Biosafety of Molecular Farming in Genetically Modified Plants

The use of genetically modified plants for large-scale production of recombinant compounds for pharmaceutical or industrial use, known as plant molecular farming, holds several promises. However, any development in this field must be counterbalanced by a thorough evaluation of risks to human health and the environment. The possible impact of accidental contamination of the food and feed chain or of transgene spread in the environment, in particular when major food/feed crops grown in open fields are involved, highlights the need to carefully address some important issues during the safety assessment of genetically modified farming plants, such as the choice of the production platform, the implementation of containment or confinement measures and the adoption of other relevant management strategies. In this chapter, we report on the applicability of the current risk assessment methodology and principles, outline some important issues linked to the assessment of environmental and health risks, and comment in more detail general management strategies that could be applied to limit potential environmental and human health impacts linked to plant molecular farming.