Risk assessment of genetic engineering work – theoretical foundations –

A written risk assessment of genetic engineering activities is the basis for ensuring the safest possible handling of genetically modified organisms (GMOs). As a result of intensive political discussions in the 1980s, German legislation established mechanisms and standards to ensure that genetic engineering activities are carried out in controlled environments (containments) and that risks are appropriately assessed. In genetic engineering activities, the GMO is the primary risk carrier. The risk of working with GMOs must therefore be evaluated in the risk assessment based on their potentially pathogenic properties and environmental reactivity.

The overall risk of genetic engineering work is assessed according to an "additive risk model." This model assumes that potential risks associated with GMOs are not determined by how an organism is genetically modified. Rather, the overall risk is assessed primarily by summing the safety risks of the individual components of the GMO (donor organism, transferred nucleic acids (e.g., inserts, and plasmids). From the overall assessment of the GMO thus determined, safety levels are defined under which conditions allow sufficiently safe work, and appropriate protective measures are derived. These, in turn, have two main goals: the protection of human health and the protection of the environment.

While the protection of human health concerns all of humanity, it particularly affects employees in genetic engineering facilities shielded from the outside world. This group of people is exposed to greater risks than other employees due to direct contact with GMOs, and most measures are therefore aimed at protecting them. Safety measures to protect the environment must be prepared and implementable at all times for the possible occurrence of adverse developments during planned releases, as well as for the accidental release of GMOs from a closed facility.