(CN) – Assessing the already 17-year-old directive on genetically modified organisms, an EU magistrate found no issue Thursday with an exemption of certain genomic alterations, but said member states should be free to pass tighter restrictions.
Advocate General Michal Bobek issued the recommendation this morning in connection to a challenge by eight organizations that have taken issue with France’s application of the EU legislation known as the GMO Directive.
The 2001 law imposes strict labeling and monitoring obligations on producers of GMOs, but it includes an exemption for organisms that are produced by a technique called mutagenesis.
Mutagenesis does not involve the insertion of foreign DNA into a living organism — a hallmark of the transgenesis process — but it does involve alteration of the genome.
Confederation paysanne and the other French environmental groups are challenging the scheme, saying modern mutagenesis techniques are more sophisticated and should no longer benefit from any exemption.
Pointing to the role in mutagenesis in creating herbicide-resistant seeds, the groups say mutagenesis carries a risk of significant harm to the environment and to human and animal health.
“It leads to an accumulation of carcinogenic molecules or endocrine disruptors in cultivated plants intended for human or animal consumption,” Bobek wrote, summarizing the position of the challengers. “The Applicants refer, moreover, to the risks of unintentional effects, such as undesired or off-target mutations on other parts of the genome. They consider that this is the result of the techniques employed when modification of the genome takes place in vitro and for the regeneration of plants from the cells thus modified.”
When France’s prime minister ignored a request by the groups to revoke the exemption, they brought their challenge to France’s Council of State. This court in turn put the proceedings on hold and invited the European Court of Justice to weigh in.
Bobek said Thursday that the EU’s GMO Directive is limited for good reason.
“The exclusion simply meant that the EU legislature did not wish to regulate that matter at EU level,” he wrote. “That would then mean that that space remains unoccupied and, provided that the member states respect their overall EU law obligations, they can legislate with regard to organisms obtained by mutagenesis.”
Bobek noted earlier in the ruling that legal interpretations “must be dynamic.”
“It must react to the societal evolution, both technical and social,” he continued. “Moral categories evolve over time: ‘degrading treatment’ in 1818 likely meant something quite different to what it means in 2018. The same goes for the more technical definitions, such as that of a ‘vehicle’ or ‘means of communication’. The suggestion that the interpretation of such notions ought to be ‘frozen’ in the factual or societal circumstances that prevailed when those notions were passed into law would represent a singularly originalist approach to legal interpretation, not frequently encountered on this side of the Atlantic.” (Emphasis in original.)
Bobek noted that the problem with Confederations paysanne’s challenge is that the group is “effectively asking for … not an interpretation of the GMO Directive but a judicial redrafting of it.”
More specifically, Bobek continued, the group wants the scope of the mutagenesis exemption redrawn “against the wording of the legislation, seeking an insertion through a judicial medium of categories which are clearly not provided for in the legislation itself.”
Bobek said this proposition carries several practical problems that “only further underline why any such assessment has to be carried out by the expert legislator, and not by courts.”
“To mention but one in lieu of a conclusion: the criterion proposed by the Applicants for such judicial redrafting of the current rules was to include into the remodelled Annex I B only techniques which were safe and had already been routinely used in 2001,” the opinion states (emphasis in original). “However, how exactly would such techniques be defined? Could they in fact be identified? What about techniques which existed, were safe, but used only in selected laboratories (not routinely) in 2001? What if a technique which existed in 2001 was slightly modified in 2005, but the research foreshadowing that modification or extension had already been there since the 1980s? What about a technique which existed and was routinely used in 2001, was believed to be safe back then, but only later was found not to be entirely safe? Incidentally, could such later developments even be taken into account in a world where it is only the knowledge that existed at the time of the adoption of the law that ought to be relevant for its interpretation?”
Bobek offered a possible solution, recommending that the court uphold the exemption for “all organisms obtained by any technique of mutagenesis, irrespective of their use at the date of the adoption of that directive, on the condition that they do not involve the use of recombinant nucleic acid molecules or genetically modified organisms other than those produced by one or more of the [covered] methods.”