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More controversy over Monsanto study (15/12/2004)

"Monsanto contradicts itself. The first time around, their studies explain, in a rather amusing manner by the way, that there are 'significant effects without a pathological significance', and the second time around, their studies say that the effects observed are no longer significant. On top of that, the file was sliced up by examining the problems separately and not in their entirety, which is unacceptable. The least fairness demands would have been to do the study over again from the beginning, which was not done. In any case, not with the same variety of corn." - Prof Séralini
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Controversy Surrounds a GMO
By Stéphane Foucart
Le Monde, Monday 14 December 2004
http://www.lemonde.fr/web/article/0,[email protected],36-390897,0.ht
ENGLISH VERSION BELOW:
http://www.truthout.org/docs_04/121504H.shtml

After having broadcast doubts about the harmlessness of a transgenic corn marketed by Monsanto, MON 863, the Biomolecular Engineering Committee (BEC), delivers an opinion favorable to its importation.

Tuesday, December 14, 2004, the French Biomolecular Engineering Committee (BEC) was to announce the award of an opinion favorable to the importation and commercialization of MON 863, a transgenic corn developed by Monsanto. There would be nothing special about the announcement, had not the same body delivered an opinion on October 28, 2003 that opposed the introduction of the same genetically modified organism (GMO).

In this way, the Committee now sides with the Agence française de sécurité sanitaire des aliments (Afssa) [French Agency for Food Health Security] and the European Agency for Food Security (EAFS) both of which gave favorable opinions on MON 863 six months ago (Le Monde, April 23, 2004). Unanimity is not, however, the case within the BEC, one member of which, Gilles-Eric Séralini, Professor of Molecular Biology at the University of Caen, voted against the opinion that was finally returned.

The affair only began in the spring of 2004, with the revelation of the minutes of BEC meetings, the opinions of which only are made public. The Comité de recherche et d'information indépendantes sur le génie génétique (Crii-Gen) [Committee for Independent Research and Information on Genetic Engineering] - an association founded by former Ecology Minister Corinne Lepage - obtained publication of these minutes by suing through the commission d'accès aux documents administratifs (CADA) [Committee for Access to Administrative Documents]. The conclusions from the first toxicological study, which Monsanto transmitted to the BEC, cataloging numerous biological effects on rats fed MON 863 for ninety days, were thus rendered public.

Researchers from Covance Laboratory - commissioned, according to customary usage, by Monsanto - discovered blood stream anomalies that varied by sex (increase in white blood cell levels and lymphocytes in males, decrease in new red blood cells in females). An increase in female blood sugar levels was also noted. Also more frequent appearances of renal lesions (inflammations, kidney stones) as well as variations in kidney weight were observed in the animals fed MON 863.

These results led the BEC to conclude in its unanimously adopted October 28, 2003 opinion that "the study of low level toxicity conducted with MON 863 corn...raised... numerous questions...relating to the...significant differences observed in blood chemistry, clinical biochemistry, urinary chemistry and the weight of certain organs of tested animals.

The matter was not settled there. "We hadn't concluded that MON 863 was toxic," explains Gérard Pascal, Director of Research at Institut national de la recherche agronomique [National Institute of Agronomic Research] and BEC member. "We simply said that in the study Monsanto had supplied, we did not have satisfactory explanations for the observed anomalies." The French body for GMO evaluation consequently requested complementary information from the seed company.

Then the latter named two well-known anatomic pathologists, Gordon Hard and Andrea Terron, to reexamine the results obtained by the Covance Laboratory. After study of the samples that had previously been taken, the two experts concluded in September 2004 that the lesions and blood anomalies were within the natural variability of these characteristics for the animals. "The tests were conducted on rats, which are not the ideal model for chronic toxicity," says Marc Fellous, Director of the unit at the Institut national de la santé et de la recherche médicale (Inserm) [National Institute of Health and Medical Research] and BEC president. "The blood anomalies and blood sugar level differences are explained by the animals' variability," Mr. Fellous continues. "As far as the renal anomalies, they are natural, because the rat, as we did not know at the time, develops them spontaneously." These new interpretations were subsequently validated by another French expert, André-Laurent Parodi, Professor at the Alfort Ecole nationale vétérinaire [National Veterinary School].

There remained the problem of the lower kidney weight in animals fed MON 863. In November 2004, Monsanto furnished a new study, this time using another variety of corn hybridized with MON 863. This new study, conducted by Wil Research Laboratory - once again chosen by Monsanto - did not bring such anomalies to light.

These last conclusions do not satisfy Gilles-Eric Séralini, BEC and Crii-Gen member, who voted against the opinion favorable to MON 863's importation that was formally adopted November 23. "Monsanto contradicts itself," Mr. Séralini judges. "The first time around, their studies explain, in a rather amusing manner by the way, that there are 'significant effects without a pathological significance', and the second time around, their studies say that the effects observed are no longer significant. On top of that, the file was sliced up by examining the problems separately and not in their entirety, which is unacceptable. The least fairness demands would have been to do the study over again from the beginning, which was not done. In any case, not with the same variety of corn." Mr. Séralini recalls, moreover, that "no test of the insecticide produced by MON 863 has been effected on the human cell" and that this substance "is not entirely natural because the Bacillus thurigensis sequence - introduced into the corn genome - has been modified."

In a December 10 communiqué, Crii-Gen demanded that the industrial secrecy surrounding the study conducted on MON 863 be lifted, so that the "scientific controversy" could be opened to the public. The association also demands that an independent expert assessment be conducted and paid for with public funds. Crii-Gen, in fact, considers the studies financed by the companies to be "dependent." Some BEC members, who are not suspect to being anti-GMO, are not far from making a similar observation. Consequently, Mr. Pascal, who voted in favor of MON 863, considers that the summary of the study on this corn "did not exactly correspond to what was in the detailed study." According to Mr. Pascale, this summary did not mention certain differences between the groups of rats observed in the study.

The BEC's methods of operation are also at the center of controversy, to the point that Mssrs. Séralini and Fellous do not agree on the number of voters present at the meeting - held without a quorum - on November 23....
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A Contrasting Situation in Europe

When it authorized the company Syngenta to market its transgenic corn Bt11 in Europe on May 19, the European Commission put an end to the Old Continent's five year moratorium on GMO - even though Syngenta immediately indicated that, in the absence of any demand, Bt11 will not be distributed in Europe. Since April 18, the presence of GMO must be labeled on products whenever it represents more than 0.9 % of a product's composition. There remains the accidental presence of GMO in conventional seed. Ecologists demand a maximum level of 0.1 % while organic farmers would accommodate themselves to a "purity" limited to 0.5 %. Nonetheless, the German parliament adopted a law November 26 that would make the cultivation of GMO de facto impossible. As of January 1, 2005, farmers who try it may be attacked by any small holder who finds GMO plants in his field. Spain, for its part, is preparing a much less restrictive decree that fixes a minimum distance of 25 meters between GMO crops and conventional crops.

Translation: t r u t h o u t French language correspondent Leslie Thatcher.

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