The European Food Safety Authority (EFSA) has belatedly discovered that the most common genetic regulatory sequence in commercial GMOs also encodes a significant fragment of a viral gene. The finding – published quietly in a new journal * has serious ramifications for crop biotechnology and its regulation, but possibly even more so for consumers and farmers. There are clear indications that this viral gene (called Gene VI) might not be safe for human consumption, although the authors fall short of stating that. It also may disturb the normal functioning of crops, including their natural pest resistance.
The authors, Nancy Podevin from the European Food Safety Authority (EFSA) and Patrick du Jardin at University of Liege in Belgium, discovered that of the 86 different transgenic events (unique insertions of foreign DNA) commercialized to-date in the United States 54 contain portions of Gene VI within them.
The discovery of Gene VI in commercial GMO crops by a scientist within EFSA must have presented regulators with sharply divergent options. They could recall all CaMV Gene VI-containing crops (in Europe that would mean revoking importation and planting approvals) or undertake a retrospective risk assessment of the CaMV promoter and its Gene VI sequences and hope to give it a clean bill of health. They clearly took the latter option as the easy way out. Recalling all GMOs would be a massive political and financial decision and would also be a huge embarrassment to the regulators themselves. But it would leave very few GMO crops on the market and might even mean the end of crop biotechnology.
Regulators, if they had been doing their proper job, would have had a third option to gauge the seriousness of any potential GMO hazard. GMO monitoring - required by EU regulations - ought to have enabled them to find out if deaths, illnesses, or crop failures have been reported by farmers or health officials that could be correlated with the Gene VI sequence. Unfortunately, not one country has carried through on promises to officially and scientifically monitor any hazardous consequences of GMOs. EFSA regulators might now be regretting their failure to implement meaningful GMO monitoring. It would be a good question for European politicians to ask EFSA and for the board of EFSA to ask the GMO panel - whose job it is to implement monitoring - why monitoring was not carried out.
It is perhaps the most basic assumption in all of risk assessment that the developer of a new product should provide regulators with accurate information about what is being assessed. Perhaps the next most basic assumption is that regulators independently verify this information. We now know, however, that for over twenty years neither of those simple expectations has been met. Major public universities, biotech multinationals, and government regulators everywhere, seemed not to have appreciated the possibility that the DNA constructs they were responsible for could harbour an extra viral gene.
This lapse occurred despite the fact that Gene VI was not truly hidden; the relevant information on the existence of Gene VI has been freely available in the scientific literature since well before the first biotech approval in the nucleotide sequence of CaMV published in 1980. The persistent inability of regulatory risk assessment to incorporate longstanding and repeated scientific findings is highly worrying; all the more so that this is not an isolated event.
A further key point relates to the biotech industry and their campaign to secure public approval aided and abetted by a permissive regulatory environment. This has led to the repeated claim that GMO technology is precise and predictable; and further, their own competence and self-interest would prevent them from ever bringing potentially harmful products to the market, and only well studied and fully understood transgenes are commercialized. All of these claims have been exposed to be false in the revelations surrounding Gene VI.
Even now that EFSA's own researchers have belatedly considered the risk, no one can say whether the public has been harmed, though harm appears a clear scientific possibility. From the perspective of professional and scientific risk assessment, this situation represents a complete and catastrophic system failure.
* Podevin N and du Jardin P. Possible consequences of the overlap between the CaMV 35S promoter regions in plant transformation vectors used and the viral gene VI in transgenic plants. GM Crops and Food 2012, 3, 1-5.
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