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

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EPA: Bacillus subtilis Strain QST 713 (006479) BRADdetermine that Bacillus subtilis strain QST 713 has low toxicity to mammals and is not expected to bepathogenic in humans when the product is used in accordance with label instructions. Standardpersonal protective equipment are required to mitigate any risk to pesticide handlers and applicators.No significant risk is expected from the terrestrial ground application of the end-use product Serenadeto birds, fish, ladybird beetles, green lacewings, parasitic wasps and aquatic invertebrates. Risks tohoneybees have been mitigated by requiring that the end-use product not be applied when bees areactively visiting the treatment area. To satisfy criterion (2) Bacillus subtilis strain QST 713 is for useon minor crops. Finally, the outstanding data was not identified in the new active ingredient screeningprocess and a reasonable period for its generation has not yet passed.The data has been reviewed and BPPD has determined that a section 3(c)(7)(C) conditionalregistration that is limited in duration is appropriate in this situation. Data requirements for grantingthe subject time-limited registrations for terrestrial ground outdoor use under section 3(c)(7)(C) of theFederal Insecticide, Fungicide, and Rodenticide Act (FIFRA) have been met. BPPD has determinedthat the use of this product will cause no unreasonable adverse effects to the environment if it is usedpursuant to the following limitations.a. This registration will automatically expire on midnight July 1, 2002.b. Standard personal protective equipment are required to mitigate anyrisk to pesticide handlers and applicators.c. Risks to honeybees are mitigated by prohibiting use on apples andpears and requiring that the end-use product not be applied when beesare actively visiting the treatment area.d. A whole hive honeybee study will be conducted following EPAapproved protocol.e. Confirmatory data will be submitted for freshwater fish, freshwateraquatic invertebrates, and parasitic hymenoptera.f. A 30 day toxicity/pathogenicity study of shrimp must be conducted.g. Although analyzed batches were acceptable, the submittedmanufacturing process did not have sufficient quality control required.Therefore, the Agency is requiring, as a term and condition of theregistration, additional quality control procedures. Batches that do notmeet the criteria must not be used for commercial production. Detailedrequirements are described in Confidential Business Appendix.Before this manufacturing process can be changed, adequate storagestability data must be provided to the Agency and approved.h. Data listed in Table 4. are required to be completed and submittedwithin specified time frames, as elaborated in Section VII, ActionsRequired by Registrant.These conditional registrations will automatically expire in two (2) years.2. Tolerances for Food Uses and /or exemptionsfile:///J|/REBECA/Meetings/1.%20Conference/REBECA%...up%20work%20bacteria%20fungi/epaprintonly.cgi.html (20 von 29)13.09.2006 18:40:13
EPA: Bacillus subtilis Strain QST 713 (006479) BRADEPA received a pesticide petition (PF-871) from AgraQuest, Inc., proposing [pursuant to section 408(d) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. section 346a(d)], to amend 40 CFR part180 by establishing an exemption from the requirement of a tolerance for residues of the microbialpesticide, Bacillus subtilis strain QST 713, on growing crops.EPA is issuing a notice establishing an exemption from the requirements of a tolerance for residuesof Bacillus subtilis strain QST 713 in or on all food commodities.3. CODEX HarmonizationThere are no CODEX values for Bacillus subtilis strain QST 713.4. Risk MitigationTo mitigate any risk to pesticide handlers and applicators, standard personal protective equipmentare required including: long sleeved shirt and long pants; waterproof gloves; shoes plus socks; dust/mist filtering respirator (MSHA/NIOSH approval number prefix TC-21C), or a NIOSH approvedrespirator with any N, P, R, or HE filter; and a Restricted-entry Interval (REI) of 4 hours are requiredto mitigate occupational exposure and risk to pesticide handlers.To mitigate risk to bees, the registration is limited to two years, apples and pears are not allowed asuse sites, and labeling to prevent application when bees are actively visiting the treatment area isrequired.5. Endangered Species StatementWe 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).However, none of these are expected to be impacted by the terrestrial use of QST -713 strain of B.subtilis because this strain has not been identified as a pathogen to amphipods and any exposurewould be extremely limited .C. Labeling Rationale1. Human Health Hazard (WPS and non-WPS)Bacillus subtilis strain QST 713 products with commercial use sites are subject to the WorkerProtection Standard. Because of the low toxicity of Bacillus subtilis strain QST 713 , the Re-EntryInterval for uses within the scope of WPS is 4 hours. Precautionary statements and personalprotective equipment as specified below are required based on the acute toxicity categories of thisorganism.2. Environmental HazardPrecautionary labeling is required as indicated below.file:///J|/REBECA/Meetings/1.%20Conference/REBECA%...up%20work%20bacteria%20fungi/epaprintonly.cgi.html (21 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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