Existing guidance appropriate for assessment of genome editing in plants

Genome editing techniques that modify the DNA of plants do not pose more hazards than conventional breeding or techniques that introduce new DNA into a plant, an EFSA assessment concludes.

The scientific opinion focuses on plants produced using different genome editing techniques: site-directed nuclease-1 (SDN-1), site-directed nuclease-2 techniques (SDN-2) and oligonucleotide-directed mutagenesis (ODM). These differ from site-directed nucleases-3 (SDN-3), which was assessed by EFSA in 2012, because they modify a specific region of the genome without introducing new DNA.

Experts concluded that the existing guidance for risk assessment of genetically modified plants is applicable for the evaluation of the three new techniques. However, fewer data for the risk assessment might be needed due to the absence of new DNA.

Genome editing changes the DNA of animals, plants and microorganisms with high precision. The technology has a wide range of applications – from new therapies for cancer and inherited diseases, to increasing the muscle mass of livestock.

It can also be used to produce plants with desired traits, such as disease resistance, drought tolerance, or enhanced nutritional profiles. However, there is a societal concern genome editing may lead to adverse effects to human health and the environment.

Currently, in the EU genome edited organisms are required to undergo a safety assessment according to the provisions laid down in the GMO legislation before being authorised.

Acknowledging the need for adequate risk assessment guidelines before these plants are considered for deployment in the European Union, the European Commission asked EFSA to assess whether its guidelines for the risk assessment of genetically modified plants can be used for the risk assessment of plants produced with ODM, SDN-1 and SDN-2.

The scientific opinion will also inform the ongoing Commission’s ongoing study on new genomic techniques.

Earlier this month EFSA published a scientific opinion on genetically modified insects containing gene drives, a closely related technology.