EFSA is wrong: New GM plants can’t be assumed to be as safe as conventional plants

EFSA is wrong: New GM plants can’t be assumed to be as safe as conventional plants

In July the European Food Safety Authority (EFSA) published its opinion on the French health agency ANSES’s evidenced-based position of December 2023, which criticised Annex I of the European Commission’s proposal on the deregulation of plants obtained from new genetic modification techniques (new genomic techniques, NGTs).
According to Annex I, “category 1” new genetically modified (GM) plants (NGT1) can be treated as equivalent to conventionally bred plants – and not be subjected to the risk assessment, traceability or labelling requirements applied for the past decades to other GM plants – based on a few simplistic criteria, such as the number and size of the intended genetic modifications. Unintended modifications in the shape of mutations (DNA damage) created by the GM processes used are ignored in the Commission’s criteria.
In a move that came as no surprise, EFSA agreed with the Commission, concluding that new genetically modified organisms (GMOs) can be considered equivalent to conventional plants if they correspond to the Annex I criteria. However, this opinion disregards important scientific evidence and seems to be designed to deliver a politically and economically convenient result to suit the interests of the agricultural biotechnology lobby, rather than to protect public health and the environment.
In particular, EFSA uses the wrong comparison to justify exempting NGT-derived plants from regulatory safety checks, comparing NGTs to chaotic chemical- or radiation-induced random mutagenesis breeding instead of conventional breeding. This is like comparing the risks of a highly toxic new pesticide to those posed by an older toxic pesticide and concluding that since the older pesticide is already out there, we may as well release the newer pesticide without regulatory oversight.
EFSA also misuses scientific evidence on the DNA damage caused by random mutagenesis, seemingly in order to “normalise” the DNA damage caused by NGTs and make it more publicly acceptable. This is in stark contrast to global regulatory policies governing (for example) chemical and radiation exposure, which aim to protect all life from the highly damaging effects resulting from exposure to DNA mutagens.
The following analysis explains the serious faults in EFSA’s arguments.
What does ANSES say?
ANSES correctly points out that it’s not just the size or number of the genetic modifications that is important, but what they do – their functional consequences. Knowing the size and number of intended mutations tells you nothing about this.
These consequences are explained in a further position statement published by ANSES on the health, environmental, and socio-economic risks of NGT-derived GMOs. Based on 10 case studies of existing NGT-derived GM plants, ANSES wrote that “certain potential risks appear repeatedly in these case studies” and that “These include risks linked to unexpected changes in the composition of the plant, which could give rise to nutritional, allergenicity or toxicity problems, or medium- and long-term environmental risks, such as the risk of gene flow from edited plants to compatible wild or cultivated populations.”
GMWatch has repeatedly drawn attention to the potential and actual “functional consequences” of genetic manipulations in NGT-derived GMOs, based on a large body of scientific studies and reviews.
EFSA momentarily agrees with ANSES's point, but then says that we also don’t understand the “functional consequences” of genetic variations in conventional plants, so they see no extra risk from GM plants obtained via NGT1 methods.
In its opinion, EFSA ignores scientific publications showing that NGTs can create mutations that are different from those arising naturally, from conventional breeding, or even from random mutagenesis breeding (where plant material is subjected to radiation or treatment with chemicals to induce mutations). Therefore, scientists have warned that the mutations arising from the application of NGTs can present very different and more serious risks compared with conventional or random mutagenesis breeding.
We would welcome EFSA’s specific arguments against the findings of these publications. We would feel reassured by the fact that they had engaged with them and found evidence-based reasons to reject them. But the agency simply pretends they don’t exist and doesn’t include them in its limited list of references, in a case of “see no evil, hear no evil, speak no evil”.
Natural mutations aren’t necessarily safe
In addition, even if it could be proven that the mutations in NGT1 plants are of the type that could happen naturally, this doesn’t mean it’s acceptable, safe, or desirable to deliberately create them rapidly and on a large scale using NGT methods, without robust regulatory oversight. Certain types of genetic mutation can occur naturally, but they can cause health- and life-threatening diseases and deformities in people, animals, and plants. So we must treat technologies aimed at creating such mutations with great caution.
The argument, “If nature does it, it’s OK for us to do it too” is full of holes, though it’s far from the first time that it’s been used. Previously, agricultural GMO lobbyists have stated that because an aspect of genetic engineering called horizontal gene transfer (HGT – transferring genes across species) has occurred naturally across species in a variety of sweet potato at some point in the plant’s evolutionary history, it’s acceptable and safe for humans to expedite HGT in genetically engineering plants to contain foreign genes – and for the products to avoid any special safety assessment.
Prof Jack Heinemann said in reply to such claims: “Of course nature can also create organisms – by HGT or other means – that are capable of causing us harm. But that is no reason for us to do it unwittingly to ourselves. Nature can squash us with a rock from space, causing injuries indistinguishable from a car crash. This is not a reason to stop motor vehicle safety testing or recommend removing seat belts.”
Prof Heinemann and co-authors formalised their arguments in a peer-reviewed publication, which explained:
“Language such as ‘natural GMOs' or ‘naturally transgenic’ (Kyndt et al., 2015) instead of ‘spontaneous/natural horizontal gene transfer’ still demonstrates – and causes – confusion, as in linking GMOs to the observation of sweet potato cultivars containing DNA sequences also found in a bacterial pathogen of plants. As the journal Nature proclaimed: ‘The sweetpotato genome contains genes from bacteria, so is an example of a naturally occurring genetically modified (GM) plant’ (Anon, 2015). In fact, all plants and animals have genes from viruses and bacteria. Some come from mitochondria that reside in each of our cells. Mitochondrial ancestors were free-living bacteria. Some of these genes from the mitochondria have migrated to the chromosomes kept in the cell nucleus (Martin, 2003). There are many examples of genes from viruses and bacteria in plant and animal genomes because of horizontal gene transfer. It would have been extraordinary if the sweet potatoes had no DNA from bacteria.
“These headlines and phrases linking spontaneous events in nature to outcomes of gene technology have the purpose to ‘influence the public’s current perception that transgenic crops are ‘unnatural’” (Kyndt et al., 2015). The DNA that the researchers found spontaneously had entered into the sweet potato lines via the same bacterium that was, beginning in the 1980s, manipulated by technologists to deliver transgenes into plant cells. Presumably, they thought that the distinction would be lost on nonbiotechnologists, in the same way that someone might confuse getting poked by a sharp branch while walking through a forest with being pierced by an arrow shot from a bow, because both the branch and arrow are made of wood.”
EFSA denies the obvious
In its opinion, EFSA engages in a spectacular exercise of denial that the Commission’s proposal actually means what it clearly says.
EFSA correctly says the proposal “defines criteria to classify NGT plants as ‘category 1 NGT plants’, equivalent to conventional plants, or NGT2, not equivalent to conventional plants.” However, EFSA then adds, “These criteria are not meant to define levels of risk but allow certain NGT plants to be classified as equivalent to conventionally bred plants.” It repeats this message several times in its opinion.
EFSA is wrong in saying that the criteria don’t say anything about risk. The Commission makes clear that the category 1 criteria do define the assumed level of risk. For example, the Commission says, “‘Category 1 NGT plants’... should be treated as plants that have occurred naturally or have been produced by conventional breeding techniques, given that they are equivalent and that their risks are comparable” (our emphasis). The Commission deduces that as category 1 NGT plants (supposedly) pose no extra risks, they are exempted from the requirement for the pre-market risk assessment that currently applies to all GM plants.
Why would EFSA claim that the Commission’s criteria don’t define the level of risk, when the Commission clearly says they do? Is it because EFSA is trying to distract attention from the undoubted outcome of these criteria – that human and animal health and the environment will not be protected from the real risks that NGT-derived GMOs present?
Perhaps because EFSA can foresee how this Alice-in-Wonderland reasoning will be received, it then instantly reverts to the question of risk, but only to deny that NGT plants (apparently of both categories, 1 and 2) pose any risk at all: “Moreover, with respect to the potential risks from NGT plants, the EFSA GMO Panel did not identify any additional hazard associated with the use of NGTs compared to conventional breeding techniques, which include random mutagenesis using physical or chemical agents.”
This is a strange and scientifically indefensible statement to make about NGT-derived plants as a whole, given the extreme genetic changes that can be brought about using new GM techniques and the widescale unintended changes that accompany the intended ones.
Scientists estimate that around 94% of new GM plants affected by the Commission’s proposal would be classed as category 1 according to its inadequate criteria, even though “our analysis suggests that they could bear environmental risks comparable to those of other GMOs, including potential insecticidal NGT1-plants based on RNA interference (RNAi) technology”.
When scientific bodies make statements that defy all logic and scientific principles, it is an indication that they are either technically out of their depth, incapable of rational thought, or attempting to deceive the public. Any of these explanations gives cause for concern. ...
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https://gmwatch.org/en/106-news/latest-news/20450

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