Rapid developments in modern biotechnology are a challenge for risk assessment

Due to developments in modern biotechnology, such as genome editing, synthetic biology and regulation of gene expression, many new applications are expected in the next ten years. For example, new forms of gene therapy, new substances produced by microorganisms and plants that are better adapted for agriculture. The method that is currently used for the assessment of risks for human health and the environment does not seem to be equipped for all future developments. These were the findings of a report by RIVM published in May. The report is now available in English.

RIVM has investigated whether the current risk assessment method for genetically modified organisms is still adequate. This was done for nearly thirty new applications. The current risk assessment appears to be adequate for about half of these. For the other half, the risk assessment method may no longer be adequate, or insufficient knowledge or information is available to effectively assess risks. 

Risk assessment method

In the present study, the risk assessment method for genetically modified organisms was reviewed. This method is used for living organisms whose genetic material has been modified, as has been the case for most current biotechnology applications. 

However, some new applications do not consist of living organisms. In the near future, for example, this will be the case for RNA sprays, which are used to suppress pests on crops. For such applications, the current risk assessment method may not be the best choice. For some applications that are still at an early stage of development, it remains unclear whether the current assessment method is usable. This applies, for example, to 'orthogonal systems’, which use biochemical building blocks or DNA coding systems that are not found in nature. 

To deal with the expected bottlenecks in the current risk assessment, there is a need to draw lessons from other risk assessment methods, to gather existing information and knowledge and to fill knowledge gaps.

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