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
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  ( 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) , 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.
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),.
Potential Hazards of GMOs
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  ( 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 , 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  ( 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 , 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.
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 , 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  ( 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 .
Meanwhile the biotech industry is hyping the ‘success' of GM crops as opposition heightens worldwide  ( 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.
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 . It is “taken into account” in the European Directive (2001/18/EC) for deliberate release into the environment of GMOs 
The European Commission (EC) published a Communication on the precautionary principle in 2000  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”  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.”  ( 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 .
A search for ‘precautionary principle' on the FSA website gave no result. But a document entitled The Food Standards Agency's Approach to Risk  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  ( 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 .
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 . 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 , having failing to cite Ermakova's findings , 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 ; 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  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  ( 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 , 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 . 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.
The UK FSA website contains the following description of genetic modification under “GM food” :
“But whereas traditional methods involve mixing thousands of genes, genetic modification allows just one individual gene, or a small number of genes, to be inserted into a plant, animal or micro-organism (such as bacteria), to change it in a pre-determined way. Through genetic modification, genes can also be 'switched' on or off to change the way a plant or animal develops.”
The description implies a level of precision and control in the process of genetic modification that flies in the face of extensive evidence indicating that the very opposite is the case, especially for plants and animals. One can easily mistake the FSA for an agency promoting GM food.
It is now generally accepted by genetic engineering scientists that the genetic modification process is uncontrollable, unreliable and unpredictable, and far from precise . It damages the natural genetic material of the organism, resulting in many unpredictable, unintended effects in the few “successes”, including gross abnormalities that you can see, and metabolic changes that you can't [14-16].
A transgenic line is essentially derived from a single cell that has taken up and integrated the transgenic DNA into its genome, so the properties of the transgenic line will depend on where and in what form in the genome the insert(s) landed, and the collateral damages done to the genome, which will differ from one event to another. That is why the EU directive  requires event-specific characterization of the transgenic insert(s), which also provides a method for detecting transgenic contamination of GM produce, an increasingly frequent occurrence involving transgenic lines that have not even been approved for commercial release.
And when that happens, as with the recent GM rice contamination, regulators come to the rescue on both sides of the Atlantic. The USDA proposed to deregulate the illegal rice to make it effectively legal, considering it as safe as a ‘similar' variety that has been approved  ( USDA Poised to Deregulate Illegal GM Rice , SiS 32), thus making a mockery of event-specific characterisation required by European law. The EFSA, while admitting that the available data were “not sufficient to allow the safety of LLRICE601 to be assessed”, nevertheless considered that “the consumption of imported long grain rice containing trace levels of LLRICE 601 is not likely to pose an imminent safety concern to humans or animal”  ( GM Rice Contamination How Regulators Tried to Sidestep the Law , SiS 32).
UK's FSA and ACNFP were even more obliging. Based on an incomplete dossier supplied by the offending company Bayer CropScience, with a lot of information withheld under confidential business information as usual, they consulted two scientists, who also decided there was no “imminent” safety concern (note the qualifier “imminent”). But while the EU had decided to ban US long grain rice, the FSA told retailers in a memo later leaked to the press that there was no need to check whether any of the rice they were selling were tainted; which was against the law. It was only when Friends of the Earth threatened to take the FSA to court that FSA backed down .
There is yet another way in which our regulators have seriously sidestepped, if not broken the law. The EU Directive for deliberate release not only requires event-specific characterisation of the transgenic line in terms of the where and in what form in the genome the foreign insert or inserts may have landed, it also requires evidence of genetic stability of the insert (s) [31, p.30].
For years, I have warned that the transgenic lines were unstable, not only functionally in the silencing of the transgene in later generations, but also structurally in that the GM inserts are structurally unstable, and tend to break, rearrange, or insert elsewhere in the genome, which would effectively transform the transgenic line into something else that could be unsafe, as well as make it impossible to identify and trace the transgenic line  ( GM Food & Feed Not Fit for "Man or Beast" , ISIS Briefing). It would also make the transgenic line illegal in European law.
And yet, when it was discovered that the GM inserts of five out of five commercially approved transgenic varieties had rearranged since characterised by the company, a clear sign of genetic instability  ( Transgenic Lines Proven Unstable , SiS 20), and the illegality pointed out to the EFSA  ( Unstable Transgenic Lines Illegal , SiS 21), neither the EFSA nor the European Commission had seen fit to withdraw commercial approval from those transgenic lines.
We do not know how many other transgenic lines have proven unstable that continue to be given positive opinion and approval for the market. The lack of transparency, and the increasing tendency to misuse business confidentiality has kept information crucial for risk assessment and risk management out of the public domain.
Former UK Minister for the Environment Michael Meacher told a public conference on Science, Medicine and the Law in the strongest terms that we need independent science and scientists who take the precautionary principle seriously, and that sweeping changes are needed in science funding and scientific advice to the government  ( Which Science or Scientists Can You Trust? , SiS 26). This applies all the more so to the regulatory agencies entrusted with the task of protecting the environment, human, animal and plant health, in which they have singularly failed so far.
Article first published 02/02/07
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