New EFSA guidelines reveals that there were no prior protocols to assess toxicity from GM foods.

Monsanto has been extremely critical of the 2012 study lead by Prof. Seralini, that caused a world wide controversy with his “findings” demonstrating the and risks of Monsanto’s genetically engineered . Seralini in 2009 had published an study that pointed out the lack of available guidelines. http://www.ijbs.com/v05p0706.htm

New guidelines available here validate Seralini’s approach in his 2012 study on 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 Test Guideline (TG) 451 protocol) designed for pure . Against this background, there is a need for guidance on the design and conduct of 2-year carcinogenicity studies

2. recommends that the same strain of rat that was used in the 90-day study on the 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. recommends that animals should be fed ad libitum, which Seralini did, but which critics complained made it impossible to measure individual food and .

4. 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 ) didn’t have a clear hypothesis or objective.

5. 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- diets, on the grounds that the are the valid controls AND what is being tested is the difference between the variety and the non- comparator. Seralini was criticised by many for not including these spurious extra control groups and for thus having “inadequate controls”.

6. 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. recommends a minimum of 10 animals per sex per group for the chronic toxicity phase, the same number that Seralini used.

8. 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.

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