The inserted gene is from the Bacillus thuringiensis which produces the Bt protein that is poisonous to insects in the order Lepidoptera (butterflies and moths), including the European corn borer.
[6] MON 810's transgene structure differs from the original plasmid constructed for the safety assessment for Monsanto[1] and has changed compared to the naturally occurring (non-active) Cry1Ab protein.
[8][9] However, the European Food Safety Authority (EFSA) reviewed this re-analysis and concluded that the differences observed were within a normal range for control rats and deemed the statistical methods used inappropriate.
[18] Ricroch et al. claim that substantial evidence cited in their review is biased towards total eco-system effects and the German decision should have been based on a "case-by-case approach" and uses an incomplete list of references.
In drawing their conclusion they point to the following weaknesses in the Ricroch et al. paper: i) important claims about the Daphnia magna study are incorrect (that the amount of toxin in the experiment was not presented), and ii) core results are omitted from the discussion (overall mortality differences and total fecundity).
[25] Analysing the controversy over MON 810 in Europe and particularly the question of the quality of the biosafety science cited to support the German ban, Wickson and Wynne[26] have highlighted how science for policy can be differentially framed in terms of its research questions, methods and data interpretation and how all studies performed, whether for or against an issue, can be legitimately debated in terms of the quality of their research process and the significance of their findings.
They suggest that debates over the quality of science for policy in the case of MON 810 are not purely technical but rather are inherently shaped by unstated normative commitments and value judgments.
Finally, they argue that for agricultural biotechnology, there are a range of conditions that make current practices of assessing the quality of biosafety science unethical.