Report is scientifically inaccurate and skewed by anti-regulatory agenda. Report: Claire Robinson and Jonathan Matthews

The European Group on Ethics in Science and New Technologies (EGE), which advises the EU Commission, has published its report on New Genetic Engineering (New GE or gene editing). The report deals with New GE applications in humans, animals and plants. While the report makes thoughtful points on gene editing in humans and livestock animals, the chapter on plants is another matter. Separate analyses of the report by GMWatch and Testbiotech have found that this section lacks balance and scientific accuracy.
 
The EGE has chosen to ignore evidence submitted by GMWatch and others to the effect that a large range of genetic errors are caused by gene editing (as well as unintended effects of the intended genetic change), which could lead to altered biochemistry in the plant. This may include the production of novel toxins and allergens or altered levels of existing toxins and allergens.

Lobbyist on board

Why, you might wonder, would the report’s authors take such a one-sided approach in this one particular chapter? Testbiotech thinks there may be a straightforward explanation: "Testbiotech is... raising questions in regard to the independence of the experts involved. Julian Kinderlerer is the leading (and presumably only) expert of the EGE group dealing with New GE applications in plants. He has also acted as a leading member of organisations funded by the biotech industry. He is known for his activities in the PRRI (Public Research and Regulation Initiative) and the ISBR (International Society for Biosafety Research). Kinderlerer is a member of the steering committee at PRRI and was treasurer at ISBR."
 
Kinderlerer is well known to us at GMWatch as a long term promoter of the use of GMOs in agriculture. We are also familiar with the PRRI, which he is part of, as a foundation established specifically to lobby against what it sees as over-stringent regulations obstructing the development and use of genetically engineered organisms. In short, its members look to promote a fast-track process for their approval via minimal biosafety frameworks. This, of course, is precisely what the EGE report calls for in relation to GE plants. In order to do so, it has to turn a blind eye to the extensive DNA damage caused by gene editing, as shown by a growing number of studies.

Genomic mayhem ignored

The report's authors set the tone at the beginning of the chapter on plant gene editing, in the description of conventional breeding and selection, which has had a long history of safe use for millennia. The authors ignore the differences between these techniques and genetic modification and do not raise the question of the specific risks of gene-edited plants.
 
They seem unaware of research showing the mayhem caused in the genome by gene editing techniques, including DNA damage at the intended edit site and other locations in the genome. This lack of awareness leads them to describe gene editing in the following piece of wishful thinking:
 
"Where the [genetic] change is in a position in the genome which has been well characterised, and the change is one which renders that portion of the genome similar or even identical to that found in similar organisms, the proportionality requirement would indicate a light-handed approach [to regulation]."
 
This is an assumption-based rather than an evidence-based statement. The authors only consider the intended change in the genome, ignoring the large numbers of genetic errors that arise from gene editing. If the EGE authors had acknowledged this evidence, they would not have made the elementary mistake of accepting the claim that the genetic changes would only occur in the expected "well characterised" position.

Naturalness assumed

The authors would also not have gone on to assume that any gene-edited organism would be likely to have a genome "similar or even identical to that found in similar organisms".
 
The EGE doesn't suggest what criteria could be applied to establish such a similarity between a gene-edited GMO and a naturally bred organism. Are we supposed to accept the assurance of the developer that they are the same? Recent history shows that this is not a sound approach to protecting public health and the environment.

Potential new toxins ignored

The majority of the section on food safety in the EGE report is taken up not by acknowledgement of the unexpected toxic effects found in animal feeding studies with first-generation GM crops, which the EGE was alerted to by GMWatch back in 2019, but by a bizarre description of natural toxins that can be present in non-GM plants, such as potatoes (which can have high levels of toxic glycoalkaloids) and kidney beans (which can cause vomiting and diarrhoea if you don't cook them for long enough). The EGE authors write, "Plant breeding could increase the concentration of such toxins or allergens in plants, yet there have been a negligible number of food poisoning issues due to the introduction of new varieties into the food chain."
 
That's true. But then, making a huge logical leap, the EGE authors add, "It is unlikely that a [genetic] modification will have deliberately or incidentally introduced new toxins into a plant."
 
Here, the EGE authors are spectacularly missing the point. They fail to ask themselves why conventional plant breeding has a history of safe use in spite of the known ability of plants to produce their own toxins.
 
The answer is this. In conventional breeding, plants with high levels of natural toxins have been selected out of the breeding program over millennia. And over this long period, breeders have been drawing on the same tried and tested gene pools. They know which toxins and allergens to test for prior to releasing a new variety. In contrast, with GM techniques, no one knows what to look for. New toxins and allergens could be produced in the plant. So thorough generic testing (i.e. testing that could detect a wide range of possible unexpected substances) and risk assessment are needed.
 
In sum, there is no admission by the EGE authors that genetic modification can result in new toxins and allergens appearing in the plant. Instead they use the history of safe use for conventional breeding (despite the “poisonous potatoes" and kidney beans) as an excuse for assuming that GM gene-edited plants will be safe, while ignoring the reasons why conventional breeding is largely safe and why GM, in some cases, may not be.

Conclusions lack scientific backing

In its assessment of the report, Testbiotech criticised the EGE for presenting conclusions on risks associated with genetically engineered plants without sufficient scientific backing.
 
Testbiotech pointed out that the EGE claims, for example, that there is no evidence of adverse environmental effects caused by the cultivation of transgenic plants, which is not correct. Testbiotech added that the report also takes a very one-sided approach in regard to the cost of applications and New GE risk assessment as well as the implications of patenting.
 
In summary, Testbiotech concluded that the potential benefits are disproportionately emphasised in comparison to the risks – far more so than can be justified from the scientific evidence. Consequently, Testbiotech wrote, "The EGE does not fulfil the high standards which it needs to follow in its high ranking publications. Testbiotech finds this regrettable as other chapters of the report are much more balanced with regard to the underlying science and conclusions. One possible reason for the difference in quality of these specific chapters seems to be that there is only one EGE member with expertise in genetic engineering in agriculture."
 
Recently Testbiotech published its own report on the regulation of New GE applications in plants. This report shows that genome editing applications, especially those using CRISPR/Cas "gene scissors", all need to undergo scientific risk assessment before any conclusions can be drawn on their safety. Contrary to these findings, the EGE claims that risk assessment is only necessary where there are complex genetic alterations, such as the knock-out of several genes, or if the intended results could not have been achieved with conventional breeding methods.
 
However, Testbiotech writes, "Reality is far from being that simple. CRISPR/Cas applications are based on a multistep procedure; frequently, the genetic changes are nowhere near as precise as intended. Therefore, it is not sufficient to simply assess the intended characteristics of the plants. In many cases, it is only after detailed examination that an assessment can be made on whether the new characteristics could also have been achieved with conventional breeding."
 
GMWatch agrees with Testbiotech's rejection of the EGE's proposal to only subject some specific plants to a mandatory approval process. While the risk assessment guidelines need to be broadened for adaption to New GE plants, there is enough flexibility within the existing approval process. There is no justification for exempting New GE plants from risk assessment.
 
Further information:
 
The EGE opinion
https://ec.europa.eu/info/files/ethics-genome-editing_en
 
Testbiotech report on regulatory questions in regard to New GE
https://www.testbiotech.org/en/content/why-new-ge-needs-be-regulated
 
Recent publication on adverse environmental effects caused by transgenic plants
https://www.testbiotech.org/en/news/disturbance-interactions-between-ge-cotton-and-environment
 
Details on funding of PRRI
https://prri.net/about-prri-donate
 
Details on funding of ISBR
https://web.archive.org/web/20210116170733/https://isbr2019.com/index.php/sponsors-m/sponsors