In this article, the general principles of genetically modified (GM) plant risk assessment and the regulatory framework for contained
use and open field production of plant-made pharmaceuticals/plant-made industrials (PMP/PMI) are described. While significant
progress has been made for the containment grown (plant cell culture) production of PMPs, with the first regulatory approval made by the
FDA in 2012, the commercialization of medicinal or industrial products produced in the field has yet to emerge in either Europe or the
US. In the current paper, we discribe the regulatory environment in Europe and the US surrounding GM crops, and provide case studies
for experimental field releases of PMP and PMI producing plants in both regions. Suggestions for reducing the regulatory burden for GM
plants will be discussed, also in light of the emerging new technologies to modify the genetics of plants. Since regulations surrounding
the commercialization of GM crops are very costly and not appropriate for most of the PMP/PMI applications in Europe, we propose that
amendments to the EU Directive 2001/18/EC are necessary to allow for the commercialization of products from GM plants without the
need of an ‘authorization’. To fully acknowledge the overall outcome of adopting plants to produce PMP/PMI, the conclusion is that
broader and more balanced legislative oversight is needed in Europe; while specific legislation is not needed in the US.
Keywords: Plant molecular farming (PMF), plant made pharmaceuticals (PMP), plant made industrials (PMI), genetically modified plants,
GM plant regulation, GM plant risk assessment.
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