this pesticide product should be mitigated by the use of protective eyewear such as goggles or a face shield, required by the product s label for applicators and handlers. Groundwater/Drinking Water Review: BLI-NIX_ is labeled for control of zoosporic fungi (e.g., blight and downy mildew) on agricultural crops including root, bulb, tuber and cane crops, such as beets, carrots, cassava, garlic, ginger, onions, potatoes, radish, sugar beets, sweet potatoes and yams. BLI-NIX_ contains 8.5% rhamnolipid biosurfactant with application rate ranges from 85 to 125 ppm which is applied foliarly to the point of saturation. The inerts do not appear to be solvent carriers. The Environmental Assessment Branch of the USEPA does not require environmental fate data on products that are exempt from food tolerances. Since environmental fate data were not necessary, there is no impact to groundwater to be assessed. Ecological Assessment: Use Pattern: BLI-NIX_ is labeled for control of Zoosporic fungal plant diseases on root, bulb, tuber, and cane crops such as: beets, carrots, cassava, garlic, ginger, onions, potatoes, radish, sugar beets, sweet potatoes, and yams. The label lists 21 examples of pathogenic fungi, by genera, which include a zoospore life stage. Included in that list are important plant diseases such as blight and downy mildew.

3 3. The label includes tabular instructions for diluting BLI-NIX_ with a range of water volumes to achieve a final active ingredient (ai), concentration of 85 to 125 parts per million (ppm). The finished solution may be applied: as a foliar spray, fog, drench, soil or growing media drench, preplant spray or mist on seeds, bulbs, cuttings, and transplants, in closed hydroponics systems, and through irrigation systems. In the Foliar Spray section of the label, it states that row crops, depending on type and size, will require up to 100 gallons of finished solution per acre for effective coverage. In 100 gallons of water, 13 to 19 fluid ounces of BLI-NIX_ are used to achieve the desired concentration; applying the resulting solution to one acre equals to lbs ai per acre. The label directs users to reapply BLI-NIX_ at five-day intervals or as needed. There is no minimum interval of use listed on the label for the growing season. It also states that if applications are made at intervals of 48 hours or less, the user should refer to the Agricultural Use Requirements section for instructions on the restricted entry requirements. No seasonal maximum application rate is stated. Chemical Description and Mode of Action: BLI-NIX_ is 8.5% rhamnolipid biosurfactant, a mixture of two rhamnolipid molecules. It is 3.34% R1 which consists of a rhamnose sugar ring and a fatty acid tail (decanoic acid, 3-[(6-deoxy-a-L-mannopyranosyl)oxy]-,1- (carboxymethyl)octyl ester, and 5.16% R2 which consists of two rhamnose rings and a fatty acid tail decanoic acid, 3-[(6-deoxy-2-O-(6-deoxy-a-L-mannopyranosyl]oxy]-, 1-(carboxymethyl)octyl ester. The ai is an extracellular secretion produced by the soil bacterium Pseudomonas aeruginosa strain SB30, American Type Culture Collection (ACTT) number P. aeruginosa SB30 was originally isolated from oil contaminated soil in Texas and Illinois. The chemical characteristic of interest for use in modeling this active ingredient is a vapor pressure of 3.1 Kpa (kilopascal) or mmhg and the fact that it is soluble in water. The rhamnolipid mode of action is described as a physio-chemical surfactant one. Fungal zoospores lack a cell wall, instead having only a plasma membrane. The active ingredient physically penetrates and disrupts the cell membrane, zoospores are immobilized and rapidly lysed. Toxicity and Environmental Fate: This rhamnolipid biosurfactant is practically nontoxic to mammals on an acute basis via all routes of administration for which study results were submitted (oral, dermal, and inhalation). All sub-chronic, chronic, developmental, genotoxicity, and immune function study requirements were waived for federal registration. Also waived were the requirements for all avian, fish, nontarget insect, and nontarget plant studies. The ai is slightly toxic to daphnia with an EC 50 of 36 mg/l, and is also slightly toxic to honey bees with a 48-hour acute contact LD 50 of 19 mg/bee. As described previously, the rhamnolipid molecules are simple glycolipids comprised of one or two rhamnose sugar rings and a fatty acid, hydroxydecanoic acid, tail. Individually, these substances are not considered toxic. Rhamnose is classified as a GRAS (Generally Recognized As Safe) food additive by the FDA. It is a relatively rare naturally occurring sugar used as the basis for strawberry flavorings in the food industry. Fatty acids are ubiquitous in plants and animals and are the major source of energy in the body.

4 4. The rhamnolipid biosurfactant used as the ai in BLI-NIX_ is readily biodegradable. In a biodegradation study, 68.4% of the ai was degraded by day ten of the study. No other fate study results for other pathways were submitted. With a vapor pressure of mmhg, volatilization and loss to the atmosphere will likely also be a significant dissipation route. Screening Modeling and Risk Assessment: With the very limited data submitted, little exposure modeling could be conducted. Worst-case scenarios were constructed for Daphnia and honey bees. The BLI-NIX_ label recommends reapplication at five-day intervals but states they may be made as needed. It implies that they may be made at intervals shorter than 48 hours. Using our half-life module, applications at the higher label rate of 125 ppm were simulated at 48-hour intervals for ten applications. The 50% degradation time interval or DT 50 was assumed to be seven days loosely based on the biodegradation study, the volatilization pathway was ignored. For Daphnia, the applications were assumed to be made directly to the surface of a water body with a six-inch depth. The same seven-day DT 50 was assumed. After the last application, the water column ai concentration under the modeled conditions is ppm. Since the Daphnia LC 50 is reported as 36 ppm, it is unlikely that aquatic invertebrates would be negatively impacted by labeled use of BLI-NIX_. The same application scenario was used to estimate direct contact exposures of honey bees. The higher label application rate is equal to grams per acre, g/a, which equals 1086 micrograms per square foot, mg/ft 2, (47.32g/43,560ft 2 /A). This equals roughly 1.2mg/cm 2 (1086/929cm 2 /ft 2 ). A rough estimate of the dorsal surface area of a honey bee based on dimensions given in the Peterson Field Guide To The Insects of North America is 0.64cm 2. The 48-hour honey bee acute contact LD 50 is reported as 19mg/bee. Using these values, a single application at the higher label rate, assuming dorsal-only deposition, would result in an exposure of roughly 0.76 mg/bee, which is well below the LD 50 value. No NOEC was reported in the honey bee study, nor was any chronic data submitted. In cases where no NOEC is provided, the Bureau of Habitat (BOH) assumes that the LD 50 /10 is a reasonable estimate of the NOEC for exposure assessment purposes. In this case, the 48-hour NOEC would be 1.9 mg/bee. Repeated applications/exposures at labeled short time intervals may exceed this NOEC at the higher BLI-NIX_ rate. BOH has no means to estimate the half-life of ai deposited on bees so this question will remain open. However, based upon the assumption used, honey bees should not be acutely impacted by labeled use of BLI- NIX_. Summary: The Department concludes that rhamnolipid biosurfactant 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.

5 Ms. Oleta A. Melnicoe 5. Therefore, the Department hereby accepts for general use registration in New York State BLI-NIX_ (EPA Reg. No ) which contains the new active ingredient rhamnolipid biosurfactant. Enclosed is your Certificate of Pesticide Registration and New York State stamped "ACCEPTED" label. Jeneil Biosurfactant Company is reminded that if New York State registration is requested for this product or for any other product which contains rhamnolipid biosurfactant 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 Samuel Jackling, Chief of our Pesticide Product Registration Section, at (518) Serafini Sincerely, Maureen P 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