GM and Brexit

Back in September, Kat Arney went along to a discussion organised by the Royal Society of Biology at the British Science Festival in Swansea, called “Can gene editing save the world?” We’ve covered some of the potential applications of this exciting new technology - commonly known as CRISPR - in previous podcasts, but this time round the researchers at the event were focusing on the legal and ethical implications of gene editing, as well as the practical applications. Rather than diving straight into the implications of new technology - not to mention what happens when the UK leaves the regulatory framework of the European Union - Kat started by taking a step back, speaking to Professor Huw Jones from Aberystwyth University, to find out who decides whether farmers can grow genetically modified crops in the first place.

Huw - If a farmer wanted to cultivate herbicide tolerant crop in Europe, he could only choose something that has been approved by the European Union and at the moment, there aren’t any. So there is no choice. The only one type of food crop – feed crop, actually - that can be cultivated legally in Europe is an insect resistant maize and that’s cultivated in certain areas of Spain and Portugal for feed uses. So, Europe hasn’t authorised – apart from one, MON 810 it’s called - and that was authorised before the current regulatory systems have been put into place. Since 2001, there haven't been any new authorisations for cultivation.

Kat - That seems quite stringent to me, given that there are other countries in the world that are growing genetically modified crops and seem to be okay with it. Is it too strict here in Europe?

Huw - There is a consensus that we have probably one of the most rigorous and risk averse, risk assessment systems, regulatory systems anyway in the world. So, we’re at the top end of the spectrum of how much information we need to carry out a risk assessment. But also, even when the risk assessment is done and EFSA that carries out the risk assessment writes an opinion – it’s called – that states that this crop is the same as the nonconventional counterpart, the politics of Europe then comes into play because it’s the politicians that authorise. EFSA merely carries out an analysis of the risk and then passes that on to the politicians and it’s the politicians that authorise. At the moment, they haven't authorised any new cultivation applications.

Kat - It looks like for now, actual GMOs – so things that have had genes inserted in them using the old transgenic technology - are a bit of a nonstarter in Europe at least. But now, we have these new technologies, genome editing, that seem to be much more precise. What is the regulatory framework around that? What's even the thinking so far?

Huw - Well currently, we don’t know whether the European Union considers these as GMOs or not. Unfortunately, it has to be that zero or one, that black and white choice because there is no opportunity to put them into a third category. Now, they’ve been discussing a range of new biotechnologies and looking at the law of GMOs, and trying to work out whether various types of new biotechnologies are captured within the law or fall outside. This process has been going on for the last 2 or 3 years. But we haven't yet got a final opinion on how the European Commission will see gene editing or other tools like that. But at the same time in other areas of the world, Argentina has just come out with a nice regulatory framework that puts simple genome editing – so genome editing that just causes small single nucleotide polymorphisms - the kind of things you could find in nature if you looked hard enough - they’ve put that outside their GMO laws. The three examples that the USA has considered have deemed those three genome edited examples as not requiring regulation, so they're putting them outside. So there is evidence from the rest of the world that other continents and other competent authorities in those countries are deeming simple genome editing as a non-GMO. Europe, we don’t yet know. But the problem is that if Europe puts them into the GMO category then they’ll have to comply with the same regulatory rigour which again, some commentators say is really the highest in the world. I think that will be disproportionate – the risks are just not there to require such a tough risk assessment for examples of small gene edits that we can find in nature anyway.

Kat - It feels like these genome editing technologies have come on us so fast that it’s only a couple of years since CRSPR was discovered and we’ve had other genome editing techniques that have been around for a couple of years longer than that. For all its wonderful things and its flaws as well, the European Union and the legislative process is not the fastest in the world. Is it that our technology is just speeding ahead, ahead of the legislative process? How do we square this kind of legal circle here ,because it feels as if there’s all this incredible technology coming along, great ideas, things that could be really beneficial, and a huge dinosaur of legal stuff behind it?

Huw - I think we’ve got a two-phase process of change here. What we’ve got in the long run is a recognition that we can no longer regulate using the method of making a change in a plant genome as the thing that puts it into a GMO or a non-GMO camp. So, using this technology or that technology is what we’re talking about now, whereas what we’d really should be focusing on is the change we’ve made in the crop. So, if it’s – let’s say, just take an example, herbicide tolerance you mentioned earlier, if herbicide tolerance has a risk and there are environmental issues with herbicide tolerance then that’s the characteristic that needs the risk assessment regardless of how it’s made. If you make a herbicide tolerant crop through a non-GMO route then at the moment it’s not regulated at all whereas if you make it through a GMO route, it undergoes heavy regulation. What I'm thinking is in the long run, we need to step out from the idea of trying to keep the regulation in check with new technologies of how you do it because they will always develop. There’ll always be changes every few years. Rather take a step back and redefine a regulatory system that focuses on the final product. Is the product new? And if it is, if it’s a new type of food, if it allows different agriculture to be used like herbicide tolerance then that’s the characteristic that needs the risk assessment. As you say, the regulation is a dinosaur. It’s going to take a long time for that to happen. So in the meantime, we need to have some interim steps to tie this over until we can make those bigger changes. I think those have to be perhaps the starting of an intermediate risk assessment category where you haven't got the risks of conventional GMOs but you also would like some sort of regulatory oversight. But it’s proportionate to the risks like in simple genome editing.

Kat - I have to ask the Brexit question. Given that Brexit at least seems to be on the table for the UK to leave the European Union, how does that affect our legal frameworks about our agriculture here in this country?

Huw - Well currently, the EU law surrounding biotechnology is transposed into our laws. So, we are obliged to follow the European law until we leave the European Union. The day that we leave, those laws will be untransposed and we then have the freedom to redefine what biotechnology is and how it’s going to be regulated. So, we have an opportunity to really look at biotechnology and to rewrite the rule book in that sense. But we have also to mindful that even if we were to have let’s say, we had genome edited crops cultivated the UK under our new system then if any of that is exported into the European Union then it anyway will have to comply with the European Union’s biotechnology laws. We have to make sure that we are aware of the fact that we are an island and if things stay on our island then it’s fine. But a lot of food that we cultivate is exported. So we have to then consider the countries that we’re exporting to and we would have to comply with their regulations. So the European Union has this very high levels for risk assessment even for imported crops. Not only for cultivated crops but crops that are imported. So, we would still have to comply anyway with the European Union. It’s not a panacea but it may be for some crops that we know are going to be grown only in the UK and consumed only in the UK then it may be a way forward.

Kat - So British crops for British people may be OK. British crops for anyone else where they don’t have our framework could be tricky.

Huw - Well, it’s no different to how it would be today or how the USA – so the USA, if they're cultivating their GMO corn, they would have to make an application into Europe and get authorisation and then it can be exported. The problem is that the European Union has a zero tolerance policy for unapproved crops. Even if one seed of an unapproved variety ends up getting mixed up in a silo of other seed, even if all of that is approved then if that one seed is detected, the whole shipment gets sent back. So there's a lot of concern that no unapproved varieties get mixed in with the bulk of the approved varieties because it’s a massive risk and it’s a massive financial burden to have a shipment of soy or potatoes turned away from a port because of that accidental mixing.

Kat - Professor Huw Jones from Aberystwyth University.