Nov 4, 2004

Archive

Send

Feed trials with MON863 maize

EFSA holds its ground: No objections

On 20 October 2004 the Scientific Committee on Genetically Modified Organisms (GMO Panel) of the European Food Safety Authority (EFSA) once again deliberated on MON863 maize and the feed trials which have been conducted. Despite seeking further expert opinions, their original opinion has not changed: the trials give no indication that MON863 maize could be harmful to human or animal health. The GMO Panel bases its latest conclusions on a report from the German authorities. MON863 maize, which is resistant to the Western corn rootworm and is already grown in the USA, is to be imported to Europe and used primarily as fodder.

No decision has yet been taken to authorise MON863 maize in the EU. On the 20 September the Regulatory Committee, on which the 25 member states are represented, postponed a planned vote on the authorisation of MON863 maize. Although the European Food Safety Authority (EFSA) had no safety concerns even at that time, other experts and opponents of GMOs questioned whether the feed trials with rats conducted by the producer Monsanto actually constituted proof of harmlessness. Some EU member states demanded further information on the risk analysis.

Immediately before the planned vote in the EU Regulatory Committee, Greenpeace asked the Minister for Consumer Affairs Renate Künast to vote against MON863 maize. Once again they drew attention to the findings of the feed trials with rats, which are said to have shown ‘abnormalities’ particularly in the animals’ blood count.

These sorts of studies are carried out by the producers to test GM crop plants or individual substances, such as the Bt toxin, for possible harmful effects on health prior to placing the products on the market. The study itself and the results are submitted to the relevant authorities for inspection together with the approval application. Summaries of the applications, which are in the public domain, contain the results but not the precise technical details of how the feed trials were conducted.

Harmful effects or normal biological variation?

The findings of the MON863 feed study have been the subject of discussion for some time now. In essence it boils down to whether the deviations observed in the rats fed on MON863 lie within the normal range of ‘biological variation’ or whether they are to be regarded as indications of health risks.

In total, four hundred rats were involved in the trials: one group received a diet of MON863 maize for 90 days, whilst another group received the unmodified parent variety. Other rats received various other maize varieties. Body and organ weight, negative effects in the blood count, microscopic tissue studies and pathological findings were evaluated. It was particularly noticeable that after 14 days the male animals in the MON863 group had an increased number of white blood cells (see chart). The kidneys of these animals also weighed less than average.

Initial doubt followed by new expert opinions

Back in autumn last year the French Committee for Genetic Engineering (CGB - Commission du Génie Biomoléculaire) was alarmed by the findings and recommended further investigations before coming to a decision about approval.

In its report of 2 April 2004, the GMO Panel of the European Food Safety Authority (EFSA) came to a different conclusion. Variations found in the trial animals were, in its view, “of no toxicological relevance” and fell within a statistically normal range. EFS experts, responsible for the scientific evaluation of the safety of GM products, had no misgivings about recommending the approval of MON863.

Authorities in other EU countries had reached similar conclusions to the EFSA, including the Robert Koch Institute (RKI), which was the relevant German authority at the time.

When the concerns of the French authorities were brought to light in a report in Le Monde, other internationally renowned experts became involved. The rats in the feed trials were closely examined again. If the results of the feed studies really did indicate health risks, the toxicologists and pathologists would have expected to find further evidence, particularly in the animals’ kidneys. But even new tissue, cell and organ examinations gave the same picture: the range of data lay within normal biological variation. The suspicion that the increased number of white blood cells in some MON863 rats was an indication of ‘genuine inflammation’ was not borne out.

The new expert reports succeeded in inducing the French CGB to largely revise its initial assessment. Even it now sees no clear indication that MON863 maize poses a risk to health.

No decision before further studies

The EU regulatory committee nevertheless remains unwilling to come to a decision about the MON863 application until further information has been submitted. France and four EU member states are demanding a new scientific examination of MON863.

According to a report in the Frankfurter Allgemeine Sonntagszeitung, Prof. Arpad Pusztai has been asked to give an expert opinion by some authorities including the German Federal Office for Nature Conservation. Pusztai made a name for himself a few years ago when he criticised the way in which safety assessments of GMO food were conducted following feed trials with certain genetically modified potatoes. Pusztai was subsequently dismissed by his employer, the Rowett Institute in Aberdeen. At the time numerous scientists criticised Pusztai’s experimental methods and procedures. Now it appears that Pusztai has drawn attention to shortcomings in the MON863 study.

Not in the public domain

All the data from the feed study has not yet been made public. So far only the authorities responsible and the experts appointed by them have set eyes on them. A summary published by Monsanto is in the public domain.

Meanwhile Greenpeace has demanded publication of the full study. Monsanto has so far declined, as have other applicants in similar cases. They point out that most lay people would find feed studies barely intelligible. Companies also fear that their competitors could profit from the studies, which are often very expensive, and use the data for their own approval applications.