Press Notice 24 May 2005 from GM Free Cymru
A GM watchdog group based in Wales has today revealed the full extent of a conspiracy by UK and EC officials which has, against the public interest, enabled a highly damaging study on the safety of GM maize to be held on a secret dossier and which has gagged scientists who have seen it.
The study, into the effects of feeding rats for 90 days on Monsanto's MON863 maize, was requested by various EU countries as part of the MON863 assessment process, and was completed in September 2003. The results showed "statistically significant" changes to blood and to certain vital organs in the rats fed on the GM maize, as compared with those in the control group, and immediately alarm bells started to ring in scientific circles throughout Europe. The French authorities tried to cover up the scientific debate about the study (1). In the autumn of 2004 concerns were expressed about the study findings by a number of other national regulatory bodies, including Belgium and Germany. Germany actually commissioned an evaluation of the rat feeding study from Dr Arpad Pusztai, but Monsanto would not allow its 1,139 page research dossier to be examined without the signing of a "declaration of confidentiality." Incredibly, the EC and the German authorities acceded to this demand, which means that their key officials are now bound by a secrecy agreement. This would not be so bad if it were not for the fact that Dr Pusztai's evaluation was highly critical of both the methods and the findings of the study, indicating that MON863 maize by no means has a "clean bill of health." Subsequent leaks (2) from France, Germany and Belgium suggest that the maize variety may indeed be unsafe for animal or human consumption, and that a major cover-up is under way, designed to protected the corporate giant Monsanto and the regulatory authorities who have prematurely advised that MON863 is perfectly safe (3) (9) (10).
The extent of the cover-up is becoming clearer by the day. In France Crii-Gen has been trying for more than 18 months to obtain sight of the full rat feeding study, national opinions and scientific advice on MON863, and other materials held on the dossier by the French authorities and the European Food Safety Authority (4). They have received point-blank refusals to their requests, on the grounds that all of these documents are covered by the "confidential / business interest" rules. However, these rules specify that the only material which may be classified as secret is data on the manufacturing process / genetic characterization of the GM variety; and that all material relating to health and safety issues must be released into the public domain. In the UK, GM Free Cymru has been trying for several months to obtain sight of the rat feeding study, the "opinions" of various EU governments, and other studies and papers relating to the MON863 application; but access has been consistently refused. The only information available to the public on the EFSA and other web sites is information which supports the EFSA / ACRE attitude that MON863 is perfectly safe; all information which might be embarrassing or uncomfortable for Monsanto and the authorities has been given a "CBI" classification (5).
In pursuit of its requests to open up the MON863 secret dossier, GM Free Cymru has written over and again to EFSA, to the President of the Commission, to individual Commissioners, and to the UK government. It has also written to the German authorities and to the EC office which deals with European "freedom of information" matters. These efforts have proved fruitless.
The organization has also been asking EFSA, the Commission and the German authorities for the "Declaration of Secrecy" which prevents Dr Pusztai and others from airing their scientific opinions on the rat feeding study to be lifted, in the public interest( 6). Again, nothing has been done. The last resort is to take the case to the European Ombudsman, and GM Free Cymru is committed to do this if a dozen or more documents which has requested are not released within the next few days.
Speaking for GM Free Cymru, Dr Brian John said: "Our attempts to open up the MON863 secret dossier to public scrutiny show that there is corruption right at the heart of the GM approvals process. EFSA, which is supposed to exist for the protection of the European public, works instead to protect the interests of multinational corporations like Monsanto. This is sinister and dangerous. With the connivance of the EC, it appears even to allow Monsanto to dictate the terms on which it submits research information as part of the approvals process. It is an outrage that any independent scientist should be asked to sign an oath of secrecy in order to examine and evaluate something as important as the 90-day rat feeding study (7).
"What we also see here is a political determination on the part of the EC to push through GM approvals, simply because this is part of its strategy in the ongoing WTO dispute with the USA (8). It is being helped by the secrecy and obfuscation of EFSA. In pursuit of that strategy, it silences potential scientific critics, suppresses key research information, and classifies as "commercially sensitive" many documents which should be open to scrutiny. In doing that, it is breaking EU law, and is playing politics with the health of the people of Europe. Ultimately, since the GM industry apparently has so much to hide, why should anybody trust it, or want anything to do with GM crops or foods?"
Contact: Dr Brian John GM Free Cymru Tel 01239-820470
(1) In the autumn of 2003 concerns were expressed in France by members of the CGB (the Commission for Genetic Engineering), whose President nonetheless submitted a positive opinion on MON863 prior to proper committee discussion. On 28 October 2003, CGB issued an unfavourable report on MON863, which has remained confidential so far. On 6 November 2003, another French commission, the Agency for the Medical Safety of Food (AFSSA) gave, for the same file, an opposite opinion. Most of the documents relating to these deliberations have been kept secret, despite strenuous efforts by Crii-Gen for them to be released. The scandal was revealed by Le Monde newspaper on 23 April 2004. The Committee for Independent Research and Information on Genetic Engineering (CRII-GEN) has the role of ensuring expert scrutiny and the greatest possible transparency on the medical and environmental risks of GM.
(2) Quote from Dr Pusztai's leaked Evaluation report: "The list of significant differences suggest that the authors' confidence that the genetic modification of the maize sample has induced no significant changes in the nutritional value and the biological/immunological, etc. properties of this important food/feed crop is almost certainly groundless. It is almost impossible to imagine that major lesions in important organs (kidneys, liver, etc) or changes in blood parameters (lymphocytes, granulocytes, glucose, etc) that occurred in GM maize-fed rats, is incidental and due to simple biological variability."
(3) EFSA Opinion of the GMO Panel on MON863 and MON863 x MON810: adopted 2 April 2004. http://www.efsa.eu.int/science/gmo/gmo_meetings/49/ minutes_gmo_09_en1.pdf) See also the comprehensive coverage of this issue in the Sunday Independent newspaper, 22 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, Sunday Independent, 22 May 2005 http://news.independent.co.uk/world/science_technology/story.jsp? story=640402
(4) For the attempts by Crii-gen to obtain key scientific information on MON863 since October 2003, see: http://www.crii-gen.org/m_fs_cx.htm Also Le Monde, 23 April 2004 and 14 December 2004
(5) EFSA web site with details of deliberations on MON863: http://www.efsa.eu.int/science/gmo/gmo_opinions/catindex_en.html http://www.efsa.eu.int/science/gmo/gmo_opinions/381_en.html
(6) Correspondence is available on request
(7) In Australia and New Zealand, in contrast, the full rat feeding study was examined by FSANZ and it was decided that it did not merit "confidential business interest" classification. "FSANZ decided that the confidentially claim by Monsanto was not justified under the FSANZ Act" --Dr Peter Abbott (Scientific Risk Assessment and Evaluation Branch, Food Standards Australia New Zealand, Tel. 02 6271 2230) in a letter to Bob Phelps, Executive Director, GeneEthics Network Australia, Tel: 03 9347 4500 or 1300 133 868, Fax: 03 9345 1166 Email: firstname.lastname@example.org http://www.geneethics.org
(8)GMO trade war: Europe accused of secrecy Official Complaint made to Ombudsman by FoE EUROPE Wednesday 16 February 2005 http://www.gmwatch.org/archive2.asp?arcid=4909 Eurocrats accused of "caving in" to US -- Eurocrats force vote on modified food http://www.gmwatch.org/archive2.asp?arcid=4358
(9) It has now been claimed by a member of the EFSA Board, Professor Giorgio Calabrese, that Monsanto is in possession of other studies which have not been shown to the regulatory authorities in Europe. This has been denied by Monsanto, but in a new move EFSA has demanded of Monsanto that the company should submit "its entire research into (the corn strain) MON 863'' (La Stampa newspaper, 23 May 2005). http://www.forbes.com/business/feeds/afx/2005/05/24/afx2049419.html email@example.com
(10) In the USA, the Center for Food Safety (CFS) has recently alerted both the Environmental Protection Agency (EPA) and Monsanto about the failure of the company to comply with the adverse reporting requirements of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA). In the view of CFS the MON863 rat feeding study showed "unreasonable adverse effects" which should have been drawn to the attention of the regulators. Failure to do this is potentially a criminal offence. A copy of the CFS letter is available on request.