By Randy Gordon, President; and Sarah Gonzalez, Director of Communications and Digital Media
The European Union (EU) Court of Justice, in a highly anticipated decision issued July 25, ruled that genetic mutation (mutagenesis) of organisms – better known as “gene editing” – is subject to the EU’s extensive regulations governing genetically modified organisms (GMOs).
The case [Case C-528/16] was brought by nine French agricultural associations – led by a group called Confédération paysanne, a French agricultural union – that asked 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. Confédération paysanne specifically alleged that mutagenesis techniques used to develop herbicide-resistant seed varieties pose a “risk of significant harm” to the environment and human and animal health, in the same way as GMOs that involve the insertion of a foreign gene (i.e., transgenic biotechnology).
In the decision, the EU Court of Justice ruled:
- Organisms obtained through mutagenesis (gene-editing) are GMOs within the meaning of the EU’s GMO directive issued in March 2001, “in so far as the techniques and methods of mutagenesis alter the genetic material of an organism in a way that does not occur naturally.” In a statement issued by the court, it said, “[I]t follows that those organisms come, in principle, within the scope of the GMO directive and are subject to the obligations laid down by that directive.” [Emphasis in original.]
- The GMO directive does not apply to organisms obtained by means of certain mutagenesis techniques, specifically those that have conventionally been used in a number of applications and have a long safety record. According to the International Seed Federation (ISF), these “classical” types of mutagenesis techniques include random mutagenesis methods involving chemical or radiation-induced changes in the gene sequence of an organism. However, the court said individual EU-member states are free to subject even these conventionally used organisms to the obligations contained in the GMO directive or other EU rules. “The fact that those organisms are excluded from the scope of the (GMO) directive does not mean that the persons concerned may proceed freely with their deliberate release into the environment or with their placement on the market within the EU,” the court-issued statement read.
- The risks potentially linked to the use of new mutagenesis techniques “might prove to be similar” to those posed by the production and release of transgenic GMOs, “since the direct modification of the genetic material in an organism through mutagenesis makes it possible to obtain the same effects as the introduction of a foreign gene into the organism and those new techniques make it possible to produce genetically modified varieties at a rate “out of proportion” to those resulting from the application of conventional breeding,” the EU court-issued statement said. “In view of these shared risks, excluding organisms obtained by new mutagenesis techniques from the scope of the (EU) GMO directive would compromise the objective pursued by that directive, which is to avoid adverse effects on human health and the environment, and would fail to respect the precautionary principle…”
- Finally, the court found that organisms developed through mutagenesis must be reviewed for safety for human and animal health and the environment before being categorized as available for marketing within the EU. By contrast, the court ruled, varieties obtained through mutagenesis techniques that have been used conventionally in a number of applications that have a long history of safe use (i.e., the “classical” techniques referenced in #2) are exempt from this requirement.
The EU court’s ruling was a significant setback for organizations seeking to have global governments either exempt from regulatory oversight new plant breeding innovation techniques like gene editing (so long as no foreign DNA is introduced from outside the plant’s genus), or to have such techniques subjected to regulatory oversight only under certain conditions based upon the extent of gene-editing used.
Seed industry organizations responded by criticizing the EU court for basing its decision “almost entirely on the breeding process (technology) involved,” and not differentiating between product categories based upon the final outcome of those processes. The seed groups also noted that the court ruling was an interpretation of existing EU law, and not a scientific assessment of the safety of plant breeding innovation technology. But they conceded that the ruling means it is unlikely any European country will be willing to approve products obtained by targeted mutagenesis without subjecting the organism to the rigorous and cumbersome EU regulatory process that currently applies to transgenic biotechnology, and that national cultivation bans for GMOs enacted by 19 of the 27 remaining EU-member states likely will be imposed on gene-edited crops.
“Even very small improvements made to a plant would be subject to burdensome regulation under the court’s definition,” the American Seed Trade Association (ASTA) stated. “This would be a huge blow to the continuing evolution of plant breeding innovation and the tremendous promise it holds for a more sustainable and secure global food production system.”
In its analysis of the decision, ASTA’s international counterpart – ISF – said, “This means product authorizations would be subjected to the same dysfunctional EU GM approval system.” ISF added that the ruling will have “significant negative economic and environmental consequences for Europe,” noting that breeders and farmers in other parts of the world “can go ahead with these innovations without unnecessary overregulation.”
Meanwhile, environmental activists like Friends of the Earth applauded the court’s decision, while calling for all products made through gene editing to be regulated and labeled.