Only missing ingredient is political will

Following is a GMWatch summary of a French-language article by the NGO, Inf'OGM.

Is it technically possible to detect and trace GMOs from new genetic modification techniques, also referred to as "new mutagenesis" or gene-editing techniques (including CRISPR)? And does this technical possibility depend on the political will to detect and trace them?

These questions are at the centre of the debate that is simmering away in the corridors of the European Union. A recent report by European experts gives arguments in support of both those who argue that it is not possible to trace the new GMOs and those who say that it is possible, if the European Union so wishes.

The report, published on 26 March by the experts of the European Network of GMO Laboratories (ENGL),[1] had been eagerly awaited. Since the July 2018 decision of the European Court of Justice ruling that the products obtained by the "new mutagenesis" gene-editing techniques are GMOs and fall under European legislation, one of the questions that has arisen is whether the companies are right or wrong to assert that their new GMOs cannot be differentiated from what nature or traditional selective breeding can do.

In September 2018, the European Commission asked its experts to address the question. As early as October 2018, a first explanatory note co-signed by the European Commission with the company DuPont Pioneer and still available on the Inf'OGM website[2] concluded that products resulting from new mutagenesis/gene-editing techniques are detectable and identifiable if "prior knowledge on the altered genome sequence, a validated detection method with appropriate selectivity and certified reference materials are available, similarly as required for the authorisation of current transgenic GMOs".

In a case where this information is not available, that is, in the case of an illegal release of a GMO, the explanatory note said it would still be possible to detect and trace the GMO through "emerging sequencing-based analysis for the detection of unknown products of genome editing", which, however, would "require significantly more time and resources by enforcement laboratories, compared to the currently applied quantitative PCR technologies" and "this may affect the timely clearance of goods entering the EU market".

This makes clear that the question is not whether new GMOs can be detected – they can –  but whether there is sufficient political will to insist on the right of the public to know how the food they eat was produced.

An ambiguous final report

The ENGL experts approached the issue in a theoretical way. For, as they note, no "experimental work on detectability of genome-edited food or feed products of plant origin" has been conducted.

Based on theoretical considerations, the ENGL experts state that the detection and quantification of products resulting from new mutagenesis techniques will be possible for GMOs with a known and unambiguous modification. This information is required by European legislation to obtain a marketing authorisation or experimental release for any GMO. But they raise concerns about GMOs for which this information is not known and which are therefore illegally present in Europe: "Under the current circumstances, market control will fail to detect unknown genome-edited plant products."

The experts confirm that the detection of a genetic modification "may" be able to be accomplished by current sequencing methods. But they consider that detecting it will not be sufficient to conclude that the analyzed product is an illegal GMO because "The same DNA alteration could have been obtained by conventional breeding or random mutagenesis techniques, which are exempted from the GMO regulations."

Random mutagenesis is a technique sometimes used by conventional breeders which involves blasting the plant's DNA with chemicals or radiation to induce mutations, in the hope of finding one or more useful mutations. While the EU's GMO legislation views it as GM, it exempts it from the GMO legislation due to what is deemed to be a long history of safe use.

In sum, if there is a political will to detect the products of new mutagenesis/gene-editing techniques, we would have to dig deeper. But there are some avenues, even if the European experts seem to doubt it.

Looking at the whole face, not just the nose

The question posed to the ENGL experts by the European Commission is whether we can differentiate between a plant genetically modified by a new mutagenesis technique and any other plant that is not subject to GMO regulation. The approach of the ENGL experts focuses narrowly on a single genetic modification: one that is claimed by the breeder or, in the case of an investigation into undeclared GMOs, one that is suspected. Such a modification may, in the case of new mutagenesis techniques, be restricted to altering one or a few base units of DNA. This type of alteration can take place naturally or be obtained by other techniques not subject to the scope of European legislation. So focusing on this alteration alone is not likely to take us far.

However, if we want to identify a face, few people will look only at the nose, or, worse, at just a nostril. We will instinctively look at the whole face and look for elements to identify the person. The same is the same for facial recognition or fingerprint software.

As the scientist Yves Bertheau, director of research at INRA in France, has already pointed out, a more holistic approach is indeed possible. Clearly, the idea would be not to look only at the genetic modification claimed or assumed in the case of illegal GMOs, but also the "scars" left by the implementation of genetic modification techniques, such as Inf'OGM has described.[3] When a scientist states that a technique makes such or such a change, he often forgets to say that it also leaves additional changes, or scars, in other parts of the genome.

This is one aspect of a broader and multi-targeted way of detecting new GMOs, based on examining clusters of evidence, which has been named the "matrix approach".

This "matrix approach" was the subject of a recent scientific publication by Dr Bertheau. Therefore the ENGL experts were forced to consider it. They did, but only to sideline it immediately (p15 of the report). They stated that these scars do not provide "realistic evidence and proof that a new breeding technique was applied and has caused a detected DNA alteration", since such scars are also "potentially created in cells that have been directly treated by any mutagenesis technique or passed through tissue culture and are not exclusively induced by genome editing".

Tissue culture techniques, which consist of reproducing new plants by in vitro multiplication of cells isolated from the rest of the plant, are certainly used outside of genome editing techniques, but they all fall within the framework of the European GMO regulation. The ENGL experts seem to deny this by saying that such tissue culture-induced scars would not be relevant to distinguish a regulated GMO from any other plant not subject to GMO regulation. Their conclusion is therefore based on an unacknowledged distortion of the meaning of the GMO regulation.

Tracing new GMOs – lack of political will

In addition to the information that can be obtained by laboratory analysis, the ENGL experts also address the information already in existence. They underline that these new GMOs can already be authorised in other countries, with a description of the modification already supplied to the appropriate authorities. They can also described in patents which also provide some information, theoretically allowing the plant to be characterised. They even go so far as to explain that computer databases can be used to collect information on "the development and marketing of genetically modified plants". But in every case, the experts finally object that these sources of information have not yet been evaluated.

It is interesting to note that industry is already using techniques to distinguish these new GMOs from other plants. On the one hand, they want to defend their patents against any abuse of their intellectual property rights, and on the other hand, they want to ensure that the genetic resources they use to select their new varieties do not contain changes already patented by their competitors.

Why is it possible to distinguish GMO changes in order to protect patents, but then apparently not possible to distinguish these same GMO changes for the purposes of subjecting them to the GMO regulation?

The ENGL experts argue that if a mutation can be detected, it would not be possible to identify its origin – whether natural, traditional selective breeding, or regulated GMO technique. However, for the European citizen and the official bodies of control, that is not the reality. In the face of a shipment imported into Europe, the only question asked is whether or not the cargo contains regulated GMOs. It does not matter which GMO techniques were used, as long as one is certain that one of them was. To answer this question, it is possible to combine the information on the characterisation of a genetic modification, the scars present in the remainder of the genome, and the pre-existing information in other databases (authorisation in another country, patent). The missing condition to implement this system is ultimately political will.

No detection method, no market

GMWatch would add that as stated in the explanatory note by the European Commission and DuPont Pioneer, the current EU GMO legislation[4] requires that a company applying for the authorisation of a GMO provide the appropriate reference material (samples of the GMO itself) and a detection method for the GMO.  

Now that the EU Court of Justice has stated that the products of certain new mutagenesis/gene-editing techniques are indeed GMOs, anyone wanting to commercialise a new GMO has to provide the above-mentioned reference material and detection method.

The EU Commission and member states only have to cite EU law and the court ruling to insist that GMO developer companies provide these.

If the company will not do so, it cannot get authorisation. No reference material or detection method, no market access. It really is that simple.

That just leaves the problem of illegally released "new GMOs". EU member states and the Commission must task the ENGL laboratories with developing comprehensive methods and systems for detection of such rogue GMOs without delay.

Notes

[1] Detection of food and feed plant products obtained by new mutagenesis techniques, ENGL, 26 March 2019
http://gmo-crl.jrc.ec.europa.eu/doc/JRC116289-GE-report-ENGL.pdf

[2] Inf'OGM, "Nouveaux OGM: la Commission veut-elle leur traçabilité?", Eric MEUNIER, 29 Nov 2018
https://www.infogm.org/6678-nouveaux-ogm-commission-europe-veut-elle-tracabilite?lang=fr
Direct link to the note: https://www.infogm.org/IMG/pdf/comeur_note-detection-nveaux-ogm_nov2018.pdf

[3] Inf'OGM, "Modifications génétiques: à chaque étape, des effets non-intentionnels", Eric MEUNIER, Lily Vergier, 13 Nov 2017
https://www.infogm.org/6323-effets-hors-cible-non-intentionnels-lors-modification-genetique?lang=fr

[4] See Reg (EC) No 1829/2003.

Main source: Eric Meunier (2019). Les experts européens l’affirment : les nouveaux OGM sont traçables. 23 April. https://www.infogm.org/les-experts-europeens-l-affirment-les-nouveaux-ogm-sont-tracables?lang=fr