Bayer scientist: ‘Regulation and risk assessment must evolve with technology’

Since new breeding technologies such as gene editing are still new and evolving, risk assessments and regulations also need to be evolving, says a molecular biologist for Bayer Life Science company.

Dr Larry Gilberston, Ph.D., spoke to EURACTIV about the technicalities of gene editing, including the biological differences between new plant breeding techniques (NBTs) and genetic modification (GM), and the risks associated with these techniques.

Are there different risk considerations for GM and NBTs? Should they be treated differently?

Fundamentally, both of these are GM technologies and these new breeding technologies like gene editing are making changes in DNA. So at that level, they’re fundamentally the same. And so there’s no intrinsic difference in the risk between those.

That being said, the two different methods allow us to assess risk in different ways. So for example, with GM, we can start to look at the gene that we’re going to insert before we even start the experiment and assess it for any kind of potential risks. We can also do that after it goes in and we can continue to do that throughout the entire development process.

The same is going to be true for new breeding technologies, we have to assess them. And so I don’t think there’s a fundamental difference in the risk between these two technologies since they’re both fundamentally just changes in DNA.

You can’t talk about risk without talking about the benefits because, of course, they are doing these changes to bring benefits, including benefits for sustainable agriculture, benefits for the farmer, benefits for the consumer as well. And so while we have to assess risks, we also have to remember all the benefits of why we’re even doing this in the first place.

Should the risk assessments for these be different then? Or would the same risk assessment be suitable for the different techniques?

Since new breeding technologies such as gene editing are still new and still evolving, the risk assessment that needs to be done is still evolving itself. And so we don’t know yet what that will be. And after all, we work in a regulated world. And so the assessments that we do will ultimately be determined by the various countries and their governing bodies.

But I do want to make the point that at a fundamental level, it’s changes in DNA, just like breeding, just like random mutagenesis technologies that have been around for centuries. And even these new breeding technologies, it’s all just changes in DNA. So at that level, you’re just looking to see if the different changes have any additional associated risks with them, in addition to the benefits.

Is it scientifically feasible to be able to detect organisms obtained by NBTs?

The short answer to that question is yes, it is scientifically feasible because in all of these methods, whether it’s classical breeding, random mutagenesis, or these new precise gene-editing technologies, we’re making precise changes in the DNA and we know the changes that we’re making any change in DNA is scientifically feasibly detectable. And so the short answer to this is yes. Now, the types of changes that are occurring when we’re doing gene editing are small, and they’re very much like natural mutations. And so any type of change in DNA, whether it’s natural or made in the laboratory, is detectable scientifically.

EU study to clarify gene editing court ruling further muddies waters

After the European Court of Justice (ECJ) ruling that organisms obtained by new plant breeding techniques (NBTs) should, in principle, fall under the GMO Directive, the Council of the EU has requested a study from the Commission to clarify the situation. But what this means in practice remains unclear.

Do you think the EU regulation on gene editing is a barrier to innovation? And would you, as a researcher, consider working in Europe?

So, regulation is important. But excessive regulation does, unfortunately, stifle innovation. And if you’re working in an area where that’s science that you’re trying to develop, and the applications you’re trying to develop are heavily regulated, then I would be personally discouraged from working on that in that area. And so we’re hopeful that these regulations will keep pace with a scientific change because we don’t want anybody to be left out of any opportunities for innovation. This is a great new tool for plant breeding, and we hope that everybody will have access to it.

Would you potentially be able to use the frequency of occurrence of a change as a way to distinguish between gene-edited and naturally occurring changes?

So, whether the change happened naturally or it was made by design using a technology like gene-editing, the prevalence of it in agriculture will depend on whether or not it entered the breeding pipeline. And so of course, our breeding pipeline is constantly selecting for better and better varieties. And indirectly when we do that, we’re selecting for all of these variations. And so what ends up on the farm will have a high prevalence, the same as the changes that we designed.

MEPs slam gene-editing court ruling as damaging for SMEs

It is much easier for larger companies to implement new GM legislation, but it’s the smaller ones that are most affected by the recent gene-editing ruling, the chair of the agriculture committee (AGRI) MEP, Norbert Lins, told at the sidelines of a recent plant breeding conference.

[Edited by Zoran Radosavljevic]

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