As an expert report uses the spectre of “non-uniqueness” as a reason not to regulate new GMOs, GMWatch is not convinced
Recently GMWatch published an article about a new report by the experts of the European Network of GMO Laboratories (ENGL), which addressed the question of whether GMOs produced with the new mutagenesis/gene-editing techniques can be traced.
The ENGL report correctly stated that products resulting from these new techniques are detectable and identifiable if "prior knowledge on the altered genome sequence, a validated detection method with appropriate selectivity and certified reference materials are available, similarly as required for the authorisation of current transgenic GMOs".
More problematically for the concerned public, the ENGL report also concluded that a gene-editing-induced DNA alteration that is "not unique" cannot be regulated under the EU's GMO regulation. According to the authors, this is because the alteration could have arisen naturally from traditional breeding or from chemical- or radiation-induced mutagenesis techniques used in conventional breeding. The latter are exempted from the GMO regulations on the basis that they have had a long history of safe use since before the regulations were written.
GMWatch finds ENGL's argument unconvincing for two reasons: the fact that all GMOs are patented, for which identification criteria are necessary; and the strong likelihood that there will be tell-tale signs that the plant has been produced through gene editing rather than conventional breeding.
Patents question ignored
The ENGL experts' argument ignores several rather obvious facts about GMOs and patents:
* The whole GMO business model centres on patents and the aggressive marketing of the GMO to farmers, the food industry, or consumers, based on its supposed special qualities. Secret or “stealth” GMOs are of zero benefit to the industry.
* If it's difficult or impossible to enforce the GMO regulation because you can't prove that the modified DNA in a product arose from gene editing, then it is also not possible to patent the product.
* A gene-edited plant is only of interest to the industry if it can patent and own it.
* If the DNA alteration brought about by the gene-editing tool is not unique and already exists in naturally bred plants, it cannot be patented.
* The “new GMO” has to be precisely molecularly characterised in terms of the alterations in its genetic sequence, or it cannot be patented.
* If the gene-editing-induced DNA alteration cannot be detected, the developer cannot protect its patent against competitors who may seek to copy the product or prevent farmers from saving and re-sowing seed (this practice is forbidden with current GMO seeds).
In order for the gene-editing commercial venture to proceed, developers must be able to prove that they have come up with a unique invention. They must characterise the changes brought about to generate the GMO and they must provide a method to detect their GMO.
As long as regulations requiring registration of new GMO products are in place, it is difficult to envisage a scenario in which the market is flooded with illegal non-detectable, non-traceable, and therefore non-patentable gene-edited products. It is in no one's interest to do this. Any problems surrounding detectability will therefore be restricted to the (presumably few) gene-edited products that have not been authorised and patented anywhere in the world and thus are not making any substantial profits for any company or individual.
No detection method, no market
The ENGL report also fails to acknowledge that if the gene-editing-induced DNA alteration cannot be detected, the developer cannot apply for authorisation under the current EU GMO law. The onus to deliver a detection method is firmly on the developer. As GMWatch has said, "No detection method, no market".
Interestingly, a draft version of the ENGL report dating from January 2019 said as much:
"It is, however, questionable if an event-specific quantitative detection method can be developed for such GMOs, particularly when they are characterised by a short DNA alteration consisting of one or a few base pairs. Such detection methods will probably lack the specificity required to target the unique DNA alteration in the genome-edited plant and quantification of the presence of the specific product in a complex food or feed material may not be possible. Detection methods may therefore fail to fulfil the method performance requirements and, as a consequence, may result in the rejection of the application" (our emphasis).
Our interpretation: If industry can't deliver a detection method for its GMO, it can't get market authorisation in the EU. Tough.
Oddly, this straightforward statement, which leaves the responsibility for detectability of new GMOs squarely on the shoulders of industry, was removed from the final ENGL report published in March. Falling back on the newly invented "non-unique" argument, the passage became:
"It is, however, questionable if event-specific identification and quantitative detection methods can be developed readily for all genome-edited plants. For instance, detection methods for those plant products that are characterised by a non-unique DNA alteration will probably lack the specificity required to identify the genome-edited plant."
The deletion has the effect of removing all responsibility from the industry and making the detectability issue appear unresolvable except by surrender to the industry, in the form of de-regulating new GMOs. GMWatch believes that the deleted phrase must be restored to all political discussions around the problem of the new GMOs, in the interests of scientific honesty and democratic freedom of choice.
Gene-edited plants won't be the same as natural plants
The ENGL report also misses the fact that even if a non-GM plant did appear to be the same as a given gene-edited plant in terms of the trait it possessed, it is highly unlikely that the alteration in genetic sequence at the basis of the trait will be the same in both cases.
For example, a trait may be due to alteration of a small number of DNA base units, leading to abolition in gene expression or changes in the encoded protein function. However, the precise nature of the DNA base unit changes would be very different between the gene-edited and naturally bred plants and thus would be readily distinguishable, even if the trait is the same in both cases.
Another difference is that a gene-edited crop variety will carry the same modification in its DNA in every cell of every plant in a sown field, since it has been generated from a single edited cell (in other words, it started life as a clone). Such uniformity in gene sequence is unlikely to be the case with naturally occurring variations in the same gene that was edited. This provides yet another means of distinguishing an edited variation from a natural one in the gene pool of a crop.
Furthermore, natural breeding does not produce the same types of collateral damage that gene-editing tools produce. This is confirmed by a new peer-reviewed publication by an author who has used gene-editing tools. The publication states that there are differences between changes brought about by the gene-editing tool CRISPR versus changes induced by conventional mutagenesis techniques used in plant breeding and from spontaneous mutations.
In conventional breeding and in natural processes, some regions in the genome undergo changes less frequently than others because these regions are especially protected by repair mechanisms in the cell. CRISPR applications can bypass these naturally occurring processes.
The ENGL authors make the error of only looking at the intended edit – and not at the whole spectrum of changes induced by the gene-editing transformation. When this whole picture is taken into account, with further study, gene-edited plants will be able to be detected.
To conclude: Finding and providing detection methods for authorised and patented GMOs is not a problem as it is the developer's responsibility. Any pretence that there is a problem is nothing more than a smokescreen for an industry that doesn't want regulation and GMO labelling for its products.
Finding and providing detection methods for unauthorised (illegal) GMOs is more difficult, but it can be done. Ensuring that it is done is a political issue. It requires that money and mandates are given to the competent detection laboratories so that they can research these methods. Otherwise a legal vacuum will be created, as the techniques are being developed faster than the regulation.
As a first step, new GMOs must be regulated in every country and/or region, so that information on them is made available to authorities across the world. And penalties for illegally releasing an unauthorised GMO must be severe enough to act as a deterrent.
1. For example, the ENGL report states:
* "Detection methods for those plant products that are characterised by a non-unique DNA alteration will probably lack the specificity required to identify the genome-edited plant. Consequently, it could be difficult for applicants to develop an event-specific detection method for a genome-edited plant carrying a DNA alteration that may not be unique."
* "The identification of DNA alterations from genome editing that are not unique remains, therefore, extremely difficult, as the altered sequences may mimic naturally occurring sequence variants, or they may not be distinguishable from those alterations obtained with conventional mutagenesis."
* "On the basis of the current knowledge and technical capabilities, it is unlikely that a method for a genome edited plant product with only single nucleotide variations or short InDels [DNA insertions and/or deletions] would fulfil the performance requirements for methods of GMO testing, e.g. regarding applicability, sensitivity, specificity and quantification aspects."
* "If a suspicious product with an unknown or non-unique DNA alteration would be detected on the EU market, it would be difficult or even impossible to provide court-proof evidence that the modified sequence originated from genome editing."