Commission must enforce EU law on GMOs. By Claire Robinson

A lawyer acting for the German Association for Food without Genetic Engineering (VLOG) has waded into the row over the newly developed detection test for Cibus's gene-edited herbicide-tolerant SU Canola (oilseed rape).

The new test was developed with funding from a group of non-governmental organisations, non-GMO food associations (including VLOG) and a food retailer. It enables canola imports to be tested for the illegal presence of the gene-edited canola, which is not approved for use in food and feed in the EU but could potentially be present in imports. The test reliably detects a single DNA base unit change – in other words, a very small change – provided information on the nature of the change is available. It could also detect the presence of very small quantities of the gene-edited canola in imports.

Company U-turn

What happened after the scientific paper announcing the test was published came as a surprise to many. Cibus, a company that has built its entire business model on its "precision" gene editing technique, denied that its SU Canola was gene-edited after all. It now claimed that the mutation conferring the herbicide tolerance was the result of an accident in a laboratory petri dish during the tissue culture process. The German Federal Office of Consumer Protection and Food Safety, BVL, issued a statement backing up Cibus's claim.

Citizens might have expected a different response from the European Network of GMO Laboratories (ENGL), the EU's GMO detection labs. Surely they would welcome the new test? Far from it: ENGL dismissed the test on the basis that it cannot prove that the detected change has been caused by gene editing and so "cannot be applied for unequivocal detection, identification and quantification".

Misleading

This struck us at GMWatch as highly misleading. In our interpretation of the EU’s GMO laws, it is irrelevant how a specific mutation was generated – whether by tissue culture or via the gene editing genetic modification process. If genetic modification techniques have been used to develop a crop, it is a GMO, even if the specific trait that the genetic engineers are aiming to achieve is generated via spontaneous mutation in tissue culture.

Happily, VLOG's lawyer agrees with us. In a letter to the European Commission, Dr Georg Buchholz of Berlin law firm GGSC states that ENGL has dismissed the test based on incorrect legal assumptions.

Dr Buchholz writes, "The ENGL evaluation is based on incorrect legal assumptions when it implies that a detection method must be able to prove that the detected mutation is caused by genome editing. In fact it is sufficient that a detection method can uniquely identify a GM organism based on detection of certain DNA sequences."

Dr Buchholz adds, "Evidence that the particular sequences used to identify the GMO arise from the application of a regulated genetic engineering technique may be provided by other means", such as documents and traceability records.

Cibus's "not gene-edited" claim disputed

Dr Buchholz disputes Cibus's claim that its SU Canola is not gene-edited. He refers to documents supplied by the company to regulators, scientific papers authored by Cibus scientists, and patent filings, which describe it as gene-edited. He writes: "As regards Cibus SU canola, the fact that the gene editing technique, oligonucleotide-directed mutagenesis (ODM) was used in the development of the trait is sufficiently documented in regulatory decisions in Canada, in the scientific literature and patent filings, among others."

Dr Buchholz states that the new test "fulfils all requirements" for detection methods used for official controls and can be used by authorities to investigate the illegal presence of Cibus's SU Canola.

Suspicion enough to prompt action

In a rebuke to the ENGL's apparent lack of concern that the EU's GMO laws might be being broken by the unauthorised presence of the gene-edited SU Canola, Dr Buchholz writes that "according to food and feed law, the competent authorities do not only have to act when a violation of the law is proven, but already when there is a suspicion that this might be the case."

Dr Buchholz is not impressed by ENGL's argument that the new test is based on prior knowledge about the genetic modification of the plant and does not provide a strategy on how to detect an unknown gene-edited based mutation if the developer has not supplied any information. He writes, "This is true. But it is no reason not to apply the test to monitor for the presence of Cibus SU Canola in seeds as well as in food and feed."

Dr Buchholz concludes by asking the Commission to "consider these legal requirements and provide for the enforcement of EU GMO law to genome edited SU canola as well as to conventional, transgenic GMOs".