EPA: Bacillus subtilis Strain QST 713 (006479) BRAD - REBECA

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EPA: Bacillus subtilis Strain QST 713 (006479) BRADL). A precise LC 50 could not be determined because there were less than 2 concentrations at whichthe percent dead were between 0 and 100. The NOEC was 1.12 x 10 8 CFU/L (5.6 mg/L). Since onlynecropsy of randomly chosen surviving trout occurred at study termination, we can not at this timeconclude that only toxicity was involved in the mortality observed since pathogenicity was not ruledout by appropriate analysis.The EEC was calculated to be 2.5 x 10 4 CFU/L. Since the a precise LC 50 could not be determined,the lower confidence limit of 1.12 x 10 8 CFU/L was used in risk calculation.The acute aquatic risk quotient (EEC/LC50) was calculated to be (2.5 x 10 4 /1.12 x 10 8 ) = 0.000223.Levels of concern for acute aquatic risk are 0.5 and 0.05.The chronic aquatic risk quotient (EEC/NOEL) was calculated to be (2.5 x 10 4 /1.12 x 10 8 ) =0.000223. The levels of concern for chronic aquatic risk is 1.Even though the risk quotients are far below the levels of concern and the risk to fish from theterrestrial ground use of Serenade TM at 10 lbs/acre are considered minimal to nonexistent, we arerequiring confirmatory data to determine potential pathogenicity. The pathogenicity data areconsidered confirmatory because Bacillus subtilis is a very well studied and no evidence of fishtoxicity or pathogenicity was found in published literature.F. Non-Target PlantsThis data requirement is waived because a review of scientific literature does not indicate thatBacillus subtilis is a common pathogen or phytotoxic agent. In addition, AgraQuest reported (5/12/99facsimile) no phytotoxicity when Serenade was applied as a foliar spray to the following crops invarious countries: almonds, crookneck and acorn squash, watermelon, mushroom, nectarine, peanut,pistachio, potato, strawberry, and tomato. A minimal amount of foliar marginal necrosis and berryscarring was reported at a 17 lbs/acre rate of Serenade on grapes. However, no phytotoxicity ingrapes was observed at the current label rate of 8 lbs.The registrant is to inform the Agency of any incidents of damage to crops or non-target plants as aresult of registered uses of Serenade for further hazard evaluation.G. Other Non-Target OrganismsA strain of B. subtilis has been shown to be pathogenic to a terrestrial amphipod in New Zealand.[Duncan, K.W., (1981)]Due to the report of disease in a terrestrial amphipod crustacean, a 30-day toxicity /pathogenicity testin the shrimp Paleomonetes vulgaris is necessary per OPPTS Microbial Pesticide Testing GuidelineOPPTS.885.4280 as a condition of these registrations to evaluate potential pathogenicity in crustacea.We note that 3 aquatic amphipods are currently listed as endangered. They are the Hay's SpringAmphipod (likely to occur in the District of Columbia), the Illinois Cave Amphipod (likely to occur inMonroe County, Illinois), and the Peck's Cave Amphipod (likely to occur in Comal County, Texas).These species are not expected to be impacted by the terrestrial use of B. subtilis strain QST-713contained in pesticide products because this strain has not been identified as a pathogen toamphipods and any exposure would be extremely limited.file:///J|/REBECA/Meetings/1.%20Conference/REBECA%...up%20work%20bacteria%20fungi/epaprintonly.cgi.html (18 von 29)13.09.2006 18:40:13
EPA: Bacillus subtilis Strain QST 713 (006479) BRADIV. EFFICACYAs no public health pests are listed as use sites, no efficacy data are required to be submitted orevaluated, although the registrant must continue to retain these studies.V. PUBLIC INTEREST FINDINGThe Agency believes the use of Bacillus subtilis strain QST 713 under this conditional registrationwould be in the public interest. The criteria for Agency evaluation of public interest findings is outlinedin 51 Fed.Reg. 7628-7634, Wednesday (March 5, 1986). As explained in part IV. A of that notice, theAgency presumes a pesticide is in the public interest if it is for minor use, is a unique replacement forpesticides of concern, or is for use against a public health pest.Bacillus subtilis strain QST 713 is intended for formulation into end-use products for control of avariety of plant pathogens including: Early Blight (Alternaria solani); Scab (Venturia spp.); and severaltypes of mildew. Most of the uses are for minor use crops and therefore, the Agency presumes thepesticide is in the public interest. The Agency has determined that a naturally occurring microbialpesticide such as Bacillus subtilis strain QST 713 may provide an alternative which can reduce thehazards posed by conventional chemical pesticides. For these reasons the Agency concludes that, itis in the public interest to grant a conditional registration.VI. RISK MANAGEMENT AND REGISTRATION DECISIONA. Determination of EligibilityData submitted are sufficient for the conditional registration under Section 3(c)(7)(C) of FIFRA ofBacillus subtilis strain QST 713 for the use patterns discussed in this document. The Agency willconditionally register this pesticide for a period of time reasonably sufficient for the generation andsubmission of additional studies that the Agency believes are required. Use of the pesticide duringthis period of conditional registration will not cause unreasonable adverse effects on the environment,and the use of this pesticide is deemed to be in the public interest.These conditional registrations will automatically expire in two (2) years. In order to be eligible forregistration and to maintain registrations, the registrant must comply with all conditions specifiedunder section VI.B.1.B. Regulatory Position1. Conditional Time-Limited RegistrationSection 3(c)(7)(C) of FIFRA provides for the conditional registration of new active ingredients if it isdetermined that 1) use of the pesticide during a defined period of time will not cause anyunreasonable adverse effect on the environment; 2) use of the pesticide is in the public interest; and3) that for the data that is lacking, a reasonable period of time sufficient for generation of the data hasnot elapsed since the Agency first imposed the data requirements.To satisfy criterion (1) above, it is believed that this new microbial pesticide will not cause anyunreasonable adverse effects on human health or the environment. Sufficient data are available tofile:///J|/REBECA/Meetings/1.%20Conference/REBECA%...up%20work%20bacteria%20fungi/epaprintonly.cgi.html (19 von 29)13.09.2006 18:40:13
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EPA: Bacillus subtilis Strain QST 713 (006479) BRAD - REBECA

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