Legislation

Last changed: 13 August 2018

Precautionary measures in need of an update

How should the precautionary principle be applied regarding GMOs? This is discussed in an article with the title “How to be cautious but open to learning: time to update biotechnology and GMO legislation”.

The basic idea is that precautionary measures to protect human health and the environment should be science-based. This means that for precaution to be applied there should be scientifically credible evidence of a potential danger. On the one hand, this evidence need not be conclusive, i.e. precaution can be based on scientifically credible suspicions of danger. On the other hand, precaution should not be based on guesses that have no scientific support. Furthermore, precautionary measures should be updated as more scientific information becomes available. Decision makers should be prepared to strengthen the precautionary measures if the danger turns out to be greater than initially suspected, and to reduce or lift them, should the danger prove to be smaller.

Most current legislation on agricultural biotechnology has not been scientifically updated in this respect for several decades. It therefore reflects outdated criteria for identifying products that can cause problems. Modern knowledge in genetics, plant biology, and ecology has provided us with much better criteria for identifying the potentially problematic breeding projects at which precautionary measures should be directed. Legislation on agricultural biotechnology should be scientifically updated so that it makes use of the scientific information that is available today.

Aticle
Hansson, S. O. 2016. How to be Cautious but Open to Learning: Time to Update Biotechnology and GMO Legislation. Risk Analysis 36: 1513–1517

The EU legislation on GMO’s is inadequate

Karin Edvardsson Björnberg and Charlotta Zetterberg have analysed the legislation on GMO’s in the EU and conclude that the framework surrounding genetically modified crops is inconsistent and unpredictable. They discuss a common framework for all new crop varieties, regardless the techniques used in the breeding process. The starting point should be sustainability.

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.

Article
Zetterberg, C. & K. Edvardsson Björnberg. 2017. Time for a new EU regulatory framework for GM crops? Journal of Agricultural and Environmental Ethics 30:325-347

Should GM crops be grown in the EU? Let the countries decide for themselves

The cultivation of genetically modified crops has long been a contentious issue in the European Union. A group of biotech specialists and legal experts propose a mechanism to take the political edge out of the authorization process.

The European Union (EU) has for many years suffered from a dysfunctional voting procedure when it comes to the authorization of genetically modified (GM) crops to be commercially cultivated in EU countries. Several countries regularly demonstrate a voting behavior that seems politically rather than scientifically motivated.

To overcome the problems of this procedure, several experts are urging the European Commission to develop legislation that will allow EU countries to individually authorize the cultivation of GM crop varieties that have passed EU risk assessment. This would allow countries to adopt specific crop traits according to their needs. It would also take the pressure off the Commission, which would no longer be forced to take (or not take) decisions against the will of several EU countries.

Two years ago, a new legislation gave individual EU countries the right to prohibit the cultivation of GM crops despite EU-level authorization. This effectively moved away from the harmonization objective of the GMO Directive in a direction whereby national capitals are put more at the helm. For consistency, countries should also have the corresponding right to authorize the cultivation of GM crops.

– The risk assessment procedure should remain collective as it is today, under the auspices of the European Food Safety Authority, says Dennis Eriksson, lead author of the proposal.

– This enables more comprehensive and consistent assessments with larger resources and highly qualified, independent experts. Our proposal would also provide a more predictable situation for both farmers and the market, enabling countries that so desire to allow the application of crop traits that will for example reduce pesticide use, provide gluten-free cereals, improve the nutritional and health-promoting qualities of our food, and much more.

Article 
Eriksson, D., etl al. 2018. Why the European Union needs a national GMO opt-in mechanism. Nature Biotechnology 36: 18-19

Responsible decision-making in the EU

Technological and scientific progress provide great potential for policy innovation and sustainable solutions for food insecurity, malnutrition, environmental impact and climate change. The technical advances can contribute to economic growth and social prosperity. In order to make this possible, it is necessary for the EU to establish a regulatory framework that enables and encourages research, using for example new plant breeding techniques, and to ensure high standards and safety of these techniques.

Sevasti Chatzopoulou and Dennis Eriksson propose a policy agenda that is compatible with the concept “Responsible Research and Innovation” which has been introduced by the European Commission. According to this concept, societal actors should be involved during the research and innovation process, in a balanced and inclusive way.
Such a process has to encourage collaboration among the involved actors (researchers, citizens, policy makers, business, organisations etcetera) so that the existing
evidence and knowledge is taken into account by the policy and decision making institutions. Moreover, it will ensure that decisions are made effectively, objectively
and based on a transparent and inclusive dialogue, and not based on vested political interests.

In their paper, the researchers use three examples to show that politicization hinders or delays an efficient decision-making process, despite the fact that the EU
regulatory framework concerning plant breeding is based on scientific evidence:

1. Regulatory delays for GM maize.
2. The GMO national opt-out Directive.
3. The lack of regulatory status for new plant breeding technologies.

The researchers also point out that all three examples indicate a high degree of politicization that nurtures fears and concerns in the public. Most worrying, the examples impede the introduction of clear and effective rules that could enhance innovation and economic growth. The proposed policy agenda has a technological baseline as a starting point and aims at a forward-looking discourse for an appropriate handling of technological progress.

Article
Eriksson, D. & Chatzopoulou, S. 2017. Responsible decision-making for plant research and breeding innovations in the European Union. GM Crops & Food 8(4)

Facts:

 


Contact

mistrabiotech@slu.se

+46 (0)18 672232