On the safety of Bacillus subtilis and B. amyloliquefaciens: a review.

Abstract

For many years the fermentation industry has used microorganisms to produce antibiotics, amino acids, enzymes and other useful compounds. These microorganisms, which have been isolated from the environment and then mutated to increase yields of the desired product, have proved safe to handle. With the advent of gene technology, it is now possible to transfer genetic properties from one organism to another. It is widely accepted that as long as the recipient microorganism (the host) is harmless and the products of the genes to be transferred are innocuous, the genetically engineered microorganism (the recombinant) is as safe as the host. An overwhelming majority of recombinant microorganisms to be used by industry are expected to be based on harmless hosts (OECD 1986). Many of these have been proven safe over many years of experience in industrial settings. Furthermore, extensive information on the incapacity to cause disease, i.e. non-pathogenic and non-toxicogenic potential, of some of these organisms can be found in the literature. We believe that a review of the literature and present experience with some of these host organisms will be useful for assessment of the safety of many recombinant organisms. In particular it may help to classify some of these as GILSP (Good Industrial Large Scale Practice) host organisms as defined by the OECD (1986), thus facilitating the use of recombinant strains by established production procedures. Furthermore, safety reviews on selected host microorganisms may ease the approval process of products produced by recombinant strains derived from these hosts. Thus it is the opinion of qualified experts that the use of genetic engineering per se does not warrant any additional safety assessment. On the contrary, use of a safe and wellknown host organism may sometimes render superfluous some of the extensive animal testing of a new