We document here that in those rare cases where disease has been relat
ed to Bacillus licheniformis, infection was associated with bypassing
the normal biological protective barriers or severely debililated pati
ents. No case suggests any invasive properties of this bacterium. B. l
icheniformis can therefore be considered non-pathogenic to humans in g
eneral. Food-borne illness caused by possible B. licheniformis toxins
have been reported, but only in a very few cases and only in connectio
n with consumption of inappropriately prepared food. Considerable expe
rience concerning the industrial use of recombinant B. licheniformis s
trains has now accumulated and authorities in the United States, Europ
e and Japan have approved production with and products from recombinan
t B. licheniformis strains. We conclude that B. licheniformis is a saf
e host for the production of harmless, industrial products.