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Importance of risk assessment for laboratory studies on gene drives

Camila Beech, Senior Regulatory Advisor to Target Malaria

Silke Fuchs, Regulatory Science Officer at Target Malaria

It has recently been reported that Germany is implementing changes to its genetic engineering laws. Under the new rules, gene drive organisms developed and used in laboratory settings, also known as “contained use”, may be subject to the highest biological safety categories. 

With changes to the Genetic Engineering Safety Ordinance (GenTSV) coming into force on March 1, 2021, gene drive organisms (GDO) are explicitly included in the scope of German genetic engineering law. This builds on an amendment from 2019 when a procedure for determining safety requirements for laboratory experiments with gene drive organisms was established.  The GenTSV ordinance assesses the risk potential of the donor and recipient organism as well as the resulting genetically modified organism, using a pre-established system that assigns organisms to four risk groups (1 to 4). These biosafety levels are used for microorganisms, plants and animals, and genetic technologies used for the production of toxins. The ordinance also refers to genetic technologies with animals, such as mosquitoes and plants that bias their inheritance, i.e. gene drives. Specifically, it states that (translated from the German original);

  • “Genetic technologies with animals or plants which are aimed, in their own spread, in populations of sexually multiplying organisms are generally to be assigned to security level 3”
  • “as part of the approval process, the authority may assign the work to a different level of security based on the risk assessment.” As a result, prior to starting a laboratory experiment, approval must be obtained from the responsible state authority.
  • “The competent authority needs to obtain a statement from the Central Commission for Biosafety (ZKBS) with recommendations on the specific safety measures required for such work.”
  • Regardless of a biased or nonbiased inheritance “work involving genetic technologies with plants or animals should be assigned to safety level 4, if there is a high risk for human health or environment or if there is reasonable suspicion that they are associated with such a risk.”

In the EU, the contained use of genetically modified (micro)organism research is regulated by Directive 2009/41/EC[i]. This Directive states that the use should be “classified in relation to the risks they present to human health and the environment…. and should be based on an assessment of the risk”.  Each Member State implements the Directive into their national laws and requirements which may go above and beyond the Directive. Most countries have decided to extend the provisions of this Directive in their national implementation to include all genetically modified organisms.  This would also involve gene drive organisms.

However, similar to Germany’s amendment of the GenTSV, statements and subsequent legislative changes have been made by regulatory bodies in the Netherlands (2016[ii]) and Australia (2019[iii]) to specifically reflect GDO in contained use within their national regulatory frameworks.

The approach by these regulatory bodies underlines the importance of the risk assessment to identify containment and control measures. These measures aim to minimise human and environmental exposure and the potential for unintentional release on a case-by-case basis, as well as assign the containment level based on the potential risks.

Risk assessments generally consider the identification of potential ways in which the genetically modified organism, including GDO, might present a hazard to human health and environment and their potential severity, likelihood to occur, and potential uncertainties along with the assignment of the relevant control measures, both physical or procedural. As mentioned above, risk assessments should be performed on a case-by-case basis and in a way that is relevant and proportionate to the actual hazards posed, also considering the scale of the research.  One example would be if the genetically modified organism could not survive outside the laboratory due to various factors, like climate, ecosystem or nutritional needs. In that case, it may require less detailed controls compared to genetically modified organisms that could survive outside the laboratory.

Once a containment level is determined by risk assessment the relevant process in national legislation is followed by the researcher. In the UK, for example, if the containment level for a genetically modified animal is determined at containment level 1, then the research is not notifiable to the authorities prior to starting the research when the centre is already registered with the authority. It does remain open to scrutiny by inspectors who enforce the regulations.  However, if the risk assessment determines that the contained use falls into classes 2 or above, then notification is required to the competent authority prior to the research starting. Guidance is also provided by the competent authority on the roles of the institutional biosafety committee and how to conduct a risk assessment[iv]. A public register of institutions conducting work in the higher tiers is maintained by the competent authority[v].

As there are many different types of gene drive research being undertaken in laboratories, it is the specific set of circumstances in each laboratory that need to be considered in assigning the classification. In the case of the German decision, a higher classification has been initially assigned and could be changed depending on the case-by-case risk assessment for the specific research.







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