Consequently, the published studies should have been able to supply the definition and evidence that the results showed no treatment-related or toxicologically relevant changes. If an existing compound can’t predict the action of a GM crop on animal health, further investigation would be necessary. Known toxicity of single components of the GM crop may not define an overall toxicity of the entire crop. It is not clear whether the test for substantial equivalence is sufficient because it does not take into account the changes that could arise from the transformation process: (1) through the random insertion of the genes, (2) through the genetic

alterations made to the transferred genes as a result of the transformation process, (3) through the genetic Gemcitabine datasheet alterations made to the plant as a result of the transformation process (Wilson et al., 2006), (4) through the insertion of several traits or genes into one crop or (5) through the alteration made to the genes encoding the desired trait prior to the transformation. Several of the reviewed publications do not adequately report their results. Some do not

even provide any results (Table 2). For example, the paper by Zhu et al. (2004) not only lacks a detailed methods section, but also limits its histopathological results to a simple statement that “although some slight lesions (such as slightly dilated alveolus cavity, pelvic dilation of the kidneys, slight disconnection of myocardial fibre and collapse of jejunum villi) occurred in rats examined, they were not treatment related.” Such a statement could imply that other mTOR inhibitor changes may have been observed, but are not reported. Furthermore, this study does not mention the incidence or severity of any histopathological changes, including whether they occurred in the treatment or non-treatment group. For example, they do not state how many rats showed collapsed jejunum GPX6 villi and whether these were more prevalent in one group or whether the collapsed

villi were more severe in one group. A lack of transparency in results does not allow other researchers to judge whether a certain finding is pathologically relevant. Another paper (Tutel’ian et al., 2010) indicated that they had performed a morphometric analysis of the small and large intestines, but they did not report the colon results. A lack of transparency is also evident in two other studies: 1) Hammond et al. (2004) report the findings from “only those tissues with an incidence of 2 or more findings”; and 2) Healy et al. (2008) state that “findings in other tissues with an incidence of 1/20 are not reported.” Neither of these papers provided a full account of pathologies present. Furthermore, Hammond et al. (2004) do not clearly state whether “incidence” pertains to two incidences per tissue or per rat. Such a lack of information does not ensure that the study and its results are reproducible or even comparable.