THE CRITERIA FOR RISK ASSESSMENT ARE BASED ON THE ORIGINAL UNMODIFIED PLANT

THE CRITERIA FOR RISK ASSESSMENT ARE BASED ON THE ORIGINAL UNMODIFIED PLANT, the novel trait or gene transferred, the novel modified plant as a whole, and its potential environmental interaction. The biology of the unmodified plant is dealt with through a series of "biology documents which review agronomic practices, reproductive biology, centre of origin, out crossing potential, weediness and potential interactions with other life forms in the Canadian environment. Characterization of the novel trait plays a central role in the assessment process and overlaps the assessment of modified plant. The main criteria considered includes information about the genetic construct (genes inserted, regulatory elements, marker genes, donors and known risks associated with the known organisms) the gene products, byproducts and breakdown products, metabolic pathways affected, and potential toxicity or allergenicity of the gene product. Next the novel plant is assessed. Emphasis is placed on its integration into the plant genome, for example, the insertion of the novel gene(s) into the plant genome, the number of sites of integration (loci), the copy numbers, presence of rearrangement, the stability, the expression, the metabolic pathways, the activity of an inserted gene product in the plant and the activity of the gene product in the environment. Potential altered interaction of the novel plant involves identifying changes to the relative phenotype with respect to stress adaptation, weediness, composition, toxins, and agronomic characteristics. As well, the novel plant is assessed for its anticipated impacts, for example what impacts might reasonably be expected from the use of the plant (such as on biodiversity, soil microbes, sustain ability and resource conservation?). Also, the novel plant is assessed for possible changes in agriculture practice and its potential environmental effects from introgression of traits into related wild plant species. Finally, the information submitted for the review must address the following five criteria which are used to make an environmental risk assessment and provide direction for any risk management decision: altered weediness potential; gene flow to related species (there are no sexually compatible wild relatives of potato in Canada); altered plant pest potential; potential impact on non target organisms; potential impact on biodiversity. If the PNT is assessed to be safe, it can be registered and commercialized.