CRISPR is illegal
The European Court of Justice and Genome Editing
Maxim Rousseau, Polit.roo
The Court of Justice of the European Union has completed a lengthy review of the case and ruled that plants and animals created using genome editing technologies should be considered as genetically modified organisms. First of all, this means that the use of such animals and plants, as well as food products produced from them, must comply with the same rules that apply to other genetically modified organisms.
Previously, various legislative acts regarding GMOs were developed for transgenic organisms, in whose genome a DNA fragment was introduced, which they did not have and could not have in nature. Such a fragment (transgen) was taken from another species or synthesized artificially.
But in the last decade, genome editing methods have become increasingly widespread, which do not imply the introduction of someone else's DNA into the body, but only the correction of the existing one. They are based on the use of special proteins – restriction endonucleases (restrictases), which are able to cut the DNA chain at a given location. With their help, you can remove a fragment of DNA, and then sew a chain. The most popular of these methods is CRISPR-Cas9.
The use of genome editing methods without introducing transgenes into it did not fall under the restrictions imposed on working with GMOs in the legislations of most countries. For example, when in 2016, Professor of molecular biology Stefan Jansson from the University of Umeå, Sweden, decided to plant cabbage in his garden, whose genome was edited using the CRISPR-Cas9 method, he, as a law-abiding Swede, appealed to the Swedish Agriculture Council and received an answer that, since this cabbage does not contain foreign DNA, it is not considered a genetically modified plant, and special permission for experimental planting is not required. A similar response was received from the US Department of Agriculture by a scientist from the University of Pennsylvania, who is engaged in editing the genome of edible mushrooms.
The case of animals and plants with an edited genome was considered in the Court of the European Union for ten years. It was launched at the request of the French agricultural trade union Confédération Paysanne, whose representatives stated that the use of such a method would lead to the spread of plants potentially harmful to health. The court eventually agreed that for organisms obtained as a result of changes in the nucleotide sequence of DNA, the same restrictions are necessary as for transgenic organisms. The full text of the ruling is published on the court's website.
Perhaps the decision of the court members was influenced by a study published last week in Nature Biotechnology, according to which the CRISPR-Cas9 genome editing system still leads to the appearance of non-target mutations. The authors of the work found that at the point where the DNA chain breaks, there may be loss of chromosome sections (deletions), and when the chain reconnects, there may be transfers of DNA sections from other chromosomes or other genome rearrangements.
Scientists evaluate the decision negatively. Professor Jonathan Napier of the Rothamsted Research Agricultural Research Center called the court's ruling "a step backwards, not progress." According to him, it will hit innovation and scientific research in Europe and slam the door on revolutionary technologies.
Recall that since July 2016, a law has been in force in Russia prohibiting the cultivation of genetically modified plants and animals on the territory of the country, with the exception of scientific research. However, this law is based on the provisions of another law adopted back in 1996, and the definition of genetically modified organisms used in it allows both to include animals and plants with an edited genome in their number, and not to include them.
According to this law, "a genetically engineered modified organism is an organism or several organisms <...> that are different from natural organisms, obtained using genetic engineering methods and containing genetically engineered material, including genes, their fragments or combinations of genes." Whereas "genetic engineering" is defined by law as "a set of methods and technologies, including technologies for obtaining recombinant ribonucleic and deoxyribonucleic acids, for isolating genes from the body, manipulating genes and introducing them into other organisms."
Modern methods of genome editing, such as CRISPR-Cas9, include only the second of these actions (manipulation of genes) and do not include the isolation of genes from the body and their introduction into other organisms. Consequently, genome editing falls within the scope of the 1996 law and the 2016 law only with one understanding: when any of the listed actions, and not all three, serves as a sufficient condition for recognizing an organism as genetically modified.
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