Rat feeding studies with genetically modified maize - a comparative evaluation of applied methods and risk assessment standards

Environmental Sciences Europe

Table 1 Compliance with the EFSA requirements by the three studies

Requirement	Level of compliance
Requirement	Séralini et al.[3]	Hammond et al.[14]	Monsanto[12]
Study objectives need to be clearly stated a priori in the study protocol	Medium	Medium	Medium
Suitable controls for all treatment groups need to be presented	No data shown (high)^a	High	High
Biological relevance of the rat strain used should be justified	Low	Low	Low
Measures taken to reduce the risk of bias (e.g. blinding) need to be taken	No data shown (high)^a	No data shown	No data shown
Critical information about the diet composition need to be reported	No data shown	No data shown	High
Details of the storage conditions of the feed need to be provided	No data shown	No data shown	No data shown
Contamination of the diets, e.g. by mycotoxins, pesticides etc., need to be reported	No data shown (medium)^a	No data shown	High
All collected endpoints should be reported openly and transparently	No data shown	Medium	High
The presented data need to ensure the calculation of exposure to the test substance	No data shown	No data shown	Medium
The sample size (power) calculation must be presented, especially when the study objectives are unclear	Low	Low	Low
	Low	(but reference to OECD GL408)	(but reference to OECD GL408)

Based on EFSA [8] and EFSA Scientific Committee [9]. ^aCompliance level is enclosed in brackets based on additional information given by Séralini et al. [15].