If a pathology is seen, regardless of whether it occurs in both groups, further analysis should be performed to determine

the nature of the occurrence and to completely rule-out disease. Furthermore, whilst the incidence of a pathology may be equal in both groups, the degree or severity may Navitoclax nmr vary. Therefore, it is always important to record and report the severity of a pathology. For example, an animal may be prone to a certain pathology (e.g. Sprague–Dawley rats are known to spontaneously develop certain neoplastic lesions) (Chandra et al., 1992 and Kaspareit and Rittinghausen, 1999), but it is possible that the GM component may increase the severity or risk of this development. In addition, the type of crop fed may cause a pathology. For example, soy is known to have adverse effects on bone and the digestive tract (Godlewski et al., 2006 and Piastowska-Ciesielska and Gralak,

Sirolimus in vitro 2010). Therefore, feeding soy would naturally cause changes to the gut, but the GM component may increase the severity of these changes. Hence, detailed histopathological and morphometric analyses are needed to completely rule out the GM crops’ involvement in the development of the lesion or pathological condition. In other words, it is not sufficient to say that the GM food is safe if incidences of a pathology or lesion are equal in both groups. Further testing should be carried out to completely rule out the GM component’s involvement in the development of the pathological incidence(s). Another common conclusion made was that no changes were

seen that could be considered treatment, test-article, or test-substance related, or toxicologically relevant. However, the six studies that 4��8C made this conclusion did not define treatment-related or toxicologically relevant. (Hammond et al., 2006a, Hammond et al., 2006b, Healy et al., 2008, Qi et al., 2012, Wang et al., 2002 and Zhu et al., 2004). Therefore, they did not provide clearly defined criteria by which to judge if a given tissue was normal or not, and if abnormal, whether the abnormality was toxicologically relevant and/or treatment-related. Some food regulators, such as Food Standards Australia New Zealand (FSANZ, 2007) describe GM food as novel food. In other words, they recognise that no definition yet exists for toxicologically relevant or test-substance related changes. However, by applying the test for substantial equivalence, food regulators argue that an existing compound or plant of known toxicity can be used to evaluate or predict the action of a novel compound or food such as a GM crop (FSANZ (Food Standards Australia New Zealand), 2007, König et al., 2004 and Kuiper and Kleter, 2003).