Continued Failure of Assumption-based Risk Assessment: the Case of RNAi-based GM Crops

Both a lack of adequate and science-based risk assessment for genetic engineering (GE) (e.g. Hilbeck et al. 2012; Freese and Schubert 2004; Pelletier, D. 2006) and actual GE regulatory failures (e.g. Latham and Wilson 2013; Gurian-Sherman, D. 2007; Bratspies R.M., 2003) have been extensively documented. Without a complete regulatory rethink, future failures seem assured. The latest case is the heavily promoted GE technology known as RNAi (Williams et al. 2004), whose use seems set to expand while regulators and developers fail to ask or answer key scientific questions.

A recent paper by JA Heinemann, SZ Agapito-Tenfen and JA Carman (2013) “A comparative evaluation of the regulation of GM crops or products containing dsRNA and suggested improvements to risk assessments” presents a careful assessment of three regulatory regimes (Australia, New Zealand and Brazil) and their use of assumption-based reasoning to discount the risks of RNAi technology and the likelihood of harmful and unintended consequences. The authors discuss evidence from the scientific literature showing key assumptions made by these regulators are already known to be wrong. In addition, they provide case studies of previous regulatory failures, such as Vioxx and BSE, that stemmed directly from faulty assumption-based risk assessment. Heinemann et al. outline an alternative science-based risk assessment strategy for RNAi technology that takes into account known sequence-specific hazards and the current state of scientific knowledge.


Bratspies RM, (2003) Myths of Voluntary Compliance: Lessons from the StarLink Corn Fiasco

Freese and Schubert: Safety Testing and Regulation of Genetically Engineered Foods (2004)

Gurian-Sherman, D (2007) Transgene Escape! – But No One Has Called Out the Guards

Hilbeck et al.: (2012) Underlying Reasons of the Controversy over Adverse Effects of Bt toxins on Lady Beetle and Lacewing Larvae

Latham and Wilson (2013): Regulators Discover a Hidden Viral Gene in Commercial GMO Crops

Pelletier, D (2006) FDA’s regulation of genetically engineered foods: Scientific, legal and political dimensions

Williams, Matt, et al. (2004) RNA Interference and its Application in Crop Improvement