EU Commission ambiguous on detection method, but
no objection on GMO status of Cibus Canola
[08 December 2020] In October 2020, Dr Georg Buchholz of the law firm GGSC wrote to the European Commission on behalf of VLOG. The letter concerned the new detection method for Cibus SU Canola and its evaluation by the European Network of GMO Laboratories (ENGL). The letter set out why the SU Canola test is adequate for the monitoring and enforcement of unauthorised GMOs, such as Cibus’ canola. It also underscored that the suspicion that SU canola is present in import consignments is sufficient for regulatory authorities to take enforcement action.
In a somewhat contradictory response, the European Commission (EC) sidesteps the standards that apply for detection of unauthorised GMOs.
Importantly, the Commission does not deny that SU canola is gene edited (unlike ENGL and BVL).
Nevertheless, the Commission says the method cannot distinguish a gene edited SU Canola from a variation that "might" also originate from a natural mutation, the method is considered "not fit for regulatory compliance".
On the other hand the Commission notes that Member States that would like to use this detection method should be aware of its limitations and complement it with appropriate official control measures – as Dr Buchholz had already advised in the letter to the Commission. That means Member States may use the method.
We urge Member States to do so to protect the integrity of the European supply chain.
EU Committee: Is Cibus SU Canola a GMO or not? What is the test good for?
[11 November 2020] Our new test keeps authorities and institutions busy. On 12 November 2020, it is on the agenda of the "Regulatory Committee 2001/18" of the EU, where representatives of all member states exchange views on questions of GMO regulation.
With regard to our detection method, two central questions are still being discussed: Is Cibus SU Canola a genetically modified organism (GMO) under EU law or not? And does a GMO detection test also have to identify the applied technology itself?
We have sent a briefing to the responsible representatives of the governments and authorities of the member states in advance, in which it is explained in detail that Cibus SU Canola is clearly to be considered a GMO under current EU law and would therefore be illegal here without approval. On the basis of the numerous documents available, there is no doubt that the genome editing technique ODM - called Cibus RTDS by Cibus - was used to produce the rapeseed. Under EU law, this is clearly a GMO.
Previously, GMO law expert Dr. Georg Buchholz had already explained in a letter to the EU Commission that under EU law a detection method for genetically modified organisms (GMOs) does not have to identify the origin of a specific genetic modification, but only the mutation itself. This is exactly what the Cibus test undisputedly does. EU member states should therefore now integrate the new procedure into their routine GMO controls so that the Cibus gene editing rapeseed does not enter the EU food and feed chains illegally.
Gene editing company must be transparent,
provide EU regulators with reference material
[29 October 2020] In September 2020, an international consortium  presented an open-source detection test for the first commercialised gene-edited crop.  The group of non-governmental organisations, non-GMO food associations and a food retailer cracked the code for detecting SU Canola, a herbicide-tolerant GM rapeseed developed by US company Cibus and grown in North America.
We did this to support the proper regulation of genetically modified organisms (GMOs) in the European Union (EU). We have given regulators a tool they need – a proven detection method - to prevent the contamination of EU food chain from this unauthorized GMO. We have also demonstrated that gene-edited crops can be detected, despite claims to the contrary.
Since the release of the detection test, Cibus has been playing hide and seek with European regulators and consumers. Contrary to previous claims, it is now denying that the crop is gene-edited. The company has also failed to provide seed samples on an open basis so that EU regulators can verify the detection test we have developed.
As a result, the German national reference laboratory for GMOs (located at the Federal Office of Consumer Protection and Food Safety, BVL) has instead come to members of the consortium for samples of SU Canola so that it can comply with instructions by the German Federal Ministry of Agriculture to verify the new detection method.
We support verification of the detection test as a step towards monitoring imports that might contain SU Canola. However, we have determined that it is not appropriate for us to provide seed samples to the BVL, for reasons of principle and good regulatory practice.
Firstly, the developer company Cibus should provide the seed samples to fulfil basic standards of transparency. Failure to do so only serves to confirm consumer and civil society distrust of GMOs and the companies that produce them.
Cibus has told the European Commission that SU Canola could be present in commodities imported in the EU. Now EU authorities have a way to control for the unauthorised presence of SU Canola in imports, the company must support these efforts as best it can.
Secondly, in case Cibus does not voluntarily supply the material, the BVL and the European Commission should require Cibus to do so. There are two reasons for this:
If Cibus is allowed to evade requests by EU regulators, like BVL, it would be a signal to GM developers like Cibus that EU GMO laws and regulators can be gamed.
In the past, GM seed developers have provided EU authorities with detection methods and reference materials in order to help detect unauthorised GMOs. (For example, Bayer did this when its GM rice strain was found in the EU supply chain).
The new test should be verified using all SU Canola varieties currently on the market. There are four SU Canola lines currently on sale in North America. Our detection method was developed using the only two cultivars that we were able to obtain. While we have every reason to believe that the detection method will pick up all SU Canola lines, the EU regulators should secure all SU canola lines to close the door to further possible attempts by the company to muddy the waters by making claims about the lines that are unavailable to regulators.
EU governments must implement the new detection method in their routine GMO testing so SU Canola does not enter food and feed supply chains illegally. 
Companies such as Cibus should provide authorities with the material they need to perform their regulatory duties. The members of the consortium that funded the development of the open-source detection test fully support any requests by the BVL and other competent authorities to Cibus to provide the seeds needed to verify the test.
 The research was funded by NGOs Greenpeace European Unit and Greenpeace Germany, and the Sustainability Council of New Zealand; associations for non-GM foods VLOG (Germany), ARGE Gentechnik-frei (Austria) and the Non-GMO Project (USA); the Organic and Natural Health Association (USA); organic food and farming association IFOAM Organics Europe; and Austria’s leading retailer SPAR. It was carried out by a team of researchers led by Dr John Fagan at the Health Research Institute (Iowa, USA).
The peer reviewed article that details the test also provides sequence information that enables laboratories to produce suitable reference material.
 Governments are obliged to apply and enforce EU GMO laws – including safety testing, traceability and labelling – for all GMOs, including those produced through gene editing.
They must act at the point there is a suspicion that the GMO laws have been violated, not only when the violation has been proven.
The legal requirements for detection tests used for official controls are laid out in Art. 34 of the Official Controls Regulation (Regulation (EU) 2017/625). These requirements apply to the detection of unauthorized GMOs, such as the Cibus SU Canola.
Lawyer says evaluation of the open-source detection test by the European Network of GMO Laboratories (ENGL) is based on incorrect legal assumptions
[27 October 2020] In an evaluation of the new detection method, the European Network of GMO Laboratories (ENGL) concluded that, while it “complies in many aspects” with the EU performance requirements for such methods, it “cannot identify the origin of the mutation in the particular [oilseed rape] line targeted and can therefore not prove that the detected mutation is caused by genome editing”.
But there is no requirement under EU law that a GMO detection test must identify the origin of a particular genetic alteration. The conclusion that the new detection method cannot be used to enforce EU GMO law, because this element is lacking, has no legal basis. German Lawyer Dr. Georg Buchholz has laid this out in a letter he sent to the EU Commission on behalf of the German Verband Lebensmittel ohne Gentechnik e.V. (VLOG – Association Food without Genetic Engineering).
As stated in our earlier release, the new open-source SU Canola detection method is a standard GMO detection test that hones in on the genetic changes in the organism, not on the technique used to make the GMO. It is sufficient under EU legislation that a detection method can uniquely identify a GMO based on certain DNA sequences. Evidence that the particular sequences used to identify the GMO arise from the application of a regulated GM technique can be provided by other means.
RESPONSE to the Statement by the German Federal Office of Consumer Protection and Food Safety (BVL)
[10 September 2020] The German Federal Office of Consumer Protection and Food Safety (BVL) has published a statement about our new detection test for SU Canola, a herbicide-tolerant rapeseed engineered by US company Cibus.
We set out to develop a detection method that uniquely identifies Cibus’ SU Canola. The BVL agrees that this test - which has been validated by the Austrian Environment Agency - performs this task. Determining what method was used to achieve the intended genetic alteration has never been a requirement for GMO detection tests under EU law.
In its statement, the BVL chose to ignore information from Canadian regulators and Cibus themselves, in which they declare that SU Canola was engineered using Cibus’ proprietary gene editing technique.
The BVL has not provided any evidence that the SU Canola sold in the US and Canada, which can be identified using the new detection method, is not a GMO according to EU law. In fact, the BVL lists the transformation event that this GM rapeseed is based on in its public database of GMOs. As such, there is no reason to doubt that it falls under EU GMO law, and that its presence in the EU would be illegal.
The BVL takes a firm stance that the intended genetic change in SU Canola was not caused by gene editing. This claim is based on two recent sources, a registration document by the Canadian Food Inspection Authority and the current Cibus website. It fails to acknowledge that the Canadian Food Inspection Authority’s document from 2013 has been amended several times. Previous versions mention the use of ODM. Only the latest version, uploaded in July 2020, does not. Since the BVL investigated Cibus’ rapeseed lines in 2014 and 2015, it is likely that it has seen the earlier versions containing the mention of ODM.
Furthermore in 2014, Cibus informed the BVL that most of the relevant mutations in their rapeseed lines are the "direct result" of gene editing. The BVL ignores this information in its latest statement and fails to consider that the likelihood this specific genetic change results from spontaneous processes is vanishingly low.
As stated in our release, the new open-source SU Canola detection method is a standard GMO detection test that hones in on the genetic changes in the organism, not on the technique used to make the GMO. It is a game changer in at least two ways. Firstly, it achieves what many have said is impossible - being able to distinguish a gene-edited crop from similar crops that are conventionally bred or engineered using established GM techniques. Secondly, it enables regulators and companies to test for Cibus’ gene-edited rapeseed, which they were previously unable to.
Some official documents supporting our claims
A) Information provided to the BVL by Cibus in 2014
Cibus requested the BVL in 2014 to determine whether SU Canola, and specifically its rapeseed line BnALS-57, falls under EU GMO law. Upon request, Cibus sent the BVL additional information on 27 October 2014, saying that:
“The majority of the mutations in the collection [of rapeseed lines with mutations in the AHAS gene that can influence tolerance to various ALS inhibitors] are the direct result of RTDS GRON targeted mutagenesis experiments. A small number of somatic mutations were also isolated from our programme using ALS inhibiting herbicide selection. (…) Within the collection we have examples of the same mutation generated independently by GRON targeting and via somatic mutation. These lines cannot be … ”.
The documentation released by the BVL can be found here. Unfortunately, most of Cibus’ five-page document dealing with the nature of the mutations has been redacted. This document starts at page 51 of the pdf.
B) Canadian documents
Until recently, none of the Canadian official documents drew a firm conclusion that the intended mutation was the result of somaclonal variation. They mentioned it but did not make any clear determination in that regard.
Registration document of the Canadian Food Inspection Agency
Previous versions of the same registration document all stated: “Although BnALS-57 was isolated following treatment of cells with the RTDS, the mutation in BnALS-57 is thought to have been created as a result of a spontaneous somaclonal variation that occurred during the tissue culture process, rather than due to the oligonucleotide used in the RTDS.”
The reference to RTDS was removed only in July 2020. This is the link to the version of September 2017. This is the link to the current version. The fact that the registration document was modified in July is stated at the bottom of the page: “Date modified: 2020-07-10”.
Registration document of Health Canada
This document has remained unchanged since 2016. It states:
“As donor of the single nucleotide mutation in the BnAHAS1C gene, Cibus canola line BnALS-57 was selected as a mutant variant of the wild-type parental line BN2. Mutants of BN2 were generated using the Rapid Trait Development System (RTDS); an oligonucleotide-directed mutagenesis method. A critical step of the RTDS protocol is the application of tissue culture techniques to generate plant cells more receptive to mutagenesis. BN2 protoplasts were subjected to the RTDS then cultured on media containing imazethapyr (an imidazolinone herbicide). Actively growing calli were isolated from a background of brownish cells. The herbicide tolerant calli were genotyped and the presence of the single nucleotide mutation in the BnAHAS1C gene was confirmed. 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 protocol.”
C) GMO database entry
The EUginius database of GMOs is an initiative of the BVL and Wageningen University and Research. It lists “Cibus Canola Event 5715” here.
At least two of the lines sold in the US and Canada, 40K and 68K, are derived from event 5715. A third line, 79K, is derived from a re-transformation or re-mutation of that event called 5720, according to the Canadian Food Inspection Agency.
Letter to EU Commissioner Kyriakides and Response
[07 September 2020] Greenpeace, also on behalf of ARGE Gentechnik-frei (Austria), IFOAM Organics Europe and VLOG – Association Food without Genetic Engineering (Germany), wrote to the European Commission to inform about the successful development of a detection test for the first commercialised gene-edited crop. Full letter and response from Commissioner Kyriakides can be found here.
Luisa Colasimone, Greenpeace EU: +351 910 678 050, , CEST (GMT+1)
Sönke Guttenberg, Verband Lebensmittel ohne Gentechnik (VLOG – Association Food without Genetic Engineering): +49 30 2359 945 12, , CEST (GMT+1)