November 26, 2018 by Claire Robinson
The European Commission’s Scientific Advice Mechanism (SAM) has issued a statement saying that the EU’s laws on GMOs should be revised to clear the path for “new GM” techniques, often referred to as gene editing. However, the statement is unscientific and is strongly biased in favour of the GMO industry, at the expense of public health and the environment.
The SAM’s statement follows this year’s ruling by the EU Court of Justice (ECJ) that certain “new GM” techniques called “directed mutagenesis” fall under the GMO legislation. This means that safety checks and GMO labelling are now mandatory for the products of these new techniques.
In its response to the court ruling, the SAM adopts the same conclusion as the GMO lobby: The democratically established regulations must be changed. The SAM’s statement says, “In view of the Court’s ruling, it becomes evident that new scientific knowledge and recent technical developments have made the GMO Directive no longer fit for purpose.”
The SAM says the rules should be changed to “to reflect current knowledge and scientific evidence, in particular on gene editing and established techniques of genetic modification” and to make them “clear, evidence-based, implementable, proportionate and flexible enough to cope with future advances in science and technology in this area”.
The SAM states, “There is danger that unless the EU improves the regulatory environment for products of gene-editing, it will be left behind in this field, which could also diminish EU influence on ongoing debates at the international level with respect to specific applications and regulatory processes.”
The political thrust of the SAM’s new statement did not escape the online magazine EURACTIV, which noted that it “is in line with a recent statement made by the US government, which basically said that the EU GM legislation is outdated”. The US wants to be able to market its “new GMOs” globally, including to the EU, without the impediments of risk assessments and GMO labelling. In addition, certain EU countries and elements of the Commission see “new GM”, with its patented seeds and probable inbuilt agrochemical dependence, as a future driver of the economy. The SAM report supports that stance.
The main scientific weaknesses of the new statement are detailed below.
1. The report is self-contradicting and unscientific
On one hand, the authors of the report want us to ignore the processes of genetic modification – notably gene editing – by which the “new GM” products will be developed – and focus on the product alone. The authors state, “the features of the final product itself must be examined regardless of the underlying technique used to generate that product”. But on the other hand, they want us to adopt as an article of faith that these new GM processes are precise, predictable, and safe – despite large amounts of evidence that they have numerous unpredicted off-target effects. Some of the evidence showing these off-target effects is even referenced in the SAM report – but the authors don’t address it.
In other words, in their new statement, the SAM authors cynically ask us to ignore the process except insofar as we are expected to focus on it through a rosy-coloured faith-based lens to believe that the process is safe.
Ignoring the process by which a food is produced is extraordinarily unscientific and illogical. It is equivalent to publishing a scientific paper without the “materials and methods” section and instead substituting the assertion, “Trust us, our methods are absolutely reliable, but we are not going to tell you what they are.”
Abolishing process-based GMO regulation in favour of product-based regulation is exactly what the GMO industry has wanted for decades. The SAM has turned itself into a mouthpiece for the industry.
The problem for the industry with process-based GMO regulation is that it takes account of the inherent uncertainties of the GM process. Product-based regulation, such as that of the US and Canada, ignores the problems inherent to the GM process and focuses only on the traits of the intended final product. It is far more likely to miss unintended changes due to the GM process because it does not look for them. This is the ‘don’t ask, don’t tell’ approach that the SAM is advocating.
We know that the SAM authors are aware of these issues because in their earlier report on the new GM methods (which they misleadingly term New Breeding Techniques or NBT), the SAM did admit, “The issues of unintended effects due to NBT (and in particular, genome editing related off-target effects) are the subject of much research at present as evidenced by the rapidly growing number of publications in the field. Conclusions cannot be drawn about the absolute or comparative safety of techniques based on the predicted occurrence of unintended effects.”
This last statement is correct, though the SAM authors fail to draw the obvious conclusion: That while there is still no evidence of safety of “new GM” food products, there’s no reason why we should volunteer to risk our health by eating them unlabelled and untested for safety.
2. The SAM authors confuse precision of the location of the intended change with safety
In the new statement, the SAM authors repeat the words “precise” and “precision” like mantras. They suggest that because the location of the intended cut of the DNA can be “precisely” targeted with gene editing techniques, the products of these techniques “are potentially safer” than those created with random mutagenesis, a technique that is not regulated under the EU’s GMO laws. Therefore, the implication goes, gene editing should not be regulated under those laws.
But this is false. Genes are interconnected and manipulating one or a few genes can have unintended knock-on effects on other genes. These effects cannot be predicted or controlled because we simply don’t know enough about the genome. By analogy, as scientists have pointed out, it is possible to “precisely” cut and paste characters into a Chinese text yet still end up with scrambled nonsense if we do not understand Chinese.
The problems don’t stop there. While gene editing can produce the intended double-strand DNA cut, the downstream effects happen independently of the editing tool and cannot be controlled nor predicted. Thus no matter how “precisely” you control the site of the DNA cut – even if you have no or few off-target cuts – you will not be able to control the outcome from the DNA repair process that ensues. This is controlled by the cell’s own repair mechanisms and not by the genetic engineer.
With gene editing, the theory was that only small insertions or deletions of DNA base units would occur. But the reality is that large deletions of DNA can occur, ranging up to thousands of DNA base units. In addition, large rearrangements of the DNA can also take place.[1,2,3] In plant gene editing, such effects risk disrupting the structure and function of neighbouring genes, with unknown consequences to the plant’s biochemistry.
3. The SAM authors compare one risky technology with another to imply that new GM is safe
Throughout their statement, the SAM authors argue that gene editing (“directed mutagenesis”) should not be subject to the GMO regulations because it is more “precise” than random mutagenesis. Random mutagenesis has been used in plant breeding since at least the 1960s and “alters an organism’s genome at multiple positions in a non-targeted way” by exposure to a chemical mutagen or irradiation. It is exempted from the EU’s GMO regulation, a fact that the SAM authors consider a gross injustice to the “directed mutagenesis” that they promote as “potentially safer”, yet which is not exempted. The SAM authors refer to random mutagenesis as a “conventional” plant breeding technique.
But in using this argument, the SAM authors show their ignorance of the law and the scientific method. Random mutagenesis is defined in EU law as a GM technique, not a “conventional” technique. But because it had been in use for many years prior to the EU GMO regulation being written, and was deemed to have a “long safety record”, it was decided to exempt it from the regulation.
The new gene editing techniques, on the other hand, cannot be said to have a long safety record, or indeed any safety record at all. No one is monitoring the effects of consumption of the small number of gene-edited foods currently on the market, and there are no studies, human or animal, that have looked at this issue. The SAM’s words, “potentially safer”, mean nothing at all, from the scientific point of view.
Moreover, the safety of foods produced using random mutagenesis has never been tested in controlled studies, so it is an unknown. We do know that random mutagenesis has devastating effects on plant genomes, resulting in a large proportion of sterile and unhealthy plants. So it would not be surprising if some of this genomic disruption created toxins or allergens.
By comparing one risky technology (gene editing) with another (random mutagenesis), the SAM authors argue that the first is not as risky as the second and thus should get a free regulatory pass. But this is like arguing that since accidents happen through chance in nature, we should allow car manufacturers to market dangerous cars that are likely to cause more accidents. Adding to an existing potential problem does not remove that problem, but compounds and complicates it.
4. Statement attempts to “normalise” mutations
It’s well established that GM causes mutations (damage to DNA). Mutations are known to be potentially harmful and thus regulators worldwide strive to minimise our exposure to man-made mutagens, such as chemicals. But because certain natural factors, such as sunlight, can also cause mutations, there is a disturbing trend among GMO advocates to “normalise” mutations and characterise them as evolutionary. The SAM statement adopts this ruse, characterising mutations as natural, spontaneous, and evolutionary.
But again, just because DNA damage sometimes occurs in nature in response to a stress, it does not mean it is acceptable or desirable to deliberately cause it in our food plants.
The SAM statement claims to be written “by the Group of Chief Scientific Advisors”. This implies that the authors were the entire group of seven advisors. However, of these seven, only two appear to have relevant expertise:
1. Janusz Bujnicki, professor and head of the laboratory of bioinformatics and protein engineering, International Institute of Molecular and Cell Biology, Warsaw; and
2. Sir Paul Nurse, director of the Francis Crick Institute and a geneticist and cell biologist.
Janusz Bujnicki holds inventor status on a number of biotechnology patents – an interest that is not declared in the SAM statement or on its website. Paul Nurse is a British pro-GMO lobbyist who has characterised opposition to GM crops as “anti-science”. At no point has he addressed the scientific research that points to risks or harm from GM crops.
Was the statement really authored by just these two people? If so, it’s clear that they cannot claim to represent any kind of scientific consensus. If the statement was authored by the whole group, as is claimed, then it was mostly written by people who don’t understand the field.
The SAM is supposed to be independent. But this is not the case. The SAM has links to the scientific advisory groups EASAC and SAPEA. SAPEA is officially part of the SAM structure and EASAC is in turn part of the SAPEA structure.
SAPEA’s coordinator is Rudolf Hielscher, who participated as a steering group member of a European Risk Forum report called “Scientific evidence and the management of risk”, along with Piet van der Meer (PRRI) and Colin Berry.
PRRI is a pro-corporate lobby group with close ties to (and funding from) the GMO industry. It has consistently lobbied to promote GMOs and weaken protective regulations and international agreements relating to the technology, notably at the meetings of the Cartagena Protocol on Biosafety.
Berry has close ties to groups that vigorously promote both GMOs and climate denial. He is an advisor to the Scientific Alliance, a lobby group that is strongly pro-GMO while being skeptical about climate change. He’s also a shareholder in Spiked Ltd, the company that owns the aggressively libertarian online magazine Spiked, which also promotes GMOs and climate skepticism.
He was identified by Monsanto in internal company documents as a consultant who might help the company move forward in case of a verdict from the cancer agency IARC that its glyphosate weedkiller was carcinogenic.
The European Risk Forum report condemned the “lack of trust in science and scientific experts” among EU political leaders, complained about attempts to exclude experts with financial conflicts of interest from decision making, and aimed to “stimulate risk-takers to invest in the innovations needed to restore growth and prosperity”.
The latest addition to the SAM group is Nicole Grobert, a Royal Society Industry Fellow specialising in nanomaterials. The Industry Fellowship scheme “is for academic scientists who want to work on a collaborative project with industry and for scientists in industry who want to work on a collaborative project with an academic organisation”. Neither the Commission nor any of the other members of the group appeared to object to this apparent conflict of interest.
Bart Staes, Green MEP, commented on the SAM statement that the “pro-biotech scientific lobby” is currently being led by the Flemish research institute VIB and the seven scientists of the SAM. Mr Staes said, “Even when their scientific advice or input can be of value, in the end the decisions on which new technologies to use or not, are and should remain a societal and political decision. If we start letting those decisions be taken by corporate driven scientific lobbies, then we’ll end up living in a technocratic world, undermining even further our already fragile democracies.
“The arguments by the scientific lobby, repeated like parrots by some European commissioners, sound familiar. ‘If we don’t deregulate we will fall behind on seed breeding’ is precisely what was advocated by the pro-GMO lobby in the 90s. The reality is the EU seed breeding sector is alive and thriving, and the EU agriculture sector has no problems that were solved by the US or Canada through the use of GMOs in the last 30 years.
“It is a shame that even EU commissioners now use a ruling of the ECJ to plead for a change of the law. The reasons for which this EU GMO regulation was put in place in 2001, have not suddenly vanished! On the contrary: releasing new GMOs into the environment create very real risks of irreversible negative impacts on ecosystems and especially on biodiversity; Also they go against the will of EU citizens who want to know if genetically modified ingredients have been used in their food and want to have a choice. There are currently no fixed methods for traceability of new GMOs.
“Evaluation, biosecurity measures and labelling of GMOs are not regulatory burdens which are stiffening innovation, they are basic measures to avoid environmental (and thus potential health) disasters. The ECJ says clearly that some new (breeding) techniques are new GMOs, and the EU law should be respected. I think there are even less reasons those new GMOs should be deregulated, as the processes used to create them are still being researched and new discoveries are made every day on their potential impacts. And several scientific publications have noted unforeseen effects.
“GMOs are not needed in food and farming. EU conventional seed breeding IS a very innovative sector, creating the solutions the farmers need in terms of resilience, adaptability, yield, taste, etc, all of these without allowing the industry to patent seeds. Patenting of seeds and food ingredients by the private sector is a threat to food sovereignty that no public power (in its right mind) should support.
“As for the potential medical uses of these new biotechnologies, they are not to be confused with their uses in agriculture as they do not involve any release of genetic material into nature, and do not pose the same risks. Actually they pose an entirely different set of risks which should be weighed against their benefits for society.”
The timing of the SAM statement – it was published on the eve of the Cartagena Protocol on Biosafety meeting (COP14) in Egypt – is noteworthy. Or, we might say, political. At this meeting, some countries and regions are arguing for strict controls on new GM technologies, including gene drives and synthetic biology, whereas other nations – including delegations from South Africa and Nigeria – are lobbying in favour of these technologies.
In conclusion, the SAM has discredited itself with its unscientific and disingenuous contributions to the GMO debate. Its performance is especially disappointing because the group was originated by the EU Commission in an attempt to regain public trust after the backlash against Anne Glover, the biotech entrepreneur and former EU chief scientific advisor. Glover was skewered by the media, scientists, an academic risk expert, an MEP and former environment minister, and (last but not least) GMWatch over her uncritical and unscientific promotion of GM crops.
Sadly, the SAM is turning out to be even wilder in its departures from the scientific method than Glover. Members of the SAM need to remind themselves that their remit is to present experimental evidence, not industry lobbying points.
1. Kosicki M, Tomberg K, Bradley A. Repair of double-strand breaks induced by CRISPR–Cas9 leads to large deletions and complex rearrangements. Nat Biotechnol. July 2018. doi:10.1038/nbt.4192
2. Shin HY, Wang C, Lee HK, et al. CRISPR/Cas9 targeting events cause complex deletions and insertions at 17 sites in the mouse genome. Nat Commun. 2017;8. doi:10.1038/ncomms15464
3. Mou H, Smith JL, Peng L, et al. CRISPR/Cas9-mediated genome editing induces exon skipping by alternative splicing or exon deletion. Genome Biol. 2017;18:108. doi:10.1186/s13059-017-1237-8