title: Molecular farming on the rise--GMO regulators still walking a tightrope.
abstract: Recent increases in EU commercial and academic activities in molecular farming, and the proximity to market-stage of the first plant-made pharmaceuticals, represent a call to action for EU regulators. Drawing on the North American debate on molecular farming, it will be argued that both the rationale and the risks of molecular farming will differ significantly from those of first generation GM crops. Based on these differences, the suitability of the existing regulatory frameworks, which were developed in response to the arrival of earlier products, is discussed, and specific options for adapting the already complex EU regulatory system to cater for molecular farming are examined.
authors.affiliation: IFZ-Inter-University Research Centre for Technology, Work and Culture, Schlögelgasse 2, A-8010 Graz, Austria.
authors.forename: Armin
authors.initials: A
authors.lastname: Spök
mesh_terms: D001709:Biotechnology / Q000592:standards / Q000639:trends; D003257:Consumer Product Safety / Q000331:legislation & jurisprudence; D004345:Drug Industry / Q000331:legislation & jurisprudence*; D005062:European Union; D004364:Pharmaceutical Preparations; D028321:Plant Preparations / Q000009:adverse effects / Q000302:isolation & purification*; D030821:Plants, Genetically Modified; D011640:Public Policy; D011994:Recombinant Proteins / Q000096:biosynthesis*; D012307:Risk Factors
chemical_list: D004364:Pharmaceutical Preparations; D028321:Plant Preparations; D011994:Recombinant Proteins