, 2006) A common criticism is that these processes are imprecise

, 2006). A common criticism is that these processes are imprecise. In both processes, the insertion site of the new DNA is random ( Altpeter et al., 2005 and Wilson et al., 2006) and more than one copy of the DNA fragment may be inserted into the target genome ( Christou, 1992 and Gasson, 2003). This can affect gene expression in a positive or negative manner, for example, by causing gene suppression or gene silencing ( Altpeter et al., 2005 and Dai et al., 2001). In microparticle bombardment, the extra copies of the inserted DNA can be scrambled, inverted or

incomplete ( Altpeter et al., 2005). In addition, in Vemurafenib datasheet microparticle bombardment, the site of insertion may undergo further recombination ( Altpeter et al., 2005, Christou et al., 1988 and Windels et al., 2001). For these reasons, the toxicity or nutritional value of the GM crop should be assessed as a whole. Transgenic crops are produced through the insertion of a gene cassette, which consists of the desired trait genes, as well as several other genes such as viral promoter and marker genes. These genes tend to be truncated or shortened versions, which may even have gene sequence changes (ISAAA, 2013, Padgette et al., 1995 and Vaeck et al., 1987). The effect of these genes acting together is not often determined or even required (FAO/WHO (Food and Agricultural Organisation of the United Nations/World Health Organisation), 2000 and FSANZ (Food Standards Australia New

Zealand), 2007). At present, establishing substantial equivalence is the only generally required safety assessment (FAO/WHO (Food and Agricultural Organisation of the United Nations/World GDC-0199 purchase Health Organisation), 2000 and FSANZ (Food Standards Australia

New Zealand), 2007). Substantial equivalence relies on the premise that the safety of GM food can be assessed through a comparison with compounds or organisms of known safety. The purpose of the test for substantial equivalence is to identify possible hazard areas, which become the focus of further assessment (FSANZ (Food Standards Australia New Zealand), 2007 and König et al., 2004). The test Exoribonuclease for substantial equivalence examines the individual characters and not the GM crop as a whole. For example, it assesses the toxicity of the new protein the plant has been designed to produce, such as an insecticidal protein or a protein conferring herbicide tolerance. Based on the safe history of consumption of that protein in its wild-type form, the protein is deemed safe (Kuiper et al., 2001). If the test for substantial equivalence shows no differences outside what could be obtained through natural variation, then food regulators may not require further examinations (Schilter and Constable, 2002). This type of general safety assessment does not consider that the genes present in the novel food may be additional or different from what is anticipated (Padgette et al., 1995, Vaeck et al., 1987 and Wilson et al., 2006).

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