On July 25, when the European Court of Justice (ECJ), the European Union's highest court, issued its ruling on directed mutagenesis, stakeholders and observers in the industry, academic, science and government arenas responded with a combination of shock and confusion.
In short, the ECJ ruled that organisms obtained by directed mutagenesis – a set of genome editing techniques, such as CRISPR, which make it possible to alter the genome of a living species without the insertion of foreign DNA – are GMOs and are subject to the obligations laid down by the GMO directive.
The Court's decision runs counter to the preliminary opinion of the ECJ's own Advocate General issued earlier this year. It is also contrary to the views taken by scientists and most regulatory bodies outside of Europe. Ultimately this action represents a severe obstacle to research and development of innovative food, agricultural and environmentally beneficial products derived from genome editing techniques.
"It is now likely that much of the potential of these innovative methods will be lost for Europe – with significant negative economic and environmental consequences. That strikes a serious blow to European agriculture and plant science.", says Garlich von Essen, European Seed Association Secretary General.
If there was any doubt about whether this ruling will have a chilling effect on future research, one only has to look at the reaction from more than a dozen EU-based scientists. Among them:
"This decision may negatively impact our ability to respond to the challenge of securing sufficient food for our growing population in a changing climate. It may also hinder the competitiveness of the EU's biotechnology sector." – Dr Nicola Patron, Head of Synthetic Biology, Earlham Institute.
"This will potentially impose highly onerous burdens on the use of genome editing both in agriculture and even in medicine, where the method has recently shown great promise for improving human health and well being." – Prof Denis Murphy, Professor of Biotechnology, University of South Wales.
Scientists here in the United States were also scratching their heads and dreading the global impact of such a ruling. Carl Zimmer quotes two in his New York Times article, "What Is a Genetically Modified Crop? A European Ruling Sows Confusion" i:
"You're not just affecting Europe, you're affecting the world with this decision." – Matthew Willmann, director of the Plant Transformation Facility at Cornell University
"I don't know why they are doing that…I was thinking, 'Do they have the right science advice?'" – Jennifer Kuzma, co-director of the Genetic Engineering and Society (GES) Center at North Carolina State University
Mark Lynas has more reaction from the science community in his blog, "Scientific community defeated by green groups in European court ruling on gene edited crops" beginning with that of Dr. Sarah Schmidt at the Institute for Molecular Physiology, Heinrich-Heine-Universität Düsseldorf, who described the ECJ ruling as "the deathblow for plant biotech in Europe."
Aside from a major blow to the research sector, for industry groups, the ruling could discourage investment in future technology development and deprive society of the tools needed to sustainably provide for our world.
Neal Gutterson is Chief Technology Officer, Corteva Agriscience, Agriculture Division of DowDuPont, explains in this post in Euractive:
"Subjecting all new breeding advances to regulatory review will stifle innovation and deprive European farmers and consumers of a range of important benefits. These include healthier vegetables, disease- and drought-resistant crops and locally produced replacements for palm oil, just to name a few."
United States Government officials are worried about how the ruling could impede trade.
"The global regulatory treatment of genome-edited agricultural products has strategic innovation and trade implications for U.S. agriculture," said U.S. Secretary of Agriculture Sonny Perdue in a statement on the ruling. "For this reason, USDA has clear science- and risk-based policies that enable needed innovation while continuing to ensure these products are safe. In light of the ECJ ruling, USDA will re-double its efforts to work with partners globally towards science- and risk-based regulatory approaches."
Questions remain about how the ruling will ultimately be interpreted and how the ruling will translate into policy. While science and innovation have taken a hit this time, there is hope that continued dialogue might yield some more positive results.
Secretary Perdue 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."
EuropaBIO's Secretary General John Brennan agrees that more discussion is desperately needed:
"Looking forward, EuropaBio believes that the next step, for the EU and its Member States, is to engage citizens in an inclusive and fact-based dialogue on what genome editing is, and what it will or will not be used for. It will be important to build knowledge, develop understanding and deliver risk-proportionate policy approaches, allowing innovation, which is already taking place in other parts of the world, to also benefit the EU's society, economy and the environment."
