RIVM National Institute for Public Health and the Environment and partner organisations from England, Germany and Belgium have developed a method to assess the risks of gene drives in laboratories. A gene drive is a genetic trait that can be passed on to almost all the offspring. Gene drives can be constructed in the laboratory by means of genetic modification. International cooperation in assessing the risks is important because cross-border problems can occur if an organism with a gene drive would escape from a laboratory.
The major concern when constructing gene drives is that they can spread quickly and permanently through an entire population. This spread is in principle irreversible. Therefore, it needs to be carefully assessed what control measures are needed to prevent the escape of an organism with a gene drive from the laboratory.
In 2015, RIVM National Institute for Public Health and the Environment warned that potentially harmful effects of organisms with a gene drive on humans and on the environment cannot be assessed (or not sufficiently assessed) with the method used until then. Follow-up research has shown that the method does offer leads that will permit proper risk assessment, and those leads have now been examined in detail.
Permit is always necessary
In the legislative amendment to the GMO Regulation in July 2016, the ministry of Infrastructure and Water decreed that permits must be requested for all applications using gene drives. The rules, with the risk assessment method described here, offer sufficient flexibility to permit the technique when the risks for humans and the environment are negligible.
The new assessment method has been published in the scientific magazine Applied Biosafety. The application to the Dutch law and regulation is outlined in a report by RIVM. Scientist who are interested in working with gene drives can find additional information on this page (in Dutch).