By Randy Gordon, President
In a widely anticipated development, the European Union Court of Justice is scheduled to issue a decision on July 25 on whether the use of genetic mutation (mutagenesis) – better known as “gene editing” – should be differentiated from the European Union’s extensive regulations governing genetically modified organisms, such as transgenic biotechnology.
The case [Case C-528/16] currently before the European court was brought by nine French agricultural associations – led by a group called Confédération paysanne, a French agricultural union – that are asking the court to limit the current EU exemption for plant varieties obtained through mutagenesis to conventional breeding techniques, rather than to gene-editing techniques such as CRISPR/Cas9 and other plant breeding tools that more quickly, efficiently and cost-effectively replace or relocate DNA gene sequences in a plant.
A signal on how the court may rule occurred when its advocate general, Michal Bobek, issued a preliminary ruling on Jan. 18 that organisms produced through mutagenesis should be exempt from the EU’s GMO rules if they do not contain foreign DNA from outside the plant’s genus. Bobek stated that determining whether a given mutagenesis technique is exempt from the EU’s GMO regulations should be based on whether the technique “involves the use of recombinant nucleic acid molecules or GMOs other than those produced by mutagenesis or cell fusion of plant cells of organisms which can exchange genetic material through traditional breeding methods.” [Emphasis added.]
However, Bobek’s opinion also said that by inserting a mutagenesis exemption in EU law, the EU legislature did not wish to regulate the matter at the EU level, leaving flexibility for individual EU member states to legislate such technology separately, so long as such legislation complies with their overall obligations under EU law. Bobek’s full 22-page opinion is available here.
The advocate general’s view is not binding on the court, but observers indicate it usually is followed by the judges. The EU court’s ruling is being watched closely by other countries that are starting the process of deciding whether or how to provide regulatory oversight of gene-edited plant biotechnology.