Jun 24, 2005

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MON863 maize: Court orders disclosure of all documents

No secrets in safety matters

(24 June 2005) Following a decision by the higher administrative court in Münster, Monsanto must disclose important documents from the authorisation procedure for MON863 genetically modified maize. The agro-biotech company had wanted to provide access to only some of the documents, citing trade secrets. The background to the dispute involves discussions about the feeding experiments that Monsanto carried out with MON863 maize. The decision by the judges in Münster upheld a judgement of the lower court in Cologne.

Monsanto had brought an action against the Bundesamt für Verbraucherschutz und Lebensmittelsicherheit (BVL), the authority responsible for genetic engineering in Germany. The company referred to the right to classify parts of the authorisation documents as confidential if trade secrets might be violated. However, Greenpeace had requested that the authority publish all the MON863 documents. The court in Münster placed a higher value on the public right to information than on protecting company secrets. In the judges’ opinion, the German Genetic Engineering Act excludes the “assessment of foreseeable effects, in particular of harmful impacts on human health and the environment” from the protection of business secrets.

Dispute about documents, discussion about safety

The background to the dispute involves discussions about the feeding experiments that Monsanto carried out with MON863 maize. Fundamentally, the discussion is about whether the individual findings with the trial animals that were fed MON863 lie within the usual “biological distribution” or whether they should be evaluated as indications of health risks. A total of four hundred rats were included in the experiments: one group was given a diet of MON863 maize for 90 days; another was given the non-genetically modified parent variety. Other rats were given various other maize varieties. Measurements were taken of body and organ weights, negative effects on the blood count, microscopic tissue tests and pathological findings. What was remarkable was that in the MON863 group the male animals displayed a higher number of white blood cells after fourteen days (see graph). The kidney weight of these animals was also below average.

The authorities had had access to more than a thousand pages of comprehensive documentation on the feeding experiments since the beginning of the authorisation procedure. The compulsory summary of the application documents was available to the public. Later on, Monsanto also put together another summary of the feeding experiments.

“Just as safe as conventional maize.” Timetable of scientific consultations

On 2 April 2004 the GMO Panel of the European Food Safety Authority (EFSA) published its first opinion on MON863 maize. In the opinion, the experts conclude that the deviations found among the trial animals were “not toxicologically relevant” and were not outside a normal statistical range. The EFSA had no reservations about recommending the authorisation of MON863.

Authorities in other EU countries had come to similar conclusions as the EFSA. They included the Robert Koch Institute (RKI), which was the responsible body in Germany at the time. In France in particular, scientists expressed doubts. As a result, the trial animals were thoroughly assessed again. But further tissue, cell and organ tests produced the same result: the data margin lay within the normal biological variability. The suspicion that the higher number of white blood cells in some MON863 rats could be an indication of “real inflammation” was not confirmed.

At this point, the experts from the French authorities joined the EFSA’s view. They too saw no apparent indication of health risks from MON863 maize.

On 20 October 2004 the EFSA’s GMO Panel consulted on MON863 maize again and affirmed the conclusions drawn in the spring: that the feeding experiments did not provide any indication that MON863 maize could be harmful to humans or animals.

But this did not put an end to public doubt. Greenpeace and other critics demanded the publication of the complete feeding study. Monsanto refused, thereby fuelling suspicion that MON863 might not be as safe as authorities and companies claimed.

The EFSA was forced to explain again on 24 Mai 2005 that their safety assessment was based on the full feeding study running to 1139 pages. According to this, MON863 maize was “just as safe as the conventional version.”

Greenpeace continues to view MON863 maize as “dangerous”. At a press conference on 22 June in Berlin they called on the German government to vote against its authorisation. Professor Eric-Gilles Seralini, a French scientist, said on that occasion that in view of the conspicuous results, it was necessary to repeat the experiments.

Authorisation decision not yet taken

On 24 June the EU Council of Ministers consulted about the application for the import of MON863 maize and for processing it for food and feed use in the EU. They failed to reach a qualified majority either for authorisation or for rejection. Germany voted for authorisation, but stated for the record that the German government “believes further research into the health compatibility of this maize line is necessary”. The EU Commission can now take a decision. If it recommends authorisation, the member states can reject the proposal only with a qualified majority.