MAIN CONSIDERATIONS IN RA & RM OF ORGANISMS DERIVED BY MODERN BIOTECHNOLOGIES

With the rapid development of organisms through regular genetic modification and synthetic biotechnology, their risk assessment and risk management (RA & RM) has become an important issue for researchers, risk assessors, and policy makers. In general, risk assessment is defined as a science-based process; thus, it should be scientifically sound. The ecological effects of biotechnologically derived organisms may include, but are not limited to, the following: 1) gene flow from those biotechnologically derived organisms to their wild relatives and other organisms; 2) effects on non-target organisms through food chain or new/changed field practices; 3) effects on biogeochemical processes and nutrient cycles; 4) competition advantages and interaction with native species; 5) resistance evolution of insect pests. Points of consideration for RA & RM may vary according to factors such as the intended use, release scale, and the receiving environment; therefore, they should be carried out on a case-by-case basis and take into consideration all necessary information. Uncertainty is an inherent and integral element of scientific analysis and should be identified and considered for critical effects on the results and conclusions of risk assessment and strategies for management. Appropriate comparators need to be selected and applied in the assessment, which is especially challenging with respect to the organisms developed by synthetic biology. One of the emergent points that should be seriously considered is the potential of gene driver technology to alter the wild population, species, and ecosystems. Experience and practices with non-modified recipient organisms are useful for RA &RM, but the principle of substantial equivalence has limited use and may not meet the request of scientific evidence-based analysis, particularly from the ecological aspect. After the environmental release of the organisms derived by modern biotechnologies, risk monitoring is a crucial measure to ensure biosafety regarding any uncertainty found in the risk assessment. Some other points are also important elements in the risk management process, such as the protection goals, which should be consistent with scientific analyses and meet the benefits of global biodiversity conservation and environmental protection.