90-day rodent feeding studies on whole GM food/feed: Is the mandatory EU requirement for 90-day rodent feeding studies on whole GM food/feed fit for purpose and consistent with animal welfare ethics?

Abstract

Genetically modified (GM) plants and derived food and feed products are subject to risk assessment and regulatory approval before these can be marketed in the European Union (EU). This pre‐market risk assessment follows international standards to evaluate whether characteristics of the GM plant associated with the genetic modification are capable of causing adverse effects on human and animal health and the environment (hereafter referred to as hazards) [1]. Such hazards can arise directly from the novel trait intentionally introduced in the GM plant, or from unintended changes (Sidebar A). As unintended changes are, by their nature, generally unexpected, it is difficult to foresee them based on a specific risk hypothesis and test for them directly [2]. The identification of unintended changes in GM plants is therefore based on the molecular, agronomic/phenotypic and compositional characterisation of the GM plant (Sidebar B) [1], [2]. Any unintended changes identified are then assessed further for their potential to cause harm to human and animal health or the environment. > … safety assessment should focus on known hazards associated with the novel traits […] in order to evaluate plausible risks instead of unknown ones Since 8 December 2013, the Implementing Regulation (EU) No. 503/2013 provides detailed instructions for the risk assessment of GM food/feed in accordance with Regulation (EC) No. 1829/2003. As part of the toxicological assessment of GM plants, the Implementing Regulation now requires a mandatory 90‐day feeding study in rodents on whole GM food/feed in order “ to identify potential adverse effects on the whole GM food/feed, or address remaining uncertainties .” The mandatory nature of this requirement introduced a significant shift in the approach to 90‐day rodent feeding studies by necessitating such a study even when no specific risk hypothesis can be formulated, that is …