Existing guidance appropriate for gene editing assessment, says EFSA

Experts concluded that the existing guidance for risk assessment of genetically modified plants is applicable for the evaluation of the three new techniques explored in the opinion. [SHUTTERSTOCK]

Genome editing does not pose any additional hazards compared to conventional breeding or other genetic modification methods, meaning that existing guidance is adequate for their assessment, the European Food Safety Agency (EFSA) has concluded.

EFSA’s latest scientific opinion, published on Wednesday (24 November), focuses on plants produced using different genome editing techniques, including oligonucleotide-directed mutagenesis and two kinds of site-directed nucleases.

These techniques modify a specific region of the genome but, unlike traditional genetic modification (GM), do not introduce foreign DNA.

The opinion was requested by the European Commission, who asked EFSA to assess whether its guidelines for the risk assessment of GM plants can be used for the risk assessment of plants produced using these techniques.

Experts concluded that the existing guidance is applicable for the evaluation of the three new techniques.

In fact, EFSA concluded that fewer datasets may be needed for the risk assessment compared to other GM techniques given the absence of new DNA.

EU health chief wants more information on gene editing

The new EU Health Commissioner Stella Kyriakides wants more information about the controversial issue of gene editing and for now, she seems less enthusiastic than her predecessor Vytenis Andriukaitis.

Gene editing is used to introduce changes into the DNA of animals, plants and microorganisms.

Proponents of the technology argue it has a wide range of applications, ranging from new therapies for cancer and inherited diseases, to introducing tolerance to pests or drought in plants.

In accordance with the GMO Directive, gene-edited organisms are currently required to undergo a safety assessment according to the provisions laid down in the GMO legislation before they can be authorised.

“We welcome that EFSA follows the scientific consensus in differentiating between transgenic and non-transgenic organisms and concludes that no additional guidance documents are needed,” biotechnology industry representatives EuropaBio told EURACTIV.

“Europabio has repeatedly pointed out that organisms with no foreign genes, whether they originate from genome editing or other breeding approaches, should not (continue to) be treated like transgenic organisms,” they added.

However, gene editing remains a controversial technology, with much concern that its deployment may adversely affect human health and the environment.

“With this new advice, EFSA is just muddying the waters. Contrary to what they state, gene editing causes hazards that are new and different from conventional breeding,” warned Green MEP Tilly Metz.

“It is well-documented that gene editing leads to both wanted and unwanted changes in the genome, and that these changes can make a product toxic or harmful to the environment. These potentially dangerous effects cannot just be brushed off, they need to be seriously examined,” said Metz.

She added that this advice “doesn’t inspire confidence” that EFSA will do a thorough job at assessing the safety of gene-edited crops.

“Parliament’s objections already highlight gaps in EFSA’s risk assessments when it comes to old-style GMOs, so it is disappointing and irresponsible that EFSA should not be paying greater attention to the specific risks of gene editing to consumer safety and the environment, as it is supposed to,” she stressed.

The opinion will now inform the Commission’s ongoing study on new genomic techniques, which is intended to clarify the situation regarding the technology after the 2018 European Court of Justice ruling that gene-edited organisms, in principle, fall under the scope of the EU GMO directive.

EU study to clarify gene editing court ruling further muddies waters

After the European Court of Justice (ECJ) ruling that organisms obtained by new plant breeding techniques (NBTs) should, in principle, fall under the GMO Directive, the Council of the EU has requested a study from the Commission to clarify the situation. But what this means in practice remains unclear.

[Edited by Benjamin Fox]

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