GMO regulations and their interpretation: how current risk assessments of GMOs are bound to fail
Channel: ENSSER
Date: 25/09/2020

00:00 Introduction
07:20 Summary Erik Millstone
12:30 Presentation Angelika Hilbeck
59:13 Discussion


Speaker: Dr. Angelika Hilbeck, ETH Zurich, Switzerland

Firstly, we compare the contrasting regulatory approaches of the US and the EU and explain their different underlaying scientific premises. While the legislative texts of the EU set appropriate objectives, their concrete implementation has fallen far short of the legislative goals. EFSA’s prevailing approach to GM crop and food risk assessment starts from what it terms a ‘comparative safety assessment’ (called ‘substantial equivalence’ in other regulatory regimes) which is based on rudimentary data sets of molecular, chemical and phenotypic data from GM plants and any non-GM varieties. Those data are inadequate (and designed) for predicting adverse biological, toxicological and ecological effects. However, when GM products are deemed to have passed a ‘comparative safety assessment’ prior to the risk assessment step, EFSA has interpreted that as grounds for conducting only very narrowly circumscribed risk assessments (if at all), which do not require meaningful data from studies of ecological or eco-toxicological impacts. This allows in the end that, despite the contrasting regulatory premises and goals, under both regulatory regimes of the US and the EU, similar dossiers seeking approval or deregulated status (as it is called in the US) can be filed – much to the convenience of the industry but not in the public interest. How this may play out if the current push for taking newly genetically engineered organisms (using so-called ‘gene editing’ tools) out of regulations succeeds and what the consequences of the ‘no transgene – no risk’ mantra will spell for human and environmental health will also be presented and discussed.