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

EPA: Bacillus subtilis Strain QST 713 (006479) BRAD885.1300Formation ofUnintentionalIngredientsACCEPTABLEwhen themanufacturingprocess required byEPA is followed andthe required QA/QCis performed.44651904,45084501885.1400 Analysis of SamplesACCEPTABLEwhen themanufacturingprocess required byEPA is followed, therequired QA/QC isperformed, andeach batch is testedfor microbialcontamination.44651902885.1500 Certification of Limits ACCEPTABLE 45084501830.6302,830.6303,830.6304,830.7000,885.7300Product ChemistryACCEPTABLEexcept for StorageStability. Storagestability data areSUPPLEMENTALand may beupgraded withsubmission ofadditional data.4465190144651903Additional manufacturing process data are required as a condition ofregistration. Details concerning requirements are discussed in aConfidential Business Information Appendix.B. Human Risk Assessment1. Human Toxicity AssessmentThe acute oral toxicity, acute dermal toxicity, acute pulmonary, acute intravenous, primary eyeirritation, primary dermal irritation, and delayed contact hypersensitivity test are acceptable. Theacute pulmonary study showed no mortality and no adverse effects when performed using thetechnical product. There was also no mortality from the acute inhalation study using the end-useproduct although some clinical signs and weight loss were noted. However, the acute inhalation studydid not measure the actual concentration of the product in the test. Considering that the particle sizeof the wettable powder poses a low risk of inhalation exposure and the nature of the inerts in theproduct, the Agency is using the acute inhalation study as confirmatory of the acute pulmonary studyand waiving the requirement for a repeated acute inhalation study. In addition, any risk is mitigated byfile:///J|/REBECA/Meetings/1.%20Conference/REBECA%...up%20work%20bacteria%20fungi/epaprintonly.cgi.html (6 von 29)13.09.2006 18:40:13