Research concludes that the EU legislation on GMO’s is inadequate

The framework on genetically modified organisms (GMOs) does not satisfy reasonable requirements of legal certainty. The legislation is inconsistent and does not take into account new scientific evidence. This is shown in a study by researchers in law and philosophy at Uppsala University and the Royal Institute of Technology (KTH).

Only one genetically modified (GM) crop, an insect resistant maize that do not need spraying against the European corn borer, is approved for cultivation within the EU. This maize variety is grown foremost in Spain but also in small scale in Portugal, the Czech Republic, Slovakia and Romania.

One problem that the researchers point out is that the current legislation complicates the development of new improved crops. Plant breeders needs clear rules to relate to.

– There is for instance an uncertainty regarding if crops developed with the genome editing technique Crispr/Cas9 will be regarded as GMOs and thereby covered by that legislation, says Karin Edvardsson Björnberg, Assistant Professor in Philosophy at KTH and one of the researchers behind the study.

The legislation also entails a discrimination, based on breeding technology instead of the crops’ traits, which is difficult to motivate. The analysis shows that the EU’s GMO legislation does not counteract risks in a consistent manner.

– The legislation restricts the GM crops, but does not regulate conventionally bred (non-GM) varieties that can result in similar, or even larger risks compared to genetically modified crops, says Karin Edvardsson Björnberg.

The fact that many people working on issues related to GMOs finds the EU legislation on the area problematic, made the researchers put the EU regulations under the philosophical and legal microscope.

The researchers set up four criteria that, according to regular measurements, can be expected to comply with legislation, and examined how well Directive 2001/18/EC on the deliberate release of GMOs into the environment, stands according to these measures.

They wanted to know: Is the legislation predictable? Does it include discrimination/equal treatment? Is the legislation proportional to the risks? Does it take the recent science into account?

In addition to shortcomings in the legal certainty and clarity of the legislation, the researchers also found lack of stringency in the evaluation of crops produced by different methods; the framework on GMOs provide very little room for assessment based on new scientific evidence about the safety of those crops.

Charlotta Zetterberg is Professor in Environmental Law at Uppsala University and one of the researchers behind the study.

– If new scientific evidence emerges showing that a GM crop is less risky than previously thought, then it is not possible to change the assessment. If, on the other hand, the risk is greater than one believed when authorization was given, then further precautions may be taken, she explains.

It was however more difficult to determine if the GMO legislation is proportionate, that is, that it is reasonable comprehensive and has the right level of stringency.

Proportionality depends on the purpose of the legislation, which in turn reflects political values. If the reason for the existence of the GMO legislation only existed for the purpose of minimizing the risks and protecting the environment and health of humans, the criticism about disproportionality be justified, as GM crops that obviously involve minimal risk are covered by the rules.

– The EU works for a sustainable development, and the directive on releasing GMOs into the environment is based on the precautionary principle. There are other considerations than those dealing with security that speak against gene technology, which legislators want to capture. First you have to decide on what you mean by sustainable development, and how to manage uncertainty, before you can say something about the proportionality of the GMO legislation, says Charlotta Zetterberg.

During the work, the researchers added a fifth criteria. They examined whether it is relevant to take other aspects than the safety of humans and the environment into account in the evaluation of new GM varieties. Should for example ethical, religious and socio-economical aspects have a part in the process of approval? To some extent, there is now room for socio-economic considerations because individual Member States may prohibit the cultivation of a GM crop approved by the EU.

Based on this analysis, the researchers suggest how the present GMO legislation could be improved. Different crop varieties could be regulated using different levels of risk assessment depending on the probability of a specific variety to pose any risk. Another option is a framework that regulates all new varieties of crops based on their performance from the perspective of sustainability, not considering what breeding technology that have been used in the development.

The study was conducted within the research programme Mistra Biotech and published in the scientific journal Journal of Agricultural and Environmental Ethics.