1. Impact of GMOs on animal health: the debate is still not resolved: A study published Dec 13 concludes GM food is safe - English translation of Le Monde article
2. Le Monde article - French original
3. No health problems for animals fed on GM crops (study) - press release by the study's authors
4. The study - abstract

NOTE: The pro-GM lobby, especially in the US, has been hyping a new review of animal feeding studies on GMOs, which concludes that there are no effects on the health of GM-fed animals (see abstract, item 4).

The French newspaper Le Monde has published an article (items 1 and 2) covering the controversy over the review.

The agenda behind the review is made clear by the authors in their press release (item 3). Here are two telling quotes:

(i) "Now, for us, the debate on GMOs from a health point of view is closed", Agnes Ricroch (AgroParisTech and University Paris-Sud), who led the study, said.

(ii) "The researchers looked at a number of parameters: growth, organ weights, their development, blood enzymes, reproductive organs, pancreas, brain and heart, a far and wide review", says Dr Ricroch. This study concludes that GMOs are not harmful to animals from a health point of view. "It's good news" she added, "Had we found the opposite, toxicological recommendations would have had to be extended to long-term studies".

Regarding point (i), we've no doubt that GM proponents would love to see the GM health risks debate closed down. Unfortunately for them, this paper isn't going to do that.

Regarding point (ii), independent researchers like Prof Gilles-Eric Seralini have requested long-term feeding studies (2 years for rodents) to be carried out on GMOs prior to approval. This would enable researchers to see if toxic effects found in 90-day studies progressed into full-blown illness or mortality. Clearly, the GM lobby opposes this suggestion, which would cost it money and could reveal inconvenient truths about the long-term effects of GM foods.

Note that in spite of the upbeat title of the review authors' press release on their study – "No health problems for animals fed on GM crops (study)" – as the statistician Lavielle points out in the Le Monde article, they admit that statistically significant differences are found in animals fed GMOs. But then they dismiss them as not biologically relevant.

Biological relevance is a favourite ruse of the biotech and chemicals lobby that has been uncritically taken on board by the European GMO regulator EFSA, among others. This is in spite of the fact that there is no scientifically rigorous definition of biological relevance when applied to GMOs.

EFSA finally published an Opinion ("Scientific Opinion: Statistical significance and biological relevance") on biological relevance late this year after relying on the concept for years, in particular to defend GMOs against Seralini's findings of statistically significant ill effects of commercialised GMOs on animal health in Monsanto's own studies.

The biological relevance argument, if indeed it may be called that, can be summed up like this:

Question: When can a statistically significant finding of harm from GMOs be dismissed as unimportant?
Answer: When it's not biologically relevant.
Question: What's biological relevance?
Answer: Whatever industry says it is.
 
EFSA's Opinion in effect leaves it up to the GM industry to decide whether any effect found is biologically relevant.

The new review also criticises several independent studies that found health effects with GMOs on the basis that the non-GM comparator was not the isogenic (closest genetically equivalent) variety, as it should have been. This is true, but the review fails to mention that the responsibility lies entirely with the GM companies, which understandably refuse to make available the non-GM isogenic lines to independent researchers or place restrictions on their use and what can be published about them (see http://www.patentbaristas.com/archives/2009/02/20/scientists-say-seed-technology-agreements-stop-research/ and http://gmwatch.org/latest-listing/1-news-items/11311).

Finally, the authors of the new review (in common with the authors of some of the studies reviewed) rely on manipulating the control data through what they call the "normal range of variation" to dismiss statistically significant findings of ill effects from GM crops.

In reality, the only scientifically valid controls are the concurrent ones within the experiment under discussion. This is because all conditions will be the same except the aspect you are testing.

In the case of animal feeding trials with GMOs, everything should be the same except that the treated group eats the GM crop and the control group eats the non-GM but otherwise genetically equivalent crop, which has been grown side-by-side in the same conditions as the GM crop.

Using proper controls means that any changes seen will be due to the GM process, not, for instance, changes in the way the crops were grown or the location they were grown in.

Scientific experiments are designed to control variables. GM proponents, and the authors of the review and some studies covered in it, are trying to artificially widen the range of variables so as to 'disappear' any effects of the GM process.

Widening the controls to include any data on crops grown in a variety of different conditions at different times is scientifically unjustifiable and only serves to mask, not reveal, the effects of the GM process – albeit it is an increasingly common practice in what passes for science in industry and regulatory circles.
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1. Impact of GMOs on animal health: the debate is still not resolved
A study published Dec. 13 concludes GM food is safe
Gilles van KoteӬ
Le Monde (France), December 16 2011
[unofficial translation from French into English by Claire Robinson of GMWatch]ӬӬ

Lovers of suspense can be reassured: the soap opera between supporters and opponents of genetically modified organisms (GMOs) is not about to end. The latest episode is the announcement on Tuesday, December 13, of the forthcoming publication in the journal Food and Chemical Toxicology, of a study by a French team led by geneticist Agnes Ricroch, of the Institute of Life Sciences and Industries and the Environment (AgroParisTech).ӬӬ

This meta-analysis, based on 24 studies from countries including the USA, Brazil, Japan and Norway, concluded that there were no health effects in animals fed a diet based on GM corn, rice, soy or potatoes. "Now, the debate on GMOs, from the health point of view, is closed," said Agnes Ricroch.

It may not be as simple as that. According to Marc Lavielle, a statistician at the National Institute for Research in Computer Science and Technology (INRIA) and member of the Scientific Council of the High Council for Biotechnology (HCB), this study is "biased" and "extremely slanted."ӬӬ

"What is terribly troubling is that it concludes that there was no difference [between animals that have consumed GMOs and those that have not] on the basis of a methodology that does not meet the guidelines published both by the National Agency for Food Safety [ANSES] or by the European Food Safety Authority [EFSA]," he said.

ӬӬThe study concludes, "The studies reviewed show that transgenic plants are nutritionally equivalent to their non-transgenic counterparts and can be used safely." The authors believe that it is not necessary to make testing periods longer than ninety days before approving new varieties of genetically modified feed intended for animals.ӬӬ

They recognize, however, that differences have been identified between animals fed with GMOs and those fed on a GM-free diet. "But when they find differences, they consider that the comparison is not valid or that the difference is not biologically significant," notes Marc Lavielle. "However, they uncritically take into account another study with groups of only three animals, a sample too small to conclude anything."ӬӬ

The passion behind the debate on GMOs in Europe and France in particular, extends far beyond the doors of the scientific world. Another meta-analysis, based on 19 international studies and published in March in the journal Environmental Science Europe, led by biologist Gilles-Eric Seralini, reached a conclusion diametrically opposed to that of the team of Agnes Ricroch.

ӬӬGilles-Eric Seralini, Chairman of the Scientific Committee for Research and Independent Information on Genetic Engineering (Criigen), defends the principle of long-term tests that would detect chronic toxicity of GMOs. "Our study showed that 9% of the animals fed GM foods have side-effects: metabolic disorders, 43% of which are concentrated in the kidneys and 28% in the liver," he says.

ӬӬBut the work of Gilles-Eric Seralini is also criticised by a significant part of the scientific community. This summer, ANSES reviewed a study published in March by the biologist. According to a scientist involved in the expert review, the opinion expected in the coming months is likely to be very harsh on the methodology used in this study.

ӬӬ"On one side you have scientists, not necessarily very high level, who find a media-saturated area and occupy the niche. On the other side are other experts who believe that science will save us and who go on a crusade to defend the biotechnology in defiance of all [scientific] rigour," laments Marc Lavielle. No doubt the debate is in good hands.
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2. Impact des OGM sur la santé animale : le débat n'est toujours pas tranché
Une étude, publiée le 13 décembre, conclut à l'innocuité de l'alimentation transgénique
Gilles van Kote
Le Monde (France), Article paru dans l'édition du 16.12.11
    
Les amateurs de suspense peuvent se rassurer : le feuilleton opposant partisans et adversaires des organismes génétiquement modifiés (OGM) n'est pas près de s'achever. Le dernier épisode en date tient à l'annonce, mardi 13 décembre, de la publication prochaine, dans la revue scientifique Food and Chemical Toxicology, d'une étude menée par une équipe française dirigée par la généticienne Agnès Ricroch, de l'Institut des sciences et industries du vivant et de l'environnement (AgroParisTech).

Cette méta-analyse, qui se fonde sur 24 études menées notamment aux Etats-Unis, au Brésil, au Japon ou en Norvège, conclut à l'absence de conséquences sanitaires, chez les animaux, d'une alimentation à base de maïs, riz, soja ou pommes de terre transgéniques. « Maintenant, le débat sur les OGM, d'un point de vue sanitaire, est clos », estime Agnès Ricroch. Ce n'est peut-être pas aussi simple que cela. Selon Marc Lavielle, statisticien à l'Institut national de recherche en informatique et en automatique (Inria) et membre du conseil scientifique du Haut Conseil aux biotechnologies (HCB), cette étude serait « biaisée » et « extrêmement orientée ».

« Ce qui est terriblement gênant, c'est qu'elle conclut à l'absence de différence [entre animaux ayant consommé des OGM et animaux n'en ayant pas consommé] sur la base d'une méthodologie ne correspondant pas aux lignes directrices publiées aussi bien par l'Agence nationale de sécurité sanitaire de l'alimentation [ANSES] que par l'Autorité européenne de sécurité des aliments [EFSA] », estime-t-il.

« Les études passées en revue démontrent que les plantes transgéniques sont nutritionnellement équivalentes à leurs contreparties non transgéniques et peuvent être utilisées en toute sécurité », conclut l'étude, dont les auteurs estiment qu'il n'est donc pas nécessaire de procéder à des essais sur des durées supérieures à quatre-vingt-dix jours avant d'autoriser de nouvelles variétés d'aliments transgéniques destinées aux animaux.

Ils reconnaissent cependant avoir repéré des différences entre animaux nourris ou non aux OGM. « Mais quand ils trouvent des différences, ils considèrent soit que la comparaison n'est pas valable, soit que la différence n'est pas biologiquement significative, note Marc Lavielle. En revanche, ils tiennent compte sans la critiquer d'une étude portant sur des groupes de trois animaux, un échantillon bien trop faible pour permettre de conclure quoi que ce soit. »

La passion qui sous-tend le débat sur les OGM en Europe, et en France en particulier, ne s'arrête pas, loin s'en faut, aux portes du monde scientifique. Une autre méta-analyse, fondée sur 19 études internationales et publiée en mars dans la revue Environmental Sciences Europe, sous la direction du biologiste Gilles-Eric Seralini, aboutissait ainsi à une conclusion diamétralement opposée à celle de l'équipe d'Agnès Ricroch.

Président du comité scientifique du Comité de recherche et d'information indépendantes sur le génie génétique (Criigen), Gilles-Eric Seralini défend le principe de tests à long terme qui permettraient de détecter une toxicité chronique des OGM. « Notre étude a montré que 9 % des animaux ayant été nourris avec des aliments transgéniques présentent des effets secondaires : des troubles du métabolisme qui se concentrent à 43 % sur les reins et à 28 % sur le foie », résume-t-il.

Les travaux de Gilles-Eric Seralini sont également critiqués par une partie importante de la communauté scientifique. L'ANSES s'est d'ailleurs autosaisie, cet été, de l'étude publiée en mars par le biologiste. Selon un scientifique ayant participé à l'expertise, l'avis attendu dans les mois à venir devrait se montrer très sévère pour la méthodologie utilisée pour réaliser cette étude.

« D'un côté, vous avez des scientifiques, pas forcément de très haut niveau, qui trouvent un terrain hypermédiatisé et occupent le créneau, de l'autre des experts convaincus que la science va nous sauver et qui partent en croisade pour défendre les biotechnologies au mépris de toute rigueur », se désole Marc Lavielle. Pas de doute : le débat est entre de bonnes mains.
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3. No health problems for animals fed on GM crops (study)
Press release
AFP, December 13 2011
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Paris – Animals fed for more than three months genetically modified maize, rice, soy or potatoes showed no health problems and were doing as well as those subject to a non-GMO diet, according to a study published in the journal Food and Chemical Toxicology*.

"Now, for us, the debate on GMOs from a health point of view is closed", Agnes Ricroch (AgroParisTech and University Paris-Sud), who led the study, said to AFP. Her team, which included eminent toxicologists, Alain Paris and Gérard Pascal, and biologists, Jean-Baptiste Bergé and Marcel Kuntz, surveyed data from 24 international studies conducted by independent institutes from the USA, Brazil, Japan, and Norway among others. More specifically, it includes 12 studies concerning a feeding period of more than 90 days and up to two years, and 12 multigenerational studies over two to five generations of animals. The particularly interesting aspect of this broad range of studies is not only the fact that they originate from different countries, but also the variety of animals tested: chickens, mice, rats, goats and cows, added Ms. Ricroch.

These animals were fed 33% of currently marketed transgenic plants (maize, soybean), and rice, triticale (a cross between wheat and rye) and potatoes in their diet at the rate set by the OECD in 1998.

"The researchers looked at a number of parameters: growth, organ weights, their development, blood enzymes, reproductive organs, pancreas, brain and heart, a far and wide review", says Dr Ricroch.

This study concludes that GMOs are not harmful to animals from a health point of view. "It's good news" she added, "Had we found the opposite, toxicological recommendations would have had to be extended to long-term studies".

"It also means that the assessments that toxicologists request for GMOs are well performed and robust," she said, since no differences in the nutritional equivalence were found between the marketed GMO and non-modified foods.

*Chelsea Snell, Aude Bernheim, Jean-Baptiste Bergé, Marcel Kuntz, Gérard Pascal, Alain Paris, & Ricroch Agnès E. (2011)
Assessment of the health impact of GM plant diets in long-term and multigenerational animal feeding trials: A literature review. Food and Chemical Toxicology, 0, pp http://www.ask-force.org/web/Longterm/Chelsea-Assessment-Health-Longterm-2011.pdf
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4. The study

Snell, C., B. Aude, et al. (2011). "Assessment of the health impact of GM plant diets in long-term and multigenerational animal feeding trials: A literature review." Food and Chemical Toxicology.

Abstract

The aim of this systematic review was to collect data concerning the effects of diets containing GM maize, potato, soybean, rice, or triticale on animal health. We examined 12 long-term studies (of more than 90 days, up to 2 years in duration) and 12 multigenerational studies (from 2 to 5 generations). We referenced the 90-day studies on GM feed for which long-term or multigenerational study data were available.

Many parameters have been examined using biochemical analyses, histological examination of specific organs, hematology and the detection of transgenic DNA. The statistical findings and methods have been considered from each study. Results from all the 24 studies do not suggest any health hazards and, in general, there were no statistically significant differences within parameters observed. However, some small differences were observed, though these fell within the normal variation range of the considered parameter and thus had no biological or toxicological significance. If required, a 90-day feeding study performed in rodents, according to the OECD Test Guideline, is generally considered sufficient in order to evaluate the health effects of GM feed. The studies reviewed present evidence to show that GM plants are nutritionally equivalent to their non-GM counterparts and can be safely used in food and feed.