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NOTE: The following very clear statement on the issues surrounding the European Food Standards Agency's approval of Monsanto's GM Maize MON 863 was sent to Members of the European Parliament by John Verrall, a pharmaceutical chemist with over 35 years experience in the pharmaceutical industry, working with both human and veterinary medicines.

In addition to being a member of the UK's Veterinary Products Committee (VPC), a former Chairman of the Farm and Food Society, and a member of The Food Ethics Council, John Verral is on the Codex Consumer Group of the Food Standards Agency and also represents the Council at Consumer and Stakeholders' Liaison meetings with the Veterinary Medicines Directorate. He also attends the recently formed UK government committee concerned with Animal Health and Welfare chaired by the Chief Veterinary Officer.

EXTRACT: After Aspartame and bovine somatotropin (rbst), GM maize Mon 863 is the third product of Monsanto, which has been shown by independent scientists, to present a potential hazard to human health. It would appear that both the EFSA as well as the UK FSA have not conducted any safety studies of their own and have accepted the company's safety studies, which in all probability have never been peer- reviewed.

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GM Maize (MON 863) --- EFSA Approval

Executive Summary

There is a real prospect of inadequately tested GM foods and products produced with the aid of GM technology being approved for consumption, within the EU in 2008 as a result of the WTO's challenge on GM crops and foods.

Scientific studies have demonstrated a significant risk of liver and kidney toxicity when GM Maize (Mon 863) is fed to rats

It seems that The EU may be forgetting the 'Precautionary Principle' and now, like the US, would appear to regard international trade as taking precedence over human health and safety of its 490 million people.

The EU have a deadline in January 2008 to respond to the WTO's proposals. It is essential that MPs and MEPs should, in both The House of Commons and The European Parliament, express their opposition to inadequately tested GM foods and in particular GM Maize MON 863.

Background Information

During March this year the European Food Standards Agency (EFSA) announced that the European Commission had requested a review of the French CRIIGEN study on GM maize (maize is the only GM product that to date has been authorised in the EU), as the results of the CRIIGEN study had indicated that there was liver and kidney toxicity in rats fed GM maize. This problem had previously been identified in other French and German studies.
http://www.lobbywatch.org/archive2.asp?arcid=8570

Maize Mon 863 received EU approval for use in animal feed in 2005 and for human consumption in 2006.

It is worth noting that Pusztai's experiment (1999), when GM potatoes were fed to rats which led to changes in the linings of their stomachs, was rubbished by some other scientists, but the experiment was never repeated although the cost would have been minimal -- a drop in the ocean of the GBP39.3m Government grant to the BBSRC and an additional GBP12.6m to DEFRA in 2005-6 - for research into 'agricultural biotechnology'. Yet Pusztai's experiments were of sufficient concern for the Editor of The Lancet to publish details.

The CRIIGEN study raises very serious doubts about the safety of GM Maize Mon 863 and in effect provides evidence to confirm Pusztai's hypothesis that chemical analysis and 'substantial equivalence' do not provide an adequate basis for assessing the safety of GM foods

The EFSA review of the CRIIGEN study has now been published and it has concluded that maize MON 863 is still safe:
http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1178621165358.htm

It could be that the comments of the UK government's Chief Scientist (at the beginning of the month - just before his retirement) urging the Government to proceed with GM science to feed the world - was planned to coincide with the EFSA report. Apparently no more experiments have been undertaken to confirm or deny the CRIIGEN study and the EFSA review seems to consist of a re-affirmation of their original statement made some years ago based on the absence of science.

In view of the CRIIGEN study one would have expected a decision based on the 'Precautionary Principle' (i.e. if in any doubt, err on the side of caution) until further studies based on the French findings could be undertaken.

It has recently been announced that the EU has until January 11th 2008 to respond to the WTO's challenge on GM crops and foods. It is important, that objections to the EFSA's findings also originate from Member States' Governments, particularly the UK Government which historically (through its employed scientists) has indicated that it favours GM technology.

DG Enterprise and Trade (An EU Commission Directorate) has recently put forward proposals to 'Replace and Repeal Council Regulation 2377/90' which concerns pharmacologically active substances in food producing animals. It is proposed that we should allow the extrapolation of scientific physiological results from one species to another when determining safety standards (which can only be regarded as both illogical and unscientific) in order to, amongst other things, facilitate international trade

It does seem that now there is a move by the EU towards the US attitude where International trade is considered to be paramount and the health and safety of EU citizens a matter of secondary importance.

After Aspartame and bovine somatotropin (rbst), GM maize Mon 863 is the third product of Monsanto, which has been shown by independent scientists, to present a potential hazard to human health. It would appear that both the EFSA as well as the UK FSA have not conducted any safety studies of their own and have accepted the company's safety studies, which in all probability have never been peer- reviewed.

With regard to bovine somatotropin (injected into cows to make them produce more milk) its human safety and that of animal health and welfare was assured by Monsanto in 1994. However when subsequently assessed by the UK Veterinary Products Committee (following years of consumer agitation and Canadian trials) the VPC announced in its 1999 report under 'conclusions':

'The likely increase of IGF1 in the gut lumen, from milk produced by rbst treated cows, raises concerns about enhanced cell proliferation of the gut mucosa and therefore increased prevalence of carcinoma in the large bowel”¦.and”¦.Treatment with rbst causes welfare problems, notably levels of mastitis lameness and injection site lesions.'

It is ironical that the FSA (followed by the EFSA) was established after Mad Cow Disease to promote public confidence and was created as:

'”¦the independent watchdog established to protect the public's health and consumer interests in relation to food safety'

The evidence indicates that both the FSA and the EFSA are failing to properly protect public health.

John Verrall MRPS DBA

17th Dec.2007