NO SAFETY ASSESSMENT METHODS ARE FULLY RELIABLE

The most extensive experience of safety assessment is in the medical drug industry. It gives an idea of the difficulties.

In drug development, very rigorous testing is done, using the best safety assessment methods available. The reason is not only that the laws of most countries demand rigorous testing of new preparations. Also, the development of a new drug is very expensive - in the order of magnitude of billions of dollars. So, if the drug turns out to be useless due to harmful effects it means enormous losses.

Therefore, the drug industry has had every reason to develop as reliable and efficient methods as ever possible for safety assessment. But yet, these methods have at failed to detect, at an average, in about three percent of all new remedies, so serious harmful effects that they have to be withdrawn from the market. These side effects have in stead been discovered at the clinical use of the remedies. In addition, about ten percent of the new remedies, approved after thorough safety assessment, have turned to be so harmful that their use must be limited to an important extent.

In the case of genetically engineered foods, testing is much more difficult, as in this case, completely unexpected chemical substances may appear. Contrary to the case for drugs, you don't know what chemical substance to look for. This may increase the risk of failed detection of harmful substances considerably above the level for drugs.

If there is no labeling of genetically engineered foods, early detection of a harmful food will be very difficult, if not impossible. For example the tryptophan disaster would have been much more limited if the preparation had been labeled.

The present regulations for safety assessment of GE-food are based on the so called "Substantial Equivalence" principle. This means in practice that genetically engineered organisms that are grossly similar to their natural counterparts do not need to be tested rigorously. However, it might very well occur that the only difference between the engineered organism and its natural counterpart is the existence of one unexpected dangerous substance - which would run a very high risk of passing undetected if the principle of substantial equivalence is applied! (see further "Inadequate safety assessment of GE foods" and "The failings of the principle of substantial equivalence in regula ting transgenic foods")

To reduce the risk of failed detection before market release to a very low level, it is necessary to include testing on a large number of humans for a long enough period to detect long term harmful effects. It has been calculated that such testing would take altogether 3-5 years before market release (see further a special article on safety assessment ).

(Professor Richard Lacey MD, microbiologist, and Professor of Food Safety, renowned for his early prediction of the dangers of "Mad cow disease")

The serious situation today is that, due to Inadequate safety assessment of GE foods, no GE-food has been thoroughly tested for safety. And even if the the best tests were used, they are unable to fully reliably detect unexpected hazardous substances.