The European Commission’s top scientific advisory panel has sharply rebuked both a recent European Court decision on gene editing and Europe’s entire framework for regulating genetically modified organisms.
Noting that the court decision could have broad consequences for international trade, food security in developing nations, European competitiveness and even the European Union’s reputation, the Group of Chief Scientific Advisors called for greater reliance on scientific evidence in creating public policies.
“Factors other than scientific evidence are and should be considered in policy-making as well as in jurisdiction,” the Nov. 13 statement read. “However, when reasons other than scientific evidence inform decision making, such as those based on ethical, legal, social and economic considerations, these should be clearly identified and communicated as such in a transparent way. At the same time, relevant and robust scientific evidence should be provided to inform decision-making and good regulation. This is essential to generate good policy and regulation, to maintain public trust in science, and to reduce the potential reputational risk to the EU, if it appears that the EU is not employing the best scientific evidence to generate good public policy.”
The panel, which is mandated to provide scientific advice to the EU’s politically independent executive arm, issued its statement in response to a July 25 decision by the Court of Justice of the European Union. The court said that organisms derived from the new techniques of directed mutagenesis, such as CRISPR/Cas9 and other gene editing methodologies, should be considered GMOs within the meaning of the GMO Directive and subject to the same requirements.
The decision meant that gene-edited crops are effectively banned for cultivation in Europe, as most member states have prohibited GMOs. It was denounced by many European plant scientists and the US Secretary of Agriculture in part for being based in regressive and outdated regulations.
The scientific panel seemed to agree, noting that the definition of GMOs in the GMO Directive dates back to 1990 and fails to consider recent evidence that mutations occur naturally and spontaneously, without human intervention, as the underlying mechanism of natural evolution.
The Directive also excludes random radiation or chemical mutagenesis from the definition of GMO even though, the scientists pointed out, gene-edited products “are potentially safer than the products of random mutagenesis.”
“In view of the Court’s ruling, it becomes evident that new scientific knowledge and recent technical developments have made the GMO Directive no longer fit for purpose,” the statement read. “Moreover, the GMO Directive gives rise to more general problems, in particular with regard to the definition of GMOs in the context of naturally occurring mutations, safety considerations, as well as detection and identification.”
The scientists called for revising the Directive to emphasize the end features of a product, rather than the techniques used to produce it.
“The safety of an organism is determined by multiple factors such as the specific characteristics of the organism, the environment in which it is cultivated, the agricultural practices used, and exposure to human beings and animals rather than by the technique used for its production,” the statement read. “Hence, the risks of a product are determined by these factors and therefore logically should be assessed in the same way independently of whether they are produced by conventional breeding techniques, random or directed mutagenesis, or by ETGM. As long as this is not the case, situations can arise where two products are identical, but because of different methods used in their production, they would have to meet completely different regulatory requirements.”
The scientists went on to say: “There is a need to improve EU GMO legislation to be clear, evidence-based, implementable, proportionate and flexible enough to cope with future advances in science and technology in this area. In addition, we conclude that there is a need for robust and independent evidence to be provided in a systematic and transparent way to the Court when dealing with complex scientific issues.”
They also said it is impossible to distinguish between spontaneously occurring mutations and those induced by human intervention, creating a major regulatory headache that could hamper trade.
The scientific statement mirrored the concerns raised by 13 nations in a recent position paper that called for supporting policies that advance agricultural innovations, including gene editing.
“There is danger that unless the EU improves the regulatory environment for products of gene-editing, it will be left behind in this field, which could also diminish EU influence on ongoing debates at the international level with respect to specific applications and regulatory processes,” the European scientists warned in their statement. “Further research and innovation in this area will help better understanding of possible risks and benefits for society, the environment, agriculture and the economy.”