Scientific Steering Committee
CRISPR and other genome editing techniques - implications for risk assessment
Report no: 2021:18
VKM concludes that the guidance prepared by the European Food Safety Authority (EFSA) on risk assessment of genetically modified organisms provides a functional framework for risk assessment of genome-edited organisms.
However, inclusion of specific considerations in the guidance regarding different properties of genome-edited organisms would be beneficial to ensure a common understanding between product developers and risk assessors regarding the type and extent of data needed to perform a risk assessment.
The development of genome-editing techniques, such as CRISPR, has revolutionized genetic engineering. In contrast to genetic modification, in which DNA fragments from other species are inserted at random sites in the genome of an organism, targeted changes in the genetic material can be made by genome editing.
In 2018, the European Court of Justice included genetically modified organisms in the definition of genetically modified organisms (GMOs). This means that the risk to health and the environment of genetically modified organisms is assessed within the same regulations as genetically modified organisms.
EFSA's guidelines for risk assessment of GMOs were developed before the new genome-editing techniques were available and is therefore originally developed to assess the risk of organisms that insertions of DNA fragments from other species.
The process of the evaluation
In order to assess whether EFSA's guidance is suitable for risk assessment of genome-edited organisms, VKM has used genome-edited plants, animals and microorganisms that are relevant to Norway as case examples.
Examples include agricultural plants which have an altered fatty acid profile, or which are resistant to diseases or tolerant to herbicides, sterile salmon, virus-resistant pigs and cows without horns.
VKM has assessed all aspects of the step-by-step approach described in EFSA's guidelines, and challenges related to health and environmental risk assessment of genome-edited organisms.
VKM has initiated the project. The report has been prepared in six broadly composed interdisciplinary project groups, consisting of both members of VKM and external experts.
The evaluation has been approved by VKMs Scientific Steering Committee.