Three months ago, the European Court of Justice (ECJ) ruled that gene-edited crops, including those created using the newer and more precise gene-editing technologies like CRISPR–Cas9, should be subject to the same stringent regulations as conventional genetically modified (GM) organisms. A position paper released on 24 October by 170 European scientists from 75 research centres has urged European authorities to alter the legislation so that gene-edited organisms are not subjected to the GMO Directive but instead fall under the regulation of crops produced through classical methods such as selective breeding. According to the paper, the ruling is “irresponsible in the face of the world’s current far-reaching agricultural challenges.”
The original 2001 EU Directive, which they call “outdated,” states that GM organisms must be identified, tracked, and monitored for their effects on the environment and consumers. The new ruling imposes the same restrictions on gene-edited crops and stipulates that extensive risk evaluations must be carried out before they can be planted or sold as crops. The researchers argue that “from a scientific point of view, the ruling makes no sense,” stating that “the EU GMO legislation does not correctly reflect the current state of scientific knowledge.” The paper goes on to argue that new gene-editing techniques follow the same principles as conventional mutagenesis, which is exempt from the EU directive, but with higher efficiency and precision.
According to the scientists, European agricultural innovation based on precision breeding will be stymied as a result of the long and expensive regulatory process that will be needed to get these crops to market. Meanwhile, the huge expenses and low probability of market admission will mean small biotech companies and startups will be pushed out since developing genome-edited crops will only be financially feasible for large multinationals. This will equate to many European farmers missing out on the opportunity to avail of more nutritious and resistant crop varieties. The authors conclude that “the impacts on our society and economy will be enormous.”
The evaluations imposed by the directive only apply to organisms released into the environment so thus far basic research has not been hugely affected, however, it does place a significant hurdle in front of many ongoing field trials and commercialization efforts. Genome edited organisms must now comply with the strict conditions of the EU GMO legislation and some researchers are starting to “feel the pinch,” including a Belgian start-up that planned to use CRISPR technology to help Africa’s banana industry.
Faced with a growing global population, set to reach 10 million by 2015 and increasing agricultural challenges owing to climate change, agricultural practices in Europe and elsewhere will need to become more sustainable. Precision breeding could help farmers to minimize their use of fertilizers and pesticides while tailoring crops to specific regions based on environmental factors.
The position paper has not been the only vocal opposition to the EU ruling. The International Plant Molecular Biology Congress in Montpellier, France started an online petition in August calling for a review of the ruling that now has more than 5,200 signatures. On 13 September, researchers from 33 science, farming and agricultural–technology organizations in the UK sent an open letter to the government asking for recognition of gene-edited crops as non-GMO. However, there is no mechanism to appeal the ruling, according to legal experts.