VIEWPOINT

SETBACK FOR GENE EDITING

European lawyers have ruled that a crop whose performance has been altered by a modern genome technique must pass the same checks as GM crops that include foreign genes.

  • 25
  • JUL
  • 2018

The Court of Justice of the European Union (CJEU) today released its long-awaited judgement regarding the scope of an existing European Directive, from March 2001, that controls the release into the environment of genetically modified organisms (GMOs).

The judgement follows an opinion from one of the court’s advocate generals, published in January, on a case brought by a French agricultural union and others against French legislation that exempts organisms obtained by mutagenesis from the obligations of the GMO Directive.

The French state, in the form of its highest legislative body for administrative justice, the Conseil d’État, sought advice from the CJEU in interpreting the scope of the GMO Directive. The Conseil d’État submitted its application to the court in October 2016.

Unlike transgenesis, notes a press statement from the CJEU, mutagenesis techniques make it possible to alter the genome of a living species without the insertion of foreign DNA. Such a technique enables, in this case, seeds to be developed that are resistant to selective herbicides.

The plaintiffs argue, records the CJEU statement, that the use of herbicide-resistant seed varieties carries a risk of significant harm to the environment and to human and animal health, in the same way as GMOs obtained by transgenesis [which is controlled by the GMO Directive].

“It is in this context that the Court of Justice has been requested by the Conseil d’ État to determine, in essence, whether organisms obtained by mutagenesis are GMOs and whether they are subject to the obligations laid down by the GMO Directive,” says the CJEU statement.

And the court has judged that they do, in what is known as a “reference for a preliminary ruling”, which allows the courts and tribunals of the EU’s Member States, in disputes that have been brought before them, to refer questions to the CJEU about the interpretation of EU law.

This interpretation does not require endorsement from any other European body. According to the CJEU statement: “The Court of Justice does not decide the dispute itself. It is for the national court or tribunal to dispose of the case in accordance with the Court’s decision, which is similarly binding on other national courts or tribunals before which a similar issue is raised.”

“In today’s judgment,” the CJEU statement notes, “the Court of Justice takes the view, first of all, that organisms obtained by mutagenesis are GMOs within the meaning of the GMO Directive, 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. It 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.

“The Court states, however, that it is apparent from the GMO Directive that it does not apply to organisms obtained by means of certain mutagenesis techniques, namely those which have conventionally been used in a number of applications and have a long safety record. The Court nevertheless specifies that the Member States are free to subject such organisms, in compliance with EU law (in particular the rules on the free movement of goods), to the obligations laid down by the GMO Directive or to other obligations. The fact that those organisms are excluded from the scope of the 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 Member States are thus free to legislate in this area in compliance with EU law, in particular with the rules on the free movement of goods.

“With regard to the question whether the GMO Directive may also be applicable to organisms obtained by mutagenesis techniques that have emerged since its adoption, the Court considers that the risks linked to the use of these new mutagenesis techniques might prove to be similar to those that result from the production and release of a GMO through transgenesis, since the direct modification of the genetic material of an organism through mutagenesis makes it possible to obtain the same effects as the introduction of a foreign gene into the organism (transgenesis) and those new techniques make it possible to produce genetically modified varieties at a rate out of all proportion to those resulting from the application of conventional methods of mutagenesis. In view of these shared risks, excluding organisms obtained by new mutagenesis techniques from the scope of the 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 which that directive seeks to implement. It follows that the GMO Directive is also applicable to organisms obtained by mutagenesis techniques that have emerged since its adoption.

“Finally, the Court examines the question whether genetically modified varieties obtained by mutagenesis must fulfil a condition laid down by another EU directive, according to which a genetically modified variety may be accepted for inclusion in the ‘common catalogue of varieties of agricultural plant species the seed of which may be marketed’ only if all appropriate measures have been taken to avoid risks to human health and the environment. The Court considers that the concept of ‘genetically modified variety’ must be construed as referring to the concept of a GMO in the GMO Directive, with the result that varieties obtained by mutagenesis that come under that directive must fulfil the condition mentioned above. By contrast, varieties obtained by means of mutagenesis techniques that have conventionally been used in a number of applications and have a long safety record are exempt from that obligation.”

Here is the CJEU ruling: http://ow.ly/jC1H30l89LN
Here is the CJEU statement: http://ow.ly/tQdl30l89GU
Here is the Advocate General’s opinion: http://ow.ly/XaY730l89BC
Here is the Application to the CJEU: http://ow.ly/hDL130l9vDj

Comment from Rothamsted Research

Nigel Halford, Crop Scientist
“This is highly unusual in that the ruling appears to have ignored the opinion of the Advocate General and scientific advice and the pleas of multiple agricultural biotech organisations and taken a decision to keep the NGOs sweet. The decision could set agbiotech in Europe back another 20 years. We are already a generation behind. Young scientists interested in agbiotech are likely to move to places where common sense and scientific evidence prevail.”

Johnathan Napier, Plant Biotechnologist
“This is a very disappointing outcome, and one that will hinder European innovation, impact and scientific advance. The classification of genome-edited organisms as falling under the GMO Directive could slam the door shut on this revolutionary technology. This is a backward step, not progress.”

Achim Dobermann, Director and Chief Executive
“This is a disappointing judgement by the European Court of Justice. European farmers are already losing out, and now risk falling further behind the rest of the world with this decision. Let’s hope other regions, outside Europe, do not follow suit and that the UN’s Sustainable Development Goals can still be achieved so that there are many fewer hungry people in the world by 2030.”

Comment from elsewhere

Nature: http://ow.ly/6lJB30l9xxo
BBC News: http://ow.ly/4ESa30l9xsn
MIT Technology Review: http://ow.ly/kLGn30l9xlZ
Science Media Centre: http://ow.ly/RZpL30l9xd5

For more information, please contact: Susan Watts, Head of Communications | email: susan.watts@rothamsted.ac.uk | tel: +44 (0) 1582 938 109 | mob: +44 (0) 7964 832 719

About Rothamsted Research
Rothamsted Research is the longest-running agricultural research institute in the world. We work from gene to field with a proud history of ground-breaking discoveries, from crop treatment to crop protection, from statistical interpretation to soils management. Our founders, in 1843, were the pioneers of modern agriculture, and we are known for our imaginative science and our collaborative influence on fresh thinking and farming practices.
Through independent science and innovation, we make significant contributions to improving agri-food systems in the UK and internationally. In terms of the institute’s economic contribution, the cumulative impact of our work in the UK was calculated to exceed £3000 million a year in 20151. Our strength lies in our systems approach, which combines science and strategic research, interdisciplinary teams and partnerships.
Rothamsted is also home to three unique resources. These National Capabilities are open to researchers from all over the world: The Long-Term Experiments, Rothamsted Insect Survey and the North Wyke Farm Platform.
We are strategically funded by the Biotechnology and Biological Sciences Research Council (BBSRC), with additional support from other national and international funding streams, and from industry. We are also supported by the Lawes Agricultural Trust (LAT).
For more information, visit https://www.rothamsted.ac.uk/; Twitter @Rothamsted
1Rothamsted Research and the Value of Excellence: A synthesis of the available evidence, by Séan Rickard (Oct 2015)

About BBSRC
The Biotechnology and Biological Sciences Research Council is part of UK Research and Innovation, a non-departmental public body funded by a grant-in-aid from the UK government.
BBSRC invests in world-class bioscience research and training on behalf of the UK public. Our aim is to further scientific knowledge, to promote economic growth, wealth and job creation and to improve quality of life in the UK and beyond.
Funded by government, BBSRC invested £469 million in world-class bioscience in 2016-17. We support research and training in universities and strategically funded institutes. BBSRC research and the people we fund are helping society to meet major challenges, including food security, green energy and healthier, longer lives. Our investments underpin important UK economic sectors, such as farming, food, industrial biotechnology and pharmaceuticals.
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About LAT
The Lawes Agricultural Trust, established in 1889 by Sir John Bennet Lawes, supports Rothamsted Research’s national and international agricultural science through the provision of land, facilities and funding. LAT, a charitable trust, owns the estates at Harpenden and Broom's Barn, including many of the buildings used by Rothamsted Research. LAT provides an annual research grant to the Director, accommodation for nearly 200 people, and support for fellowships for young scientists from developing countries. LAT also makes capital grants to help modernise facilities at Rothamsted, or invests in new buildings.