An extensive survey of regulations of genetically modified microbial (GMM) agents including Australia, Canada, China, European Union, Japan, New Zealand, Singapore, Taiwan and USA have been completed during this year. The characteristics and management model of each country including document requirements for applications, risk assessment procedures and labeling of the GMMs products had been further analyzed and compared. According to Taiwan’s domestic needs, economics and social system and the essence of the article 7th of the Environmental Agent Control Act of Taiwan, the system for management models has been designed to be implemented in Taiwan and a draft of recommendation has been made to add on the article 7th of the Environmental Agent Control Act in Taiwan. The recommended draft consists four parts: (1) Genetically modified environmental microbial agents management regulation. (2) Pre-notified procedures of the genetically modified environmental microbial agents. (3) Risk assessment procedures of the genetically modified environmental microbial agents. (4) Emergency response plan of the genetically modified environmental microbial agents. According to PART (1) of the draft, the “Biosafety Committee of Environmental Genetically Modified Microbial Agents (BCEGMMA)” would be established. Those verified and approved “recipient microorganisms and vectors” by the BCEGMMA could be produced the GMM agents with the PART (2) of the draft. The approved authorization of the GMM agents made by BCEGMMA regarded as NON- or LOW-risk would be regulated under the Environmental Agent Control Act with the notice ”This product contained Genetically Modified Organisms”.

genetically modified,environmental microbial agents,management model,emergency plan,microbial database