BSE, drug trials and GM food, who are the regulators protecting? Prof. Peter Saunders
The European Union has legislation requiring that any GM product put on the European market must have passed an authorisation procedure. Although the scientific assessments used are superficial and ignore a great deal of important evidence  (GM Food Animals Coming, this issue), but at least the law is clear. As the Commissioner for Health and Consumer Protection Markos Kyprianou said, “There is no flexibility for unauthorised GMOs – these cannot enter the EU food and feed chain under any circumstances.” 
So when the US Department of Agriculture (USDA) announced on 18 August that some commercially grown long grain rice had been contaminated with small amounts of the GM rice LLRICE601, the EU acted swiftly. The European Commission adopted emergency measures that forbid US long grain rice entering the EU unless accompanied by a certificate from an accredited laboratory assuring that LLRICE601 is absent. This is necessary because the present US procedures for testing are clearly inadequate: by mid-October, LLRICE601 had been detected in 74 separate incidents in 15 European countries .
The Commission also asked the European Food Standards Agency (EFSA) to examine the data supplied by the US and to assess whether they were sufficient to allow a proper safety assessment to be carried out; and the EFSA duly reported :
“The available data are not sufficient to allow the safety of LLRICE601 to be assessed in accordance with the EFSA guidance for risk assessment. However, on the basis of the available molecular and compositional data and on the toxicological profile of PAT proteins, EFSA considers that the consumption of imported long grain rice containing trace levels of LLRICE601 is not likely to pose an imminent safety concern to humans or animals.”
The UK Food Standards Agency (FSA) also sought advice, but only informally from two members of the Advisory Committee on Novel Foods and Processes (ACNFP). They too were told that there was no imminent safety concern. As with the EFSA, this positive advice was based on a dossier supplied by Bayer CropScience on 25 August with about 30 pages deleted as confidential business information (CBI).
Bayer CropScience eventually sent the full dossier, but too late to be used by the scientists who advised either of the agencies.
But while the EU decided to ban US long grain rice, the UK FSA told retailers in a memo later leaked to the press that there was no need to check whether any of the rice they were selling included some LLRICE601. It is, however, illegal to sell unauthorised GMOs in the UK, and Friends of the Earth threatened to take the FSA to court to make them comply with the law.
It would have made an interesting case, but the FSA backed down. On 5 October a new item appeared on their web site. It included the following statement :
“The Agency has reconsidered and updated its advice to retailers regarding rice contaminated with GM material in the light of the EFSA risk assessment. The Agency had previously advised retailers that it would not be proportionate to track down and remove all products from sale that contain LLRICE601 because they were not thought to pose an imminent risk to health.
“However, the law states that no unauthorised GM material should be present in food on sale in the UK. Therefore the Agency is reminding food businesses of their responsibility to ensure that food they sell complies with the law. Any rice known to be contaminated with GM material is illegal and should be removed from sale.”
You may get the impression from this that the FSA has modified its advice in the light of new scientific evidence, as any responsible body should, and that’s obviously what you’re meant to think. Not so. The EFSA risk assessment was based on the same evidence that was available to the FSA, the expurgated dossier originally provided by Bayer, and it reached the same conclusion.
In fact, the public statement from the FSA on 1 September did say that food retailers are responsible for ensuring that the food they sell does not contain unauthorised GM material . At the same time, however, the FSA was privately advising retailers that it would not expect them actually to stop selling such food. It is the private advice that has changed.
The FSA is now admitting that it had previously advised retailers not to take measures to ensure they were complying with the law. It is also admitting that the reason it is now advising them to check if their rice is contaminated and, if it is, not to sell it, is simply that it is illegal to sell unauthorised GM products in the UK. But that was just as true in August as it was in October. Nothing has changed, except that the FSA now accepts that regulatory bodies are not supposed to advise businesses to ignore the law of the land.
The reference to the EFSA risk assessment is presumably an attempt to deflect criticism from whoever gave the original advice, just the sort of thing you’d expect if you’ve read Richard Packer’s book , which gives an Inside Story of BSE (this issue).
The EFSA risk assessment was bad enough, as it was not made in accordance with the EU’s own guidelines, partly because it was carried out in a hurry, but also because Bayer did not provide the full dossier in time. The FSA’s risk assessment was worse; it was done informally by only two scientists, and on the basis of the same expurgated dossier that contained little information relevant to safety. But you would not have gathered that from the great confidence with which both the EFSA and the FSA advised the public that there was no danger.
The power of the vested interests that Packer mentions in his book is as much in evidence with GM as with BSE. The UK government has always been a major supporter of GM crops. That is not because UK consumers want them; on the contrary, they have made clear that they do not. The real reason is that both the chemical and pharmaceutical industries are very powerful in the UK. The British government is worried about the prospect of what it sees as the next generation of products being developed somewhere else. So there has always been pressure to approve GM crops, not because we need them in the UK but in the hope that our industries can profit from developing them.
For exactly the same reason, the Medical and Healthcare products Regulatory Agency has failed in its duty to protect the participants in the TGN1412 drug trials that went so disastrously wrong in the spring of this year [8, 9] (Post Mortem on the TGN1412 Disaster). The UK Consumers’ Association has just published a wide-ranging and devastating criticism of the MHRA  When they put to the MHRA the charge that it was too much in the pocket of the drug manufacturers, the Agency replied (emphasis added): “We have a responsibility to ensure that regulation is designed to enable rather than hinder the development of new products that would improve health.”
Of course regulation should not place unnecessary obstacles in the way of progress. But the primary responsibility of regulators is to protect the public. They must never be allowed to forget that.
Article first published 24/10/06
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