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[SANET-MG] GM Food Nightmare Unfolding and the Regulatory Sham
time for a clean sweep of the regulatory regimes
ISIS Press Release 02/02/07
GM Food Nightmare Unfolding and the Regulatory Sham
How our regulators are ignoring the precautionary principle,
manipulating and corrupting science, sidestepping the law, and helping
to promote GMOs in the face of massive public opposition and damning
evidence piling up against the safety of GM food and feed Dr. Mae-Wan Ho
Based on talk delivered at Franco-British Council Symposium, Policy
Making and Risk Management: French and British Viewpoints, 8 February
2007, Paris, France
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GM nightmare unfolds
Female rats whose diets were supplemented with genetically modified (GM)
Roundup Ready soybeans gave birth to many severely stunted pups, with
over half of the litter dead by three weeks, and the surviving pups were
sterile [1] ( GM Soya Fed Rats: Stunted, Dead, or Sterile , SiS 33 ).
This is the first time that anyone has investigated the effects of GM
feed on reproductive function, foetal and neonatal development, in an
experiment lasting more than 90 days, a period set by the European Food
Standards Authority (EFSA) [2], and the GM soya has been commercialised
worldwide for food and feed since 1996.
Like a long string of scientists who have tried to tell the public what
they have found, Dr. Irina Ermakova, senior scientist of the Russian
Academy of Sciences who heads the investigation, has had her funding
cut, and is now strongly discouraged from continuing with the research.
She is pleading for other scientists to repeat her experiment to see if
they can replicate her results.
Ermakova's findings are not an isolated case. They top a growing stack
of evidence accumulated from all over the world, indicating that GM food
and feed may be inherently hazardous to health (see Box 1). GM crops are
also proving disastrous for agriculture [3, 4] ( Roundup Ready Sudden
Death, Superweeds, Allergens... , Scientists Confirm Failures of
Bt-Crops , SiS 28), which is all the more reason they should be banned.
Box 1
Accumulating evidence on the health hazards of GM food and feed
Between 2005 and 2006, scientists at the Russian Academy of Sciences
reported that female rats fed glyphosate-tolerant GM soybeans produced
excessive numbers of severely stunted pups and more than half of the
litter dying within three weeks, while the surviving pups are completely
sterile (see main article).
Between 2004 and 2005, hundreds of farm workers and cotton handlers in
Madhya Pradesh, India, suffered allergy symptoms from exposure to Bt
cotton [5] ( More Illnesses Linked to Bt Crops , SiS 30).
Between 2005 and 2006, thousands of sheep died after grazing on Bt
cotton crop residues in four villages in the Warangal district of Andhra
Pradesh in India [6] ( Mass Deaths in Sheep Grazing on Bt Cotton , SiS 30).
In 2005, scientists at the Commonwealth Scientific and Industrial
Research Organization in Canberra Australia tested a transgenic pea
containing a normally harmless protein in bean (alpha-amylase inhibitor
1), and found it caused inflammation in the lungs of mice and provoked
sensitivities to other proteins in the diet [7] ( Transgenic Pea that
Made Mice Ill , SiS 29)
From 2002 to 2005, scientists at the Universities of Urbino, Perugia
and Pavia in Italy published reports indicating that GM-soya fed to
young mice affected cells in the pancreas, liver and testes [8] ( GM Ban
Long Overdue , SiS 29)
In 2003, villagers in the south of the Philippines suffered mysterious
illnesses when a Monsanto Bt maize hybrid came into flower; antibodies
to the Bt protein were found in the villagers, there have been at least
five unexplained deaths and some remain ill to this day [8]
In 2004, Monsanto's secret research dossier showed that rats fed MON863
GM maize developed serious kidney and blood abnormalities [9] (see main
text).
Between 2001 and 2002, a dozen cows died in Hesse Germany after eating
Syngenta GM maize Bt176, and more in the herd had to be slaughtered from
mysterious illnesses [10] ( Cows Ate GM Maize & Died , SiS 21)
In 1998, Dr . Arpad Pusztai and colleagues formerly of the Rowett
Institute in Scotland reported damage in every organ system of young
rats fed GM potatoes containing snowdrop lectin, including a stomach
lining twice as thick as controls [11]
Also in 1998, scientists in Egypt found similar effects in the gut of
mice fed Bt potato [12]
The US Food and Drug Administration had data dating back to early 1990s
showing that rats fed GM tomatoes with antisense gene to delay ripening
had developed small holes in their stomach [11]
In 2002, Aventis company (later Bayer Cropscience) submitted data to UK
regulators showing that chickens fed glufosinate-tolerant GM maize
Chardon LL were twice as likely to die compared with controls [13] (
Animals Avoid GM Food, for Good Reasons , SiS 21 ).
Many varieties of GM crops - soybean, tomato, maize, cotton, potato, pea
- with different transgenes, fed to rats, mice, cows, sheep, chickens,
or human beings, resulted in illnesses and deaths. The obvious suspect
is the GM process and/or the artificial genetic material used. It is
worth mentioning here that synthetic approximations of the natural genes
are invariably used, and in new combinations that have no counterparts
in billions of years of evolution.
Numerous publications from the Institute of Science in Society have
spelt out the potential dangers of the GM process based on extensive
review of the scientific literature (see Box 2) [14-16, for example] (
FAQ on Genetic Engineering , ISIS Tutorial; Special Safety Concerns of
Transgenic Agriculture and Related Issues , ISIS Briefing; GMO Free:
Exposing the Hazards of Biotechnology to Ensure the Integrity of our
Food Supply , ISP Report),.
Box 2
Potential Hazards of GMOs
Synthetic genes and gene products new to evolution could be toxic and/or
immunogenic for humans and other animals
Genetic modification represents greatly enhanced and facilitated
horizontal gene transfer and recombination, the main route to creating
pathogens responsible for major disease epidemics
GM DNA consists of antibiotic resistance marker genes as well as copies
of genes from many viral and bacterial pathogens, which further
increases the likelihood that it will transfer horizontally and
recombine to create new pathogens and spread antibiotic resistance in
the process
The uncontrollable, imprecise process involved in making GMOs can
generate unintended toxic and immunogenic products, a problem
exacerbated by the instability of the transgenic varieties
Endogenous viruses and viral genes that cause diseases could be
activated by the transgenic process
The GM DNA, enormously amplified in GMOs released into the environment,
is readily transferred to other species via pollen, or by direct uptake
into cells of all organisms interacting with the GMOs, within the GMOs
themselves, in the soil, the water and the gut of animals feeding on the
GMOs, providing plenty of opportunity for horizontal gene transfer and
recombination to create new pathogens and spread antibiotic resistance
GM DNA is designed to integrate into genomes; unintended integration of
GM DNA into the genome of cells of animals including humans can result
in harmful insertion mutagenesis including those that trigger cancer
Herbicide tolerant GM crops accumulate herbicide and herbicide residues
that could be highly toxic (see main text)
“GM food is safe”
For those who believe our regulators assuring us that “GM food is safe”
because people have been eating GM food since its first release in 1994
and no one has fallen ill or died from it, think again. First, there has
been no labelling in countries like the US where GM food and feed are
most available. Second, many GM products are helpfully ‘de-regulated' by
US regulators and hence not known or traceable as such. Third, there has
been no post-release monitoring, so it is impossible to tell how many
people and animals have become ill or have died from eating GM food and
feed, although researchers at the Centers for Disease Control have
published a paper in 1999 suggesting that food-related illnesses went up
2 to 10 fold compared with a survey done just before GM food was
commercially released in 1994 [17, 18] ( US Foodborne Illnesses Up Two
to Ten Fold , SiS 13/14 ) . Fourth, GM food and feed may be linked to
chronic illnesses such as autoimmune disease, slow viruses or cancer
[19] ( Horizontal Gene Transfer – The Hidden Hazards of Genetic
Engineering , ISIS Briefing ) , which may be difficult to detect.
Finally, animal feed accounts for up to half the world's harvest [20],
so most of the GM produce so far has probably ended up in animal feed
after being processed for seed oil, corn starch and syrup, and
increasingly, ethanol and biodiesel [21, 22] ( Biofuels for Oil Addicts
, Biodiesel Boom in Europe? SiS 30). That means GM produce is seldom
eaten directly by either animals or human beings so far, except in
Argentina, with dire consequences for health [23] ( Argentina's GM Woes
, SiS 20 ). In Argentina, GM soya has been promoted as a staple food
especially for the poor, which has no precedent in the world, so it is
not possible to tell which effects are due to soya per se , which due to
GM soya, and further, due to the toxic herbicide Roundup (see later)
sprayed from the air, dousing people and their homes.
Unfortunately, GM food is still being send to Africa as ‘food aid',
after widespread rejection and protest [24], putting millions of the
most hungry and vulnerable people at risk from the health hazards of
GMOs, and threatening to contaminate their food supply for years to come.
Regulatory bias towards GMOs
The list of evidence of GM hazards in Box 1 consists of both laboratory
experiments reported in the scientific literature and experience in the
field where GM crops are grown, and is by no means complete. In fact,
evidence of GM hazards has been building up since the 1980s that should
have halted the development or commercialisation of many, if not all GM
crops [5], if the precautionary principle had been applied. But our
regulators were biased in favour of GM from the first, and have
systematically ignored and dismissed research findings that might harm
the fledgling biotech industry [25] ( Fatal Flaws in Food Safety
Assessment: Critique of the Joint FAO ... , ISIS Scientific
Publication). By now, the evidence has accumulated to such an extent
that the regulators should be answering a charge of criminal negligence
at the very least in continuing their campaign of denial and
misrepresentation while failing to impose a ban on further releases of
all GM crops until and unless they have been proven safe by thorough
independent investigations [8].
Meanwhile the biotech industry is hyping the ‘success' of GM crops as
opposition heightens worldwide [26] ( Global GM Crops Area Exaggerated ,
SiS 33), and aggressively pushing new generations of products [27, 28] (
GM Crops and Microbes for Health or Public Health Hazards? , GM Food
Animals Coming , SiS 32) potentially even more dangerous as well as
unethical. The latest are cloned transgenic animals that the regulators
are presenting in a misleadingly positive light for market approval [29,
30] ( Is FDA Promoting or Regulating Cloned Meat and Milk? , Cloned
BSE-Free Cows, Not Safe Nor Proper Science SiS 33).
In short, there is no protection for the public and the environment
under the current regulatory regime that has no regard for the
precautionary principle, where crucial evidence is ignored or dismissed,
where scientific data are routinely manipulated and science abused, and
regulators are colluding with industry to promote the products they are
supposed to regulate, even to the extent of breaking the law.
Abusing science and the precautionary principle
Our regulators are bound by law to operate on the precautionary
principle as stated in the international Cartegena Protocol on Biosafety
for genetically modified organisms (GMOs); and UK and the European Union
have signed up to that, as have 137 other countries worldwide [31]. It
is “taken into account” in the European Directive (2001/18/EC) for
deliberate release into the environment of GMOs [32]
The European Commission (EC) published a Communication on the
precautionary principle in 2000 [33] clearly stating that: “the
Commission considers that the precautionary principle is a general one
which should in particular be taken into consideration in the fields of
environmental protection and human, animal and plant health.” It
recognized that the precautionary principle has become “a full-fledged
and general principle of international law”, since it was written into
the UN's Framework Convention of Climate Change, Convention on
Biological Diversity and then in January 2000, Cartegena Protocol on
Biosafety; it is also in the World Trade Organisation's Agreement on
Sanitary and Phytosanitary Measures and the Agreement on Technical
Barriers to Trade.
The EC Communication cites the Rio declaration that, “ in order to
protect the environment, the precautionary approach shall be widely
applied by States according to their capability. Where there are threats
of serious or irreversible damage, lack of full scientific certainty
shall not be used as a reason for postponing cost-effective measures to
prevent environmental degradation .” The EC also emphasized that the
precautionary principle is much wider in scope, and covers also human,
animal or plant health in the EU [33, p. 9]: “ Although the
precautionary principle is not explicitly mentioned in the Treaty except
in the environmental field, its scope is far wider and covers those
specific circumstances where scientific evidence is insufficient,
inconclusive or uncertain and there are indications through preliminary
objective scientific evaluation that there are reasonable grounds for
concern that the potentially dangerous effects on the environment,
human, animal or plant health may be inconsistent with the chosen level
of protection .”
In practice, however, scientific evidence has been manipulated, and
science abused and pressed into service to prevent the precautionary
principle being ever invoked at both the international and national
levels, let alone applied. Science is used to exclude important evidence
arising in the real world where farmers are growing GM crops in the
fields, and farm workers and crop handlers are exposed for the first
time and made ill, and livestock are dying from the new GM feed (see Box
1). Scientists have been drawn into a tightly closed loop of
self-reinforcing “advocacy science” [34] that deliberately excludes not
just counter scientific evidence but input from the real world, the only
goal of which is to smooth the passage of GM produce into the market,
without regard for safety or moral, ethical concerns.
In the European Union (EU), scientific assessment on safety of GM food
products is done by the EFSA; and a ‘positive opinion' from the EFSA
would invariably result in commercial approval for the product. But
EFSA's positive opinions have been challenged [35, 36, for example] (
Approval of Bt11 Maize Endangers Humans and Livestock , SiS 23; No to GM
Oilseed Rape GT73 , SiS 24) and accusations of bias towards the biotech
industry have come from both member states and civil society
organisations. So much so that in April 2006, the EC decided to
introduce improvements to EFSA's “scientific consistency and
transparency of the decisions on GMOs.” [37] ( European Food Safety
Authority Criticised for GMO Bias , SiS 30).
UK's watchdog, the Food Standards Agency (FSA,) is advised by the
Advisory Committee on Novel Foods and Processes (ACNFP), which
advertises itself as “a nonstatutory independent body of scientific
experts,” even though the majority of its members, including the chair,
have vested biotech interests as shareholders of companies, paid
consultants or recipients of research grants [38].
A search for ‘precautionary principle' on the FSA website gave no
result. But a document entitled The Food Standards Agency's Approach to
Risk [39] states: “We will take a precautionary approach – that is, we
will not always wait until we have proof of a potential hazard to take
action or issue advice. Such action will be taken on the best available
evidence to protect public health. It will be reviewed if new evidence
becomes available.”
In reality, the manipulation of scientific evidence appears to be the
mainstay of the regulatory process. Both the FSA and the ACNFP have been
operating on the anti -precautionary principle [40] ( Use and Abuse of
the Precautionary Principle , ISIS Briefing). Not only do they require
the public and genuinely independent scientists to prove there is
hazard, they have persistently ignored all evidence of hazards submitted
to them, and instead, continue to misinform the public by citing highly
flawed studies that claim to find no effect against the latest findings
[1].
Many of the papers cited by the regulatory agencies that failed to find
significant effects of GMOs, or failed to detect GM DNA in meat or milk,
have been thoroughly reviewed and exposed to be highly misleading and/or
seriously flawed [41-45, for example] ( Swallowing the Tale of the
Swallowtail , ISIS News 5; Exposed: More Shoddy Science in GM Maize
Approval , Bogus Comparison in GM Maize Trial , SiS 22; DNA in GM Food &
Feed , SiS 23; Cover-up over GM DNA in milk , SiS 27)
The EFSA put out a consultation document on the role of animal studies
in assessing the safety and nutritional value of GM foods and feed in
December 2006 [2]. Its review of the evidence is selective and biased,
citing all studies that find no effect without comment, while excluding
most of the evidence of serious adverse effects - all that comes from
the real world and several laboratory studies that have been published
or available in the public domain - practically the entire list in Box 1
except for items5, 9 and 10. The few studies it has cited that found
significant adverse effects are all dismissed with irrelevant,
unsubstantiated criticisms. It made no mention at all of the large
volume of literature on the potential hazards of transgenic DNA (see Box
2) and its detection in food and feed and in tissues and cells of
animals fed GM produce [44, 45].
The EFSA consultation document [2], having failing to cite Ermakova's
findings [1], insists that 90 day feeding trials in rodents are adequate
to detect chronic effects, ignoring impacts on reproductive, embryonic,
foetal and postnatal development , which would require much longer trial
periods of between one to two years.
Studies that claimed GM feed had no adverse effects came mainly from
biotech companies , as Prof. Gilles-Eric Seralini and colleagues at Caen
University in France point out [46]; but even these were often contested
by independent scientific review , including those from ISIS [13,
41-43]. In Monsanto's study on glyphosate tolerant maize NK603 which
claimed no effect, Seralini and colleagues [46] found “more than 50
significant differences between GM fed and control rats” . They further
point out that glyphosate tolerant crops, which cover some 80 percent of
the global area of GM crops grown, are likely to be contaminated with
toxic levels of glyphosate and Roundup (Monsanto's formulation)
herbicide and metabolites. Seralini's research team has found that
glyphosate is indeed highly toxic to human placental cells and embryonic
cells, and Roundup even more so [46, 47] ( Glyphosate Toxic & Roundup
Worse , SiS 26), while other researchers have shown that the herbicide
is lethal to frogs [48] ( Roundup Kills Frogs , SiS 26).
The most notorious case is Monsanto's study on MON 863 maize with
insecticide Cry3Bb1, where many adverse effects were found [9], but
Monsanto and EFSA both dismissed the effects as “biologically
insignificant.” Monsanto, supported by EFSA, kept the study from the
public domain under a bogus claim of confidential business information.
It was only after a German court order a year later that Monsanto was
forced to release the full report including the raw data. Preliminary
analysis by Seralini and colleagues revealed serious flaws in the study
at every stage, from experimental design, to data collection, analysis,
and reporting [49]. The GM fed group was compared, not just to the group
fed the non-GM isogenic line (from which the GM line was derived), but
also to five more ‘control' groups fed other non-GM varieties. This had
the effect of increasing the range of variation and making the treatment
group of animals too small, thereby considerably decreasing the
sensitivity of the trial. The researchers then used the wrong
statistical tests on the results, and despite having compared many
variables, failed to use the correct standard statistical tools that
analysed multiple variables at the same time. Instead, they compared one
variable at a time, and failed to note significant trends in body weight
differences between experimental and control animals. Statistically
significant differences that nevertheless turned up were then all
dismissed as biologically insignificant; and the EFSA agreed and gave it
a ‘positive opinion'. It is an absolute travesty that the health of
people and planet is hanging on such gross distortion and corruption of
science, aided and abetted by our regulators.
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