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ISIS Report 05/09/11
GM Feed Toxic, New Meta-Analysis Confirms
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
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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 , 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.”
organ abnormalities revealed on re-analysis
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.TheBt 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
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
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
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 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
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
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.
experiments by Monsanto deeply flawed
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
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.
to improve risk assessment studies for GM foods
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
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
Finally, all raw data from industry studies must be made
publicly available so they can be objectively scrutinised and analysed.
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.
1. Séralini G-E, Mesnage R, Clair E, Gress S,Vendômois J, Cellier D. Genetically
modified crops safety assessments: present limits and possible improvements.
2011. Environmental Sciences Europe, 23, 10-20
2. Benachour N and Séralini G-E. 2009. Glyphosate formulations Induce
Apoptosis and Necrosis in Human Umbilical, Embryonic, and Placental Cells Chemical
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,
9. Sirinathsinghji E and Ho MW. EU regulators Regulators and Monstanto
Exposed for Hiding Glyphosate Toxicity. Science
in Society 51, 46-48, 2011
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 .
Tom Comment left 13th November 2011 21:09:41 So what does fda have to say about this?
My IT Site
Mark Proctor Comment left 23rd February 2012 18:06:15 I work on a farm> new at this kind of things. Can I post this on my page? Good work you have done here,Monsantos> a Monster.
JIM DOOLEY Comment left 4th March 2012 16:04:07 I NEED TO FIND OUT MORE ABOUT SOY WASTE OUT OF A PROTIEN PLANT NEAR PRYOR OK. SOLAE CO..THEY SEND THEIR WASTE CALLED CAKE TO A RANCHER NEST TO ME BY HUNDERD OF TONS TO BE SPREAD ON THE PASTURES AROUND THE YEAR 12MO. THEY CALL IT COW FEED AND HAVE A AGRI.PERMIT IM TOLD BY THE STATE..HE FEEDS NO OTHER FEED IN THE WINTER OR SUMMER. HAY FROM PASTURES AND FIELDS FERTILIZED WITH SOY WASTE..I HAVE A CONCERN THAT THE TONS OF WASTE AND RUNOFF WATER IS DANGERIOUS TO US AND OTHERS.
PLEASE LET ME KNOW IF THIS IS DANGROUS..
Rose Comment left 19th April 2013 09:09:03 What is happening here is horrifying. The video is well done and extremely informative.
On another note the work you are doing is awesome.