ABSTRACT
Exhaust gas from culture vessels must be released through filters to trap recombinant microorganisms or through equipment that has the same ability. Recombinant DNA experiments have been divided into four classes, depending on the host-vector systems, the DNA to be introduced, the volumes of culture broths, and the physical containment level. The Japanese government appears to have provided little encouragement in the form of transparent risk-based regulation to those contemplating field trials. Containment measures for production by the use of recombinant microorganisms were issued from Ministry of International Trade and Industry, Ministry of Agriculture, Forestry, and Fishery, and Ministry of Health and Welfare. Therefore, for recombinant DNA-manipulated organisms, there is no need for additional regulatory mechanisms to be superimposed on existing regulation. In conclusion, the introduction of product-based regulation, but not process-based regulation, has been proposed, although the present Japanese guidelines are process-based.
