New GMO Studies Demonstrate ‘Substantial Non-Equivalence’
document substantial differences of GM maize and GM soybean from their
conventional non-GM counterparts, exposing a permissive regulatory regime that
has failed miserably in protecting public health and biodiversityDr Eva Sirinathsinghji
Announcing a new Report from ISIS. The most complete up-to-date summary of the dangers of GM agriculture in 52 pages. Buy Now, or download here
new studies carried out by scientists independent of the biotech industry are
showing up glaring differences between GMOs and their non-GMO counterparts.
This makes a mockery of the regulatory principle of ‘Substantial Equivalence’ which
has facilitated approvals of GMOs with practically no protection for public health
and the environment
 (see  The Principle of
Substantial equivalence is Unscientific and Arbitrary, ISIS news).
principle of ‘Substantial Equivalence’
concept of ‘Substantial Equivalence’ was first introduced in 1993 by the Organisation
for Economic Development (OECD), an international economic and trade
organisation, not a public health body. The principle states that if a
new food is found to be substantially equivalent to an already existing food
product, it can be treated the same way as the existing product with respect to
safety. This concept has greatly benefited the trade of GM produce, allowing it
to effectively bypass regulatory requirements that would apply to novel food
and other products including novel chemical compounds, pharmaceuticals,
pesticides and food additives, all of which require a range of toxicological
tests and can be subject to legal limitations on safe consumption/intake.
agencies including the US Food and Drug Administration, the Canadian Food
Inspection Agency and Japan’s Ministry of Health and Welfare, generally base
their GM food safety regulations on substantial equivalence.
are many good reasons for consumers to feel unprotected by these regulatory
policies, not least because the principle itself is designed to be as flexible
and open to interpretation for the approval of just about any and every GMO
submitted. In practice, the principle allows the comparison of a GM line to any
existing variety within the same species, and even to an abstract entity made
up of ingredients from a collection of species. This means that a GM variety
can have all the worst traits of many different varieties and still be deemed
substantially equivalent [1, 2]. Traits used for comparisons are also based
solely on gross and insensitive chemical compositional tests such as levels of
carbohydrate, protein and sugars. This process cannot even begin to tackle
safety issues. Ironically, for the GMOs to be patentable as they are, a clear novelty,
i.e., a difference or non-substantial equivalence is indeed required.
assessments of substantial equivalence have shown how this ill-defined practice
is not only inadequate but untrustworthy [3- 5], and the new studies most
clearly confirm this.
in Egypt showed substantial non-equivalence and toxicity for GM corn
April 2013, an Egyptian publication led by Professor El-Sayed Shaltout at Alexandria
University found that Monsanto’s 810 Corn (Ajeeb-YG®), modified to express the
insecticidal Bt Cry1Ab gene, has increased total protein, crude fat, crude fibre
& total saccharides and decreased starch content compared with non-GM Ajeeb
corn. Abnormal levels of certain amino acids, fatty acids and elements were also
recorded . These compositional differences only gave the merest hint of the toxicity
of the GM corn revealed in previous male rat feeding studies conducted by the
same team documenting a wide range of organ and tissue abnormalities [7, 8]. Liver
cells displayed vacuolation and fatty degeneration. The kidneys had congested blood
vessels and dilation of renal tubules. The testes showed signs of necrosis and
desquamation of spermatogoneal germ cells lining the seminiferous tubules. The
spleens were congested with slight lymphocytic depletion. The small intestines showed
hyperplasia and hyperactivation of mucous secretory glands, with necrosis of
intestinal villi. Most certainly, the GM corn was not substantially equivalent
to non-GM corn.
GM and non-GM soybeans
not substantially equivalent
recent study led by Thomas Bøhn at the Norwegian Centre for Biosafety  tested
31 batches of whole soybeans from Iowa, US in
three categories: 1) GM glyphosate-tolerant soy; 2) unmodified soy cultivated
using conventional “chemical” regime and 3) unmodified organically cultivated
soy. The three groups were analysed for chemical contamination (organochlorine, organophosphorus, pyrethroides, PCBs,
glyphosate and AMPA (aminomethylphosponic acid - the major degradation product
of glyphosate) based on the list of pesticide brand names used by the farmers) as
well as nutritional content. Testing pesticide levels is
important as substantial equivalence assessments for GM glyphosate-tolerant soy
were not previously done with herbicide residue in the crop despite common
knowledge that glyphosate is actually taken into the plant, and also alters the
metabolism and biochemistry, and hence the chemical composition of crops. Any
assessment of its equivalence is obviously irrelevant when glyphosate is not
couldn’t be clearer. As shown in Figure 1, glyphosate and AMPA were only
present in GM soy samples and not at all in conventional non-GM and organic varieties.
In the GM-soy samples, the concentration of AMPA (mean concentration = 5.74
mg/kg) was on average nearly twice as high as glyphosate (3.26 mg/kg). Other herbicides were detected: Fluazifop-P a selective
phenoxy herbicide, was found at a concentration of 0.078 mg/kg in one of the
GM-soy samples, malathion was found at a concentration of 0.02 mg/kg in one of
the conventional soy samples and Dieldrin was found at a concentration of 0.002
mg/kg in one of the organic soy samples. No other residues were detected. Additional
testing for pesticide residues in pooled samples of GM, conventional and
organic soybeans showed trace-levels of Alpha-endosulfane, Trans-nonachlor and
Trans-chlordane, all close to the detection limit of 0.05 µg/kg and in all soy
types. Dieldrin was also found in very low levels with 0.51, 0.45 and 0.6 µg/kg
in GM, conventional and organic soybeans, respectively.
Figure 1 Gyphosate and its metabolite AMPA present only in GM
looked at chemical composition of the soy samples including composition of
protein, fat and sugar content, as well as individual
amino acids, vitamins, fatty acids and elements. Organic soy samples show significant
differences from both GM and conventional non-GM soybean samples, with higher
and lower levels of protein and saturated fats respectively, plus significant
differences in levels of total as well as individual levels of amino acids,
vitamins, and minerals. A further statistical multivariate analysis of the
compositional results found without exception that each individual soybean sample
could be discriminated statistically into their respective agricultural
background, even excluding the data on glyphosate/AMPA levels. The organic
soybean was nutritionally superior to both conventionally grown non-GM soybean
and GM soybean.
technologies for biosafety analyses
technologies, such as proteomics, allow the simultaneous measurement and
comparison of thousands of plant components, in this case proteins, without
prior knowledge of their identity. These methods are now being employed by
independent scientists to provide a more thorough, unbiased and global profile
of GM crop composition for risk assessment.
study conducted in Brazil by Agapito-Tenfen and colleagues at the FederalUniversity
of Santa Catarinais an example of this type of analysis, with global
protein expression analysed in GM MON810 compared with the non-GM maize control
grown in two different environmental conditions. Analysis
of the total leaf-derived proteome showed 32 differentially expressed proteins (out
of an average 458 and 643 detected proteins for each condition) between GM and
non-GM maize with most of them involved in carbohydrate metabolism, stress
response as well as genetic information processing such as post-translational
modification of newly made proteins . Sixteen proteins were differentially
expressed between GM and non-GM maize at each of the two growing locations
(Campos Novos and Chapecó). In Campos Novos, the experiment found 8 proteins
detectable only in the GM samples, the remaining 8 were
absent in the GM samples. In Chapecó, there were seven proteins exclusive to GM
plants and seven to non-GM plants. 2 proteins showed quantitative differences
in expression. For example, glyceraldehydes 3-phosphate degydrogenase (GAPDH)
and fructose-biphosphate, ferredoxin-NAPD was exclusive to GM plants in Capos
Novos and relate directly to energy metabolism. When it comes to carbohydrate
metabolism, this is consistent with previous studies that found increased sugar
levels in MON810 plants, with up 14, 7 and 1.8-fold increases in glucose,
fructose and sucrose respectively . Indeed, maize plants go through many
developmental stages in their leaves that exclusively rely on carbohydrate
metabolism. Further, transgenes with high constitutive promoters have been
shown to have a high energetic cost e.g. cauliflower mosaic virus 35S promoter [12,
13], which the authors speculate may cause a problem for transgenic plants.
response genes e.g. those related to glutathione metabolism (glyoxylase 1 and
IN2-1), peroxidises and pathogenesis-related protein were expressed only in
non-GM plants. It was also revealed that 2-cysteine peroxiredoxin BAS1 (2-CP)
proteins are over-expressed in GM plants from both locations. Peroxidases are
of great importance for eliminating H2O2 resulting from
genetic information processing proteins were differentially expressed. Two of
these were only present in GM plants from Campos Novos, the adenine
phosphoribosyl transferase (APT), and the ATP-dependent
Clp protease ATP-binding subunit ClpA (Clp-ClpA). APT works on adenine salvage
in plants, while Clp-ClpA proteases exert unfoldase activity, playing a key
role in regulating the availability of certain short-lived regulatory proteins.
Chaperonin protein and S-adenosylmethionine synthetase 1 were upregulated in
non-GM plants. S-adenosylmethionine synthetase 1 is involved in
transmethylation of proteins, nucleic acids, polysaccharides and fatty acids.
Interestingly, many of these genetic information processing proteins are
directly related to gene expression control.
study is the first of its kind to use such technologies to assess how both the
environment and genotype can influence plant composition in Brazil and
highlights the routine profiling analyses now widely available for proteins,
transcripts and metabolites that are still not required by governments for regulatory
approval as they should be.
further note in this study is the effect of environmental conditions on the
composition of crops. GM proponents often argue that other factors such as
environmental conditions as well as hybrid varieties determine the composition
and physiology of a plant but genetic modification can influence such
conditions. Indeed, the environment did cause variation in composition of the
crops, but interestingly, it appeared that the GM maize protein expression
profile was more affected by the environment.
conclude, the numerous differences demonstrated between GM varieties and
their non-GM counterpart may well impact consumer health and biodiversity, and clearly
exposes the substantial equivalence principle as pseudoscience. In reality,
genetic modification causes very real and substantial, unpredictable and
uncontrollable changes in the host genome including mutations, and
rearrangements as well as new transcripts and proteins. Further, glyphosate
and GM crops have already been shown to cause damage to both health and the
environment in many independent studies (see  Ban GMOs Now, ISIS special report). This is
now fully confirmed in the new studies.
Pietro Perrino Comment left 19th February 2014 19:07:20 Dear Mae Wan, I am reading "Frankenstein's Cat - Cuddling Up to Biotech's Brave New Beasts", 2013, by Emily Anthes. The book tries to convince the reader that genetic engineering is the right tool for the future. I am sure you have head of it. I would like to know your thought.
Rory Short Comment left 20th February 2014 11:11:16 The 'substantial equivalence principle' is from a scientific point of view completely meaningless. Equivalence of what to what? It does not say. And what are the measurements that are being compared? It cannot say because it does not say what is to be measured and how it is to be measured. It is a phrase dreamed up by marketers not scientists and the word 'principle' was particularly included in it in order to give, fraudulently, a veneer of science to the phrase.
Theresa Comment left 21st February 2014 10:10:14 GM foods and application of the precautionary principle in Europe
Link to consultation, deadline noon 23 April:
Theresa Comment left 21st February 2014 10:10:00 Following on from Pietro's comment, I have just listened to Emily Anthes being interviewed. She appears to contradict herself, admits there are important areas that she does not know about... What are my thoughts? It would be impolite to say.
Listening to her was excruciatingly painful.
Luckily, as you will see from the comments on this link, others (majority) are not so naive as her.
Todd Millions Comment left 25th February 2014 08:08:29 interesting article further to this;by Antony Samsel and Stephanie Seneff- Glyphosate pathways to modern diseases II:Celiac sprue and gluten intolerance from;Interdisilpinary toxicology 2013 vol6.The graphs are paticularly-
Florence Nightengale grade- Striking.
Best enjoyed on an empty stomach.If search doesn't bring it up, go to Globalresearch.ca
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