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

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EPA: Bacillus subtilis Strain QST 713 (006479) BRADuse of protective clothing.6. Other Considerationsa. Endocrine DisruptorsThe Agency has no information to suggest that Bacillus subtilis strain QST 713 has an effect on theendocrine system. No specific tests have been conducted with Bacillus subtilis strain QST 713 todetermine such effects. However, the submitted toxicity/pathogenicity studies in rodents indicatedthat following several routes of exposure, the immune system is still intact and able to process andclear the active ingredient. Bacillus subtilis strain QST 713 is a ubiquitous organism in theenvironment and there have been no reports of the organism affecting endocrine systems. Therefore,it is unlikely that this organism would have estrogenic or endocrine effects because it is practicallynon-toxic to mammals.b. Analytical Method(s)The Agency proposes to establish an exemption from the requirement of a tolerance without anynumerical limitation; therefore, the Agency has concluded that an analytical method is not required forenforcement purposes for Bacillus subtilis strain QST 713.C. Environmental Assessment1. Environmental FateB. subtilis is common in soil and plant litter without documented toxicity or pathogenicity in theenvironment. When B. subtilis was used as a tracer in ground water studies it was noted that it movesfaster than rhodomine WT dye in an alluvial gravel aquifer. B. subtilis endospores are reported ashaving longevity in ground water (Pang, L; Close, M. and ; Noonan, M; 1998).2. Ecological ToxicityFollowing ecological effects data requirements listed in 40 CFR Part 158 for microbial pesticides,studies were conducted on birds, fish, non-target insects, aquatic invertebrates, and non-target plantsusing B. subtilis strain QST 713. As described below, QST 713 was determined to be practically nontoxicto bobwhite quail and the risk quotients for fish were far below the levels of concern. Exposureto aquatic sites and organisms (fish and aquatic invertebrates) are minimal to non-existent. There areno aquatic use sites and application methods are restricted to ground sprays. No phytotoxicity wasreported at the specified label rates. Bacillus subtilis is a very well studied microorganism and noevidence of fish or aquatic invertebrate toxicity or pathogenicity was found in published literature.However, additional data on freshwater fish, aquatic invertebrates, parasitic hymenoptera, andPaleomonetes vulgaris to evaluate pathogenicity potential of B. subtilis strain QST 713 are required.Extremely high levels of the bacteria were used in the non-target insect testing which exceed theamount which would be used in the field. These high test concentrations resulted in mortality whichcomplicated interpretation of the studies. In only one case (honeybees), did all test concentrationsshow treatment related mortality. The honeybee study is very difficult to conduct without mortalitybecause bees are removed from their hive and queen to be exposed to the pesticide. Mortality incontrols as well as from treatment are common in honeybee tests and were seen in this case also. Inaddition, this test was conducted for a shorter duration than recommended in EPA guidelines.Although toxicity was observed in the laboratory studies, numerous researchers and beekeepersfile:///J|/REBECA/Meetings/1.%20Conference/REBECA%...up%20work%20bacteria%20fungi/epaprintonly.cgi.html (10 von 29)13.09.2006 18:40:13
EPA: Bacillus subtilis Strain QST 713 (006479) BRADreported to EPA that no bee mortality was observed in the field during the experimental trials. Thepotential risk to honeybees will be mitigated by prohibiting use of QST 713 on certain bee-sensitivecrops such as apples and pears and a bee warning statement on the label until additional data suchas a whole hive study is conducted and reviewed to determine bees are not at risk from use of thispesticide.Toxicity was observed at very high concentrations for parasitic hymenoptera. EPA guidelines, whichprovide registrants with guidance for conducting studies, recommend that if mortality is observed, thatpathogenicity tests be conducted. Because these tests were not conducted, EPA is requiringconfirmatory testing on parasitic hymenoptera.No significant risk is expected from the terrestrial ground application of the end-use product of B.subtilis strain QST 713 to birds, fish, ladybird beetles, green lacewings, parasitic wasps, honeybeesand aquatic invertebrates during the time-limited, conditional registration. Toxicity is not expected tobe a concern for non-target insects. To ensure no significant risk to bees the end-use product labelmust bear a bee warning statement. Risks to honeybees have been mitigated because bee sensitiveplants such as apples and pears are not allowable use sites and bee warning statements are requiredon the label.Table 3. Summary of Submitted DataGRN MRID # Study Status, Classification & Comments885.4050 44651910 Avian Oral(Quail)The avian oral LD 50 is greater than 5000 mg/kg body weight. QST 713 Technicalcontaining B. subtilis strain QST 713 isconsidered practically non-toxic to bobwhitequail due to the high dose used and theeffects observed. The 1 bird mortality and the7 other birds exhibiting signs of clinical toxicitywere considered due to toxicity at the highdose administered.CLASSIFICATION: Acceptable.154-17AvianInjection testNot required since B. subtilis is not a birdpathogen and signs of pathogenicity were notdemonstrated in the avian oral study.file:///J|/REBECA/Meetings/1.%20Conference/REBECA%...up%20work%20bacteria%20fungi/epaprintonly.cgi.html (11 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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