The Need for Better Risk Governance of Gene-Edited Products

THIRD WORLD NETWORK BIOSAFETY INFORMATION SERVICE

Dear Friends and Colleagues

The Need for Better Risk Governance of Gene-Edited Products

New and emerging gene-editing techniques, such as CRISPR, are being developed. They open the possibility for editing genetic information and modulating gene expression in organisms in faster and more targeted ways, but carry risks. Genome changes can vary in location (target and/or off-target sites), in quantity (how many sites were changed) and also in quality (deletion, insertion, substitution of nucleotides in a sequence). Genome changes at the target site can have both intended and unintended effects depending on the quality/type of the change. Unintended effects can arise from both the target site and off-target sites.

In general terms, genetically modified organisms (GMOs) require regulatory approval before environmental release and use in food and feed, but the current risk assessment framework in the European Union was developed for products of classical GM techniques. A new journal paper discusses the potential challenges new and emerging gene-editing techniques pose to established risk governance strategies.

There are challenges with the traceability and monitoring of products developed using new and emerging gene-editing techniques. In addition, risk assessment and management of GM plants is constrained by limitations in transparency regarding public disclosure related to product development. The paper also identifies several gaps in the knowledge base with regards to application of new and emerging gene-editing techniques to plants, for example, the target and off-target effects of intervention in plant genomes.

The authors propose that the framework of responsible research and innovation offers a useful way to improve GM risk governance research and practice for biosafety of crop development with new and emerging gene-editing techniques. Such an approach, supplemented with technological advances of whole genome sequencing and -omics approaches, could involve a broader community of people, organizations, and interest groups when reflecting on, anticipating, and responding to risk governance challenges. The broad plant-biotechnology community could similarly explore more open and coordinated pursuit of societally desirable, ethically acceptable, and sustainable changes to plant life, grounded in principles of biosafety.

With best wishes,

REVISITING RISK GOVERNANCE OF GM PLANTS: THE NEED TO CONSIDER NEW AND EMERGING GENE-EDITING TECHNIQUES

Agapito-Tenfen, Okoli, Bernstein, Wikmark and Myhr

Frontiers in Plant Science
https://doi.org/10.3389/fpls.2018.01874

21 Dec 2018
https://www.frontiersin.org/articles/10.3389/fpls.2018.01874/full
 

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.