A Risk-Based Approach to the Regulation of Genetically Engineered Organisms

Originally co-authored with Drew L. Kershen, Henry Miller, and Wayne A. Parrott in Nature Biotechnology 

Current regulatory regimes for genetically engineered crops fail to use a scientifically defensible approach or tailor the degree of regulatory review to the level of actual hazard or risk. We describe a rational way forward.


The use of molecular techniques for genetic engineering (GE), also known colloquially as 'genetic modification' (GM), offers plant breeders the tools to make old crop plants do spectacular new things. For a quarter-century, GE crops have been the most scrutinized foods in human history, despite a lack of scientific justification for such a burden. Although study after study—formal risk assessments as well as observations of 'real-world use'—have failed to show any new or incremental risks associated with GE, there has been no rationalization or reduction of the regulatory burden placed on GE crops. If anything, regulatory stringency continues to increase. As a deeper understanding of biology expands the range of technologies available for precision breeding, including genome editing, synthetic biology, oligo-directed mutagenesis, agro-infiltration, grafting onto transgenic rootstock and reverse breeding, removing unnecessary regulatory obstacles should be a high priority.

In this article, we describe a risk-based approach, building on that outlined originally by the National Research Council (NRC; Washington, DC) report in 1989 and then later in the 'Stanford Model' for risk assessment. With the US regulatory framework currently being re-evaluated, and with half a century of experience with transgenic organisms and almost two decades of experience with commercial GE crops in hand, the time is right to adopt such a risk-based regulatory approach.