When the European Court of Justice ruled that CRISPR products must obey the same cumbersome rules as GMOs, European ag scientists were shocked. After complaining, it’s time to advance new proposals. A German council advising the Federal Government has just released its recommendations, calling for new EU legislation. According to the 17 members panel, named Bioökonomierat, we should adopt a differentiated approach to the genome-editing technology and its applications, ranging from single letter mutations to complex genome modifications. For example, graduated licensing and approval procedures for different classes of risk. Please see the main points below.
– In terms of future regulation, the legislator could stipulate that no particular provisions would be required under genetic engineering legislation where only a few base pairs (e.g., less than 20) were modified but, in this case, the plants could be released and the tried and tested variety registration regulations applied.
– As a consequence, the development of a herbicide-tolerant crop would not be subject to genetic engineering legislation where herbicide tolerance was achieved through a specific point mutation, but its potential ecological risk could be regulated anyway in other specific areas of law (for example pesticide legislation).
– Even in the amended legal framework, plants in which gene fragments larger than 20 base pairs are modified or gene sequences are transferred across species boundaries would still have to be evaluated and licensed under genetic engineering legislation. With the current procedure, it takes more than 15 years for a genetically modified variety to be allowed onto the market. Therefore we would have to weight up whether it would be possible to accelerate or simplify the approval process for produce with more complex mutations that could also occur in nature.
– Some applications of genome editing are detectable in the end product, but some are not. This argues in favor of moving away from the general statutory labeling obligation for genetically modified products and opting instead for the voluntary declaration “Not genetically engineered.”