In 2015, the prestigious journal Science singled out CRISPR-Cas9 as the breakthrough of the year. Although it has been possible since the 1970s to alter the genetic material of organisms, it was not until the discovery of CRISPR-Cas9 that such technologies became, easier, faster, and less expensive. This caused a revolution in the laboratory, but also gave new impetus to the debate about the current regulation of biotechnology.
Debate on rules
The Rathenau Instituut studied the significance of genome-editing technologies for agriculture; specifically, its significance in the debate on the regulation of biotechnology in plant breeding in Europe. So far, the debate in Europe on genome editing in plant breeding has concentrated mainly on great expectations of this new technology, economic benefits and legislative issues.
With the new genome-editing technologies, it is possible to make small, targeted changes to the genome in the laboratory. In contrast to the older recombinant-DNA techniques, it is possible for gene-edited plants to not contain any foreign DNA. This has intensified the debate whether the European GMO Directive applies to this and other new breeding techniques. In accordance with the precautionary principle, this Directive was adopted to ensure that all appropriate measures are taken to avoid adverse effects on human health and the environment, because genetic modification technologies introduce organisms with new characteristics in the environment.
Currently, agrochemical and plant breeding companies, as well as many research institutes, argue that the risks of these new techniques are smaller than those of classic mutagenesis methods. And because these latter are exempt from the GMO Directive, the new genome-editing techniques should also be exempted. In contrast, NGOs and the organic sector claim that long-term safety for public health and the environment has not been demonstrated, as these techniques have only been in the lab for a couple of years.
Legal clarity on EU-policy
The European Court of Justice ruled in July 2018 that only conventional (in-vivo) mutagenesis methods that have been used for several decades without creating identified risks for the environment or health are exempt. Therefore, all products of genome-editing techniques (irrespective of the presence of foreign DNA) are subject to the GMO regulation. Although this has settled the discussion on the legal status of these new techniques, it has not settled the debate.
The ball is in the European Commission’s court. Two policy options for the EU dominate the debate on genome editing in plants and crops.
- One option is to uphold the GMO Directive,
- the other is to exempt genome-editing techniques from the GMO Directive if and only if there is no foreign DNA present in the endproduct.
In this report, we discuss the societal consequences and challenges of both policy options.
A third, less prominent policy option in the debate attempts to unify the benefits of both options.
A new direction for legislation
This third option requires new legislation. Applications will be assessed individually for safety at different assessment levels. Which level applies is based on, for example, the degree of genetic modification, the techniques used, the characteristics of the end product and their complexity. In addition, applications are assessed for their value for society.
Taking into account the differences of opinion of various stakeholders, as well as the ruling of the European Court of Justice, we offer a way forward to modernize the current biotechnology policy. In this report we present a level-based approval policy focused on differences in risks while simultaneously taking account of ethical and societal factors, based on a Norwegian proposal. The history of the GMO debate illustrates how important these cultural and ethical issues are. The space necessary for broader issues to be considered was created a number of years ago through a change to the European GMO Directive. This amendment gives individual member states the right to either ban or permit cultivation of genetically modified crops, based on societal, cultural and ethical issues. It is essential that these broader issues are taken into account when drawing up new regulation for biotechnology.
The space necessary for considering these broader aspects was created a number of years ago through an amendment to the European GMO Directive. The 2015 amendment to the Directive gives individual member states the right to either ban or restrict cultivation of EU-approved genetically modified crops based on societal, cultural and ethical issues.
Regulating genetic modification of plants and crops has long been a controversial topic in society. The debate about new techniques, such as CRISPR-Cas9, is also threatening to become bogged down by the assumed incompatibility between safety and innovation. In the report Genome editing in plants and crops, the Rathenau Instituut shows that both aspects can be given a place in the debate. A more differentiated policy in which societal and ethical aspects have a proper place, will facilitate responsible decision-making as regards the position of biotechnology in society. Norway has shown that this is possible.
The Rathenau Instituut thinks it is desirable to develop a biotechnology policy for plants and crops that distinguishes between levels of risk assessments. For years there has been such a level-based policy for working with GMOs in enclosed spaces, such as laboratories or greenhouses.
This approach is in line with the importance of safety as well as the need to encourage socially responsible innovation. The strictness and speed of the risk assessment procedure would depend on the presumed risks. Estimating the risks is based on the technique used and the safe use of that technique in practice. In the procedures for authorising plants and crops, there should also be a systematic consideration of the desirability of GMOs and the contribution they make to challenges faced by society. Furthermore, attention should be paid to citizens’ concerns about large-scale land use; the centralisation of power in large agrochemical and plant breeding companies operating globally; and the social and economic position of farmers.
In this context, it is desirable to study how a broader assessment framework for authorising GM cultivation can be in line with a differentiated risk assessment process. An example of such a policy can be found in Norway.
For decades, Norway has been comprehensively weighing up the risks versus societal values. It now wants to revise its policy by including a differentiated risk assessment. A public consultation was held in 2018 on this subject.
Norway’s proposal involves three different procedures for assessing risks: the current standard risk assessment, an expedited procedure and a notification procedure. Which procedure will be followed depends on the type of genetic modification. New genome-editing techniques can alter the DNA of crops in various ways, for example by adding several genes (genes of the same species as well as foreign genes), but also by changing one single letter of the DNA. The expected risks vary and depend on the alteration.
However, market approval is also influenced by an assessment of broader considerations: the benefit to society, sustainability and ethical justifiability. In this manner, for example, a societal benefit of a new crop can have a positive influence on the approval procedure. An alternative is to assess the risks and the broader aspects simultaneously.