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Streptomyces lydicus strain WYEC 108 - Registration of One New Pesticide Product Actinovate SP 3/05

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

March 30, 2005


Ms. Oleta A. Melnicoe
Agent for Natural Industries, 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 One New Pesticide Product, Actinovate SP (EPA Reg. No. 73314-1), Which Contains the New Active Ingredient Streptomyces lydicus strain WYEC 108

The New York State Department of Environmental Conservation (Department) has completed its review of your application, received September 23, 2004, to register the new product Actinovate SP (EPA Reg. No. 73314-1) in New York State. The product contains the new active ingredient Streptomyces lydicus strain WYEC 108 (chemical code 006327).

Actinovate SP (EPA Reg. No. 73314-1) is a soluble powder biological fungicide for the control of root rot and damping-off fungi. The active ingredient in Actinovate SP colonizes the root system and protects it from harmful fungi. Actinovate SP can also suppress foliar diseases such as Powdery Mildew, Botrytis and Downy Mildew. The product is labeled for use in greenhouses and nurseries, for application to turf, as a dip for cuttings or bare rooted transplants, and as a soak for ornamental bulb crops.

The application was deemed complete for purposes of review on November 4, 2004 and a registration decision is due by April 1, 2005.

The Department has reviewed the information supplied to date in support of registration of the new product Actinovate SP (EPA Reg. No. 73314-1).

The New York State Department of Health (DOH) stated that Streptomyces lydicus strain WYEC 108 is a common, well characterized naturally occurring soil bacterium. Consequently, the United States Environmental Protection Agency (USEPA) required limited data for federal registration of Actinovate SP. The data from acute toxicity/pathogenicity studies on the active ingredient indicate that Streptomyces lydicus strain WYEC 108 is not toxic, infective or pathogenic via the pulmonary route of exposure (tested at 9.1 x 108 colony forming units (CFU) per animal), or via intravenous injection (tested at 9.33 x 108 CFU/animal). The end product was not very acutely toxic via the oral route of exposure. It was slightly irritating to the skin and eyes (tested on rabbits). Due to lack of toxicity, infectivity and pathogenicity as well as minimal irritation potential of Streptomyces lydicus strain WYEC 108, the USEPA granted a data waiver for acute inhalation and dermal toxicity testing. The USEPA also waived the requirement for dermal sensitization, subchronic, chronic, developmental/reproductive, genotoxicity and oncogenicity studies for federal registration of Actinovate SP. The DOH's search of the toxicological literature did not find any additional significant information on Streptomyces lydicus strain WYEC 108.

Based on the ubiquitous natural occurrence of Streptomyces lydicus strain WYEC 108 and the absence of toxicological or pathogenic effects, the USEPA established an exemption from the requirement of a tolerance for residues of Streptomyces lydicus strain WYEC 108 in or on all agricultural commodities when applied or used in accordance with product label directions.

A quantitative worker risk assessment was not provided in the registration package. However, according to the registrant, there have been no hypersensitivity incidents during production and testing of Streptomyces lydicus strain WYEC 108 (active ingredient or end use product). Furthermore, the toxicity and irritation studies have shown very low toxicity and irritation potential of the active ingredient. Also, the product label requires applicators and other handlers to wear long-sleeved shirt and long pants, and shoes plus socks. In addition, handlers must also use a dust/mist-filtering respirator that meets NIOSH standards of at least N-95, R-95 or P-95.

The limited toxicity data required to support federal registration of Actinovate SP indicate that this product is not very toxic following acute exposures. The active ingredient Streptomyces lydicus strain WYEC 108 also was neither infective nor pathogenic in laboratory animals, and no hypersensitivity reactions in humans have been associated with this active ingredient or the Actinovate SP product. Although there are no animal study data on longer-term exposures, significant risks to workers or to the general public from Actinovate SP use are not expected given the use pattern and the required personal protective equipment. Given the above, the DOH does not object to registration of the Actinovate SP product in New York State.

The Department's Division of Fish, Wildlife & Marine Resources' Bureau of Habitat (BOH) stated that the only currently labeled use that has the potential to result in significant fish or wildlife exposures is the application to turf. On turf, an initial application of 52 oz. of Actinovate SP in 100-125 gallons of water per acre (0.0012 lbs. ai/acre) is made followed by maintenance applications every 6-8 weeks at 18 oz. Actinovate SP per acre. No seasonal maximum application limit is given.

Actinovate SP is 0.0371% Streptomyces lydicus strain WYEC 108 by weight. It contains 1 x 107 S. lydicus WYEC 108 CFU per gram of formulation. WYEC 108 is a naturally occurring strain originally isolated from agricultural soil in England and is not related to any known plant or animal pathogen.

Streptomyces species are ubiquitous free-living saprophytic soil bacteria that are pivotal organisms in soil ecology. They produce a wide array of extracellular "secondary metabolites" including hydrolytic enzymes that allow them to degrade and utilize tough organic materials like lignin and chitin. They are perhaps best known for their ability to produce antibiotic compounds that are widely used in human and veterinary medicine to treat bacterial diseases, e.g. streptomycin and neomycin.

Very few toxicity studies were required for federal registration of Actinovate SP. Those that were conducted, and references from the open literature, demonstrate that as free-living soil saprophytes with no animal or plant hosts, streptomyces species in general and WYEC 108 in particular are not likely to pose a risk to fish or wildlife resources. Rat acute studies show that WYEC 108 is not toxic, infective, or pathogenic to rats via oral ingestion, inhalation, or direct injection exposures. The No Observable Effect Concentration, NOEC, in a submitted Static-Acute Rainbow Trout toxicity study was 167 ug ai/L which is 83X the concentration that would result from the (estimated) seasonal maximum turf application rate being applied at once to the surface of a 6 inch deep water body. In the trout study, S. lydicus died off rapidly once introduced to the test vessel water. In the highest test concentration, viable S. lydicus WYEC 108 had fallen to 18% of its initial concentration by test termination at 96 hours. All other ecotoxicity and environmental fate testing requirements were waived by the USEPA.

There are no reports of birds, mammals, or insects serving as hosts for S. lydicus in the open literature. Streptomyces are a well-studied group, of the 500 known species only two are known to pathogenic to plants. S. scabies causes superficial scabs on potatoes and S. ipomoea causes similar damage to sweet potatoes. Given the ubiquitous occurrence of S. lydicus in soils, daily plant and animal exposure is likely. Slightly increased exposure from Actinovate SP use is not likely to have any adverse effect on fish or wildlife resources.

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

The Department concludes that Actinovate SP 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 Actinovate SP (EPA Reg. No. 73314-1).

The Certificate of Pesticide Registration and a copy of the New York State stamped "ACCEPTED" labeling for Actinovate SP are enclosed for your records.

Natural Industries, Inc. and their agent, Technology Sciences Group, Inc., are reminded that if New York State registration is requested for this product or for any other product which contains Streptomyces lydicus strain WYEC 108 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) 402-8768.


Maureen P. Serafini
Bureau of Pesticides Management

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