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bacillus licheniformis SB3086 NYS DEC Letter - New Active Ingredient Registration 8/03

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

August 15, 2003

CERTIFIED MAIL
RETURN RECEIPT REQUESTED


Ms. Rebecca Horton
Novozymes Biologicals, Inc.
c/o Registrations by Design, Inc.
118 1/2 E. Main Street, Suite 1
Salem, Virginia 24153-3805

Dear Ms. Horton:

Re: Registration of the New Active Ingredient Bacillus licheniformis SB3086 Contained in the Pesticide Product EcoGuard TM Biofungicide (EPA Reg. No. 70127-2)

    The New York State Department of Environmental Conservation (Department) has completed review of the application (received 02/12/03) and supplemental information supplied to date regarding registration of the referenced product in New York State. EcoGuardTM Biofungicide (EPA Reg. No. 70127-2) contains the active ingredients Bacillus licheniformis SB3086 (0.14%) and indole-3-butyric acid (0.00096%). Bacillus licheniformis SB3086 is a new active ingredient in New York State while indole-3-butyric acid, a plant growth regulator, is a component of a number of currently-registered pesticide products labeled for application to ornamental turf.

    EcoGuardTM Biofungicide contains a concentrated suspension of the organism Bacillus licheniformis SB3086, which has been found effective as a natural inhibitor of a variety of agronomically important fungal disease species. Product is labeled as a preventative or curative treatment for Dollar Spot (Sclerotinia homoeocarpa) at the following sites: lawns, golf courses, sports turf, turf farms and arboretums. Applications of up to 6.8 gallons/acre of EcoGuardTM, in sufficient water to provide complete coverage, may be made at intervals of 3-4 to 14 days, depending on disease pressure. No seasonal or yearly maximum use rate is given. The Environmental Hazards section of the labeling bears the statement "Do not feed treated plants to livestock or domestic animals."

    The registration package was deemed complete for purposes of technical review on April 2, 2003. Pursuant to the review time frame specified in Environmental Conservation Law (ECL) 33-0704.2, a registration decision date of August 30, 2003 was established.

    The Department conducted toxicological, ecological and environmental fate risk assessments for Bacillus licheniformis SB3086 and the EcoGuardTM Biofungicide formulation.

TOXICOLOGICAL RISK ASSESSMENT: B. licheniformis SB3086 is a naturally occurring, ubiquitous bacterium originally isolated from United States farm soil. Consequently, the United States Environmental Protection Agency (USEPA) required limited data for federal registration of EcoGuardTM Biofungicide. The data from acute toxicity/pathogenicity studies on the active ingredient indicate that Bacillus licheniformis SB3086 is not toxic, infective or pathogenic via the oral or inhalation routes of exposure (tested at 1 x 108 Colony Forming Units (CFU) per animal), or via intravenous injection (tested at 1x10' CFU/animal). The end product was not very acutely toxic via oral, dermal, or inhalation routes of exposure. It was also not irritating to the eyes (tested on rabbits) or a dermal sensitizer (tested on guinea pigs), but was a slight dermal irritant (tested on rabbits).

    The USEPA waived the requirement for subchronic, chronic, developmental, reproductive toxicity, genotoxicity and oncogenicity studies for federal registration of EcoGuardTM Biofungicide. Instead, the USEPA used reports from the scientific literature to evaluate this product. The data from these reports suggest that B. licheniformis is occasionally associated with infections in individuals who have significant preexisting health problems such as severe immune system depression, cancer or trauma. In addition, it has been associated with reproductive failures (spontaneous abortions and inflammation of the placenta) in cattle, sheep and swine, usually in association with the ingestion of moldy hay. A search of the toxicological literature did not find any additional significant information on B. licheniformis.

    A quantitative worker risk assessment was not provided in the registration package. However, B. licheniformis has been used in various industrial fermentation processes for a number of years and, according to the registrant, no pathogenicity, toxicity or hypersensitivity has been reported among these workers. Given the use pattern of the EcoGuardTM product, exposure of applicators would likely be less than that of fermentation workers. Also, the product label requires applicators and other handlers to wear a long-sleeved shirt, long pants, and shoes plus socks. In addition, handlers must also use a non-powered air purifying NIOSH approved respirator.

    The limited toxicity data required to support the federal registration of EcoGuardTM Biofungicide indicate that this product is not very toxic following acute exposures. The active ingredient B. licheniformis also appears to have a low degree of pathogenicity and infectivity to animals and humans. Although there are no animal study data on longer-term exposure, significant risks to workers or the general public from EcoGuardTM use are not expected given the use pattern and the required personal protective equipment. The required personal protective equipment also should protect against the slight dermal irritation that EcoGuardTM may cause.

ECOLOGICAL RISK ASSESSMENT: EcoGuard contains 0.14% (w/v) Bacillus licheniformis SB3086, 1.0 x 109 Colony Forming Units (CFU)/ml, and 0.00096% (w/v) indole-3-butyric acid as its active ingredients. B. licheniformis is a common saprophytic soil microbe that contributes to nutrient cycling. Its antifungal mode of action has not been definitively determined but is thought to be due to production of a small molecule antibiotic agent, possibly in combination with an antifungal hydrolytic enzyme. SB3086 is a naturally occurring B. Licheniformis strain. Indole-3-butync acid (IBA) is similar in structure and biological activity to the naturally occurring plant growth hormone indole-3-acetic acid (IAA), a principle hormone of higher plants.

    B. licheniformis SB3086 is not toxic, infective, or pathogenic to mammals when administered orally, by inhalation, direct tracheal injection, dermally, and by intravenous injection. A significant decrease in weight gain in young mallard ducks was observed when administered EcoGuardTM formulation at a rate of approximately 1.0 ml/kg body weight. The effect was attributed to formulation ingredients other than the active ingredients. B. licheniformis SB3086 appears not to be toxic, infective, or pathogenic to mallards; there were no mortalities.

    The 30-day EcoGuardTM rainbow trout LC50 is greater than 1.1 xl06 CFU/ml which is roughly I I 7X (times) the expected environmental concentration (EEC) when the maximum application rate is applied directly to the surface of six-inch deep water body. The daphnia No Observable Adverse Effect Concentration (NOAEC) is 120X the EEC. There was no sign of infection or pathogenicity in either study.

    The EcoGuardTM formulation had no effect on honeybee larva when exposed to B. licheniformis SB3086 at 1.6 x106 CFU/ml, roughly 2/3 full strength formulation, in their diet. No adverse behavioral or developmental abnormalities were observed in emerged adult honeybees that had been exposed as larva. All marine/estuarine organism and nontarget plant testing was waived by the USEPA.

    Bacillus licheniformis is a ubiquitous soil organism. While numbers of B. licheniformis in soil are unknown and likely vary from soil to soil, the total number of Bacillus organisms is estimated to be 10' CFU/g soil. The added soil density of B. licheniformis from the proposed use rates would be 0.42% to 1.5%. This is a very small proportion of the naturally occurring bacilli in soil and is not expected to add substantially to the effects of the normally occurring Bacillus populations. No adverse effects to fish or wildlife resources are expected from use of EcoGuardTM Biofungicide when used as labeled. There are reports in the literature of B. licheniformis being a sporadic mammal pathogen. B. licheniformis diseases appear to be limited to cows, sheep, and swine as very unusual events associated with the ingestion of moldy hay. Wild ruminants exposure to the combination of conditions seemingly implicated in livestock disease should be minimal.

    The IBA contained in EcoGuardTM poses no risk to fish or wildlife resources: The IBA concentration in EcoGuardTM is very low, application at the maximum label rate results in an IBA application rate of roughly 30 milligrams/acre.

    Compounds similar to IBA are intermediate metabolites in the synthesis of IAA from the amino acid tryptophan, which occurs widely in plants, fungi, bacteria, and other organisms. Most organisms likely have metabolic mechanisms for these types of compounds.

    The submitted avian and aquatic toxicity testing was conducted with the EcoGuardTM formulation at concentrations much higher than will result from labeled use with little or adverse effects.

ENVIRONMENTAL FATE RISK ASSESSMENT: EcoGuardTM Biofungicide contains 0.14% Bacillus licheniformis SB3086 (or a minimum of 109 Colony Forming Units/ml) and 0.00096% indole-3-butyric acid. The application rate ranges from 1 to 9 3/4 gallons of product in 100 gallons of water for turf areas. The product is applied as a foliar spray and use directions require that enough be used to provide complete coverage. Depending on the use site, the product may be reapplied every 3-14 days. The inerts do not appear to be solvent carriers.

    The Environmental Assessment Branch of the USEPA does not perform an environmental exposure assessment on biological active ingredients unless the Toxicology Branch has a problem with the information presented by the registrant. Since environmental fate data were not required, there is no information to assess impact to groundwater/drinking water.

CONCLUSION: When used as labeled, EcoGuardTM Biofungicide should not cause unreasonable adverse effects to humans or the environment. The Department hereby accepts EcoGuardTM Biofungicide (EPA Reg. No. 70127-2) for registration in New York State. Enclosed for your files are the Certificate of Pesticide Registration and New York State stamped "ACCEPTED" labeling.

    Please note that a proposal by Novozymes Biologicals, Inc., or any other registrant, to register a product containing Bacillus licheniformis SB3086, whose labeled uses are likely to increase the potential for significant exposure to humans or impact to the environment (e.g., a product labeled for homeowner use), 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 specified in 6 NYCRR Part 326.17.

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

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