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EU genetically edited plants at legal limbo

Plant geneticist Stefan Jansson is champing at the bit to start field trials on crops tweaked with powerful gene-editing technologies. He plans to begin by using edits to study how the cress plant Arabidopsis protects its photosynthetic machinery from damage in excessively bright light.

But the future of his work depends on the European Commission’s answer to a legal conundrum. Should it regulate a gene-edited plant that has no foreign DNA as a genetically modified (GM) organism?

Jansson, who works at Umeå University in Sweden, says that he will drop his experiments if the plants are classed as GM, because Europe’s onerous regulations would make his work too expensive and slow. He and many others are anxiously awaiting the commission’s decision, which will dictate how they approach experiments using the latest gene-editing techniques, including the popular CRISPR–Cas9 method.

The commission has repeatedly stalled on delivering its verdict, which will apply to edited animals and microorganisms as well as plants. It now says that it will make its legal analysis public by the end of March. Swedish authorities, meanwhile, have told Jansson that unless the commission specifies otherwise, they will not require his cress to be subject to GM regulations.

GENETIC EDITING

The legal limbo is having a big impact on research, says René Smulders of the plant-breeding division at Wageningen University and Research Centre in the Netherlands. He says that this year, he was rejected for a European Union grant —on changing the composition of a plant’s oils by editing a gene— because referees were concerned about the legal uncertainty. “Some scientists hesitate to start using the new methods in case they end up being regulated and their research projects hit a dead end,” he says.

At issue is the interpretation of a 2001 European Commission directive on releasing GM organisms into the environment, which covers field trials and cultivation. It defines GM organisms as having alterations that cannot occur naturally, which were made by genetic engineering.

What is unclear is how this relates to experiments, such as Jansson’s, in which researchers introduce foreign DNA to direct a precise edit in a plant’s own genetic material but then use selective breeding to remove the foreign gene. The final plant has a few tweaked nucleotides, but cannot be distinguished from a wild plant that might have acquired the same mutation naturally — so it cannot be traced in the environ­ment as EU regulations require.

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12/20/2015 - Nature.com



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