The current burdensome approval procedure for new breeding technologies doesn’t make sense, argues Joost van Kasteren. If the European Union wants to fully utilise the genetic potential of crops, they should be treated no differently than traditional breeding methods.
While European politicians keep debating, a study by the IITA showed disease-resistant varieties developed through gene editing can manage diseases. (Images: European Parliament, IFPRI/Milo Mitchell)
To most agricultural experts it’s obvious that new breeding technologies (NBTs), including gene editing, hold great potential. Plant breeders using NBTs can quickly find traits that make crops more resilient to drought and diseases, and improve nutrient use efficiency, minimising losses to the environment, by screening the genomes of different varieties, including wild and cultured plants. This means they can enhance productivity and reduce the environmental impact.
These technologies can also strengthen food systems and supply chains that are vulnerable to disruptions, whether these are extreme weather events or international crises such as the war in Ukraine. They can enhance the safety and nutritional value of food products. The environmental risks associated with NBTs are comparable to, or even lower than, those of classical breeding technologies that have been used for centuries or more.
All this suggests that there is no need for NBTs to be subjected to stricter regulations than those applied to methods farmers have traditionally used.
And indeed, until recently, member states in the European Union had the right to create their own policy. However, in June 2018 the European Court of Justice ruled, despite evidence to the contrary, that new breeding technologies are no different from genetic modification techniques and are therefore subject to the GMO-directive from 2001. As a result, NBT crops cannot be produced in the EU without overcoming endless regulatory hurdles.
After all, to date there has been only one GMO crop grown in Europe (Bt-maize). It was admitted before the GMO-directive came into effect.
Environmental risks associated with new breeding technologies are comparable to, or even lower than, those of centuries-old classical breeding technologies
While it’s encouraging that the ruling prompted several member states to urge the European Commission to revise and update the GMO-legislation in the light of these fast-developing new breeding technologies, it’s sad to see that changing EU legislation is quite a cumbersome process.
After an almost five-year-long process of fact-finding, consultations and debates, the European Commission was supposed to present a proposal for new legislation for plants derived from new breeding technologies. However, it recently became clear that the accompanying ‘Impact Assessment’ was rejected by the Regulatory Scrutiny Board, an independent body within the Commission for quality assurance of legislation.
According to officials from the Commission, it concerns minor adjustments, and they hope to get approval in the second half of June. However, sources in Brussels – according to the newsletter Agra Facts no. 23-28 – say it might well be postponed until the next administration takes office, given the highly sensitive and political nature of the dossier. That will only be in November 2024 when the new Commission takes office.
Meanwhile, other countries continue to tweak legislation, putting the European Union at risk of becoming a museum.
Whereas NBTs develop fast, changing EU legislation is quite a cumbersome process
Concerns have been raised about the potential social and economic consequences of using modern breeding techniques. Critics argue that new varieties may be unaffordable for small farmers in low- and middle-income countries, leading to consolidation and monopolisation of the seed sector. However, the opposite may actually be true.
Gene-editing technologies are, in fact, becoming increasingly accessible and are democratising the benefits of science. These techniques are relatively inexpensive to implement and can be used to enhance both major and minor crops, making it possible for smallholder farms to benefit from gene editing.
Gene-editing technologies are affordable and can produce results quickly, making them accessible to small- and medium-sized breeding companies as well as farmers’ collectives. Both research institutes and commercial companies can provide the necessary facilities for developing and implementing new crop varieties. An example of this is the work of the International Institute of Tropical Agriculture on gene editing bananas for disease resistance.
Gene-editing is democratising the benefits of science. These techniques are relatively inexpensive, making it possible for smallholder farms to benefit
One potential obstacle is the patents associated with modern techniques such as CRISPR. Fortunately, these technologies provide enormous freedom to operate for small and starting entrepreneurs. They require little investment, and the number of available and accessible tools is so vast that a patent is no longer a major concern.
Moreover, many of these techniques are developed at universities and other public research institutions and are in the public domain. For foundational CRISPR technologies, non-exclusive licences are available for many patents. Besides, if monopolisation becomes a problem, the EU has one of the world’s best antitrust agencies, the European Commission, to address the issue.
If accessibility to NBTs for small- and medium-sized farms is a concern, imposing heavy-handed safety rules and regulations is not the answer. Such rules would only make it harder for small farmers to access these technologies, as the cost of red tape and administrative burdens weigh more heavily on small farmers than on corporations.
If accessibility to NBTs for small- and medium-sized farms is a concern, imposing heavy-handed safety rules and regulations is not the answer
Despite the potential for sustainable and healthy food systems, a large minority among member states and European Members of Parliament have raised concerns about potential unintended consequences of modern gene-editing techniques. They talk about the creation of harmful products or by-products, and the emergence of invasive species. Such concerns can be traced back to the debates on GMOs at the turn of the century, which have led to a political trauma the effects of which are still visible.
The critics focus selectively, if not arbitrarily, on the use of modern genetic techniques alone. Classical cross-breeding techniques, which have been employed for thousands of years, as well as classical mutagenesis (in which seeds are exposed to radiation and chemicals), are considered ‘safe’. However, people tend to forget that unintended effects can occur with any breeding technique, including in nature where spontaneous mutations are the driving force behind evolution.
And so, regulators and policymakers should instead consider whether the chance of negative effects happening is more or less likely compared to traditional cross-breeding and classical mutagenesis techniques. It appears that the chance of unintended effects occurring is actually lower with modern, targeted breeding techniques than with traditional, less precise methods.
The reason for this is clear. In traditional cross-breeding, the genetic material of two different varieties is combined, and through a series of crosses, breeders aim to produce a new variety with the desired characteristics. It is like mixing the words of two voluminous Tolstoy novels in an attempt to create a coherent novel.
The chance of unintended effects occurring is lower with modern, targeted breeding techniques than with traditional, less precise methods
Meanwhile, in classical mutagenesis, seeds are exposed to chemicals or radiation with the aim of inducing useful mutations in the genetic material. This is like firing a shotgun and hoping one of the pellets will hit the target.
Both methods are accepted, even though they’re time-consuming and involve the element of chance when it comes to unintended damage. However, they’re considered safe due to the regulatory framework. The infrastructure for monitoring and compliance is set up to prevent potentially harmful varieties from entering the market and reaching consumers.
In the EU, for instance, new varieties must be included in the Plant Variety database, and products derived from these varieties must be authorised under the Novel Foods Regulation. This system of rules and regulations has been effective so far, and there are no current proposals to tighten it.
It is difficult to understand why new breeding technologies – which offer a much more precise and reliable way of achieving the same goals as established technologies – should require more stringent regulations. There is simply no need to regulate NBTs more strictly than traditional methods.
By imposing excessively strict regulatory requirements for NBTs, the EU is undermining its own achievements
Over the past 50 years, the EU has successfully established an infrastructure that ensures the quality of seeds. Europe’s robust economic and knowledge ecosystem has thrived, producing some of the best and most innovative agricultural science in the world and leading in numerous other ways. However, by imposing excessively strict regulatory requirements for NBTs, the EU is undermining its own achievements.
New breeding technologies can be a powerful tool for promoting green innovation and achieving public health objectives. But if the current situation remains unchanged, Europe will not be at the forefront of this technological breakthrough. Other countries, including the UK, Switzerland and Canada, are likely to take the lead, which contradicts Europe’s ambition to excel in the green economy and strengthen its technological autonomy.
Joost van Kasteren is a molecular biologist by (academic) education and a freelance science journalist by profession. For the last ten years he has been chief editor of Vork, a magazine on agriculture, food and nature conservation. He is also a co-founder of RePlanet Nederland. This is a summary of the essay ‘Gene editing: An essential tool for sustainable and healthy food systems’, published in Future Europe.