High stakes for CRISPR and GMO regulation in Europe

January 23, 2018 by Lawrence Woodward

The European Court of Justice has been considering whether organisms obtained by mutagenesis are exempt from the EU’s Genetically Modified Organisms Directive.

That might sound esoteric or gobbledygook but both pro- and anti-GMO camps are keenly awaiting the outcome as many believe it will determine the legal status in the EU of the “new genetic engineering techniques”.

It almost certainly won’t but it might set the stage – or one of them.

These techniques are usually and erroneously lumped together and called gene (more properly genome) editing; chief of which is the much vaunted – some might say irresponsibly over hyped and promoted – CRISPR-Cas. Together with “synthetic biology” they make up what has been called GMO 2.0 and are seen by proponents and opponents as the future – direction and/or battleground – of genetic engineering in food and farming.

High stakes on all sides

On January 18th the Court’s principal advisor, the Advocate General, published his opinion which created widespread confusion as differing interpretations of his interpretation were promoted by differing experts and interest groups with differing opinions.

Ah, the largely unfathomable fun and games of law where my interpretation matches your interpretation, raises his or her interpretation, sees off all opinions and trumps the game!

It’s the sort of stuff that gives even insiders headaches and turns most other people off; thereby creating further complexity, legal loopholes, political game playing and an increase in the democratic deficit.

Unfortunately, this game is a bit like Jumanji; hiding a load of horrors and a plague of long term consequences which may be good or maybe bad depending on who you are and where you are on the business, food safety, health, food, farming, environment and corporate control spectrum.

Put at its simplest; if the European Court decides that these techniques are GMOs they will be regulated; and if it decides they are not GMOs, they won’t be regulated; and the agro-tech business, loads of academics and researchers (corporate ones, corporate influenced ones and a few non-corporate ones), patent holders and investors will throw a big party and fantasise about the brave, new, unregulated, unmonitored, unlabelled and unaccountable world they will inherit.

As this is likely to be an unpalatable world for the rest of us, it’s a good idea to unpick the Advocate General’s Opinion and the confusion around it.

This is especially so for those of us living in the UK where post-Brexit we are likely to be faced with Government which is very pro-deregulation and sees an emancipated agro-technology (including genetic engineering) industry as a key economic driver.

Why is the case about mutagenesis?

The first thread of confusion to unpick is why the European Court is considering mutagenesis – which has been around as an approach to plant breeding since the early 20^th century – and not the new genetic engineering techniques including CRISPR-Cas.

In short, as the Advocate General notes in his Opinion, mutagenesis – which does not involve inserting foreign DNA into a living organism but does alter organism’s genome – is, in principle, exempt from the EU’s GMO Directive.

Although in moments of honesty and candour – often private – most genetic engineers/developers will acknowledge that genome editing is a form of genetic engineering, they also argue it is essentially mutagenesis and should not be under the GMO regulations.

In contrast Confédération Paysanne, a French agricultural union of small-scale farmers, and others, whose legal action in the French Council of State has led to the European Court consideration, say that mutagenesis techniques have evolved since the adoption of the GMO Directive in 2001, and are now at odds with exemption granted at that time.

They further argue that plant material created by “modern mutagenesis” carries a risk of significant harm to the environment and to human and animal health and should be covered by the precautionary principle which is part of EU law.

As an article in the science journal Nature points out:

“The stakes are high, because if gene-edited products are deemed to be subject to the directive, the required checks and controls would make it too expensive for European academics and small companies to develop such products for the market, say scientists and entrepreneurs. What’s more, they fear that if gene-edited products were to be considered GMOs, the public would reject them, as happened with genetically modified food.”

Confusingly clear and clearly confusing

Is it possible to be clear and confusing at the same time? At the nexus of law, science and politics it seems like it is.

Key points from the opinion are:

Having noted that in principle mutagenesis is exempt from the requirements of the EU GMO Directive, the Advocate General goes on to state that genetic material which has been altered in such a way that does not occur naturally can be characterised as a GMO.
And further, he concludes that mutagenesis which involves such material and/or the use of recombinant nucleic acid molecules would fall within the scope of the Directive.
The Advocate General also considers that where types of mutagenesis fall outside of the GMO Directive, individual member states can regulate separately provided overall EU law is respected.

That seems clear – at least from a legal perspective – and according to Dr Michael Antoniou, Head of the Gene Expression and Therapy Group at King’s College London, from a scientific one too:

“In my view, the genome editing tools based on zinc finger nucleases and TALENs, as well as oligonucleotide-directed mutagenesis, all involve the use of recombinant nucleic acid molecules and therefore all organisms produced using these methods will have to be regulated as GMOs, by the definition set out in the advocate general’s legal opinion.

“As for the CRISPR genome editing system, the guide RNA that is an integral part of the genome targeting mechanism of this technology is also a recombinant nucleic acid molecule. Therefore it seems to me that organisms produced with the CRISPR system, according to this opinion, are also GMOs and should be regulated accordingly.”

Researchers who are strong supporters of the use of genetic engineering in plant breeding appear to disagree somewhat with Dr. Antoniou but reacted cautiously and possibly with a degree of disappointment.

Dr Wendy Harwood, a senior crop scientist at the UK’s John Innes Centre welcomed the opinion but acknowledged uncertainty saying that “the term recombinant nucleic acids is still open to interpretation”

Whilst Ralf Wilhelm of the Julius Kühn Institute, the German federal research centre for cultivated plants, in Quedlinburg was more forthright; “At least the opinion doesn’t say that all products created with the new gene-editing techniques should automatically be considered under all the obligations of the GMO regulations.”

Prof Huw Jones, Chair in Translational Genomics for Plant Breeding, Aberystwyth University, said: “I am happy that this proposal excludes simple gene editing from GMO regulation. However, allowing member states to legislate independently will inevitably complicate innovation, commercialisation and trade in gene edited products.”

But this caution didn’t come out in the media where ignorant, inaccurate and prejudicial reporting of the opinion has fostered a deal of confusion.

The Guardian and Reuters set the tone. “Gene edited crops should be exempted from GM food laws, says EU lawyer”, was the Guardian’s grossly inaccurate headline, therein continuing the media’s blinkered love affair with the all things gene edited: An affair which bolsters rather than questions politician’s fantasies that the genetic technology silver bullet will solve all manner of problems and, at the same time, boost economic growth.

More confusion and drama to come

Shakespeare wrote that “All the world’s a stage” but he was wrong – at least in this case – because this drama is going to be played out in and on several stages. It also going to be a long running affair and it’s a moot point as to who is going to be satisfied with that.

Here’s the scenario:

Whilst it is not binding, the Advocate General’s Opinion is usually followed by the judges in the subsequent Court of Justice deliberations. It is important to remember that in this case the Court is being asked by the French Council of State to clarify the scope of the GMO Directive and the validity of the “mutagenesis exemption” in the light of the passage of time and evolution of technology. So later this year the Court will issue not a ruling but a clarification.
It will then be up to the French Council of State to make a ruling on the action brought by the Confédération Paysanne et al which may (or may not) declare some, all or none of the new genetic engineering techniques fall under GMO law as it is applied in France.
Probably whatever it decides will be appealed by someone, somewhere – and possibly back in the European Court.
In the meantime the EU Commission, which has been ducking and diving to avoid taking action on the issue will be considering the Court of Justice clarification and will continue its evasive tactics until it runs out of space.
It will then have to do what it should have already been doing, which is to amend the EU GMO Directive or propose a completely new one to deal with these techniques.
At which point a sequel to the long running “GMO standoff in the EU” will start up where the Commission, Parliament and Member States fail to agree.
Unless, that is, there is a sea change in attitudes in some Member States and in Parliament.
It is important to take into account here that the Netherlands, with some support in other Member States and the Commission, has proposed an amendment to the EU GMO Directive which would specifically exclude new genetic engineering techniques and would shift the evaluation of these techniques from a process based one to a final product based one. It is the kind of superficially attractive but essentially incoherent proposal which EU compromises are often built on.
Of course none of this takes place in a vacuum and stages 4,5,6,7, 8 are subject to a political dynamic which is influenced by business, science and technology and crucially, if it can be galvanised, public opinion.

In the court of public opinion

Much as it galls them, politicians and policy makers in the EU cannot wholly ignore the views, moods and wishes of citizens. In their role as consumers, citizens also have the attention of one of the biggest parts of big business – the major retailers.

Ultimately, therefore it is in that Court of Public Opinion and not in the European Court of Justice or in a French or Dutch court that the fate of the new genetic engineering techniques will be decided.

That is not to say there will be not be court actions which will determine the applicability of aspects of the technology. It is highly likely and that is concerning.

However, what is more concerning is that the Court of Public Opinion can be swayed – in some cases and places – relatively easily by media pressure, by seriously sounding members of the research establishment dressed in a cloak of spurious impartiality and by the complacency and cack-handedness of NGOs and campaigners.

There are signs that some people, sectors and countries who have historically been opposed to GMOs are beginning to think differently about some of these new genetic engineering techniques. The Dutch proposal which apparently has a good measure of support in that country is an example of this.

This shift in attitudes should be taken into account in efforts to build a citizenship which is informed and engaged in considering the environmental, safety, regulatory and social ramifications of this emerging technology.

The stages may be the same – the media, politics and policy making, research and scientific forums, farmers and citizen/consumer groups – but the old style campaigning of reports, press releases and campaign slogans are not enough. More listening, more nuanced conversations and more real grassroots engagement is also needed.