Thanks to Claire Robinson for this unofficial translation of a highly disturbing article we've been forwarded from Le Monde which exposes the total subjectivity of approval decisions on GMOs.

The article explains, on the basis of documents Le Monde has seen and which would not normally have been made public, that one group of leading experts is saying this Monsanto GM corn's health effects on rats appear very disturbing, while another has given this GM corn a "green light" for marketing in the EU!

Beneath Claire's translation is the original article (apologies for the problems with some symbols in a text format), followed by quotes from leading scientists, including those who have played a key part in the regulatory process, which point up how the current regulatory system in Europe is wide open to challenge simply because all sorts of judgments are being made on the basis of what is little more than wishful thinking and with no credible scientific evidence. The regulatory situation in the US is still more lax.

As one European regulator puts it, ""Potentially disastrous effects may come from undetected harmful substances in genetically modified foods".
...

Translation of Le Monde article “L'expertise confidentielle sur un inquiétant maïs transgénique”
Cofidential report on a worrying GM corn
by Herve Kempf
http://www.lemonde.fr/web/article/0,1-0@2-3226,36-362061,0.html
LE MONDE | 22.04.04

The French commission for genetic engineering, which delivers an opinion on GMOs, has become worried about the marketing of a GM corn after studying the results of an experiment on rats.

The European scientific committee however gave the GMO the green light on 19 April. A corn produced by Monsanto company, MY 863, received on April 19 the go-ahead for marketing from the European scientific committee.

This corn, in the experts' view, does not affect the health of the animals, or, moreover, that of humans.

Though the opinion is public, official reports of meeting of this scientific committee, the EFSA (European Food Safety Authority), are confidential.  As are the debates of the committees of the Member States, including those of the French commission for genetic engineering (CGB).

However the CGB, on the contrary, put out on October 28, 2003 an unfavourable report, and was very disturbed by the malformations observed in a sample of rats fed on MY 863 corn.

No one would ever have known anything of it if an association, the Committee of research and of information on genetic engineering (Crii-Gen), chaired by the lawyer Corinne Lepage, ex-Minister for the environment of Alain Juppe, had not forced the door of the CGB while obtaining, thanks to the commission of access to administrative documents (CADA), these official reports, of which Le Monde was made aware.

The opinion of the CGB is clear: the commission "is not able to show the absence of health risks to animals with regard to MY 863 corn."

Quarrels of experts?  Undoubtedly, but this at least leads us to think that the scientific question of the influence of GMOs on health is not closed, and that the expert procedures are not always able to bring clear answers.

The new Minister for ecology, Serge Lepeltier, said on April 15, at the time of its first emergence in the press:  "One needs much transparency.  Our fellow-citizens must know what it is.  And then rigour is needed."

Much apparently is at stake.  The story starts in August 2002, when Monsanto company submitted a request for authorization of marketing of a corn genetically engineered to produce insecticidal proteins.

It did it in Germany:  in the European procedure, the request for examination of the GMO is lodged with a first State, which gives a preliminary opinion.

The Commission of Brussels then distributes it to the Member States, in order to collect their opinion.  The opinions are finally brought before the EFSA in Brussels, which makes a decisive "opinion".  The German experts immediately expressed reservations on MY 863, giving the reason that it integrates an antibiotic resistance gene.

The file was passed in June 2003 to the scientific committees of the various countries, with the precise details provided by Monsanto company.

But it is not the antibiotic which posed a problem with the French.  The file indeed included a study of nutrition on rats, the usual test to evaluate the harmlessness of GMOs. One feeds with GM food a group of animals, which one compares at the end of 90 days with a control group of rats fed with the same corn, but not modified.  The biological examination of tens of indicators on all the rats makes it possible for toxicologists to judge if there is a significant variation.

However, the French commission for genetic engineering (CGB) worried about many biological effects:  "significant increase in the white blood cells and lymphocytes in the males" of the batch fed with the MY 863;"reduced levels of reticulocytes"(immature red blood cells) in the females; "significant increase in blood sugar in the females";  "higher frequency of anomalies (inflammation, regeneration)" in kidneys of the males.

After a long debate, the CGB indicated, in "the absence of satisfactory interpretation of some of the significant differences observed", that it was not "able to show the absence of health risks to animals".

Such an opinion is exceptional from a commission which was always rather favorable, since its creation in 1986, to the authorization of GMOs.

However, a few days later, November 6, 2003, another French commission, the French Agency of health safety of food (Afssa), returned, on the basis of the same file, an opposite opinion:  the differences observed, determined the agency, "are without biological significance", and it estimates that MY 863 "does not present a nutritional risk".

In Brussels, the EFSA concluded in the same direction on April 19.  It however entered in detail the differences observed in the hematologic [blood] parameters, the renal reticulocytes, malformations and albumin levels.  But, for each one, it estimates that these differences "fall into the normal variation in control populations" or, in connection with renal malformations, that they are "of minimal importance".

However, the CGB will not budge from its position an inch. Gerard Pascal, director of research at the National Institute of agronomic research (INRA), who was a rapporteur of the file on MY 863 with the CGB, of which he has been a member since 1986, maintains his doubts.

"I hear the argument of natural variability, but what struck me in this file is the number of anomalies.  There are too many elements here where significant variations are observed.  I never saw that in another file.  It will have to be done again."

All the questioned experts confirm that the analysis of the statistical results implies a share of subjectivity:  "One can have different feelings on the same case", notes Joel Guillemain, who studied MY 863 for Afssa.

There also exist, in other files, details of effects on animals:  on the four GMOs examined by the CGB in 2003, which gave place to nutritional tests on rats, anomalies were raised.

For oilseed rape WP 73, "significant effects" were observed on the liver and the kidneys of the animals, but they were related to a parameter which has since been rectified. [???can any scientist explain this???]

However, the tests on the rats were not carried out during 90 days as is usual, but only for 28.  The commission also regrets that "the idea to ask for a test on dairy cows" was not retained or that follow-up data after the marketing in Canada are not available.

On the corn T 1507, the commission observes "a significant difference in food consumption" of the rats which ate the GMO. For corn NK 603, "significant differences" in 50 statistical comparisons out of 1 200 were found, but they "do not have toxicological significance".

A Member of the Commission worries finally about allergies to this product, and estimates that "it is not possible to conclude in such a final manner on the absence of such a risk ".  In spite of internal dissent, these files however received a favourable opinion from the commission, then from the EFSA.
***

Herve Kempf, "L'expertise confidentielle sur un inquietant mais transgenique", Le Monde 22 April 2004
http://www.lemonde.fr/web/article/0,1-0@2-3226,36-362061,0.html

La commission du génie biomoléculaire française, qui délivre un avis sur les OGM, s'est inquiétée de la commercialisation d'un maïs génétiquement modifié en étudiant les résultats d'une expérimentation sur les rats. Le comité scientifique européen a pourtant donné son feu vert le 19 avril.

Un maïs transgénique produit par la société Monsanto, le MON 863, a reçu le 19 avril un avis favorable de mise sur le marché du comité scientifique européen.  

Ce maïs, pour les experts, n'a donc pas d'incidence sur la santé des animaux, a fortiori sur celle des hommes

Si l'avis est public, les procès-verbaux de réunion de ce comité scientifique, l'EFSA (European Food Safety Authority), sont confidentiels. Comme le sont les débats des comités des pays membres, y compris ceux de la commission du génie biomoléculaire (CGB) française.  

Or la CGB a, au contraire, émis le 28 octobre 2003 un avis défavorable, et a été très troublée par les malformations observées sur un échantillon de rats nourris au maïs MON 863. Nul n'en aurait jamais rien su si une association, le Comité de recherches et d'information sur le génie génétique (Crii-Gen), présidée par l'avocate Corinne Lepage, ancienne ministre de l'environnement d'Alain Juppé, n'avait forcé la porte de la CGB en obtenant, grâce à la commission d'accès aux documents administratifs (CADA), ces procès-verbaux, dont Le Monde a pu prendre connaissance.

L'avis de la CGB est net : la commission "n'est pas en mesure de conclure à l'absence de risque pour la santé animale en ce qui concerne le maïs MON 863." Querelle d'experts ? Sans doute, mais qui laisse au moins penser que la question scientifique de l'influence des organismes génétiquement modifiés sur la santé n'est pas close, et que les procédures d'expertise ne sont pas toujours capables d'apporter des réponses claires. Le nouveau ministre de l'écologie, Serge Lepeltier, a indiqué, le 15 avril, lors de son premier point de presse : "Il faut beaucoup de transparence. Nos concitoyens doivent savoir ce qu'il en est. Et puis il faut de la rigueur." Beaucoup, semble-t-il, reste à faire.

L'histoire commence en août 2002, quand la société Monsanto soumet une demande d'autorisation de commercialisation d'un maïs transformé génétiquement pour produire des protéines insecticides. Elle l'a fait en Allemagne : dans la procédure européenne, la demande d'examen des OGM est déposée auprès d'un premier Etat, qui rend un avis préliminaire. La Commission de Bruxelles le distribue ensuite aux pays membres, afin de recueillir leur avis. Les avis sont enfin confrontés, à Bruxelles, par l'EFSA, qui rend une "opinion" décisive.

Les experts allemands ont tout de suite émis des réserves sur le MON 863, au motif qu'il intègre un gène de résistance à un antibiotique. Le dossier a été transmis en juin 2003 aux comités scientifiques des différents pays, avec les précisions apportées par la société Monsanto. Mais ce n'est pas l'antibiotique qui a posé problème aux Français.

Le dossier comprend en effet une étude de nutrition sur des rats, un test habituel pour évaluer l'innocuité des OGM. On nourrit avec l'aliment transgénique un groupe d'animaux, qu'on compare au bout de 90 jours à un groupe "témoin" de rats nourris avec le même maïs, mais non modifié. L'examen biologique de dizaines d'indicateurs sur tous les rats permet aux toxicologues de juger s'il existe un écart significatif.

Or la commission du génie biomoléculaire française (CGB) s'est inquiétée de nombreux effets biologiques : "augmentation significative des globules blancs et des lymphocytes chez les mâles" du lot nourri au MON 863 ;"baisse des réticulocytes"(les jeunes globules rouges) chez les femelles ; "augmentation significative de la glycémie chez les femelles" ; "fréquence plus élevée d'anomalies (inflammation, régénération...)" des reins chez les mâles. Après un long débat, la CGB a indiqué, en "l'absence d'interprétation satisfaisante de certaines des différences significatives observées", ne pas être "en mesure de conclure à l'absence de risque pour la santé animale". Un tel avis est exceptionnel chez une commission qui a toujours été plutôt favorable, depuis sa création en 1986, à l'autorisation des OGM.

Cependant, quelques jours plus tard, le 6 novembre 2003, une autre commission française, l'Agence française de sécurité sanitaire des aliments (Afssa), a rendu, sur la foi du même dossier, un avis opposé : les différences observées, tranche l'agence, "sont sans signification biologique", et elle estime que le MON 863 "ne présente pas de risque nutritionnel".

A Bruxelles, l'EFSA a conclu dans le même sens, le 19 avril. Elle est cependant entrée dans le détail des différences observées sur les paramètres hématologiques, les réticulocytes, les malformations rénales ou les taux d'albumine. Mais, pour chacun, elle estime que ces différences "rentrent dans la variation normale des populations de contrôle" ou, à propos des malformations rénales, qu'elles sont "d'une importance minimale".

Cependant, la CGB n'en démord pas. Gérard Pascal, directeur de recherche à l'Institut national de la recherche agronomique (INRA), qui était rapporteur du dossier MON 863 à la CGB, dont il est membre depuis 1986, garde tous ses doutes. "J'entends l'argument de la variabilité naturelle, mais ce qui m'a frappé dans ce dossier, c'est le nombre d'anomalies. Il y a ici trop d'éléments où l'on observe des variations significatives. Je n'ai jamais vu cela dans un autre dossier. Il faudrait le reprendre."

Tous les experts interrogés confirment que l'analyse des résultats statistiques implique une part de subjectivité : "On peut avoir des sensibilités différentes sur un même cas", note Joël Guillemain, qui a étudié le MON 863 pour l'Afssa.

Il existe également, dans d'autres dossiers, des effets sur les animaux : sur les quatre OGM examinés par la CGB en 2003, qui ont donné lieu à des essais nutritionnels sur des rats, des anomalies ont été relevées. Pour le colza GT 73, "des effets significatifs" ont été observés sur le foie et le rein des animaux, mais ils étaient liés à un paramètre, rectifié depuis. Cependant, les essais sur les rats n'ont pas été menés pendant 90 jours comme c'est l'usage, mais seulement sur 28. La commission regrette aussi que "l'idée de demander un essai sur vache laitière" n'ait pas été retenue ou que les données de suivi après la mise sur le marché au Canada ne soient pas disponibles.

Sur le maïs T 1507, la commission observe "une différence significative de consommation alimentaire" des rats qui ont absorbé des OGM. Pour le maïs NK 603, des "différences significatives" de 50 comparaisons statistiques sur 1 200 ont été relevées, mais elles "n'ont pas de signification toxicologique". Un membre de la commission s'inquiète enfin des allergies à ce produit, et estime qu'"il n'est pas possible de conclure d'une manière aussi définitive sur l'absence d'un tel risque". Malgré des désaccords internes, ces dossiers ont cependant reçu un avis favorable de la commission, puis de l'EFSA.  
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For more comments likethese:http://www.gmwatch.org/p1temp.asp?pid=3&page=1

Dr. Erik Millstone, Sussex University, "The fundamental problem of the way in  which GM foods have been approved is that they haven't really been tested properly at all. All that has happened is something which I would characterise as an exercise in wishful thinking." see Dr Millstone's article on this

"With genetic engineering familiar foods could become metabolically dangerous or even toxic." Statement by 21 scientists including the following, Professor Brian Goodwin, Professor Jacqueline McGlade, Professor Peter Saunders and Professor Richard Lacey

Professor Richard Lacey, microbiologist and Professor of Food Safety at Leeds University - one of the scientists who predicted the BSE disaster from early on - has spoken out strongly against the introduction of genetically engineered foods because of "the essentially unlimited health risks."

Professor Arpad Pusztai, world-leading nutritional science expert, formerly of the Food, Gut, and Microbial Interactions Group, Rowett Research Institute, "If it is left to me, I would certainly not eat it. We are putting new things into food which have not been eaten before. The effects on the immune system are not easily predictable and I challenge anyone who will say that the effects are predictable."

Professor Colin Blakemore, Waynflete professor of physiology at Oxford University and former President of the British Association for the Advancement of Science, has said of the genetic engineering of food crops: "We shouldn't be complacent in thinking that we can predict the results."

Professor James (the main architect of the UK Food Standards Agency) has commented on genetically engineered food: "The perception that everything is totally straightforward and safe is utterly naive. I don't think we fully understand the dimensions of what we're getting into." He has also said, "There is... a need to develop more effective and appropriate screening methods to alert companies and government agencies to the unexpected consequences of the often random insertion of genetic traits into plants." Professor James has also remarked that the current regulatory system is open to challenge simply because we are making all sorts of judgments with so little evidence at hand."

Dr Andrew Chesson, vice chairman of European Commission scientific committee on animal nutrition, "Potentially disastrous effects may come from undetected harmful substances in genetically modified foods"