2023-07-25 21:03:38
A few months ago I published an article in which I lamented the blockage that, in my opinion and that of many other professionals in the sector, new genomic techniques (NGT) were suffering for their possible application in plants. NGT techniques include the new gene editing procedures, in particular the latest, most versatile and powerful CRISPR gene editing tools, which have revolutionized biology, biomedicine and also biotechnology in both animals and plants.
An inexplicable one judgment of the court of justice of the European Union of July 2018 had equated the potential risks of plants genetically modified by the addition of a new gene or DNA fragment (transgenic) with those of plants gene-edited with CRISPR. However, in the latter, no transgene is usually added, but genes are inactivated or modified with small genetic variations (insertions, deletions or substitutions), similar or identical to those existing in other natural varieties of the same plant.
The ruling indicated, without providing scientific justification, that all genetically edited plants should be evaluated for potential risks to human health and the environment. This implies the preparation of complex and expensive dossiers, just as includes Directive 2001/18. This directive has been applied to all genetically modified organisms (GMOs) and has caused, in factthe non-approval for the cultivation of any new GMO variety since then.
This nonsense isolated Europe -already New Zealand, although lately they are reconsidering their position– from the rest of the world, which has largely chosen not to regulate gene-edited plants as GMOs. This allows them to promote technological innovation and take advantage of the productive advantages of incorporating these NGT methods in agriculture.
A new proposal from the European Commission to change things
However, something seems to be moving in Europe on this issue. On July 5, the European Commission published a proposal to modify the regulation of plants obtained through gene editing using one of the NGT methods, such as CRISPR tools.
He summary of this proposal It underlines several aspects. Firstly, it recognizes that NGT techniques did not exist in 2001, when the current European legislation that applies to GMOs was adopted. It certainly seems strange to say the least trying to apply the dictates of a directive that was passed 12 years before CRISPR technology appeared (in 2013).
Secondly, the proposal incorporates a long-awaited modification by the sector: those plants obtained through any NGT technique that could also have been obtained naturally or through traditional crosses would be subject to a verification process.
Those that pass this process would be treated as conventional plants and, therefore, would be exempt from complying with GMO Directive 2001/18. In fact, they would not have to be identified as such, although naturally they should comply with food safety standards, like any other product intended for food.
And what would happen to the NGT plants that do not pass this verification? That they would continue to be considered GMOs and would continue to have to face the aforementioned directive, although in a different, less exhaustive way. And this is the third of the important novelties of the proposal: the same analyzes that are currently applied to transgenic plants will not be carried out on them. The risk assessment should be justified by a testable risk hypothesis. Or what is the same, only those risks for which there was a plausible hypothesis would be evaluated.
Inserting a gene at random is not the same as doing it using CRISPR
Including a verification process for plants obtained through NGT incorporates the flexibility that the scientific community had been demanding for many years. Not all genetic modifications or edits can be treated equally.
That was the mistake of the judgment of July 2018: which equated randomly inserting a gene from another organism (for example from a bacterium) into the genome of a plant to generate a transgenic plant resistant to an insect pest, with precisely modifying, using CRISPR, some letters of a plant’s DNA so that a gene stops working or acquires a different genetic variant, already existing in nature, that provides it with some distinctive characteristic that can be used agroeconomically. For example, different flavor, greater resistance to drought, change in the content of metabolic compounds, resistance to pests, etc.
The new (and big) step by the European Commission would bring the fate of plant biotechnology in Europe closer to that of the rest of the world, and end our isolation. Something that the Ministry of Agriculture has already done in the US Five years ago.
Winds of change that invite optimism
The EPSO(the European Organization for Plant Science) has already publicly acknowledged the willingness of the European Commission to change the GMO legislation in the right direction. And he has also welcomed the proposal the ARRIGE scientific advisory boardthe Association for Responsible Research and Innovation in Gene Editing.
Naturally this proposal does not arouse the agreement of all, and both European Green parties like Germany and Austria They have already positioned themselves against it, claiming to maintain the precautionary principle that has hindered progress in Europe in this field in recent years.
some nonsense
In any initiative, the devil is in the details, and this case is no exception. The verification procedure for NGT plants allows them to be exempted from complying with Directive 2001/18 only in certain situations, described in the annexes of the proposal.
Specifically, it is proposed that a plant obtained by NGT will be considered equivalent to a conventional plant if the number of substitutions or insertions of letters in the genome affected by the modification is less than or equal to 20. But if it is about removing letters (deletions) or reversing the direction of a DNA fragment, this number is unlimited. Why do we differentiate between insertions/substitutions and deletions/inversions? Why do we limit the first ones to precisely 20 and not to 18, or 25, or 30? In plants, naturally,there are much larger insertions and deletions.
These are arbitrary reasons for which, again, the corresponding scientific justification seems to be lacking and may leave many NGT plants that do not comply with these limitations out of this proposal.
Finally, NGT plants that are considered equivalent to conventional plants cannot, however, be used in ecological/organic agriculture. Another contradiction.
Be that as it may, this proposal by the European Commission must be debated in the European Parliament and by the European Council before it is approved. You may face further modifications during negotiation. But there is hope and something is moving –finally!– in Europe.
And that is why it is so important to tell it, so that European society knows about the existence of this proposal and its foreseeable impact on biotechnology and our economy.
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