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

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EPA: Bacillus subtilis Strain QST 713 (006479) BRAD885.3200AcuteIntravenousToxicity/PathogenicityAcceptable. No mortality and noadverse clinical signs in rats dosedwith QST 713 technical powder.The test microbe cleared from mostorgans by day 35; however, lowlevels detected in spleen and liverafter 35 days.44651908870.2400Primary EyeIrritationAcceptable, Toxicity Category III 44664602870.2500Primary DermalIrritationAcceptable, Toxicity Category IV 44664601870.2600DelayedContactHypersensitivityin Guinea Pigs(QST 713WettablePowder)Acceptable - QST 713 WP productdid elicit a very mild delayedhypersensitivity response. Potentialdermal sensitizer446647052. Toxicological ProfileConsistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the available scientific data andother relevant information in support of this action and considered its validity, completeness, andreliability and the relationship of this information to human risk. EPA has also considered availableinformation concerning the variability of the sensitivities of major identifiable subgroups of consumers,including infants and children.A battery of tests determined that QST 713 Technical product is not pathogenic and has nosignificant toxicity. The acute oral toxicity/pathogenicity, acute pulmonary toxicity/pathogenicity, andacute intravenous toxicity/ pathogenicity studies demonstrated no significant toxicity and a lack ofpathogenicity. The dermal toxicity and eye irritation studies resulted in a Toxicity Category IIIclassification. The acute dermal irritation study resulted in a Toxicity Category IV classification.Bacillus subtilis is a ubiquitous organism in the environment and there have been no reports of theorganism affecting the immune system. The submitted toxicity/pathogenicity studies in rodents withBacillus subtilis strain QST 713 indicated that following several routes of exposure, the immunesystem is still intact and able to process and clear the active ingredient. As would be expected for anymicrobial pesticide, QST 713 did elicit a very mild delayed hypersensitivity response and isconsidered a potential dermal sensitizer. Further, although it is not known whether strain QST 713does, the species is known to produce the enzyme subtilisin which has been reported to produceallergenic or hypersensitivity reactions to individuals repeatedly exposed to the enzyme in industrialsettings. The use of personal protective equipment required for applicators and other handlersmitigates the hypersensitivity risk by minimizing exposure. No hypersensitivity risk is expected fordietary exposure due to the low likelihood that any significant residues will occur on treated food.3. Aggregate Exposuresfile:///J|/REBECA/Meetings/1.%20Conference/REBECA%...up%20work%20bacteria%20fungi/epaprintonly.cgi.html (8 von 29)13.09.2006 18:40:13
EPA: Bacillus subtilis Strain QST 713 (006479) BRADIn examining aggregate exposure, FFDCA section 408 directs EPA to consider available informationconcerning exposures from the pesticide residue in food and all other non-occupational exposures,including drinking water from ground water or surface water and exposure through pesticide use ingardens, lawns, or buildings (residential and other indoor uses).a. Dietary ExposureDietary exposure to the microbial pesticide is likely to occur, however the lack of acute oral toxicity/pathogenicity and the ubiquitous nature of the microbial, support the establishment of an exemptionfrom the requirement of a tolerance for Bacillus subtilis strain QST 713.1) Food. Dietary exposure to the microbial is expected to be minimal. The risk posed to adults, infantsand children is minimal because of the low acute oral toxicity/pathogenicity potential of the microbialpesticide. In addition, standard practices of washing, peeling, cooking or processing fruits andvegetables reduces residues of Bacillus subtilis strain QST 713 and further minimizes dietaryexposure.2) Drinking water exposure. Oral exposure, at very low levels, may occur from ingestion of drinkingwater. Drinking water is not being screened for Bacillus subtilis strain QST 713 as a potentialindicator of microbial contamination. Both percolation through soil and municipal treatment of drinkingwater would reduce the possibility of exposure to the bacterial active ingredient through drinkingwater. If oral exposure should occur through drinking water, the Agency concludes that suchexposure would present insignificant risk due to the lack of acute oral toxicity/pathogenicity and theubiquitous nature of the microbe.b. Other Non-Occupational ExposureThe use sites proposed are for agricultural sites. Dermal and inhalation exposure is expected to belimited to those who apply or handle the pesticide in orchards and farms. Bacillus subtilis presence isubiquitous in the environment and the use of this product is not expected to increase dermal orinhalation exposure in non-occupational settings.4. Cumulative EffectsNo mechanism of toxicity in mammals has been identified for Bacillus subtilis strain QST 713.Therefore no cumulative effect with other related organisms is anticipated. Because the dataavailable demonstrate a low toxicity/pathogenicity potential of the active ingredient, the likelihood ofadverse dietary effects is expected to be minimal.5. Determination of Safety for U.S. Population, Infants and ChildrenBased on the acute toxicity information discussed above, EPA concludes that there is a reasonablecertainty that no harm will result from aggregate exposure to the United States population, includinginfants and children, to residues of Bacillus subtilis strain QST 713 . This includes all anticipateddietary exposures and all other exposures for which there is reliable information. The Agency hasarrived at this conclusion because, the data available on Bacillus subtilis strain QST 713 demonstratea low toxicity/pathogenicity potential. Bacillus subtilis is not a human pathogen and has not beenimplicated in human disease, but has been isolated as a rare contaminant from human infections.Risk of increased exposure is likely only to exist for pesticide applicators and manufacturers of theproduct. The Agency has imposed appropriate risk mitigation measures to protect the workers via thefile:///J|/REBECA/Meetings/1.%20Conference/REBECA%...up%20work%20bacteria%20fungi/epaprintonly.cgi.html (9 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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