GM Free Cymru

EU's GM policy circumvents the precautionary principle


The Parliament Magazine, Issue 186 (12 July 2004).

Open Letter To Commissioner David Byrne From Steven M. Druker
Please fully assess the facts about the health risks of GM foods.

Dear Commissioner Byrne,

Thank you for responding (June 21st) to my letter in the May 31st issue in which I asserted that officials in both the US and EU had failed to apply the precautionary principle to GM foods – and challenged you to substantiate your claim about the rigour of the testing. Although I’m sure you are well-intentioned, your response indicates you have received an imbalanced picture of the facts and are still not aware of the extent to which EU policy circumvents the precautionary principle, which I hope to make clear.

In contrast to those scientists who claim GM foods are as safe as others, hundreds regard them as inherently more risky. These experts state that gene-splicing can disrupt the organism in many ways and produce unexpected toxins that are difficult to detect. They caution that the only way to adequately monitor for such side effects is to subject the whole GM food to long-term toxicological testing. But the EU does not require such tests, and the manufacturers do not perform them.

It’s hard to see how this accords with the precautionary principle. Even if the experts who view GM foods as more risky are not a majority, the Commission has stated that when precautionary measures are counselled by only “a minority fraction of the scientific community, due account should be taken of their views.” (Communication on the Precautionary Principle, 2002). It has further noted that such a split among experts can itself be sufficient indication of scientific uncertainty to trigger application of the principle.

Such uncertainty clearly exists. The rapporteurs’ summary of the OECD Conference of 2000 states: “There remains uncertainty about the potential long-term effects of GM food on human health …. Current methods for testing toxicity and allergenicity … leave some uncertainties and need to be improved.” And the 2001 report of the Royal Society of Canada says the “default prediction” for every GM food is that potentially harmful unintended effects are present.

Further, the presumption that gene-splicing does not increase the risk of such unintended effects is unsubstantiated and theoretically dubious, and the Canadian report brands it “scientifically unjustifiable.” From a scientific standpoint, given the ambiguous state of the evidence, there is clearly no more reason to adopt this presumption than its opposite; and as a matter of law and policy, the precautionary principle dictates choosing the latter. Yet, the presumption of no increased risk has become the foundation for the EU regulatory system. Thus, by arbitrarily assuming GM foods are unlikely to harbour unintended toxins, EU officials forego the tests that could detect them – hardly the course of caution.

Moreover, the tests actually employed are frequently substandard. Tests for toxicity and allergenicity of the proteins produced by the transgene routinely use a protein expressed by an engineered bacterium, not by the GM plant, even though it is known that the version expressed within the plant could differ in significant ways. And independent experts note that the data packages supplied by the manufacturers routinely lack critical information and that most could never have qualified for publication in standard peerreviewed journals.

The laxness of EU regulation is highlighted by the case of Bt11. There was no long-term toxicological testing with the whole plant, and the more superficial nutritional studies did not use the sweet maize under consideration but a variety of field maize intended for livestock, which the French Food Safety Agency (AFFSA) noted has "significant genetic differences." It warned that "unforeseen effects” from the sweet maize “cannot be discounted" and called for new tests. The report of the Austrian agency noted that the allergy tests were insufficient. Additionally, it said that Syngenta’s claim of safety was based on hypotheses rather than direct evidence and that several of its presumptions are false. The Belgian Biosafety Council also withheld approval. Its own analysis revealed genetic rearrangements in the maize, and Syngenta failed to provide additional information it deemed necessary and had requested.

According to the UK newspaper The Independent, the irregularities involved with Bt11 “cast doubt over the entire system for checking GM food safety in Europe.” But the Commission went ahead and approved it anyway.

It is difficult to square these facts with your assertion that “European scientists … have raised no issue concerning the safety of Bt11.” Further, although the AFSSA repeatedly refused to approve Bt11 and warned about possible unforeseen effects, you allege it “did not deliver a negative opinion on the safety of Bt11.” It is one thing to say the agency did not determine that Bt11 is unsafe – which it had no basis for doing, given the minimal testing. But your wording obscures the fact the agency registered reasonable doubts and implies it did not. This is doubly unfair, since the Commission is substantially responsible for the lack of meaningful data.

It is also misleading to claim, as you and members of EU advisory committees have done, that Bt11 “is as safe for human consumption as its conventional counterparts.” There is no evidence for this declaration of safety – and it creates the false impression adequate testing has been performed. It is similarly unjustified and misleading to claim that the rigour of the testing is of the highest class, and I’m surprised you persist in it. Although some GMOs have undergone toxicological testing employing the whole food (and yielded troubling data), Bt11 has not been so tested. To assert that its assessment has been “the most rigorous in the world” unfairly implies it successfully passed every safety test that’s been applied to a GM food and that each was administered to the highest standards, neither of which is the case.

Equally surprising is your statement that the precautionary principle is inapplicable to Bt11 because it’s relevant only when scientific evidence is insufficient, inconclusive or uncertain, which “is obviously not the case for Bt11.” As I hope is clear by now, there is scientific uncertainty about the safety of every GM food because a substantial number of credible experts have identified reasonable grounds for regarding each as inherently more likely to entail unexpected harmful side effects than its conventional counterpart – and the uncertainty can only be resolved by a positive demonstration that such side effects are not present.

Because this demonstration requires tests that the EU does not insist on and does not receive, even if a GMO passed all the tests on which the EU does rely, safety would not be established. And because in the case of Bt11 and many other GMOs several of these tests have been poorly designed and/or conducted, their safety is even more dubious.

Steven M. Druker Executive Director, Alliance for Bio-Integrity (A US-based NGO)


Note: The Parliament Magazine reflects and reports upon the work of the European Parliament, the Council, the European Commission as well as broader European issues, providing impartial insight and analysis into European politics and policy. … It is read by senior politicians and staffers throughout the European Union institutions, Member States, enlargement countries and individuals from key companies and organisations across Europe.