International Seed Federation (ISF) Provides Information About Gene Editing And A Global Policy Update

Date Posted: Jul 07, 2021

Dr. Szabolcs Ruthner

Nyon, Switzerland (July 7, 2021) - International Seed Federation (ISF) Regulatory Affairs Manager Dr. Szabolcs Ruthner talked with Seed Today Editor Chris Lusvardi during the ISF Virtual Congress on July 7.

Watch the interview on Channel World Seed.

Ruthner provided information about gene editing and a global policy update.

CL: Could you explain what we mean by gene editing? What exactly is it?

SR: Nowadays it is all over the place. You can hear about it through all the media and other channels. We usually explain what the plant breeders do and how the plant breeders edit a plant’s DNA. It’s similar to editing a text on a word processor. When you sequence, DNA are like sentences, words that can be replaced or edited and results in a change in meaning. It’s very similar to that.

The newest methods don’t even require cutting the DNA, just chemically editing the base pair. It’s called prime or base editing.

Breeders are working on the gene pool of the plant without introducing foreign genes. This will be important when we are speaking about the regulatory aspects.

Maybe what is also important is why breeders are doing this, what is the motivation behind what breeders do to genome editing. It’s very simple. Since breeding started centuries ago, the aim was to increase the genetic variability of the cross, which is the major source of plant breeding. Then what breeders do with genome editing that is additional is to induce more genetic variations through the breeding process.

Also, there is a frequently asked question that we have this genome editing that will make earlier methods obsolete. The clear answer is no. Genome editing, or we can call it targeted mutagenesis, is part of the breeding cycle. Traditional breeding methods like crossing and selection will be part of what breeders use in the future. This only makes some of the application more efficient than what is in the past.

CL: What are the main benefits of gene editing?

SR: One of the main benefits is the precision. We know much more about the genome today. This right now enables us to make changes in a much more targeted way than we did in the past. It also, because of the efficiency, it’s saving time, inducing less unintended changes in the DNA compared to previous methods like random mutation when it was really all over the place when breeders use it, and it was difficult to predict the change.

This is pretty much the beginning of the story. We already see many possibilities to improve plants and their characteristics. Those types of characteristics were difficult to breed or improve with earlier methods. I’m thinking about polyploid plants when you have many chromosomes, and you have to alter at the same time. Obviously, this makes crossing much more difficult. Or different characteristics which are controlled by many genes so most of the characteristics are controlled by gene families which was very difficult to improve with earlier methods. We think this could really be an advantage.

Also, this is a relatively inexpensive method. It requires laboratory background and certain type of knowledge. It gives access not just for a few bigger companies but to public institutes and small and medium sized enterprises as well.

CL: Who are the developers behind the products obtained by genome editing?

SR: Interestingly, there are only two products in the market at the moment which are fully commercialized. One well-known example is high-oleic soybean from Calyxt which is marketed in the U.S. and just recently high GABA tomato in Japan.

On the other hand, we see a lot of research and publication and also in some countries there are some public consultations started in certain products. It’s a really diverse picture in terms of the size and geography of the stakeholders. Public institutes small, medium size companies and specialized startups are flourishing and starting their research and product development.

We see many public-private partnerships. University, public institutes are teaming up with the private sector. It’s a really diverse and good type of cooperation at the moment. We often hear this criticism that it is just for the big companies, but what we are seeing is absolutely the contrary.

CL: What is the ISF’s position as to policies around genome editing?

SR: It’s one of our key strategic objectives. It’s important for the seed industry and important for the breeding sector. Early on we had set up a specialized working group to deal with this issue. It was established six years ago.

Right in the beginning, we said our baseline, our principles that we would like to convey to policymakers and regulators that they should look at the product and not the technology behind. If a genetically edited product could have been achieved by other traditional breeding methods or natural processes, they should be regulated the same way. Based on these principles, regulators can relatively easily decide if a genetically edited product should fall under the respective GMO or biotech regulation or not. It was early on agreed and I think we managed to somehow get traction and some of the governments are taking to this kind of thinking.

The other important element which also underlines the importance of this kind of product-based approach is that this is a rapidly evolving technology. New publications are coming out. The only way to keep up with these challenges from the regulatory perspective is to look at the outcome rather than the process. If you’re looking at the process, we are already late. The next day, next month, or next year, there will be new technologies available, so I think this is very important.

CL: How soon could we see these policies approved and implemented?

SR: It’s already a discussion in different countries that started five years ago. There are some countries that already have adopted policies, while others are in the phase of reviewing their regulatory framework. There are countries who are in this the 5-6 years rethinking again because they felt it’s not really futureproof what they have at the moment.

What is important for us as ISF on how to approach these discussions is that there is no international organization who will oversee this policy development. For instance, for plant variety protection, we have UPOV, for seed testing, we have ISTA. For genome editing, we don’t have. Our role and since the beginning, and I think we did quite successfully, to try government to speak and agree on certain principals. This kind of discussion needs to be maintained in the future.

CL: What has been happening in terms of the attempts to provide regulations for gene editing, particularly in Europe?

SR: Europe is very important, but I will start with more positive examples. I think this is what we can build in the future. Right now, it’s a moving target. Not every country has finalized fully their policies.

One positive example to be mentioned first is South America. We are seeing a great alignment of countries. They have the same regulatory triggers. It means that when the genome editing product contains a genetic combination or foreign genes is advanced, they are considered GMOs. If not, they are considered as any other conventional product. These countries have case-by-case pre-consultation. Developers can approach them and within 60-90 days, they can answer that they can commercialize their products as a conventional or they have to go through on the regulatory approval of GM products.

There are other good examples. In Australia, they have upfront exemptions so some of the small modifications are exempted without any need of consultation. Japan has voluntary consultation and also certain products are treated as conventional. You have the U.S. and Canada, where again the discussion, hasn’t been fully finished. It really is a positive.

In regards to the European Union, it is an important region. It obviously has a big impact on the rest of the world. Unfortunately, in 2019, they made a legal interpretation of their GM legislation. Their interpretation concluded that all targeted mutations meaning genome editing will be considered as GMOs, which was obviously a huge shock for the research community and private companies. What is important to know is that this GM regulation is already 20 years old. It’s based on the knowledge of the 1990’s.

The Commission started thinking this isn’t really feasible or enforceable. They started a commission study. It took a little bit more than a year to conclude. There were various stakeholders consulted, consultation with private research, with public research, with the respective stakeholders like farmers and so forth. They published this study with some very promising results for the future. There is really hope in Europe to change that. Basically, the conclusion was that this recent GM legislation had clear implementation challenges and there are legal uncertainties in regards to these new methods. There was a strong indication it was not fit for purpose. It needs to be somehow modified and needs to be adapted to the scientific and technology progress. It has recognized the importance of future innovation.

This is a very positive first step, but as we know in the European Union, things don’t happen overnight. It’s going to be a long procedure to go through the political levels with the European parliament to get things moving. There is this first step, the positive element is there, so hopefully we can build on it and this current situation can be changed in the future.

CL: How could the outcome of the debate in Europe impact regulations in the rest of the world?

SR: It depends on the outcome. At the moment, we are hopeful, but we don’t know what we will get in the end. There are two elements which are important. Europe is one of the largest seed import and export globally, and also with being significant in the import of commodities in food and feed. Any regulatory uncertainty will pose a very big trade barrier of these products. If Europe deviates from the rest of the world, this will pose a real nightmare from a trade perspective.

The regulatory implication is also interesting because some of the countries in Africa or Asia are looking at the European regulation. They think this is sound and safe and science based. They have some idealistic views that if something is coming from Europe, it needs to be followed. There is a danger that if the outcome were to be negative from Europe, this will trickle down in other countries and impact the regulatory framework. There is a lot at stake, not just because of Europe itself, but it has a great impact on the rest of the world as well.

CL: What could be the consequences of disproportionate and inconsistent regulation?

SR: We have this nice example of GMO regulation. We know the result of benchwork of regulation and the decisions in regards to GM products. If it’s repeated, the negative consequences could be the same where only the largest companies will have the financial capacity to manage the costs related to regulation. We know, for instance, GMs which are already an expensive technology, but sometimes the regulatory costs are higher than the development costs. This can happen to genome editing as well. What we see today is that there are really many crop breeders and researchers who are using a wide range of crosses, not just soybeans, maize, and cotton. Again, if this will be a higher entry because of the regulatory costs, this will be limited to the highest benefit crops, which we would like to avoid for sure.

We see a great interest with the academic community, domestic agriculture research organization, international agriculture research organization, so there is a great deal of public research which could be hindered or restricted with a high regulatory burden.

This has a trigger effect to all types of research cooperation, germplasm exchange, and so forth. In the end, it will be difficult to increase productivity in a sustainable way. It will become more and more challenge. We have some negative experience from the past with GM regulation, and we don’t want a repeat with genome editing.

CL: Why is it important to provide farmers with choices and access to quality seeds?

SR: It may sound like common sense, but we are living in an age with many global challenges, like climate change, increasing population, and so forth. We cannot afford to lose any of the breeding methods. As the industry, the only way to provide high-quality seed if we have access to those technologies and methods. We don’t think any type of production methods would be superior compared to others, but I do think we have a place for conventional, biotech, genome editing type of products.

What is important is to have locally adapted varieties available for farmers and they need to choose what is their preference, not the regulators choose instead of farmers.

The bottom line is we have to provide a wide variety of choices, different varieties developed through different types of techniques. If it’s safe, if it’s tested, it needs to be available for the farmers.

CL: Any other top priority issues the ISF is focused on right now?

SR: One of the priorities related to plant breeding innovation is the communication. We as a seed industry have a really clear role to explain why we are doing this, what we are doing, and how we are doing it to the general public. In the past, and in the future, we try to have some communication materials that we try to explain the real story, the fact-based story, about genome editing and why it is important, not just for breeders, not just for the farming community, but also for the entire society. It is very important, and we are working on it.

We are in heavy preparation for the UN Food Systems Summit. This will be the biggest agricultural event of the year, and we are part of the discussion. We have the chance to show how the seed sector can contribute to a more resilient and sustainable food system.

One of our key priorities is the free movement of seeds. We have a lot of regulatory hurdles, especially in the field of phytosanitary regulations. This is an ongoing subject, but it’s really evergreen and a very important subject because this is what seed traders can face every day with market restrictions and market access problems. This is something we are doing on an ongoing, continuous manner.

CL: How can the global seed industry become involved and make their voices heard on these issues?

SR: On the ISF level, we have various committees and working groups who are working on these different procedures. It’s open for seed companies and the experts of the seed industry to join this kind of preparatory work which then can be presented in the international forum we have.

What is not more important, but equally important, is that the implementation level is always national and regional. It’s important to be involved at the global level, but it’s equally important to have the same representation at the national discussion. We have national seed associations who are our members. Companies’ activity at the national level is also very important.

For additional information, go to the ISF website and watch all the presentations.

International Seed Federation (ISF) Provides Information About Gene Editing And A Global Policy Update

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