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The type and extent of genetic modifications obtained by SDN-1 and SDN-2 approaches are similar to what can be obtained by chemical mutagenesis, by irradiation or by spontaneous natural mutations, and are not distinguishable from them. The genetic modifications are a result of the cellular DNA repair mechanisms of the host that can also occur naturally.
Off-target changes induced by SDN-1 and SDN-2 approaches of the CRISPR/Cas9 system are of the same type as those changes produced by conventional breeding techniques, therefore not raising additional safety concerns. Moreover, unintended mutations in plants can be segregated away during the selection and breeding process.
SDN-1 or SDN-2 applications of the CRISPR/Cas9 system can be considered as a refinement of the conventional mutagenesis (using chemicals or ionizing radiation), with an increased specificity and fewer unintended effects.
The SBB is of the opinion that the following genetic modifications induced by the CRISPR/Cas9 system can be considered similar in type and extent to those that can be obtained via natural or induced (using chemical or physical agents) mutagenesis and therefore can be considered as a form of mutagenesis:
- Genetic modifications induced in plants and animals by the transient presence of the CRISPR/Cas9 system delivered as purified ribonucleoprotein with or without a homologous repair DNA template
- Genetic modifications induced in plants by the delivery of a T-DNA cassette encoding the components of the CRISPR/Cas9 system followed by its subsequent out-segregation out of the resulting plant
In case these SDN-1 and SDN-2 approaches are used to induce mutations that do not go beyond small nucleotide deletions and/or insertions, the SBB is of the opinion that these forms of mutagenesis using the CRISPR/Cas9 system in plants and animals (as described in A and B) provide for increased specificity and lead to fewer unintended effects compared to conventional mutagenesis techniques.
The SBB also considers that mutagenesis induced by the transient presence of components of the CRISPR/Cas9 system (as described in A) is a technique of genetic modification that does not involve the use of recombinant nucleic acid molecules or genetically modified organisms in the meaning of the chapeau of Annex I B of the Belgian Royal Decree on GMOs of 21 February 2005 (Annex I B of Directive 2001/18/EC or Annex II Part A of Directive 2009/41/EC).
Therefore the SBB considers that the exclusion from the scope of the GMO legislation should apply to:
- all uses (with or without specific containment measures) involving genetically modified plants obtained as described in A;
- all uses (with or without specific containment measures) involving genetically modified plants obtained as described in B;
- genetically modified animals obtained as described in A when used as models for research & development under containment.
In cases where genetically modified animals are used in commercial breeding programs, the SBB considers that the exclusion from the scope of the GMO legislation should only be granted on a case-by-case basis following a preliminary risk assessment, given the lack of history of use of mutagenesis techniques in these cases.