The biotech industry, as well as the US and Canadian governments, are lobbying hard to have a whole new generation of genetic engineering techniques excluded from the European regulations on GMOs. As the European Commission just confirmed they would not issue their long awaited interpretation on the matter pending a decision by the EU Court of Justice in 2018, danger rises that these ‘new GMOs’ will start to spread in the EU fields and food without risk-assessment, labelling, or monitoring, and more importantly, before the EU citizens even know about their existence.

GMO has become a dirty word in the European Union, mainly thanks to the difficult fights won by the civil society, supported from the beginning by the Greens. These genetically modified organisms became a public issue in the 1990s, when transgenesis – a process aiming at introducing a foreign DNA  (usually coming from another species) in a cell was perfected by the seed and agrochemical industry. With pioneers in different European countries explaining the downsides of the technology to the public, GMOs were soon massively rejected by the citizens, be it in their food or in their fields. This, and far from perfect EU regulations, have helped to keep GMO cultivation extremely low in the EU, as well as use of GM ingredients in food. But the influence of citizens is much less important when neither traceability nor labelling is available: for example the absence of labelling on products from GMO fed animals do not allow consumers to make an informed choice. As a result, EU farm animals are fed for a significant part by imported GM soya, maize and canola (GM plants amount for 55% of the protein-rich feed in the EU), despite the general mistrust.

That is why these last ten years, the biotech and agroindustry has been so keen on evading these regulations for their new babies (a dozen techniques, procedures and/or concepts), which are supposed, according to them, to finally deliver all the wild promises of the transgenesis-based GMOs – which were basically supposed to end world hunger – without presenting any of their risks. That is also why they were extremely careful in their communication approach concerning these techniques: less boasting about revolutionary meddling in genome this time. Instead, they coined the term “new breeding techniques” (NBTs), to blur the distinction with conventional breeding. But don’t be fooled – these new biotech methods work in the same way as older GM techniques, by direct interference in cells and genomes.

New breeding techniques: the lowdown

They are a group of lab techniques, procedures or concepts which allow to modify plants and/or animals by intervening directly into the genome. Most of them are gene-editing techniques.

Gene-editing techniques generally use enzymes to ‘cut’ parts of the genome. The genome then ‘repairs’ itself. The result is an insertion, replacement or removal of bits of DNA. Unintended DNA cuts or other gene alterations can also occur, with unknown consequences. These techniques include zinc finger nucleases (ZFN), transcription activator-like effector nucleases (TALENs) and the clustered regularly interspaced short palindromic repeat (CRISPR) systems.

Another gene-editing technique involves the introduction of short strands of synthetic DNA (so called “oligonucleotides”) that triggers cells to modify their DNA to match the introduced fragments.

Old wine in new bottles

Supporters of these new biotechnologies claim they will miraculously cure hunger, produce plants that are resistant to drought or floods, help reduce the need for pesticides, and much more. Interestingly, we were promised the exact same things for transgenesis-based GMOs.  However, these promises were patently not kept, a reality acknowledged in a recent New York Times article.

In fact, regardless of whether it is NBTs or transgenesis, the result remains the same: what they are trying to impose are herbicide-resistant plants that are designed for use with products such as glyphosate (main component of Monsanto’s Roundup and in the middle of a scientific controversy concerning its carcinogenic properties), or pesticide plants designed to produce their own poison to kill pests. The use of herbicides has increased throughout the world as a result of the planting of herbicide-resistant plants at the same time as hard-to-control herbicide-resistant weeds have proliferated. Some of these herbicides are highly controversial, arousing significant concerns in terms of their impacts on environment and human health.

Plus, we do have an innovative technical solution to answer all these extremely important needs, already: classical breeding has been the first source of innovation in crops for “simple” traits as yields or mono resistance these last 50 years, as it has been since the beginning of agriculture. This is even clearer for complex traits such as drought resistance, which are not embedded in a single gene, and are much more efficiently obtained through the use of classical methods using traditional and regionally adapted species and varieties.

New risks

What about the claim that these techniques are without risks because they are more precise? Well, the European Food Safety Authority (EFSA) confirmed that two of the concerned techniques, cisgenesis and intragenesis[1] “can produce variable frequencies and severities of unintended effects. The frequency of unintended changes may differ between breeding techniques and their occurrence cannot be predicted and needs to be assessed case by case”. Strangely EFSA has not been asked to give an opinion on any of the other techniques and procedures commonly referred under the umbrella of “New breeding techniques”.

Some independent scientists and national agencies have made their own evaluation, with discordant conclusions. While the French Haut Conseil aux Biotechnologies issued a very NBT friendly first report – prompting the resignation of all its civil society members – several other reports warn that, not only these new techniques are displaying some of the same risks as transgenesis (linked to an imprecise insertion of the gene, unwanted effects of the insertion, and unwanted effects of the tissue culture), but their risk of “off target effects” could be higher.

The high potency, relatively low cost, and broad accessibility of some of these techniques are also a concern, especially as they are difficult to detect in the final organism. One of them, CRISPR Cas9 – which allows to modify animals as well as plants, has for this same reason recently been included by the US Intelligence Community on a list of new potential bio terrorism weapon. Do we really want to see this technique used in our food system without any impact assessment?

A nightmare for farmers

These techniques, and the resulting organisms (plants or animal), will be patented. Being more flexible and possibly cheaper than transgenesis (especially if they can avoid the costly EU GMO regulatory framework), NBTs will also allow to recreate plant or animal characteristics already existing in nature and patent them. A handful agrochemical multinational companies will soon be able to claim rights on the most used crop varieties or promising wild plants – an insidious privatisation of life through “legal” biopiracy that would put cultivated biodiversity and our food security at stake… and would trap farmers in an obligation of buying new seeds every year, without the possibility of reusing them (which would be an infringement of the patent).

Let’s add that the genetic contamination of other plants is as probable with these techniques as with ‘old’ GMOs, inevitably leading to biodiversity loss. For organic farmers, this contamination would be especially problematic, as these new biotechnologies are incompatible with organic principles, not to mention the broader consumer demand for GMO-free food. Yet without traceability or labelling, these techniques could still be imposed on farmers and consumers alike.

Tales of a legal limbo…

Matters seem quite clear from the legal point of view. This techniques clearly fall under the definition of genetically modified organism (GMO) of the European Directive on GMO dissemination (Directive  2001/18), and none of its exemptions apply here, as they are aimed at well-known techniques with “a long safety record”. These techniques are thus genetically modified organisms and should be treated as such, as two legal experts concluded last year. However, representatives of the biotech industry and some EU Member States are advocating total or partial deregulation.

The European Commission has been wondering how to handle the new biotechnologies since 2008, but without reaching any decisions or putting forward proposals. Because of the increasing pressure from Member States, industry, and rural protection and environmental organisations, they announced in 2015 that they would put forward a non-legally binding interpretation for classification of eight new techniques. Their aim was to solve the issue quickly and to keep it mainly between experts. We are now in December 2016: no interpretation has come and none is foreseen anymore. So what happened?

Several events concurred to the Commission prudent retreat. First, civil society’s organisations started to voice their concerns more strongly, calling these techniques by their rightful name – GMOs. To the great displeasure of the Commission, which would have preferred to avoid this term polluting the discussions. Then several debates in the European Parliament made clear there was no majority within this institution supporting deregulation of the new techniques. Pressures in the other direction came from the USA and Canada, which took the occasion of the TTIP and CETA negotiations to express their very strong opposition to NBTs being defined as GMOs in the EU.

But the final blow – or the right occasion? – came from the French Conseil d’Etat, who submitted in November to the EU Court of Justice four questions on mutagenesis and oligonucleotide-based techniques. The EU Commission has let it known (yet not officially) that no interpretation would be produced before the ruling, which is foreseen for April 2018.

In the meantime, several Member States have started producing their own interpretations: Sweden for example decided that trials of CRISPR CAS 9 plants didn’t require to fulfil the GMO framework, while Austria declared they regarded all the new techniques as producing genetically modified organisms. The risk is that the modified plants, unmonitored and unchecked, will start to spread in the fields and in our food, without any way to backtrack them in the future if we finally get a proper legal framework.

While the debate will continue at the EU level, it is now time for citizens and civil society organisations to call on their governments to recognize officially at the national level the so-called “New breeding techniques” as producing GMOs. Only this way can we hope to obtain a clear and stringent legal European framework for these techniques, in line with the precautionary principle.

[1] Genetic modification of plants with one or several genes from the same plant species or from sexually compatible plant species.

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