ENSSER’s Response to the Inception Impact Assessment (IAA) on new Genomic Techniques

ENSSER regards this current Commission initiative as ill-advised and scientifically ill-founded.

The IAA provides no clarity as to what is planned or how to achieve it. It however states what the Commission does not want, namely to regulate GM plants (and foods) derived by genome editing or cisgenesis as GMOs. It does so on grounds that are and have been scientifically disputed and are more akin to wishful thinking than to responsible oversight.

We urge to keep all new GM techniques covered under the current directive and its obligations, in particular as they are new; necessary research, evidence and empirical data will only emerge over time and cannot be assumed. There is already a body of evidence and research that reveals the falsity of current simplistic assertions, assumptions and extrapolations regarding precision, ‘equivalent to nature’, safety, and clarity of risks.

We and our members have repeatedly submitted state of the art evidence, analysis and scientific papers in  EC, EFSA and recent stakeholder consultations.

We are disturbed that neither science nor the precautionary principle prevail in the current initiative/IIA, and that instead half-sciences are used, assumptions asserted as facts and the crucial issue of scale being ignored.


Concerning scale: as stated by Heinemann et al. 2021b: “Unfortunately, the risks from technology don’t disappear by calling it natural. The risk of harm from gene technology accumulates over time and scale of production. … we propose a framework that regulates technologies depending on their scale of use.


“Proponents of deregulation of gene technology use the naturalness argument to make their case. But we argue this is not a good basis for deciding whether a technology should be regulated.”

“Any potential harmful outcomes of the use of gene technology increase as it is used more. What makes gene technology useful is also what makes it risky.”

If it “is carried out on a large enough scale then we can say that if anything can happen it certainly will.”  Nobel laureate Sydney Brenner quoted in Heinemann et al. 2021a, DOI: 10.1525/elementa.2021.00086.

If it ignores the importance of scale, and the traps of pseudo-scales (e.g. foreignness, naturalness, distinguishable from nature or from other mutations), regulation will not protect from harm but enhance the risk of harm – as discussed by Heinemann et al. 2001 (attached to our letter).


Proportionality flaw

The Commission describes their envisaged regulatory regime for new GM plants as ‘proportionate’ to the risks involved. But such rhetoric fails to acknowledge the complexity of the uncertainties that characterise the science, in particular of  hazards and risks. Proportionality can only be relevant to what is reliably known and quantifiable (i.e. case-by-case basis); the possible adverse effects of genome edited plants are far from reliably knowable, including risks through scaling and across time. The Commission also does not acknowledge the relevance of regulatory precaution as a prudent response to uncertainty.

We observe that the Commission has succumbed to, and articulates, naïve boosterish rhetoric about how beneficial genome edited GM crops could be; it enthuses about hoped-for benefits. Based on this it suggests that regulatory regimes should be changed so it could actively facilitate and incentivise the development and marketing of ‘safe’ plants derived through new GM. This is yet another expression of the bias the Commission and the processes have shown towards high-tech innovations and techno-fix solutions rather than ensuring the furthering of proven approaches for sustainable and biodiversity enhancing agriculture, such as agroecology. We maintain that research funding and incentives for system approaches and for risk research of new GM is required.

We are deeply concerned that the current roadmap is heading towards deregulation of new GM, lack of transparency, traceability and labelling, setting the wrong signal at a time when other signals and actions are needed.

We further reject that the current regulation is not “fit for purpose”. It may not be as strong as it could be, and it does not contain the aspects of sustainability and proof of benefit, as pointed out in the roadmap. These however should be applicable to all GMOs, not just to new GM. Importantly, no competence exists for such assessments.

Please also see two attachments.