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

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EPA: Bacillus subtilis Strain QST 713 (006479) BRADconditionally required. The registrant must submit a protocol for EPA review before initiating the study.Nineteen individuals who participated in field trials of the end-use product of this active ingredient,Serenade TM WP Biofungicide submitted letters attesting that they observed no negative effect tobees. The field testing performed was designed to research efficacy and phytotoxicity. In many butnot all cases a hive was located at the sites at time of treatment. EPA contacted the individualresearchers to obtain clarification and locate beekeepers whose bees were exposed to the microbialproduct. None of these were formal studies designed to investigate the effects this microbial productmay have on honeybees. However, their observations and of the beekeepers who had hives exposedto Bacillus subtilis strain QST 713 provide some information about its lack of reported effects to beesin actual field conditions. A summary of the information collected is below.BEEKEEPER INTERVIEW SUMMARYThree beekeepers whose bees were exposed at field trials of Serenade report that no problems werenoted. They all indicated that written records were not usually taken unless a problem was noted.One of them reported giving special examination to a hive because of a hive kill one mile away whereinsecticides were applied. In addition, hives are subject to inspection by county or state bee agents.Due to the migratory nature of this profession, there were difficulties locating other beekeepers.SUMMARY OF LETTERS AND INTERVIEWS OF RESEARCHERSNineteen agricultural researchers submitted letters. Several indicated some applications were madeat bloom. They reported:1) No increase of honeybee mortality was observed in the field or by the hives;2) No difference in foraging or activity before and after application;3) Honeybees were not avoiding material;4) No negative effects on pollination observed at apple, pear, cherry, cucurbit,strawberry, grape. snap beans, bell pepper, potato, and watermelon;5) Cucurbits which are entirely dependent on bees for pollination produced normalyields; And6) They received no complaints from beekeepers or orchardist.2. Parasitic hymenopteraQST Technical was shown to cause mortality to parasitic Hymenoptera (Nasonia vitripennis). Thedietary LC 50 for 15 days was calculated as being approximately 28,000 ppm by the moving averagemethod with 95 percent confidence intervals of approximately 18,000 ppm and 51,000 ppm. TheLOEC was 600 ppm. Estimated environmental concentrations (EECs) were estimated via the Keneganomogram which provides expected residue levels on terrestrial food/feed items. Based on a singleapplication at the 10 lb product /acre, the EECs for the technical grade active ingredient are 250 ppmand 115 ppm. Thus, the LC 50 of 28,000 ppm is approximately one hundred and twelve (112) timesthe EEC based on foliar residue. Parasitic wasps directly sprayed with QST 713 would be exposed tofile:///J|/REBECA/Meetings/1.%20Conference/REBECA%...up%20work%20bacteria%20fungi/epaprintonly.cgi.html (16 von 29)13.09.2006 18:40:13
EPA: Bacillus subtilis Strain QST 713 (006479) BRADapproximately 8000 ppm. Given the high LC 50 of 28,000 ppm, the risk to parasitic wasps is notsignificant. The study is graded acceptable with required confirmatory data to evaluate potentialpathogenicity.3. Ladybird beetleThe study is acceptable and fulfills the guideline requirement. The mortalities observed were nottreatment related and the LC 50 was greater than 60,000 ppm. The no observed effect concentration(NOEC) was 60,000 ppm (1.2 x 10 9 CFU/mL). Data requirement is satisfied. The risk to ladybirdbeetles from the use of the end-use product Serenade TM is not considered significant.4. Green lacewingAfter QST Technical treatment, the mortalities observed were not treatment related and the LC 50 wasgreater than 60,000 ppm. However, due to decreased pupation, the no observed effect concentration(NOEC) was 600 ppm (1.2 x 10 7 CFU/g). The LOEC was 6000 ppm or 24 times the EEC of 250 ppm.The data requirement is satisfied. The risk to green lacewing from the use of the end-use productSerenade TM is not considered significant.D. Freshwater Aquatic InvertebrateThe 21-day LC 50 was determined to be greater than 3 x 10 7 CFU/L (1.5 mg/L). The lowestobservable effect concentration (LOEC), based on reproduction, mean length and mean dry weightwas determined to be 1.5 x 10 7 CFU/L (0.75 mg/L). The NOEC was determined to be 7.5 x 10 6 CFU/L (0.38 mg/L). The cause of death and whether pathogenicity was involved was not determined.An estimated environmental concentration (EEC) was calculated using some of the sameassumptions used in the GENEEC model. Namely, 1) runoff from a ten hectare field into a onehectare by two meter pond is sufficient to remove 10% of the pesticide from the ten hectare area aftertwo days; and 2) direct spray drift into the pond at the time of application is 1% for ground application.The EEC was calculated to be 2.5 x 10 4 CFU/L.The acute aquatic risk quotient (EEC/LC50) was calculated to be (2.5 x 10 4 / 3 x 10 7 ) = 0.00083.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 / 7.5 x 10 6 ) = 0.0033.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 aquaticinvertebrates from the terrestrial ground use of Serenade at 10 lbs/acre are considered minimal tononexistent, we are requiring confirmatory data for potential pathogenicity. The pathogenicity data areconsidered confirmatory because Bacillus subtilis is very well studied and no evidence of aquaticinvertebrate toxicity or pathogenicity was found in published literature.E. Freshwater FishIn the 30-day trout study, an approximate LC 50 using the binomial method was 2.62 x 10 8 CFU/L(13.1 mg/L) with 95% confidence limits of 1.12 x 10 8 CFU/L (5.6 mg/L) and 4.2 x 10 8 CFU/L (21 mg/file:///J|/REBECA/Meetings/1.%20Conference/REBECA%...up%20work%20bacteria%20fungi/epaprintonly.cgi.html (17 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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