Monsanto agrees to release of feeding study evaluations (31/5/2005)

You can read the reports at:

All we need now is Monsanto to release its actual 1,139-page report on the feeding of MON863 to lab rats, to allow proper scientific discussion.

Monsanto agrees to release of feeding study evaluations
Press Notice from GM Free Cymru

In a major new development in the MON863 scandal, Monsanto has agreed that it does not object to the widespread dissemination of the "Pusztai Report" on its controversial 90-day rat feeding studies.

After an extended campaign from NGOs to achieve the publication of Dr Pusztai's evaluation, Monsanto's UK head of Corporate Affairs, Tony Combes, has now written to GM Free Cymru (1) to say that the company has not been responsible for the suppression of this Report, and claiming that the refusal to release it into the public domain was entirely down to the German Regulatory Authorities. Some of the findings of the rat feeding study were exposed in a special feature in the "Independent on Sunday" newspaper on 22 May 2005 (2), and the repercussions of the newspaper coverage have gone around the world.

Dr Arpad Pustai, one of the few genuinely independent scientists specializing in plant genetics and animal feeding studies, was asked by the German authorities in the autumn of 2004 to examine Monsanto's 1,139-page report on the feeding of MON863 to laboratory rats over a 90-day period. The study found "statistically significant" differences to kidney weights and certain blood parameters in the rats fed on the GM maize as compared with the control groups, and a number of scientists across Europe who saw the study (and heavily-censored summaries of it) expressed concerns about the health and safety implications if MON863 should ever enter the food chain. There was particular concern in France, where Prof Gilles-Eric Seralini of the University of Caen has been trying (without success) for almost eighteen months to obtain full disclosure of all documents relating to the MON863 study (3).

Dr Pusztai was forced by the German authorities to sign a "declaration of secrecy" before he was allowed to see the rat feeding study, on the grounds that the document is classified as "CBI" or "confidential business interest" (4). However, he assumed that this would not prevent the publication of his findings by the Germans themselves, should his evaluation highlight any health and safety concerns. In the event, his evaluation was highly critical of the methodology of the study, and he also expressed concerns about what the researchers had found. These concerns were identical to those of Prof Seralini and scientists in Germany and elsewhere, but the German Government refused to publish them and insisted that Dr Pusztai should respect his "gagging order." So he has been unable to circulate his written material and unable to speak on the record about what he has found.

The gagging of scientists like Prof Seralini and Dr Pusztai is serious enough, but the MON863 scandal was compounded when the European Food Safety Authority (EFSA) examined the reactions of all the EU regulatory bodies, decided that it did not like what was contained in the "Pusztai Report", and commissioned other experts to evaluate the evaluation (5). Then, having got the recommendation that it wanted -- namely that the statistically significant physiological changes in the rats fed on MON863 were not really significant at all -- EFSA published a Statement (6) advising the EC that MON863 was perfectly safe and wholesome. More seriously, in the EFSA Statement, and in subsequent Monsanto press releases, Dr Pusztai was named and criticized in spite of the fact that it was known by all concerned that he was effectively "gagged" and could not defend himself (7).

The "Pusztai Report" actually consists of three separate short documents (8), and although Dr Pusztai himself cannot release them, they have been circulating widely among NGOs and the GM scientific community in Europe because they have been examined by all of the European GM regulatory authorities and committees. Leaks could not be prevented, and GM Free Cymru obtained copies of the documents from the United States, Brussels and Eastern Europe. Since they were already published through the Email network, it was inevitable that they would eventually find their way onto the internet. They are now accessible via several different web sites (9).

Dr Brian John, speaking for GM Free Cymru, said: "We are delighted that this material is now available for examination by the scientific community, and we are grateful to Monsanto for confirming that it has no objection to the publication of the three documents (1). But we are appalled at the manner in which Dr Pusztai has been prevented from discussing his concerns with fellow scientists, and we will not give up on this issue until the German authorities remove his "gagging order." It will be easier for them to do this now that Monsanto has said that it has no objections to a free and open scientific debate. But we are even more appalled at the behaviour of EFSA, which is supposed to protect the European public from unwanted health hazards. Instead, when the organization has hazards brought to its attention, it refuses to see them. It is now widely perceived as having just one priority as far as GM issues are concerned -- namely the facilitation of GM approvals for the biotechnology corporations (10). The EC should get rid of this complacent and secretive body before it does any more harm."


Contact: Dr Brian John
GM Free Cymru
Tel: 01239-820470


(1) Email letter from Mr Tony Combes of Monsanto to GM Free Cymru, dated 28 May 2005

"Revealed: health fears over secret study into GM food. Rats fed GM corn due for sale in Britain developed abnormalities in blood and kidneys" By Geoffrey Lean, Environment Editor
22 May 2005
"Rats fed on a diet rich in genetically modified corn developed abnormalities to internal organs and changes to their blood, raising fears that human health could be affected by eating GM food..........."

(3) For the attempts by Crii-gen to obtain key scientific information on MON863 since October 2003, see:
Also Le Monde, 23 April 2004 and 14 December 2004

(4) GM Free Cymru has now submitted a request under the EU Freedom of Information legislation for sight of the certificate granting CBI status to the Monsanto rat feeding study, and the "Declaratioin of Secrecy" that Dr Pusztai was asked to sign.

(5) "Considerations regarding the scientific assessment of the safety of food and feed from GM plants, exemplified with GM insect resistant corn (MON863) as a case," Dr Ib Knudsen for the Swedish Board of Agriculture, 13 November 2004. 7 pp (available as a PDF file)

(6) The EFSA Statement on MON863 is at the following site:

MON 863 Maize 90-Day Rat Feeding Study Design and Conduct Fact Sheet

(8) The three documents in the "Pusztai Report" are as follows: (1) "Interim Report and Preliminary Evaluation..."; (2) "Evaluation and Final Report..."; (3) "Report on the newly provided data..."

(9) EU legislation states that research material on GM crops and foods which has health and safety implications must be placed in the public domain. The German authorities, and the EC, have been breaking their own laws by seeking to restrict consideration of the findings of Prof Seralini, Dr Pusztai and others to specialist committees which do not necessarily act in the public i


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