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.
Inconsistent risk regulation of food crops in EU
The present regulatory divide in risk assessment, between genetically modified (GM) crops and crops bred using other methods, cannot be justified from the viewpoint of risk assessment, since the GM/non-GM dichotomy is not an accurate indicator of either health risk or environmental risk. Assessments of new crop varieties should be based on traits and should not only involve risks but also take benefits into account. This is concluded in a recent study by researchers in law, ethics and plant genetics.
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. In a study published in the Journal of Risk Research, researchers in Mistra Biotech investigate 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
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