The microarray should comprehensively represent the genomes of the cultivar of maize modified and unmodified, and any novel RNA species should be tested against the human genome for RNAi activity [emphasis added].” “Microarray descriptions should be capable of detecting novel RNA species in the modified plant, with the RNA source being the plant grown under a variety of relevant field conditions. The microarray should comprehensively represent the genomes of the cultivar of maize modified and unmodified. Since LY038 may be found in food, variant RNAs should be screen using a microarray

for the human genome.” FSANZ: “The rationale behind this recommendation is presented in the NZIGE submission in Section 1.3. This section presents a summary of the biological GSK J4 order properties of RNA that is generally accurate. However, the scientific evidence does not support the theory that RNA molecules in food can

be transmitted to mammalian cells and exert effects on endogenous genes. RNA is rapidly degraded even in intact cells. Following harvest, processing, cooking and digestion, it is unlikely that intact RNA would remain. Even if Gamma-secretase inhibitor it did, it is very unlikely that it would enter human cells and be able to exert effects on endogenous genes [emphasis added]. What little is known about transcription levels of genes across entire plant genomes indicates that gene transcription may vary considerably even between closely related plants (Bruce et al., 2001; Guo et al., 2003; Umezawa et al., 2004). This high level of differential expression is thought to be due to a number of factors including environmental conditions and genotype. For this reason, analysis of changes in the transcriptome, while interesting, would not indicate whether these changes are within the range of natural variation nor would it provide any further information on the safety of the food” ( FSANZ, 2006). Full-size table Table options View in workspace Download as CSV FSANZ drew several assumption-based lines of reasoning at the time to argue that existing evidence was sufficient to dismiss relevant exposure routes. For example, FSANZ did not draw on scientific evidence when it said that dsRNA would

be degraded in the stomach, all dsRNA Edoxaban would be equally prone to degradation, none would be subject to recruitment, all would be passed through ingestion (and not also inhalation), and that plant-derived dsRNAs were incapable of being taken up by human cells. In doing so, it avoided having to consider the possibility of adverse effects of dsRNA because it did not recognize a route of exposure. Critically, FSANZ ignored sequence-determined risks when it referred to natural variation in transcription. INBI continued to alert FSANZ both to the use of assumption-based reasoning and to the scientific plausibility of the exposure routes in its subsequent submission on application A1018 (2009), where a GM soybean was intended to produce a novel dsRNA.