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gene editing regulation

Europe’s Gene Editing Regulation Exposes the Messy Relationship Between Science and Politics

April 10, 2019

John van der Oost has a bone to pick with Europe. Van der Oost is a microbiologist at Wageningen University in the Netherlands. His research in the late 1990s contributed to the development of the CRISPR Cas9 gene editing technology which, among other gene editing tools, has the potential to produce climate-resilient crops to curing genetic diseases in humans to other genomic modifications in both people and animals. And he’s furious about a ruling from the European Court of Justice (ECJ) last year that he and other proponents of gene editing say will dramatically slow Europe’s innovation in the field of crop science.

“This is very bad for the biotech business. It may take years to correct it,” he told AgFunderNews. “We hoped Europe would follow the decisions over the last year in the US, Japan, India, and China.”

Van der Oost will speak on the topic of the recent ECJ ruling and its implications at the F&A Next conference at Wageningen University on the 15-16 May.

A quick refresher: CRISPR Cas9 allows for pieces of genetic material to be cut or added to an organism, thereby removing or altering specific characteristics. That could be snipping genes from potatoes that will yield a less disease-prone crop, or altering genes in wheat so they won’t trigger gluten allergies, or adding a gene from a wild boar to make a domesticated pig resistant to certain disease strains.

GMO vs. gene editing

A clear differentiator between gene editing and what’s largely considered GMO is that gene editing does not involve the insertion of genes from another species. The AquAdvantage Salmon, for example, is GMO because it includes a growth hormone-regulating gene from another species of salmon — the Pacific Chinook salmon — and a promoter gene from an eel-like species of fish — the ocean pout — to enable it to grow year-round instead of only during spring and summer.

The genetic changes made through gene editing, such as gene deletions, can occur naturally as part of an organism’s own mutational process and over many years of breeding. Proponents refer to the technique as advanced breeding. Further, they argue it is more exact and efficient than older DNA editing tools, making results more predictable.

But despite these differences, the ECJ ruled that it would regulate gene editing under its existing directive for genetically modified organisms (GMOs). The ruling uses GMO technologies that were primarily developed in the 1980s as a precedent for modern gene editing technology.

These distinctions are what make the ECJ’s ruling so frustrating for van der Oost. He touts the new technology’s promise of not only solving several social and environmental problems but also democratizing innovation in ways that older, costlier modification technologies, like those the multinational agrochemical companies used to make genetically modified corn, for example, could not.

Indeed, in the US, where the Department of Agriculture clarified last Spring that it would “not regulate plants that could otherwise have been developed through traditional breeding techniques,” numerous agtech startups have begun developing products using CRISPR Cas-9 and other gene editing approaches. Berkeley, Calif.-based Caribou Biosciences, which was founded by one of the inventors of CRISPR Cas-9, is developing “waxy corn.” Minnesota-based Calyxt is making a canola oil with a healthier mix of fats and wheat that contains more fiber. And advanced breeding platform Benson Hill Biosystems has developed CRISPR 3.0 to use across a range of crops developed internally and by its partners.

Diverging interpretations

The ECJ, on the other hand, is more concerned about the process of making such products than determining their safety and natural implications after the fact. Its ruling was the result of legal action initiated by French agricultural union Confédération paysanne, arguing that even though modern gene editing technologies imitate the natural mutation process, they still carry risks to human, animal and environmental health.

“In the US, they said simple changes also occur in nature, this is the same as nature, so it should not be called GMO. That’s the big difference,” Van der Oost explains.

Van der Oost blames the ECJ’s decision on a lack of scientific understanding on the part of politicians and the general public, and a lack of trust in the scientific community. “People who don’t have proper scientific backgrounds can’t judge how safe this is or how far we want to take this,” he says. “If they have to vote on it, they say ‘We don’t know what this is, so we don’t trust it,’ and the politicians listen to these people.”

He’s sympathetic to that and sees it as the scientific community’s responsibility to help educate the public. For his part, van der Oost dedicates time to speaking informally at so-called Science Cafes that bring together people from different backgrounds, disciplines, and organizations to discuss scientific topics. He’s also been on a high school speaking circuit, to educate future biologists about how gene editing technology works.

Nevertheless, van der Oost feels the immediate impact of the ECJ’s ruling on Europe’s innovation will be significant and make opportunities to innovate less democratic. “Products can still reach the market, but it will take two, three, four times as long to make that happen,” he says, adding that this could effectively consolidate access to these tools in the hands of the very same companies behind most genetically modified crops, because large companies will be the only ones that can afford using them.

Others counter that there is a political undercurrent that influenced the ECJ’s decision—to which the scientific community is less attuned.

“Why the E.U. has been cautious is part of a wider historical narrative that dates back to the 1990s, when the debate about GMO crops and foods became a very contentious political issue, not just a scientific issue,” explains social scientist Phil Macnaghten, who is part of Wageningen University’s Knowledge, Technology and Innovation group. “A lot of the questions surrounding the technology are not really scientific but about what this technology is feeding into: power politics, the changing structure of agriculture and smallholder farmers, long-term unknown effects.”  

Professor Phil Macnaghten will present a keynote address on the cultural and social dimensions of responsible innovation in food and agriculture at the F&A Next conference at Wageningen University on the 15-16 May.

Reasonable questions; unsophisticated framework

The evolution of the science of GMOs, and how that translated into practical application by the large agrochemical companies, influences how society thinks about modern gene editing technology, regardless of how sophisticated the new technology may be, adds Macnaghten. Too little attention was given to local cultural, political, and economic factors when the GMO crops were developed and deployed. A study by Macnaghten in the Journal of Responsible Innovation cites examples of GM crop introduction in Mexico and India.

“Maize in Mexico was highly culturally resonant, deeply ingrained in Mexican identity and history, as well as in everyday food practices,” the study says. “We found that smallholder farmers retain strong and enduring relations around maize agriculture and that they see the prospect of [genetically modified] maize as an intrusion on traditional practices.”

Likewise, in India, genetically-modified cotton was widely viewed as a “symbol of foreign control and imposition.”

Macnaghten says these are issues that the industry could have easily anticipated, but that thinking requires a different orientation from the scientific community.

As such, Macnaghten believes that many of the questions asked in Europe of the scientific community are substantial and reasonable. But the regulatory framework for exhibiting caution, on the other hand, is limited and unsophisticated and could, as van der Oost suggests, intensify monopolies.

Academics as ‘honest brokers’

In the absence of a more sophisticated regulatory environment for gene editing, Macnaghten says it is the academic community’s responsibility to be “honest brokers” between science and politics. Macnaghten is part of a group of social scientists who are developing frameworks to ensure that gene editing and other biotechnologies are produced responsibly, and can be used as tools to support sustainable advancements in agriculture, energy, and health. More inclusive and two-way dialogue with the public is the most critical piece.

“It’s a process of involving communities, rather than some scientists saying ‘This is great for sustainability,’ and plunking it down. It’s a process of opening up a dialogue about what constitutes a “benefit,” because benefits are not self-evident,” Macnaghten says.

“It needs to be a two-way conversation that is not just participative, but where communities are involved in co-design,” he adds, speaking of technological applications. “If we get that right, then we can do a lot with radical innovation.”

Join the conversation which John van der Oost and Professor Phil Macnaghten at F&A Next F&A Next conference at Wageningen University on the 15-16 May.

*This post was sponsored by F&A Next, an AgFunder Network Partner. Find out more about F&A Next here, and the program, here.*

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