Abstract
New and emerging gene-editing techniques make it possible to target specific genes in species with greater speed and specificity than previously possible. Of major relevance for plant breeding, regulators and scientists are discussing how to regulate products developed using these gene-editing techniques. Such discussions include whether to adopt or adapt the current framework for GMO risk governance in evaluating the impacts of gene-edited plants, and derived products, on the environment, human and animal health and society. Product classification or definition is one of several aspects of the current framework being criticized. Further, knowledge gaps related to risk assessments of gene-edited organisms—for example of target and off-target effects of intervention in plant genomes—are also of concern. Resolving these and related aspects of the current framework will involve addressing many subjective, value-laden positions, for example how to specify protection goals through ecosystem service approaches. A process informed by responsible research and innovation practices, involving a broader community of people, organizations, experts, and interest groups, could help scientists, regulators, and other stakeholders address these complex, value-laden concerns related to gene-editing of plants with and for society.
Highlights
New and emerging gene-editing techniques being developed include clustered regularly interspaced short palindromic repeats (CRISPR), oligonucleotide directed mutagenesis (ODMs), meganucleases (EMNs), zinc finger nucleases (ZFNs), and transcription activator-like effector nucleases (TALENs)
We propose that the framework of responsible research and innovation (RRI) offers a useful way to improve genetically modified (GM) risk governance research and practice for biosafety of crop development with new and emerging gene-editing techniques
By adopting a process-based system, genetically modified organisms (GMOs) are regulated differently than other products and according to a specific regulatory framework: this is the case in Europe
Summary
New and emerging gene-editing techniques being developed include clustered regularly interspaced short palindromic repeats (CRISPR), oligonucleotide directed mutagenesis (ODMs), meganucleases (EMNs), zinc finger nucleases (ZFNs), and transcription activator-like effector nucleases (TALENs). By adopting a process-based system, GMOs are regulated differently than other products (e.g., organisms and plants developed by other methods than GM technology) and according to a specific regulatory framework: this is the case in Europe Those who argue against novel regulation to new and emerging gene-editing techniques object on the grounds of a product-based system of regulation. The EFSA GMO Panel opinion addressing the safety assessment of plants developed using Zinc Finger Nuclease and other Site-Directed Nucleases with similar function (EFSA Panel on Genetically modified organisms (GMO), 2012) and the Institute for Prospective Technological Studies and Institute for Health and Consumer Protection (both from the Joint Research Centre at the European Commission) (Lusser et al, 2011) have set forth three major categories of new and emerging gene-editing techniques (Box 1). These studies either looked only at potential off-target sites predicted by computer programs (bias analysis) or fell short of full analysis of all the
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