Team:TU-Delft/Meet with RIVM

During May, we had the opportunity to meet the people from the GMO department of the Dutch National Institute for Public Health and the Environment (RIVM). The aim of that meeting was to discuss about:

The questions that we made as well as the answers that we got are depicted below.

1. Do you get complaints from researchers on the current legislation? Does it impede innovation?
   

   Researchers will complain when safety rules are delaying their work, which is to be expected, but we don’t see it very often.

2. Is the regulation often revised?
   

   An update mostly entails making a study proceed with biosafety level 1 instead of level 2 (i.e. requiring less safety rules). We evaluate risk assessments case by case, the overall regulation is not updated often. However, since the biosafety officer platform is a very small community, all biosafety officers will hear about adaptations we made with respect to one case and communicate that to their researchers.

3. Have you heard concerns (biosafety, biosecurity) on the current legislation?
   

   We get complaints from a small number of people (±10, always the same individuals). Their concerns are about ethical issues with respect to GMO’s. However the permit given out by the RIVM only covers the environmental risk and does not regard ethics, so we cannot do anything about these complaints.

   The use of GMOs can be split into green and white applications. By green GMOs the modified seeds are meant, by white GMOs we refer to industrial applications (food enzymes etc.). The public is mostly aware of the green GMOs and not of the white ones. So public concerns are mostly about the seeds and the crops although this is only one part of the GMO applications.

4. How does the Dutch regulation relate to the regulation on the European level?
   

   When you want to proceed to a market application, the regulation is at the European level. The regulation with respect to clinical application of GMOs is done by the RIVM.

5. How are synthetic biology regulation and GMO regulation related?
   

   Synthetic biology is a very broad field where GMOs are one part of. The term synthetic biology covers also:
           1.Working with genes that are not present in nature
           2.Working with biological pathways
   Most of these synthetic biology studies are still in the university phase. However the question whether these concepts should be covered by legislation is currently under investigation.

6. When regarding safety, what factors do you assess?

   The three factors that mainly influence our risk assessment are:
           1.Host strain
           2.Vector (viable/plasmid?)
           3.Inserts (toxic for other organisms?)
   

7. What do you think an ideal regulation on synthetic biology should entail?
           1.Regulation should be adapted to new organisms(xeno-organisms, adapted ribosomes..).
           2.Use other technologies to make an assessment about safety, for example bioinformatics.
           3.Open source would make regulation easier.
   

Figure 1: RIVM meeting