Genetic modification (GM) technology can offer solutions so that farmers can more efficiently grow crops with less environmental impact. Despite many GM crops being developed in Europe, none of them have reached European farmers. This is largely due to the procedure of getting GMOs approved. While it is sensible that we ask ourselves whether there are safety questions in relation to the use of new technologies, politicians should also ask themselves what the consequences are of not deploying those new methods. Here is an interview with Piet van der Meer: formerly responsible for GMO biosafety regulation in the Netherlands and currently an independent consultant and guest-professor at the Ghent University and the Vrije Universiteit Brussel.
Since the first scientific publications about recombinant DNA in the early 70s, GMOs have been a hot topic. In the major UN Conference on Environment and Development (the Earth Summit in 1992), the world community outlined an overall policy towards modern biotechnology, which can be summarised as ‘Maximising Benefits and Minimising Risks’.
Since the mid-80s, countries have been establishing biosafety regulations making GMOs subject to risk assessments. For the EU, the current regulatory system for biosafety is a combination of Directives on contained use (e.g. laboratory) and release of GMOs (e.g. field trials and placing on the market), and several Regulations, such as a Regulation for GM Food and Feed.
It seems that the short-term interests of politicians are interfering with long-term views on sustainable agriculture in Europe and the potential benefits of GM technology to contribute to that.
Van der Meer comments: “Over the last few years, many countries have been reviewing their regulatory systems for biosafety. The conclusion that many people – me included - draw with regard to the EU product approval system for GMOs is that it does not function as it was designed, because in many cases decisions were not taken within the legal time frames and not based on the legal criteria. One frequently quoted cause for this is the changed attitude towards modern biotechnology. It seems that the short-term interests of politicians are interfering with long-term views on sustainable agriculture in Europe and the potential benefits of GM technology to contribute to that.”
New breeding techniques - What's in a name?
Another question that has arisen during the review of regulatory systems is: to what extent are organisms developed through ‘New Breeding Techniques’ covered by the current regulatory system? Van der Meer: “There is actually too much in that name, because the term New Plant Breeding Techniques is used to refer to a range of different techniques, some of which are not new and some of which are not breeding. For a meaningful debate it is better to be more specific, e.g. genome editing, which is a technique that allows for very precisely targeted changes in the genome.”
Read more about genome editing techniques such as CRISPR-CAS being used to more efficiently culture plants in the article "Dupont pioneer's next generation of waxy corn shows the green side of CRISPR-CAS"
GMOs are regulated because they contain novel genetic combinations, not because the technique is considered intrinsically dangerous.
One of the big debates at this point is: which organisms that have been developed through genome editing fall under the GMO biosafety regulations? Van der Meer explains: “Not every use of a molecular technique results in a GMO. If genome editing is used to introduce a novel genetic combination that goes beyond what can be achieved through mating or natural recombination, then the resulting organism is a GMO. However, genome editing can also be used to develop something that could also be obtained with conventional crossing or natural recombination. Once it is established whether an organism is a GMO, then the next question is whether that GMO falls under Annex IB of the GMO Directive. This directive defines which GMOs are exempt, e.g. certain GMOs developed through mutagenesis or cell fusion. These exemptions have been subject to quite some discussion and should be clarified.” A French court requested the European Court of Justice last year to give a preliminary ruling on this exemptions for mutagenesis in relation to organisms developed through genome editing. Van der Meer: “The ECJ ruling is expected later this year, but a recently issued opinion of the Advocat General provides a good analysis and points in the right direction”.
GMOs 'stuck' in regulations?
“GMOs are regulated because they contain novel genetic combinations, not because the technique is considered intrinsically dangerous,” says van der Meer. “We regulate on the basis of novelty, in the same way as we look at the safety of food additives: because they are novel to our food, and not because food additives are considered by definition dangerous.”
The logical consequence of regulating based on novelty is that when the novelty reduces, the rules and conditions are adjusted. However, despite the substantive experience with the safe use of GMOs that has been accumulated over the last decades, the rules and conditions in the EU have not been simplified.
The EU GMO approval process has developed into a system that has become virtually prohibitive for small start-up companies and the public research sector.
Van der Meer: “The EU GMO approval process has developed into a system that has become virtually prohibitive for small start-up companies and the public research sector. In the European agricultural public research sector, many GM crops and trees are under development that can be beneficial to farmers, consumers and the environment, but these products may never become available to growers. The main problem is not with the regulations themselves, because in the first years of these regulations the system worked well. Decisions were made within in the legal time frames and on the basis of the risk assessment.
Because of the changed public attitude in Europe towards GMOs, the process has become politicized, even to such a degree that some Member States repeatedly cited ‘new safety concerns’ in justifying bans on GMOs. According to EFSA and the European Commission these concerns had no ground. To address this undesirable situation, the EU has changed the GMO Directive so that Member States can now ban the cultivation of GMOs on the basis of grounds other than safety."
Consindering the consequences of not using this technology
The future of agriculture is not a choice between either this or that technique, but a combination of the best available solutions, tailored to local needs.
“The regulatory situation has gotten to the point where large multinationals are no longer submitting any GMOs in Europe for cultivation (and have even withdrawn dossiers). If this is already the case for large multinationals, then imagine what this process means for SMEs and the public sector. The irony is that the EU spends hundreds of millions of tax-payers’ money on public research to develop new biotechnological solutions to agricultural challenges, but none of these products ever reached European farmers, because of the approval process. It is important that politicians remain aware of the bigger picture in agriculture; that they take into account things such as climate change making pests and diseases migrate more than before, while at the same time farmers having fewer pesticides available due to environmental requirements,” warns van der Meer.
Van der Meer underlines: “It is a sensible thing that we check whether there are safety questions before a GMO is placed on the market. However, it is also important that politicians consider with the same rigor the consequences of not deploying this technology. What are the consequences of keeping conventional agriculture as it is? What are the alternatives? How can we feed Europe in a sustainable way? The future of agriculture is not a choice between either this or that technique, but a combination of the best available solutions, tailored to local needs.”