As far as we are concerned there is more than enough evidence to show that GM plants, foods/feeds derived from GM plants, and meat and other products (such as milk and eggs from animals fed on GM materials), all differ from their conventional counterparts. Having said this, the regulators still base their safety assessment on the idea of sameness, in other words on "substantial equivalence”.
In addition GM technology is considered “neutral”, in spite of all research data published in the scientific literature showing that when transformation occurs 1 to 4% of the genes of the host genome alters its function. None of the regulatory bodies takes this into account. At EFSA meetings EFSA representatives get rattled as soon as the words “insertional mutagenesis” are mentioned. As a result, the effects of insertional mutagenesis, occurring during transformation, are ignored during safety assessments. No one ever looks for these effects during the authorisation process or acknowledges their exsistence. Although it has been clearly spelled out in several papers, including the Ewen and Pusztai paper in the Lancet, insertional mutagenesis might be responsible for severe health effects from alterations in body metabolism to to the production of toxins or allergens.
The regulators also ignore the facts found by independent researchers that the reproductive organs and their function might be affected by consuming GMOs. Effects on the reproductive organs of both males and females have been described by several authors. Our own experiment with GNA GM potatoes showed significant differences in the weight of the prostate and testicles in male rats. Although Ermakova’s experiments were severely criticised when she showed increased mortality and decreased growth rate of rat pups on GM soy, instead of repeating those experiments with the “right” GM and isogenic, non-GM soy lines, nothing has happened. A large proportion of the World’s populations have been exposed to RoundupReady GM soy in their diet for the last 14 years. What if the effects found with rats also apply to Humans?
The safety considerations of glyphosate are still based on the data produced in the 1980s, using a much lower concentration than the one used in agricultural practices today. In spite of the work of Seralini and others in warning about hormone disruptive and reproductive consequences, the safety of glyphosate has not been re-evaluated. Since glyphosate residue levels had to be increased to be able to accommodate GM crops using this herbicide we would not be surprised if glyphosate would turn out to be the DDT of the 21st Century. This is an issue which needs to be urgently examined.
The research on the reproductive abilities of mice fed the MON810xNK603 maize line, which clearly shows significant effects, is being ignored, because the data were published in a brochure by the Austrian Government instead of in a peer reviewed journal. We checked those data and could not find anything wrong with the experimental design, the conduct of the experiments, or with the authors' conclusions.
Civilisation diseases, including cancer, cardiovascular diseases or diabetes and metabolic disorders are costing the health services billions all over the World. In spite of these, not a single study is required by the regulatory authorities on the effects of GM plants/ food/feed on cancer development. When significant differences suggest effects on body metabolism, they are considered by the regulators to be "biologically insignificant".
In spite of the EU signing the Carthagina Protocol, the precautionary principle is not part of the assessment process.
EFSA in its new regulation framework would like to use approved GM events as “conventional comparators”, usually considered GRAS.
There is evidence that meat and produce (such as milk and eggs) from animals fed on GM ingredients differ in their metabolites from those fed non-GM feeds. However, according to EU regulation the safety testing of these products is presently not subject to the approval process. The same is true for GM animals, whose meat may end up in the food chain, since they are considered substantially equivalent to non-GM animals.
As far as animal experiments are concerned, there are always question marks about the applicability to the human situation. As a reminder we would like to state that all basic nutritional requirements were worked out by using rats. This is true for amino acid, vitamin and other requirements. Also, diet, digestion and all other functions of the porcine intestinal tract are considered to be nearest to that of humans. Since animal experimentation with primates are out of the question, we are used as subjects in a badly designed, uncontrolled and botched gigantic GM experiment without proper controls.
Susan Bardocz and Arpad Pusztai