Outcome of the public consultation on the draft EFSA guidance on conducting repeated‐dose 90‐day oral toxicity study in rodents on whole food/feed

report from the EFSA GMO Panel Working Group entitled "Safety and nutritional assessment of GM plants and derived food and feed: The role of animal feeding trials". The somewhat contradictory conclusion of the 2008 document was that, although 90-day studies are not sensitive enough to detect potential adverse health effects due to unintended changes in whole GM foods, they should nonetheless be conducted if compositional and other comparative analyses do not satisfactorily demonstrate equivalence of a GM crop to its conventional counterpart. In answer to this recommendation the current guidance suggests study design and statistical considerations for conducting 90-day repeat-dose rodent feeding studies on whole food test materials, extending the intended test materials to include novel foods as well as GM foods. It is apparent from this guidance that considerable thought has been given to the conduct of whole food rodent feeding studies, particularly to reducing variability that may arise from experimental conditions. However, it may be argued that no amount of attention to the details of this particular study design will address the fundamental issues that render a toxicology study unsuitable for use in determining whether one or more unidentified ingredients present at relatively low levels in a complex food matrix may produce adverse health effects when consumed. These issues have been elaborated upon at length elsewhere, including EFSA ( On a more positive note, the inclusion of novel foods in this guidance is a step towards eliminating inconsistencies in regulatory approaches for foods. By this standard, the guidance might also be expected to apply to new conventionally bred crops that do not meet an agreed upon standard of equivalence to an appropriate comparator. Regrettably, whole food rodent feeding studies are as unlikely to generate useful data to support the safety assessment of novel foods or conventionally crops as they are for GM crops. Health Canada Summary Page 2, lines 50-52: These sentences imply that all statistically significant changes are biologically relevant, and some changes that are not statistically significant may also be biologically relevant. In reality, it is equally important to assess the biological relevance of observed differences that do reach the level of statistical significance. Health Canada Summary Page 2, lines 53-59: The text recommends that reference groups should not be included in the experimental design because it would increase the number of test animals. This statement is correct however the use of reference groups would be extremely helpful in the interpretation of the differences found between control and test groups. The reference groups would give a broad context of the findings and assist in defining what values are within a normal range.

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