Monsanto has been extremely critical of the 2012 study lead by Prof. Seralini, that caused a world wide controversy with his “findings” demonstrating the public health concerns and risks of Monsanto’s genetically engineered food products. Seralini in 2009 had published an experimental design study that pointed out the lack of available guidelines. http://www.ijbs.com/v05p0706.htm
New EFSA guidelines available here validate Seralini’s approach in his 2012 study on GM maize NK603 and point out the following:
1. As of today, no standardized protocol or guidelines exist for this type of study and applicants have to adapt protocols (such as the OECD Test Guideline (TG) 451 protocol) designed for pure chemical substances. Against this background, there is a need for guidance on the design and conduct of 2-year carcinogenicity studies
2. EFSA recommends that the same strain of rat that was used in the 90-day study on the GM food should be used in the longer study – thus vindicating Seralini’s use of the Sprague-Dawley rat, which Monsanto used in its 90-day study on the same maize.
3. EFSA recommends that animals should be fed ad libitum, which Seralini did, but which critics complained made it impossible to measure individual food and water consumption.
4. EFSA recommends that you do not necessarily need a narrow and fixed hypothesis and that such a study can be “exploratory”, in spite of its previous claim that Seralini’s experiment was flawed because it (according to EFSA) didn’t have a clear hypothesis or objective.
5. EFSA recommends against using the extra control or “reference diet” groups commonly included by Monsanto in its 90-day studies and fed a variety of supposedly non-GM diets, on the grounds that the concurrent controls are the valid controls AND what is being tested is the difference between the GM variety and the non-GM comparator. Seralini was criticised by many for not including these spurious extra control groups and for thus having “inadequate controls”.
6. EFSA cautions strongly AGAINST relying on historical control data and if it is used, restricts it to within 5 years of the current experiment and to the same testing facility. This is a much stricter requirement than industry ever applies; industry uses ancient data from a wide variety of sources.
7. EFSA recommends a minimum of 10 animals per sex per group for the chronic toxicity phase, the same number that Seralini used.
8. EFSA recommends housing animals in pairs, as Seralini did, so individual food consumption cannot be measured.
The new guidelines have validated Seralini’s results available here.