Abstract
Genome editing describes a variety of molecular biology applications enabling targeted and precise alterations of the genomes of plants, animals and microorganisms. These rapidly developing techniques are likely to revolutionize the breeding of new crop varieties. Since genome editing can lead to the development of plants that could also have come into existence naturally or by conventional breeding techniques, there are strong arguments that these cases should not be classified as genetically modified organisms (GMOs) and be regulated no differently from conventionally bred crops. If a specific regulation would be regarded necessary, the application of genome editing for crop development may challenge risk assessment and post-market monitoring. In the session “Plant genome editing—any novel features to consider for ERA and regulation?” held at the 14th ISBGMO, scientists from various disciplines as well as regulators, risk assessors and potential users of the new technologies were brought together for a knowledge-based discussion to identify knowledge gaps and analyze scenarios for the introduction of genome-edited crops into the environment. It was aimed to enable an open exchange forum on the regulatory approaches, ethical aspects and decision-making considerations.
Highlights
New plant breeding techniques, such as genome editing, enable a previously unachievable targeted and precise modification of the genome
Shall the types of genome edited crops that could have been created by conventional breeding techniques be regulated no differently from conventionally bred crops? Does the current scientific development represent the ultimate trigger to design a novel framework for risk assessment which focusses on the product and its potential effects on health and environment irrespective of the technique used to develop it, as suggested by Conko et al (2016)?. To help answer these questions, the session “Plant genome editing—any novel features to consider for ecological risk assessment (ERA) and regulation?” held at the 14th ISBGMO4, used both, expert presentations and an interactive “World Café” discussion to bring together scientists from various disciplines as well as regulators, risk assessors and potential users of the new technologies
Regulatory systems may face additional challenges posed by genome-edited products, which were discussed by Martin Lema. These include for instance the debate between technology-based and product-based regulations and the potential impact on product monitoring: The Core Issue of Regulatory Touchstones Debates regarding the regulatory status of genome-edited organisms generally follow a comparative approach with genetically modified organisms (GMOs) and with conventional organisms obtained by mutation and breeding
Summary
Genome editing describes a variety of molecular biology applications enabling targeted and precise alterations of the genomes of plants, animals and microorganisms. These rapidly developing techniques are likely to revolutionize the breeding of new crop varieties. Since genome editing can lead to the development of plants that could have come into existence naturally or by conventional breeding techniques, there are strong arguments that these cases should not be classified as genetically modified organisms (GMOs) and be regulated no differently from conventionally bred crops. If a specific regulation would be regarded necessary, the application of genome editing for crop development may challenge risk assessment and post-market monitoring.
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