The Court of Justice of the European Union has highlighted the fact that failing to classify mutagenesis (purposeful changes in DNA) as genetic engineering is a backdoor way of allowing GMOs (genetically modified organisms) without labeling them as such. The court issued an opinion on July 25, saying, “Organisms obtained by mutagenesis are GMOs [genetically engineered organisms] and are, in principle, subject to the obligations laid down by the GMO directive.” Although the opinion does not apply to techniques that “have been conventionally used in a number of applications and have a long safety record,” the court says that member states may subject even those organisms to the obligations of the GMO or other directives. The court finds that the risks of new mutagenesis techniques, may yield results –and risks— similar to those of transgenesis (introducing genes from other organisms), and should thus be regulated as genetically engineered organisms.
This issue is one on which the Agricultural Marketing Service (AMS) of the U.S. Department of Agriculture requested comment during an informal comment period that ended July 17. Given the importance of the EU Court finding for consumer transparency and international trade, AMS must consider the ruling in defining “bioengineering” (genetic modification) for the purposes of labeling GMO food produced in the U.S. It must also consider it in developing regulations and policies governing the National Organic Program.
The opinion of the Advocate General of the EU Court of Justice states, “For the Applicants, the use of herbicide resistant seed varieties obtained by 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. 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.”