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 It therefore reflects outdated criteria for identifying products that can cause problems.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.
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.
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
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.
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.
Eriksson, D. & Chatzopoulou, S. 2017. Responsible decision-making for plant research and breeding innovations in the European Union. GM Crops & Food 8(4)
Legislators presented the early draft legislative texts on genetically modified organisms (GMOs) three decades ago. The purpose of the regulatory framework was to be cautious about new technologies and to ensure that the environment and human health are not exposed to risks. A lot has happened since then. Techniques used by scientists to combine DNA molecules and regulate different crop traits have become more advanced and the GM crops that have so far become food and animal feed have proven to be as safe to eat as crops bred by conventional methods such as cross breeding. The regulations have instead become an obstacle to applications that promote health and the environment.
– The progress within biotechnology has been outstanding, but the legislation surrounding the technologies is basically standing still. Those who make decisions about GMOs in the EU have neither developed nor interpreted the GMO regulations as it was originally intended, says Dennis Eriksson who is studying GMO legislation in the EU, in the Mistra Biotech research programme at the Swedish University of Agricultural Sciences.
In a recently published opinion in the scientific journal Frontiers in Bioengineering and Biotechnology, Dennis Eriksson lists four details which he thinks policy makers in the EU need to consider in their discussions on GMOs.
The EU needs to recover the original intentions of the GMO legislation, it is absolutely necessary, says Dennis Eriksson.
– We need an updated legislation, and an interpretation of the same, which acknowledge the traits and benefits of the crops. It is obvious in documents from the late 1980s that that was the original idea on how the regulatory framework should work.
In 1988, the Commission of the European Communities made the draft underlying the first Directive (Dir 90/220 / EEC) on the deliberate release of GMO into the environment. Dir 90/220 / EEC was repealed and replaced in 2001 by Directive 2001/18 / EC. This meant that the decision-making process went from being handled at national level to centralization within the EU, and in 2002 the European Food Safety Authority (EFSA) was established to make risk assessments of GMOs.
Decisions about approvals of cultivation of GM crops and consumption of GM products are now taken by qualified majority in a committee of representatives from all EU Member States. However, a major problem is that qualified majority is never achieved, at least when it´s about cultivation, as many Member States do not comply with EFSA recommendations.
Significant improvements in public health can be achieved if we manage to enhance the nutritional quality of our diets. This is true for populations in all parts of the world, although the needs for dietary change are partly different. Plant and animal breeding can contribute to promote human health by providing new and healthier food products that farmers can produce in an economically viable way and consumers can choose to buy and eat. However, this will only be achieved if breeding makes full use of knowledge about nutrition, consumer behaviour, farming and agricultural economics. A strategy is needed for breeding for public health. A multidisciplinary group of researchers, food scientists, nutritionists, animal and plant scientists and social scientists led by Sven Ove Hansson has developed a strategy for plant and animal breeding for public health. The strategy includes the following:
The current market structure for farm products does not give farmers sufficient incentives to produce more healthy plant and animal products. Farmers are often paid for quantity, without any reward for health-related quality. The food production chain needs to be reformed so that consumer demands for healthier products have a stronger impact.
Hansson, S.O., Åman, P., Becker, W., De Koning, D-J., Lagerkvist, C-J., Larsson, I., Lehrman, A., Risérus, U. & Stymne, S. 2018. Breeding for public health: A strategy. Trends in Food Science & Technology 80: 131-140
Swedish authorities share an innovation-promoting approach to directed mutagenesis in plant breeding with 1) each other, 2) six other EU countries, and 3) the science community.
Sweden shares a liberal attitude towards new technologies in plant breeding with authorities and advisory bodies in the EU countries Finland, Belgium, France, Germany, the Netherlands and the United Kingdom. These entities have said that organisms developed with the new techniques that enable so-called directed mutations should not be regulated as GMOs.
Dennis Eriksson has studied the approach and involvement of the Swedish government and governmental authorities on issues related to directed mutagenesis, and compared it with statements and reports from other EU member states and EU entities.
– The purpose of the study was to see if there is a consistent line in how Swedish authorities act in cases of new plant breeding techniques, as well as to compare with other EU countries," he explains.
The regulation of genetically modified (GM) crops in the EU has in practice meant that farmers in Europe do not grow GM plants (with one exception: maize resistant to insects grown in Spain and some other countries). Therefore, it will make a big difference if the plants with directed mutations are to be regulated as GM crops or not.
In particular, it will be crucial for small plant breeding companies, universities and research institutes who wants to invest in developing crops for smaller markets where environment, sustainability, nutritional content, taste or cultivation in a particular region could be the top priority rather than increased yields.
There is political disagreement in the EU regarding this regulation. The EU has not decided whether the directed mutations should fall under the GMO regulatory framework.
Unlike, for example, in Germany and France, the various governmental authorities in Sweden are consistent and aligned as they agree on the opinion that plants with directed mutations should not be regulated as GMOs. That is, authorities that advise on GMOs, make decisions or coordinate GMO issues. In Germany, the Federal Agency for Nature Conservation is in favor of a regulation while the Federal Office of Consumer Protection and Food Safety is against. In the French High Council for Biotechnology there is disagreement and fragmentation within the organization.
Definitions of concepts are of course crucial for how laws and regulations are to be interpreted, and in terms of GMO legislation, a crucial question is what exactly constitutes a "recombinant nucleic acid”. In his study, Dennis Eriksson has observed that authorities in some EU countries have concluded that targeted mutations fall within the term "recombinant nucleic acid" while other EU members have concluded that these mutations fall outside the concept.
– Sweden has a scientific approach here, supported by a large number of reports. It is about being able to prove the origin of the nucleic acid, and then you get about 20 nucleotides. If it is less, then a genetic change may as well have occurred spontaneously in nature and not through laboratory work, says Dennis Eriksson.
Also characteristic for the Swedish approach is that we prefer to focus on the plant itself rather than the techniques used to produce it.
– This delights us scientists and creates a climate in Swedish plant research that makes us dare to invest in development and to use these valuable and useful molecular tools, says Dennis Eriksson.
Eriksson, D. 2018. The Swedish policy approach to directed mutagenesis in a European context. Physiologia Plantarum doi: 10.1111/ppl.12740
Is it relevant to control how genetic changes have occurred though the biosafety legislation? That is the key issue in a recently published scientific article in which the researcher Dennis Eriksson gives an overview of the EU regulatory framework for genetically modified organisms (GMOs) and its potential application also on newer plant breeding methods, where you know more exactly which DNA sequences that is altered.
-Because it is not possible to see any differences in the crop or the end-product if a genetic change has occurred randomly in the breeding process or if more targeted methods are the reason for the change. Is there any point for regulating the different methods differently? says Dennis Eriksson. You have to ask yourself what, in this context, is relevant from a biosafety point of view.
He suggests that researchers and legislators, more thoroughly than before, review this question.
Plant breeding – to develop new, improved crop varieties – is based on the existence of a diversity of traits to select from. And the basis of the diversity is genetic differences in the plant genomes. Since the 1970s researchers have been able, with increasing precision, to make deliberate genes changes with molecular genetic techniques. Partly due to knowledge about which of the plants’ genes that regulate interesting traits (i.e. cultivation or health related characteristics), and partly due to genetic tools.
This summer the European Court of Justice ruled that the strict GMO legislation should apply also to targeted mutagenesis, such as CRISPR. The court concluded that the products of directed mutagenesis should be regulated under the GMO Directive, a verdict that a large part of the research community is skeptical to.
This is contradictory given the fact that today's EU regulation do not require old random mutation techniques to be regulated. Therefore, products from such breeding do not need to undergo extensive risk assessments to be approved and available for farmers in the EU.
In the EU legal system, there is a large difference between the procedures and requirements for the introduction of crops that are classified as genetically modified (GM) and so called conventional crops. Researchers have investigated to what extent the regulatory division between conventional and GM crops can be justified, given the available evidence on health and environmental risks.
The special precaution to GM varieties originated in the 1970s when the researchers that first managed to produce recombinant DNA wanted to investigate potential risks before they proceeded with their research.
– The precaution was justified then, given the state of knowledge at the time about potential risks. However, today our knowledge in genetics, plant biology and ecology has increased dramatically, says Karin Edvardsson Björnberg, associated professor of environmental philosophy at the Royal Institute of Technology (KTH) in Stockholm and the main author of the study.
In the study the researchers use four hypothetical introductions of new cultivars as examples: two varieties of field cress and two varieties of potato, with one of each species being classified as GMO. All four cases are realistic since they are based on ongoing plant breeding projects at SLU. The researchers test the relevance of the current legislation regarding risks by answering a number of question about for example invasiveness or toxicity, on the four cases. The researchers conclude that invasiveness depends on the crop’s ability to survive outside of an agricultural field, which could be a risk factor in field cress. It is also well known that conventional potato breeding can lead to inadvertent increase in toxic substances such as solanine. Thus a good case can be made for a precautionary approach to those risks, however, how these traits have been obtained is irrelevant from a risk perspective.
The researchers also conclude that the European GM legislation on crops differs from several other risk-related legislations, e.g. regarding pesticides and pharmaceuticals, in another aspect as well.
- The legislation is based on a risk assessment that only considers risks, and not the associated benefits. Usually risks are required to be weighed against the benefits. Neither of them are determined by the breeding method of the crop, says Karin Edvardsson Björnberg.
The mandatory labelling of GM products has only the purpose to inform about the process used when the plants were bred, not about the properties of the products. Consumers may be against ‘tampering with nature’, or have other existential or religious grounds for rejecting GM products. Such concerns may justify legislation, but the legislation would have to be tailored to deal with those particular issues. With a separation of issues, it will be possible to reconsider what type of legislation on agricultural crops is needed in order to prevent risks to health and the environment.
Edvardsson Björnberg, K., Zetterberg, C., Hansson, S.O., Andreasson, E. & Zhu, L-H. 2018. Consistent risk regulation? Differences in the European regulation of food crops. Journal of Risk Research https://doi.org/10.1080/13669877.2018.1501594
According to the EU Directive 2001/18/EC (the Release directive), a GM variety can only be introduced into the environment after a specific permission has been granted. Permissions may be granted only if cultivation and distribution do not pose a significant risk to human health or the environment. The burden of proof rests with the applicant, who must provide extensive documentation before a decision can be made. Conventional crops can normally be placed on the market after a variety certification (Variety directive 2002/53/EC). This certification presumes that the variety has been included in the national or common EU list of varieties, which in turn requires that the variety is distinct, stable and sufficiently uniform (DUS) and has satisfactory value for cultivation and use (VCU). However, the DUS and VCU examinations do not contain any environmental or health risk assessment, and the certification process for conventional crops is therefore much less demanding than that for GM crops.
Technology neutrality is sometimes thought to be a desirable feature of the regulations surrounding agricultural biotechnology. But what is it? The basic idea is that different technologies should be treated fairly. Per Sandin, Karin Edvardsson Björnberg and their colleague Christian Munthe (University of Gothenburg) argue that technology neutrality must be understood in relation to the regulatory rationale, that is, the purpose of the regulation. They offer a definition of technology neutrality stating in effect that similar rules apply to technologies that are alike in terms of the regulatory rationale. If the reason for regulating some technology is safety, then the regulation is technology neutral to the extent that it treats equally safe technologies in the same way.
Technology neutrality also has to be understood in scalar terms; a structure can be more or less technology neutral. Regulation may be viewed as quite technology neutral in relation to a specific regulatory rationale (such as safety) and at the same time viewed as quite technology specific with regard to some other regulatory rationale, for instance environmental impact. The current legislation on genetically modified organisms (GMOs) in the EU can be described as process based and technology specific, since it singles out crops developed by the use of a certain technology and subjects them to more stringent regulation than
other crops, while the USA and Canada among other countries have GMO legislations that are described as product based and more technology neutral.
A number of authors have previously argued that the current EU GMO regulatory processes are unfair and should be made more technology neutral. A typical statement is that similar cases should be treated uniformly and that differences in treatment must be justified.
Requirements of coherence in the EU GMO legislation are used as a basis for requiring that similar regulatory arrangements should apply to relevantly similar technologies. However, there are different views on what makes different technologies relevantly similar, and different ideas on what level of regulatory force should be equally applied on the similar set of technologies. The researchers note that biotechnology advocates apparently would like to see regulatory force to be uniformly relaxed, while biotechnology skeptics desire the opposite move.
Sandin, P., Munthe, C. & Edvardsson Björnberg, K. 2018. Technology neutrality and regulation of agricultural biotechnology. In Springer, S. & Grimm, H. (red.) Professionals in food chains. Wageningen Academic Publishers pp: 223-228, ISBN: 978-90-8686-321-1
Since 2015, the EU legislation states that individual Member States can prohibit the cultivation of GM crops within their own borders, even if the crop has been approved for cultivation at EU level. 17 member countries (for example, Germany, Poland, France and Italy), and two regions (Wallonia in Belgium and Scotland, Wales and Northern Ireland) have chosen to take advantage of this so-called opt-out mechanism and prohibited the cultivation of the approved GM maize in their own territories. This maize, approved in 1998, carries a gene from the soil bacterium Bacillus thuringiensis that produce a protein which makes the plant resistant to insect pests.
Nowadays it never happens that the EU approves a GM crop for cultivation (with one temporary exception in 2010-2012). The decision-making process is in deadlock as some of the member states want to approve specific GM crops and others oppose this. But the countries that want to grow other GM crops then? Should they not, in the name of fairness, be able to apply an opt-in mechanism and "select" new GM crops for cultivation instead of being blocked by some other member countries?
Dennis Eriksson, biologist and researcher at SLU, have together with twelve colleagues from different EU countries, presented how such an opt-in mechanism could work. In the journal EMBO Reports they describe two possibilities. For both alternatives, the crops must first have been assessed as being as safe as a conventional counterpart by the European Food Safety Authority (EFSA).
According to one scenario, the opt-in mechanism could come into force immediately after EFSA's safety assessment of a new GM crop. In that case, Member States would not need to vote on approval for cultivation. The countries that want to grow the crop approved by EFSA do so, and those who do not want to do not. The issue would be "de-politicized" at EU level. However, this would remove the possibility of an EU-wide authorization.
According to the second scenario, the opt-in mechanism could be applied later in the process, after the Member States first voted on whether or not to approve the safety-assessed GM crop for cultivation. Only when the member states fail to make a decision (do not reach a qualified majority), neither for nor against cultivation, then the opt-in mechanism would come into force and it would be up to the member states to make their own decisions. If the mechanism is applied in this way, there is still the possibility of harmonized decisions, which after all is one of the important principles of the Union.
The authors see benefits with both proposals, but believe that applying the mechanism after a vote (which results in no decision in one way or another) would probably be easier to implement politically. That proposal is more in line with the EU's general principles. It would allow Member States to make their own choices when the EU cannot deliver decisions.
Eriksson, D., de Andrade, E., Bohanec, B., Chatzopoulou, S., Defez, R., Leiva Eriksson, N., van der Meer, P., van der Meulen, B., Ritala, A., Sági, L., Schiemann, J., Twardowski, J., & Vaněk, T. 2019. Implementing an EU opt‐in mechanism for GM crop cultivation. EMBO reports DOI: 10.15252/embr.201948036