Re-assessment of the risk due to

Dr. Petra Kauch

How quickly does the risk assessment need to be adjusted if necessary?

In practice, it occasionally happens that organisms are assessed differently, i.e., upgraded or downgraded, for example, due to a change in the ZKBS list of organisms or a ZKBS statement. In these cases, Section 6 (2) (half-sentence) 2 GenTG stipulates that the risk assessment must be revised immediately. In practice, it is often unclear what "immediately" means in the case of ad hoc revisions to the risk assessment. Legally, the term is interpreted to mean that there must be no culpable delay. This, in turn, means that the change regarding risks and safety measures must be acknowledged and then implemented.

  • In the case of a higher security level, this would certainly mean that the risk assessment must be reviewed and modified immediately upon receipt, and if necessary, security measures must be initiated according to a higher security level. A time window of several weeks will no longer be considered immediate in the case of an upgrade. However, it should be noted that the project manager must first be aware of the upgrade. Only once the opportunity for knowledge has been given can the obligation to revise the assessment, and thus the deadline for immediate action, begin.
  • If the organisms are downgraded, lower safety measures should then be sufficient, allowing the revision of the risk assessment to be completed within a somewhat longer timeframe. This is particularly true because a risk assessment for the work already exists. However, if the responsible party takes more time to revise the risk assessment, there is a risk that the obligation to revise it will be forgotten, which will certainly have a negative impact during the next revision. Therefore, the project manager must also ensure that the obligation to adjust the risk assessment is kept in mind in this case.
Back to blog

More articles in the AGCT Genetic Engineering report