United States Environmental Protection Agency between the years 1961 and 1995 registered 177 products containing viable Bacillus thuringiensis (Bt), Numerous laboratory studies have demonstrated that Bt and Bt products are noninfectious and are toxic to mammals only at a dose greater than or equal to 10(8) colony forming units (cfu) per mouse (a human equivalent based on the weight of >10(11) cfu), In contrast, as few as three vegetative cells of Bacillus anthracis can kill mice (a human equivalent of >10(3) cfu), There are only two literature reports of Bt infection in man between the year 1997 and the present, and all infected individuals had experienced either extensive burns or a blast injury, which predisposed them to infection. Two epidemiology studies conducted during large-scale aerial Bt serovar kurstaki spray campaigns reported no increased incidence of illness, Some recent papers have expressed concern about the production of Bacillus cereus enterotoxins by Bt isolates, Laboratory studies found no evidence of illness in rats and sheep fed Bt products, nor have epidemiology studies found increased incidence of diarrhea during Bt aerial spray campaigns, Increases in human antibody levels following exposure to Bt products have been reported but there was no increased incidence in asthma or other illness, Based on laboratory studies and field experience, Bt insecticides have an excellent safety record.