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Navigating the European Court of Justice stance on GMOs

“The breeder’s dream is, of course, of an agency which would enable him to produce at will a particular kind of mutation uncontaminated by others which would merely be a nuisance to him….”

“There is as yet no indication from genetics of how, or even whether, this could be done… The dream of directed mutation as a tool in stock and crop improvement is still very much a dream”

These words were part of a lecture given by the well-known geneticist Kenneth Mather at the John Innes Institute in 1960. Now, after more than 50 years of research, his dream of directed mutation has become a reality.

So much so that the potential of these methods to modify the existing genome of plants and animals for the benefit of farming was included in a recent speech given by Michael Gove, the UK Secretary of State at the Department of Food and Rural Affairs, to the annual conference of the British National Farmers Union held in Birmingham.

However, whether this potential will be realized with the UK is very uncertain. This uncertainty is not based on any lack of progress with the basic science, but rather with the associated regulatory environment.

In the USA, and many other parts of the globe, gene editing is considered a form of directed mutation, just like Mather wished for in 1960, and not a form of genetic modification (GM). Indeed the list of gene-edited products that are under development in the USA and not deemed to be GM expands rapidly. The most recent example to be granted this non-GM status by the United States Department of Agriculture Animal and Plant Health Inspection Service (USDA APHIS: Am I Regulated Letter of Inquiry: USDA APHIS: Response) is gene-edited non-browning lettuce being developed by Intrexon and designed to reduce food waste.

In Europe, the regulatory situation is very different. In a well-known and far-reaching decision, the European Court of Justice announced in July 2018 that they considered the new breeding technique of gene-editing, despite its precision, should be regulated as a form of GM rather than mutagenesis. “Traditional” chemical or radiation induced mutagenesis were always excluded from the EU GM regulations (Annex 1B), and the ECJ decision allows this status to be maintained. Therefore precision and efficiency have been penalized.

Not surprisingly, this decision met with much criticism from the industry. For example, the European Seed Association Secretary General responded “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”.

More recently, in November 2018 the European Commission’s Chief Scientific Advisors published a statement on the regulation of gene editing, in which they concluded: “that the GMO Directive should be revised to reflect current knowledge and scientific evidence, and as part of a broad dialogue with relevant stakeholders and the public at large.”

Of course, the other dominant area of uncertainty is Brexit and whether perhaps the UK should use its new status (assuming an exit agreement is reached) to rewrite the regulations surrounding these new breeding techniques. The options for retaining the status quo or moving to a new legislative system post Brexit were considered in a report commissioned by the Agricultural Biotechnology and published in September 2019. This report explores the context of UK commercial agbiotech and gives a detailed analysis of the various future options.

To conclude, it is unlikely that any change in the EU legislation will take place in the near future, with a new EU Parliament and Commission due to be appointed later this year, and dependent upon the UK Brexit decision we will be bound by EU rules during any interim period prior to finally leaving. Notably, the WTO stance in this area, which they describe as “precision biotechnology” supports the US position.

A useful summary of the several issues raised above can be found here.

 

Jim Dunwell is Professor in the School of Agriculture, Policy, and Development at Reading University. He will be joining us to discuss the European Court of Justice ruling on GMOs at the 7th Plant Genomics & Gene Editing Congress: Europe.

 

Latest insights on the role of soil and plant microbiomes are on offer at the 7th Plant Genomics & Gene Editing Congress: Europe. To see what you could learn, download the agenda today!

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