The European Union Court of Justice ruled on July 25, 2018, that organisms obtained by mutagenesis are GMOs and are, in principle, subject to the obligations laid down by the GMO Directive.
What is mutagenesis?
Mutagenesis refers to the origin and development of a genetic mutation, which occurs either naturally or spontaneously, according to the Biology Online Dictionary. It is also about the process in which the nucleotide sequence of the gene or the chromosome changes, resulting in a mutation.
Mutagenesis as a scientific discipline was developed from the works of Hermann Muller, Charlotte Auerbach and J. M. Robson in the first half of the 20th century.
Mutagenesis techniques have made it possible to develop seed varieties that are resistant to select herbicides.
What is the GMO Directive?
The directive, modified as of March 2018, sets out the requirements for the environmental risk assessment of GMOs.
What did the European Court of Justice say in their decision?
Here are 3 points from the decision:
- Organisms obtained by mutagenesis are GMOs within the meaning of the GMO Directive.
- Organisms obtained by mutagenesis are, in principle, within the scope of the GMO Directive and are subject to the regulations in that directive.
- Organisms obtained by mutagenesis techniques that have been used in a number of applications and have a long safety record are exempt from the GMO Directive regulations, however member states are free to apply them in compliance with EU law to the regulations in the directive.
Who brought the challenge?
Confederation paysanne, a French agricultural union that defends the interests of small-scale farmers, and eight other associations joined to bring an action before the French State Council to challenge the French legislation exempting organisms obtained by mutagenesis from the obligations imposed on GMOs by the directive.
The Confederation argued that mutagenesis techniques have changed over time from in vivo to in vitro. It argues that herbicide-resistant seed varieties carry a risk of significant harm to the environment and to human and animal health in the same way as GMOs obtained by transgenesis.
Agriculture Secretary Sonny Perdue has this to say:
“Government policies should encourage scientific innovation without creating unnecessary barriers or unjustifiably stigmatizing new technologies. Unfortunately, this week’s ECJ ruling is a setback in this regard in that it narrowly considers newer genome editing methods to be within the scope of the European Union’s regressive and outdated regulations governing genetically modified organisms,” he said. "We encourage the European Union to seek input from the scientific and agricultural communities, as well as its trading partners, in determining the appropriate implementation of the ruling.”