By Dr. Sarah Agapito, GenØk – Centre for Biosafety
17/09/2020

In a recent open-access scientific publication, scientists from the Health Research Institute and Somagenics, Inc. developed a laboratorial detection method for the first commercialized gene-edited canola. The method is based on the real-time PCR technique and has been validated by an independent laboratory in Austria, meeting all legal requirements for genetically modified (GMO) analytical methods in EU jurisdiction and consistent with ISO17025 accreditation standards.

The method is crucial to uphold border controls in Europe on unapproved GMOs which is a critical pillar of the EU regulatory regime as per Directive 2001/18/EC. Norway’s regulation present within the Gene Technology Act also follows EU standards.

But where does this publication stand within the controversy of gene-editing regulation?

Biotechnology companies and pro-biotech researchers have claimed, among other things, that gene-edited organisms cannot be detected and therefore should not be regulated as genetically modified organisms. On the contrary, the European Court of Justice decided that such organisms are produced by new biotechnologies that do not have a history of safe use in the environment and as human and animal food. The risks associated with them might be similar to those posed by GMOs and therefore, they should undergo safety scrutiny from competent authorities. Such regulations also require product labelling.

Whereas the issue is still under discussion at the UN Convention on Biological Diversity – the UN treaty dealing with modern biotechnologies and its potential threats to biodiversity, various countries have come up with quite different approaches to regulating gene-edited organisms. This asynchronous situation has left some products in the legal limbo, without a harmonized detection and identification database and without reliable information that all countries could access. The Cibus rapeseed has not been authorized in Europe, but because no testing method has been available, it is not clear if this product has already entered Europe and Norway, unauthorized.

After the publication of the paper, The German Federal Office of Consumer Protection and Food Safety (BVL) published a statement saying that the method developed by the researchers for the gene-edited oilseed rape is robust but cannot identify that the oilseed rape variety was genetically modified using a gene-editing technique and therefore doesn’t meet EU requirements for GMO detection methods. However, this statement conflicts with the wording of the EU GMO laws and regulations.  The BVL then refers to two Canadian regulatory documents, one from  the Canadian Health Authority, which clearly states that gene editing was a step in the process of developing the SU canola. The second Canadian document has no reference to gene editing but claims that the alteration in the Cibus canola varieties targeted by the new method was the result of a random mutagenesis method, somaclonal variation. However, the document cited was altered only a few weeks ago to remove reference to gene-editing. It would appear that there has been an effort to re-write history regarding the Cibus canola.

The result has been widespread confusion for regulators, farmers and consumers. Contradictory information about this gene-edited oilseed rape variety has been published by different authorities around the globe and by the compmay itself. To our surprise, the entire controversy comes down to one line in the Canadian Authority report:

“The petitioner hypothesized that the single nucleotide mutation was the result of a spontaneous somaclonal variation that occurred during the tissue culture process, and not due to the specific oligonucleotide used in the RTDS [gene editing] protocol.”

That is, the company was not sure whether the gene editing had even worked or whether the mutation was the result of an accidental random mutation during the gene-editing process.

There is no further information explaining the hypothesis, there is no data testing this hypothesis and there is no confidence in what kind of gene-editing outcome is present in this plant variety. The company, Cibus US LLC who developed the variety and owns its property rights, has not yet provided any credible evidence regarding  the case, leaving countries, farmers and consumers without an explanation.

This is a prime example of why organisms developed through these new biotechnologies need to be regulated and subjected to requirements for minimum information by competent safety authorities worldwide.

In this specific case, the gene-edited oilseed rape was developed to tolerate herbicide spraying. Testing with the new method can create transparency that will ensure that the farmer will know if they can spray herbicides on the rapeseed that they plant. For the consumers, the new test creates the transparency that will enable them to know if herbicide residues are on the rapeseed products that they eat. For all of us, the new test will help create the transparency needed to enable us to know if we are moving towards clean and sustainable agriculture and promoting food security or if we will use these novel technologies just to maintain the agrochemical status quo.