Since the 1996 introduction of genetically engineered crops — crops that are altered
with inserted genetic material to exhibit a desired trait — U.S. agribusiness and policymakers have embraced biotechnology as a silver bullet for the food system. The industry promotes biotechnology as an environmentally responsible, profitable way for farmers to feed a growing global population. But despite all the hype, genetically engineered plants and animals do not perform better than their traditional counterparts, and they raise a slew of health, environmental and ethical concerns. The next wave of the “Green Revolution” promises increased technology to ensure food security and mitigate the effects of climate change, but it has not delivered. The only people who are experiencing security are the few, massive corporations that are controlling the food system at every step and seeing large profit margins.
Gilles-Eric Séralini, Robin Mesnage, Emilie Clair, Steeve Gress, Joël Spiroux de Vendômois, Dominique Cellier
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Abstract Purpose: We reviewed 19 studies of mammals fed with commercialized genetically modified soybean and maize which represent, per trait and plant, more than 80% of all environmental genetically modified organisms (GMOs) cultivated on a large scale, after they were modified to tolerate or produce a pesticide. We have also obtained the raw data of 90-day-long rat tests following court actions or official requests. The data obtained include biochemical blood and urine parameters of mammals eating GMOs with numerous organ weights and histopathology findings. Methods: We have thoroughly reviewed these tests from a statistical and a biological point of view. Some of these tests used controversial protocols which are discussed and statistically significant results that were considered as not being biologically meaningful by regulatory authorities, thus raising the question of their interpretations. Results: Several convergent data appear to indicate liver and kidney problems as end points of GMO diet effects in the above-mentioned experiments. This was confirmed by our meta-analysis of all the in vivo studies published, which revealed that the kidneys were particularly affected, concentrating 43.5% of all disrupted parameters in males, whereas the liver was more specifically disrupted in females (30.8% of all disrupted parameters). Conclusions: The 90-day-long tests are insufficient to evaluate chronic toxicity, and the signs highlighted in the kidneys and livers could be the onset of chronic diseases. However, no minimal length for the tests is yet obligatory for any of the GMOs cultivated on a large scale, and this is socially unacceptable in terms of consumer health protection. We are suggesting that the studies should be improved and prolonged, as well as being made compulsory, and that the sexual hormones should be assessed too, and moreover, reproductive and multigenerational studies ought to be conducted too
A meta-analysis on 19 studies confirms kidney and liver toxicity in rats and mice fed on GM soybean and maize, representing more than 80 percent of all commercially available GM food; it also exposes gross inadequacies of current risk assessment Dr Eva Sirinathsinghji
Courtesy: Institute of Science in Soceity
A team of independent scientists led by Gilles-Eric Séralini at Caen University in France carried out a meta-analysis combining the results of 19 previous studies  (for complete report http://www.enveurope.com/content/23/1/10), and their report concluded: “From the regulatory tests performed today, it is unacceptable to submit 500 million Europeans and several billions of consumers worldwide to the new pesticide GM-derived foods or feed, this being done without more controls (if any) than the only 3-month-long toxicological tests and using only one mammalian species, especially since there is growing evidence of concern.”
Multiple organ abnormalities revealed on re-analysis
The nineteen feeding studies performed to date were performed by both industry and independent scientists on either Bt maize or RR soybean, which constitute 83 percent of commercially available GM food. The Bt maize varieties all contain a specific pesticidal protein from the soil bacterium Bt (Bacillus thuringiensis), one variety was also glufosinate herbicide tolerant; the RR soybean is tolerant to Roundup Ready (glyphosate) herbicide. The data were re-analysed with new biological and statistical methods, including the meta-analysis. Meta-analyses allow a more objective appraisal of the evidence and provide a more precise estimate of a treatment effect, giving greater statistical power, and reducing the significance of false-positive or false-negative results.
Although none of the findings are new, the meta-analysis gives further strength to the previous evidence. Importantly, it found that nine percent of tested parameters were disrupted, which is almost double the five percent that could be obtained by chance alone.
Forty-three percent of significant abnormalities were found in the kidneys of males. The liver was more affected in females and the kidney was more affected in males.
Kidney pathology in animals fed RR soybean included significant ionic disturbances resulting from renal leakage. This is consistent with results from cell cultures treated with glyphosate  (see  Death by multiple poisoning, glyphosate and Roundup, SiS 42), suggesting that the presence of the herbicide in the GM food was responsible.
Rats fed Bt maize had significantly decreased kidney size as well as focal inflammation. This was acknowledged by the European Food Safety Authority (EFSA) even though they went on to approve the products.
Liver pathology of animals fed RR soybean included the development of irregular hepatocyte nuclei, more nuclear pores, numerous small fibrillar centres, and abundant dense fibrillar components, indicating increased metabolic rates. These features were consistent with previous findings in cell cultures treated with herbicides .
GM maize-fed animals showed significant abnormal blood protein levels, indicative of disturbed liver metabolism. Histopathological features were also found in some cases. Again, this was acknowledged by the EFSA.
EFSA risk assessment totally inadequate
Current risk assessment of GM foods is based on the ‘substantial equivalence’ concept, where the genetically modified food is deemed equivalent to other products already consumed with regards to components such as fats and oils, carbohydrates and proteins, in which the GMO can be compared, not to the non-GM variety from which it was created, but to an arbitrary combination of conventional varieties or produce. This practice has been thoroughly criticised since the beginning (see  The Principle of Substantial equivalence is Unscientific and Arbitary, ISIS scientific publication).
On that already shaky basis, animal feeding experiments are not always required for regulatory tests, and those that have been performed have been analysed with very dubious methods.
Feeding experiments by Monsanto deeply flawed
While studies carried out by independent scientists all reported significant effects due to GM-feeding, those carried out by Monsanto on MON863, MON810 (both Bt maize lines), and NK603 (glyphosate-tolerant soybean line) reported no evidence of toxicity. The results were kept confidential by Monsanto and the EFSA, until Séralini and his colleagues gained access to the raw data through court action, and found the experiments deeply flawed at every stage, from experimental design to data analysis and interpretation.
Statistical power was greatly reduced by the small number of animals in GM-treated groups, while unmatched groups on 7 different diets were inappropriately included as controls. The findings lack generality as only one species (rat) was used, and tests were performed just once for each GM line. The trials lasted at most 90 days, which is insufficient to pick up chronic effects. No developmental, carcinogenic, reproductive, multi-generational or endocrine parameters were tested. Only two doses of GM foods were used, making it inadequate for detecting dose-dependent effects.
The statistical methods for analysing the data were inadequate, and EFSA had suggested a revision of the methods, highlighting current inadequacies in risk assessment. Statistical comparisons of GM-fed animals to ‘historical’ control groups from previous unreferenced studies were sometimes used instead of control groups from the same study, thereby introducing large variations that hide actual treatment effects. Séralini’s team re-analysed the data comparing treated groups to the closest control group, as is standard scientific practice.
Significant effects were often ignored by Monsanto, and were only taken into account if seen across both sexes. This is unjustified as sex differences are expected for certain pathologies including endocrine-related disturbances, carcinogenesis and liver and kidney abnormalities. As is the case with non-diabetic renal disease, females show protective effects compared with males . Monsanto dismissed differences that were not dose-dependent, but their experimental design precluded the detection of such effects.
Correlations between significant effects were required by Monsanto for accepting disturbances, even though many of them are not expected until long after the beginning of GM-feeding. For example, in the MON863 study, Monsanto noted anatomic signs of “chronic progressive nephropathy” on GM-fed male rats’ kidneys. However, they stated that this was normal in aging rats, even though they were only 5 months old, and these signs were not reported in similar aged rats used for the MON810 and NK603 studies. The animal tissues in question are not available for independent re-analysis as they belong to Monsanto.
There was no assessment of the chemical composition of food. The food was not analysed with regards to herbicides, pesticides or genetic modification, making it impossible to determine whether it was the pesticide/herbicide or the genetic modification that caused the toxicity.
Séralini and his colleagues also suggested that bias of interpretation could be expected as all the studies were performed by the very industry that was hoping to get their product onto the market.
Proposals to improve risk assessment studies for GM foods
With millions of people being subjected to GM foods, Séralini and his colleagues said, more thorough experiments are necessary.
One suggestion is the toxotest approach for chronic environmental, as well as reproductive and developmental effects. They last two years, are multigenerational, and include testing pregnant females, adding information on endocrine, carcinogenic, neural and hormonal dysfunctions. The existing 90-day trials on adult animals cannot match the sensitivity of these developmental tests on neonates. Developmental parameters such as disturbances in genomic imprinting, which determines whether maternal or paternal copy of the gene is expressed, may not be apparent until the second generation. Such abnormalities have been observed with endocrine disrupters such as bisphenol A and estrogenic compounds [7, 8] and are important unanswered questions with regards to GM foods.
Toxotests should also be performed on three animal species (same species as used in pesticide studies), with three doses of GM diet of 11, 22 and 33 percent. These should then be compared to control GM-free diets with equal sample size that are genetically identical, or as similar as possible to the GM lines. To deduce whether the toxic effects are due to herbicides or the genetic modification itself, it would be more informative to feed animals with GM foods both treated and untreated with herbicides. Lastly, statistical experimental design needs to be improved.
Post-market monitoring of GM diets on the human population should be employed to deduce unexpected effects such as allergenicity. Blood samples could be banked and screened for antibodies against the transgene and its products. For such human studies, the labelling of all GM products is necessary.
Finally, all raw data from industry studies must be made publicly available so they can be objectively scrutinised and analysed.
Current risk-assessment studies are inadequate in detecting and acknowledging the toxicity of GM food consumption. Previous independent studies have clearly indicated the hazards of GM crops to human health, with widespread pathologies including birth defects and spontaneous abortions; (see for example  EU regulators Regulators and Monstanto Exposed for Hiding Glyphosate Toxicity, SiS 51) infertility, stunting and sudden deaths (see  GM Soya Fed Rats: Stunted, Dead, or Sterile, SiS 33); immune reactions and allergenicity, (see  More Illnesses Linked to Bt Crops, SiS 30), and as highlighted here, kidney and liver toxicity. This review provides clear improvements to current study designs that need to be upheld by industry as well as the EU government.
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2. Benachour N and Séralini G-E. 2009. Glyphosate formulations Induce Apoptosis and Necrosis in Human Umbilical, Embryonic, and Placental CellsChemical Research. Toxicology, 22, 97–105
3. Ho MW and Cherry B. Death by multiple poisoning, glyphosate and Roundup. Science in Society 42, 14, 2009
4. Malatesta M, Perdoni F, Santin G, Battistelli S, Muller S, Biggiogera M. 2008. Hepatoma tissue culture (HTC) cells as a model for investigating the effects of low concentrations of herbicide on cell structure and function. Toxicology In Vitro, 22, 1853-1860
5. Ho MW and Steinbrecher R. Fatal flaws in food safety assessment: critique of the joint FAO/WHO biotechnology and food safety report.Environmental & Nutritional Interactions 1998, 2, 51-84.
6. Cherney DZ, Sochett EB and Miller JA. 2005. Gender differences in renal responses to hyperglycemia and angiotensin-converting enzyme inhibition in diabetes. Kidney International, 68, 1722–1728
7. Braun JM, Yolton K, Dietrich KN, Hornung R, Ye X, Calafat AM, Lanphear BP. 2009. Prenatal bisphenol A exposure and early childhood behavior.Environmental Health Perspectives, 117, 1945-1952
8. Anway MD, Cupp AS, Uzumcu M, Skinner MK. 2005. Epigenetic transgenerational actions of endocrine disruptors and male fertility. Science, 308, 1466-1469
9. Sirinathsinghji E and Ho MW. EU regulators Regulators and Monstanto Exposed for Hiding Glyphosate Toxicity. Science in Society 51, 46-48, 2011
10. Ho MW. GM Soya Fed Rats: Stunted, Dead, or Sterile. Science in Society 33, 4-6, 2007
11. Ho MW More illnesses linked to GM crops. Science in Society 30, 8-10, 2006
|There are 5 comments on this article so far. Add your comment|
|David R.(Canada) Comment left 5th September 2011 22:10:08
Suddenly,two of my favourites; liver and onions or steak and kidney pie do not sound very appetizing!
|Caroline Senter Comment left 6th September 2011 09:09:03
I very much hope that this study will be reported in the broadsheets since it potentially affects us all. I find it particularly disturbing that the EFSA has not carried out robust independent studies on GM toxicity and published them, since it should be protecting the health of society.
|Evelyn Ransley Comment left 6th September 2011 17:05:49
About time for the truth to come out. Please keep it going to hopefully put a stop to all this nonsense.
|Jose Bulatao, Jr. Comment left 6th September 2011 16:04:46
Even if there were robust independent studies on GM toxicity published and distributed, protecting the health of society (in the United States) must also include some major paradigm shifts in Congressional intestinal fortitude to legislate the laws and regulations to enforce effective and prohibitive measures that will safeguard our food supply.
|Peter Brenton Comment left 8th September 2011 20:08:10
This should be circulated to all health and safety departments throughout the country so they understand what illegally non-labelled GM soya oil used in the majority of food establishments might be doing to the customer amd why it should be banned.Also all those using GM animal feed suppliers .
today we had a wonderful day in the meeting with parliamentary standing committee.
Not sharing in detail as the scientists were asked to be frank and promised that they will not be quoted for what they say…by the committee…
The meeting was well attended by the Scientists from Agri univ, DOR, DRR, NRCS, CRIDA, NBPGR, department of agriculture, farmers unions…
Basudev Acharya in his opening remarks itself mentioned that there is a divided opinion on GM crops and particularly food crops.
Mr. Chaturvedi, member of PSM on agril said he want specific information on
a. whether state want to go for GM not want to go for GM or take a cautious approach till the finding prooves it completely safe.
b. what is the opinion and plan of the govt on farm saved seed as the dependency and monopoly of MNCs is increasing
c. GM foods seems to have been violating consumers choices…
d. how and who will be made accountable in case of contamination fo traditional germplasm
e. what is the relation between bt cotton and farmers suicides.
few others asked
a. why there were animal deaths and what does research has to say?
b. is it true that gm crops requires more fertilisers?
c. do u have any data on reduction in pesticide use?
d. there is a big war between traditional technologies and modern technologies and how they are contributing to improvising traditional practices..
e. is any district biosafety committee is functional? when senior people like u are not able to understand and test the GM related problems how equipped are these committees to handle the issues
f. when 64 % of farmers are small and marginal is there any relevance for these technologies…
from univ there was a presentation by univ…which was a bland presentation….saying we can do wonders and there are some problems like pest resistance, resurgence etc. but she focused more on the process than on any data …and basudev commented saying from ur presentation i can only understand that the problems are more than advantages.
on the soil fertility the univ said it wont need more fertilisers and their data shows that the nitrogen in plants is more…dont no why…
i quoted their farm almanac recommending 15 % more fertiliser.
one member said he has seen farmers complaining that second crop being effected…and specifically can u answer whether farmers are using more or ru recommending more…he could nt say anything…the committee said..looks like u havent done any research…without which we cannot come to any conclusion of its benefits…
on the animal deaths…again univ said animals cannot die…hukum dev narayan said this is unfair…and if animals have not died because of bt cotton…u should explore what are the reasons…my personal experience shows that abortions and deaths in animals have increased in bt cotton growing areas….and have u done any study on the impact of the cotton cake on the cattle milk and human health and there was no response….
MA Khan, MP from AP said…the monopoly of monsanto is increasing and no one is able to stand…AP govt which could fight till recently has lost out this year…and if this happens with food crops the situation would be worse.
on pesticide use the scientists said it is coming down but the report submitted to the committee was otherwise.
the committee was serious on illegal spread of HT cotton…commissioner said it was only field trials and they have uprooted them…one of the member had data from the state govt report to GEAC saying 20,000 acres of HT cotton district wise…and said u cannot say it is a trial and u failed to book the culprit…why farmers should bear the burden?
Farmers Federation representative… was as usual saying when my mobile ur mike and all our vehicles are from MNC why should farmers be worried about MNC seed and it is not farmers responsibility’s for national food security and farmers want technology. Mr. chaturvedi…said we appreciate ur concern and u have freedom to say what u want and we understand it is our responsibility to safeguard farmers and consumers interests and thats why we are hear…and food is different from cell phones……
among the audience…saraswati could get time for few questions…two farmers from guntur spoke well …saying they need technology but not problems…bt cotton had several problems and every one is irresponsible.
i could get good time to intervene almost on every point to counter what univ was saying….and in the end..basudev gave good time…
we submitted a written memorandum attached…..
The committee asked to send any further information we want to share with them