http://www.enveurope.com/content/23/1/10Conclusion
Transcriptomics, proteomics and other related methods are not ready yet for routine use in the laboratories, and moreover they may be inappropriate for studying toxicity in animals, and could not in any way replace in vivo studies with all the physiological and biochemical parameters that are measured with organs weight, appearance, and histology. By contrast, afterwards, new approaches could well help to explain pathological results or action mechanisms of pesticides present in the GM plants or GM-fed animals, if found.
To obtain the transparency of raw data (including rat blood analyses) for toxicological tests, maintained illegally confidential, is crucial. It has also become crucial to apply objective criteria of interpretation like the criteria described here: sex-specific side effects or non-linear ones. Such data can be put online on the EFSA website with a view to provide a fuller review to the wider scientific community, and in order to better inform the citizen to make biotechnologies more socially acceptable. Since fundamental research is published on a regular basis, it should be the same for this kind of applied research on long-term health effects, as suggested by the CE/2001/18 and the corresponding 1829/2003 regulations.
We can conclude, from the regulatory tests performed today, that it is unacceptable to submit 500 million Europeans and several billions of consumers worldwide to the new pesticide GM-derived foods or feed, this being done without more controls (if any) than the only 3-month-long toxicological tests and using only one mammalian species, especially since there is growing evidence of concern (Tables 1 and 2). This is why we propose to improve the protocol of the 90-day studies to 2-year studies with mature rats, using the Toxotest approach, which should be rendered obligatory, and including sexual hormones assessment too. The reproductive, developmental, and transgenerational studies should also be performed. The new SSC statistical method of analysis is proposed in addition. This should not be optional if the plant is designed to contain a pesticide (as it is the case for more than 99% of cultivated commercialized GMOs), whilst for others, depending on the inserted trait, a case-by-case approach in the method to study toxicity will be necessary.
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