Scientists ask EU to change regulations for modern editing of plant genome

Scientists from 121 European institutions have asked the European Union for a change of legislation on genetically modified crops (GMOs). Researchers want the use of new genome editing methods, such as CRISPR, not to be subject to GMO Directives, as the EU ruled a year ago. They argue that plants that have undergone simple and targeted genome editing by precision breeding and that do not contain foreign genes are at least as safe as if they were derived from classical breeding techniques. According to scientists, the legislation does not reflect the current state of scientific knowledge and thus fundamentally limits European research. They believe that new methods have great potential for research and innovation and can help meet current challenges and keep pace with global competition. Czech researchers have joined the initiative.

On 25 July last year, the Court of Justice of the European Union ruled that plants obtained by new methods of precision breeding, such as CRISPR, are genetically modified organisms (GMOs). According to biologists and other researchers, this means that crops with the most minor modifications of the genome, which can also occur spontaneously in nature, are subject to European regulations, thus practically prohibiting such modifications. In an open declaration, they are once again asking the European Parliament and the European Commission for legislative change so that they can properly conduct research for the benefit of agriculture, the economy and society in general. A first statement by scientists warning of the negative impacts of the ban on society and the economy was released in autumn 2018.

According to Dirk Inzé, the initiator of the open statement and scientific director of the Centre for Plant Systems Biology in Ghent, this year’s statement is one of few examples where the scientific community has mobilized across the European Union and called for a revision of European legislation affecting genome editing. “The initiative has already been joined by 121 leading European institutions, and this topic is also beginning to resonate among politicians at both European and national levels. Our effort is supported by most ministries of agriculture across the European Union. It is now necessary to act at European Parliament level,” Dirk Inzé said.

The Czech Republic stands behind the statement. Representatives of scientific institutions and universities as well as heads of relevant institutes of the Czech Academy of Sciences have signed the document.

“We generally support these new methods, provided that the results of such plant and animal breeding are not patented. The reason is that we protect small and medium-sized Czech breeding companies so that their breeders can continue to use the breeding material in the creation of new varieties,” Czech Minister of Agriculture Miroslav Toman said in a press release issued by scientists.

According to Karel Říha, Deputy Director for Research at the CEITEC Institute in Brno and himself a researcher in plant genetics, there is a risk that the EU will lose its important position in research on an international level. Moreover, the European Union is surrounded by an ever-increasing number of countries that are much more receptive and open to genomic editing. “The ruling of the European Court of Justice de facto means a shift in the focus of research outside Europe and thus a loss of control of this progressive technology, by which we will or will not significantly shape new approaches in agriculture and medicine,” said Říha. He believes that plant breeding can contribute significantly to the development of new crop varieties that are less susceptible to pathogens and more resistant to drought. “This will allow farmers to increase their yields while reducing the use of chemicals and water,” he added.

In response to the current legislation of the Court of Justice of the EU, last December scientists from the Centre of the Region Haná for Biotechnological and Agricultural Research (CRH) called on the Prime Minister and other Czech politicians to push for changes in European legislation on genetically modified crops. According to CRH director Ivo Frébort and scientific director Jaroslav Doležel, there is concern that this position could permanently harm European countries. “While there are more and more countries in the world that allow these modern technologies, Europe remains fixed in its approach. This increases the gap between it and progressive countries every month. This may have a very negative impact on European agriculture, food production and quality, as well as on the environment.”

Read more in: Facilitate authorization of GMOs in Europe, Czech scientists are demanding

OPEN STATEMENT IN ORIGINAL VERSION
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Open Statement
European scientists urgently reach out to the newly elected European Parliament and European Commission to enable the potential of genome editing for sustainable agriculture and food production.

European agriculture can make considerable contributions to the UN Sustainable Development Goals. Precision breeding methods like genome editing with CRISPR are innovative tools that have the potential to help reach these goals in a faster and more efficient way.

The current interpretation of the European legislation (case C-528/16) prevents the use of genome editing for sustainable agriculture and food production in the EU.

A small revision of the European legislation will harmonize it with the legal framework in other nations and enable European scientists, breeders, farmers and producers to include genome editing as one of their tools to meet the future challenges of sustainable development.

Our planet is facing unprecedented challenges because of a rising, more affluent world population, while biodiversity is diminishing at an alarming pace and the average temperature on earth continues to rise. To meet these global challenges and others, we will have to shift our mentality and lifestyle, to increase investments in knowledge creation and facilitate the use of innovative technologies.

This also means that agriculture and food production must become more sustainable. The environmental footprint of agriculture has to diminish and farming has to adapt to the rapidly-changing climate. Drought is one of the major factors that is threatening crop yields. We are witnessing this today in Europe. All possible approaches are required to meet these challenges. Plant breeding can make a substantial contribution by developing new crop varieties that are less susceptible to pathogens and are more resilient to drought. This will enable farmers to produce high yields while decreasing the use of chemicals and water.

To develop these varieties, scientists and plant breeders must have access to the widest possible array of breeding tools. The most recent addition to the toolbox is precision breeding with CRISPR. It allows scientists and breeders to develop desired crop varieties in a faster, relatively simple and much more directed way compared to previous breeding techniques. Scientists and breeders in the EU should be enabled to use precision breeding techniques with CRISPR to contribute to a more sustainable agriculture and food production.

Fungicides no longer needed for wheat cultivation thanks to precision breeding
Scientists have used modern precision breeding techniques to develop a mildew resistant wheat variety. In only a single step they introduced a small alteration into the so-called MLO gene that confers resistance to powdery mildew. This type of alteration of the MLO gene already exists in nature but is very difficult and time consuming to introduce via conventional breeding approaches. This is a clear example that shows how innovative methods like CRISPR can significantly accelerate the introduction of beneficial properties into crops. The cultivation of the MLO wheat does not require the application of fungicides to prevent disease, thus making it more sustainable.

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Exactly one year ago, on the 25th of July 2018, the European Court of Justice (ECJ) ruled that plants obtained by precision breeding techniques like CRISPR are genetically modified organisms (GMOs) which, in contrast to the products of much less precise mutation breeding techniques, are not exempt from the GMO legislation. As of consequence, even crops with the smallest CRISPR-mediated alteration, which can also arise spontaneously in nature, are subjected to these provisions. This is highly problematic as the European GMO legislation presents an unreasonable regulatory threshold affecting research institutes and small breeder companies. It is simply too complicated and too expensive to comply with.

The EU GMO legislation, issued in 2001, no longer correctly reflects the current state of scientific knowledge. There are no scientific reasons to consider genome-edited crops differently than conventionally-bred varieties that have similar alterations. Plants that have undergone simple and targeted genome edits by means of precision breeding and which do not contain foreign genes are at least as safe as varieties derived from conventional breeding techniques.

The consequence of the ECJ ruling is that the use of precision breeding techniques like CRISPR are becoming the privilege of a select group of large multinational companies to exploit it in large cash crops. Consequently, the inability to market genome edited crops in Europe will cause a chilling effect on the investments in R&D in the European breeding sector. The result will be that the further development of beneficial varieties in a faster and much more directed way will be halted in Europe, while the rest of the world embraces the technology.
The EU GMO legislation differs from the legislation in many other nations. These countries apply legislation which is more adapted to the current state of scientific knowledge, excluding plants that have alterations that could also occur naturally or result from conventional breeding activities. In other words, in these countries genome-edited plants are not subjected to the GMO legislation, enabling scientists and breeders to use genome editing for a more sustainable agriculture and food production.
The difference in regulatory approach will likely lead to disruptions of international trade and have consequences for food security in Europe. As stated before, small alterations introduced by precision breeding also arise spontaneously in nature. Therefore, it is not possible to determine the origin of such small alterations implying that the current EU GMO legislation cannot be enforced on imported products. A small revision of the European legislation, by means of harmonizing the legal framework with the other countries of the world, is vital to enable European scientists and breeders to use precision breeding methods like CRISPR as one of the tools to meet the global challenges of sustainable development. It will unlock scientific progress to help provide solutions to the current challenges we are facing.

The European scientific community, signatory to this Open Statement, urgently calls upon the European institutions including the European Council, the new European Parliament and the upcoming European Commission to take appropriate legal action to enable European scientists and breeders to apply genome editing for sustainable agriculture and food. The ability to use genome editing is crucial for the well-fare and food security of European citizens.

EU maintains a high standard in food safety and the environment
It is important to note that not being subject to GMO legislation does not mean that such crops and foods are not regulated. There is general food safety legislation that prescribes that foods introduced onto the European market must be safe, and there is environmental legislation that will hold market players liable in case they would introduce crops into the environment that cause damage to biodiversity and protected habitats.