In light of the ongoing discussion in the EU whether new plant varieties generated by genome editing are genetically modified organisms (GMOs) or not, we propose a novel approach for regulating plant breeding in general. Our proposal involves a flexible and scalable system that is capable of adapting to the rapid evolution of new technologies such as genome editing. It proposes an operational method that accounts for traditional and novel technologies, and a dynamically scalable risk assessment, which focuses on the phenotype of a novel breed instead of the method used to generate it. This approach would also resolve various dichotomies in the current debate, namely declaring new genome editing methods as highly efficient, while ignoring the impact of yet unknown risks, and proposing exemptions from regulation on the basis of the type of DNA created, whereas an older technology with fully characterized risks would still carry a heavy regulatory burden. Our proposal also takes into account that any new risk paradigm must be understood and accepted by the public, suggesting a greater role for farmers in ensuring the safe use of new breeding technologies.
There are various guidelines and regulations worldwide used to assess the risks of genetically modified crops (see Further Reading Box 1 for USA and Canada), but the EU's regulatory framework arguably has the biggest impact given the size of the market and given its influence on other jurisdictions around the world. In 1990, the EU adopted its first regulatory framework, replaced in 2001 by Directive 2001/18/EC “on the deliberate release into the environment of genetically modified organisms” (GMO). According to Article 2, a GMO “means an organism, with the exception of human beings, in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination”. However, “the …
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