India: Genetic Engineering - Petition Accuses Govenment Over Biosafety Testing

Public Interest Petition For a Moratorium ON THE RELEASE OF GMOs Into the Indian Environment And The Need For Biosafety Testing

New Delhi, May 12:

If ever there was a subject that was more critical to life and living, it is genetically modified organisms or GMOs. There is a significant degree of opaqueness about what these are and their implications for us, in terms of the food we eat, our health choices, farmers’ rights, and our environment. Instead of protecting the national interest, the regulatory authorities comprising the Department of Biotechnology and the Genetic Engineering Approval Committee (GEAC) of the government are brazenly subverting the democratic process and are determined to promote GE technology and the commercial interest of the biotech industry. Exposing the unaware population to serious risks that cannot be undone, the government therefore stands accused of unconscionable offences against the Indian people.

The draft National Biotechnology Development Strategy of the Department of Biotechnology recently made public underscores and confirms this conclusion.

The joint petition before the Supreme Court indicts the Government of India for the declared intentions of the proposed policy which: “Mortgages the public interest, public safety and the environment, to the commercial interests of Biotech Corporations “.

1. Genetic Engineering or Recombinant DNA technology presents unique risks to human health, animal health and to the environment and these risks are inherent in the technology. The technology involves recombining DNA that is often from different organisms, e.g. plant to animal, animal to plant and inserting them into the genomes of target organisms to make GMOs. Genetically modified organisms are unnatural, not just because they have been produced in the laboratory, but because they can only be made in the laboratory, creating organisms and in ways that have never existed in the course of 3.8 billion years of evolution. These mainly untested and potentially hazardous GM crops are now spreading all over the world, creating irreversible risks for the environment. Scientists concede that with GE we are moving from science to applied technology and the science of GE has not kept pace with the technology. This technology is powerful, crude but powerful, but the scientific ignorance of it is huge. Scientists do not understand the mechanisms of GE-induced changes in gene expression in sufficient detail. They do not know what to look for and these things are termed ‘unintended effects’. Unintended effects are common in all cases where GE techniques are used. So on a whole range of issues, a great deal of research is required before they can predict an outcome. Yet, it is being used to irrevocably change the fundamental molecular structure of the world’s food supply and impact the biodiversity through un-recallable, self-replicating organisms. Independent scientists from all over the world have gone on record to say that GE crops and foods raise outstanding safety concerns and there should be a global moratorium on the release of these GMOs into the environment. In our petition, world-renowned scientists have provided evidence of the kind of potential hazards GE presents.

2. India doesn’t have to reinvent the wheel. Sense and commonsense should help us to avoid this route because it is too dangerous to go down that road. There have been 10 years of commercialisation of this technology in the US and Canada and more recently in Argentina. There is plenty of evidence that has emerged from these countries of the serious hazards associated with this technology despite the significant hindrances to the emergence of these facts: independent scientists have been threatened, gagged or fired; regulatory authorities round the world have been compromised. In India, as the media knows, Monsanto has doctored reports on Bt cotton. It is a story of skulduggery, dodgy science and shaky ethics. It is all there in the evidence before the Supreme Court.

3. It is a proven fact, no longer under dispute that ‘transgenic’ contamination, which is the contamination of the environment by transgenic DNA, is a certainty. It is bound to occur once these GMOs are let out, like the proverbial genie in the bottle. This particular genie however is not about to spread light and goodness all round; quite the reverse. Thus India must get it right the first time, because genetic manipulations are essentially irreversible. Doesn’t this call for the most extreme caution from our government? Doesn’t it need utmost care and precaution on the health front and therefore the sound application of the precautionary principle? Instead we find an unholy rush by the government to open every door to welcome this risky technology. Why? Let us look at some more facts.

4. The reason why transgenic contamination is such a huge issue is precisely because the potential hazards associated with this technology are so serious. Dr. Arpad Pusztai is a leading nutrition scientist and toxicologist, who is even requested by the biotech companies to assess their ‘creations’, of course after having to sign an agreement of confidentiality. He has also given evidence for us and in a prepared statement to the Supreme Court where he says:

“No comprehensive health and environmental risk assessment has been carried out with Bt cotton and even less published in peer-reviewed science journals. With a potentially toxic crop whose anti-nutrients, (toxins such as gossypol, cyclopropenoid fatty acids or the potent carcinogenic aflatoxins, are well-known to accumulate in the subcutaneous fatty tissues of consumers---. In the absence of conclusive evidence for the lack of toxicity, responsible GM regulatory authorities must prevent the cultivation, commercialisation and food use of GM cotton and its products”.

Yet, look at the unsavoury manner of the approvals of GM cotton (Bt) in India and the large efforts of the GEAC on behalf of the biotech industry to further the prospects of Bt cotton. Let’s first of all, look at the States in which approvals were granted. They are the milk-producing heartlands of India. -- Two quick questions. What happens to the seed stock of cottonseed, because of the mixing that has occurred, since there was absolutely no attempt made to have a mechanism in place to segregate GM from non-GM cottonseed? And secondly, do we not know that cottonseed is not just a very important source of animal feed, it is expressly given to milk cattle by our dairy farmers to increase the fat content of milk? So the sloppy, couldn’t-care-less regulatory departments of the Government are risking the contamination of our milk supply in these States, mainly Gujarat, Madhya Pradesh and Punjab. The implications for the young, the old, especially infants are especially grave, but also for animal health. Let’s just stop and think about it. This is what the UK Ministries of Agriculture Fisheries and Food (MAFF), has to say on the subject of GM contamination of animal feed.

“In view of the potential health impacts due to the secondary horizontal transfer of transgenic DNA on livestock and human beings, all current animal feed should be withdrawn immediately. Steps should be taken to ensure that no GM material is fed to animals directly or incorporated into commercial animal feed”.

5. One of the most insidious ‘unintended’ effects of GE is Horizontal Gene Transfer (HGT). The above comments with regard to the potential GM contamination of animal feed and how it can have an impact on milk, and products made from milk, is an apt and good example of HGT. It happens when genetic material moves between organisms, which is asynchronous with the process of reproduction of the organisms; so genes can also be transferred between distant species that would never interbreed in nature. For example, human genes are transferred into rice and those from pig, sheep, fish and bacteria are transferred into plants. Thereafter, unintended HGT can take place from GE crops released into the environment. The Petition deals with serious examples of this secondary HGT as it is sometimes called. The grave implications and risks of HGT, for the whole stream of life, don’t require a Ph.D in science to be understood. They include: new strains of antibiotic resistant bacteria, new viruses and bacteria arising from those introduced into the transgenic plants, random secondary insertion into other unrelated organisms, causing harmful effects including cancer, reactivation of dormant viruses etc. For these reasons, concerns with HGT make the technology of GE highly unpredictable and also extremely dangerous and put in doubt the safety of the GE process itself.

6. The Food and Drug Administration of the United States (FDA) was under a Whitehouse directive to” foster” the commercialisation of the Biotech industry, ‘spinning’ it into a multibillion $ patent-based industry for the US. It should be a matter of great concern to us in India, that contrary to what is generally believed, the FDA‘s review process means that it has not approved a single GM food as safe for human consumption. An impression has been fostered in the minds of people that GM crops are safe and in fact offer a technological solution to food shortages. This impression has been created because of the extensive use of GM foods in the US; that these foods are safe and must have passed the normally stringent approval processes of the US regulatory authorities that govern the release of food additives, drugs and pharmaceuticals. Nothing could be further from the truth. Its clearance of GE foods was manoeuvred under GRAS status (Generally Recognised As Safe), and therefore, no testing is required. This amounts to a scientific sleight of hand clearance for GE foods. If the FDA had not “approved” GE foods and crops then no other country would have, including India.

7. By now the evidence is in, without any ambiguity, of super pests and super weeds because of resistance, as a direct result of GE technology. And, it is growing. Scientists always knew that resistance would happen. It isn’t as though this phenomenon is new to us. The US is set to take the number 1 spot for herbicide resistant GM crops and India, has been warned that pest resistance is already evident in those States that are growing Bt cotton. So this particular myth and spin as well, of the biotech corporations, has been demolished, that GM crops would offer farmers a significant advantage in managing weeds and pests. On the contrary, GE by definition impedes the transition to integrated pest management; It is a noxious technology on the farm, that hurts farmers financially, especially Indian farming. It traps farmers on to a treadmill of increasing herbicide and pesticide use. These herbicides are known metabolic poisons, harmful for human and animal health and the environment.

8. In the US and Canada, after 10 years of commercialisation the whole commodity system is contaminated. It is important to understand the implications of this for US trade and India’s opportunity to respond to a market that hungers for Non-GM food and also, feed for animals. The US has consistently blocked laws for labelling, both within the US and in other countries. World wide, including in the US, people do not want to eat GM food and labelling would give them the choice to reject such foods. What would this do to US exports? Let’s be very clear about this: it is not in the USA’s trading interest to encourage labelling of GM foods. It is seeking to force an acceptance of GM foods on world markets by entirely removing consumer choice, through a fait accompli situation in which other countries and now especially India, may find that their farms and products are equally contaminated by GM content. It must be noted that for the US, ‘re-tooling’ its commodity grain and oil-seed infrastructure to enable segregation of uncontaminated products would be at the very least prohibitively expensive, if not impossible. For India, the GM fiasco is providing an unmatched opportunity to respond to a spiralling demand for organic produce and non-GM conventional farm products. We are indeed puzzled. Whose interests is the Government upholding and supporting?

9. India’s policy on GE is deeply flawed both in logic and in science. Furthermore, the Government is under an obligation to look at issues that extend far beyond science and technology. Science should not control us: It should be at our service “on tap, not on top”. These issues include vitally, India’s agriculture, which will be unravelled by GE, affecting the livelihoods of hundreds of millions of farmers, the food security of our country and our biodiversity. In India, we have some of the few surviving ecological hotspots that exist in the world. The American farming experience now, and more poignantly, Argentina clearly demonstrates the unleashing power of the multi-national biotech industry and the stranglehold it is exercising on agriculture. Anyone who believes, that the biotech industry exists for the public good, is living on another planet. This is sheer nonsense. It would seem that many of our Ministers and government servants have taken up residence on some other planet.

Aruna Rodrigues, (Mhow)
Devinder Sharma, (Delhi)

On behalf of the co-petitioners,

PV Satheesh,
(Deccan Development Society, Hyderabad)
Rajeev Baruah
(Maikal bioRe, Mhow)

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Update April 2006: Rejoinder affidavit filed in court. Some of the things discussed by Aruna Rodrigues in this affidavit:

The fact that GMOs in the US have received a blanket GRAS status (meaning that all GMOs in the US are automatically accepted as "Generally Recognized as Safe"), on the strength of a concept, which is the idea that GMO varieties are "substantially equivalent" to natural ones. This of course is equivalent to closing both eyes to the fact that the changes introduced by gene splicing are largely unpredictable.

Transgenic cotton is potentially poisonous. Cotton is used not only for its fiber but the seeds make oil consumed by humans and cottonseed cake which is used as animal feed. As an aside (not part of the affidavit, but interesting in this context), look at this recent report by the Institute for Science in Society: Mass Deaths in Sheep Grazing on Bt Cotton

The recent disastrous drug trial in the UK, involving a genetically modified (monoclonal antibody) drug is cited as one of the reasons why we must approach genetic modification with extreme caution. See also: Six In London Hospital After GE-Drug Trial

The justification for BT (bacillus thuringiensis) corn and cotton, the major transgenic crops, to be considered safe, apparently is the argument - strange as it might seem - that BT toxin has been used successfully and for a long time as a pesticide. ("It's been on the market for years - no need to test it"...)

A report from Dr. Arpad Pusztai and Susan Bardocz is cited, which states that �most GM and parent line crops fall short of the definition of substantial equivalence�, and concludes that "the safety of GM foods rests more on, trusting the assurances given by the biotechnology industry than on rigorous and independently verified risk assessment�.

... with regard to the growing criticism of EFSA, (European Food Safety Authority), as a deeply compromised watchdog of food safety, several of the EU's 25 environment ministers at their last meeting in March, accused EFSA of failing to take independent and national studies into account for its GMO risk assessments and of not allowing proper access to its research:

"There are questions like whether scientific opinions rendered by EFSA have relied exclusively on information provided by companies that look at short-term effects�, and "EFSA cannot give a sound scientific opinion on long-term effects of GMOs. There are also questions on whether GMO companies are providing the right information to the European Commission�.

Horizontal gene transfer is an "unintended side effect" of the release of genetically modified crops into the environment. The altered genes transfer from GMO crop to wild or "normal" crop plants. "...genes can also be transferred between distant species that would never interbreed in nature."

Monsanto is said to have lied about the equivalence of their modified soy to the traditional plants, by simply deleting the contrary information from their published study (1996). They report increases in yield from BT cotton, while the farmers "on the ground" see smaller yields.

The most common allergen in soy is called trypsin inhibitor. GM soy contains significantly more of this compared with natural soy. The British Medical Association had warned that GM foods might lead to the emergence of new allergies.

... wild rape or Charlock in the UK being contaminated by GM rape reinforces ... the seriousness of the issue of contamination. Thus secret open field trials of rape and other foods in undisclosed and un-known locations, emphasise the extreme urgency for remedial action if the food chain is to be protected from GM contamination and potential biosafety hazards.

From examination of a report on a Monsanto BT Corn variety: �Mon 863 feeding study in 3 parts by AP�. "... rats fed Mon 863 developed several reactions, including those typically found with allergies (increased basophils), in response to infections, toxins and various diseases including cancer (increased lymphocytes and white blood cells), and in the presence of anaemia (decreased reticulocyte count) and blood pressure problems (decreased kidney weights). There were also increased blood sugar levels, kidney inflammation, liver and kidney lesions, and other changes."

A peer-reviewed study by Dr. Irina Ermakova, a biologist at the Institute of Higher Nervous Activity and Neurophysiology of the Russian Academy of Sciences showed that when female rats were fed Roundup Ready genetically engineered soy flour before and during pregnancy, and during lactation an astounding 55.6% of the offspring died within three weeks, compared to only 9% from the group whose mothers consumed non-genetically engineered soy flour.

An Australian project to develop genetically modified peas with built-in pest-resistance has been abandoned after 10 years, when tests showed they caused allergic lung damage in mice. It was determined that the results were too dangerous to continue with the project.

Depressing picture

The depressing picture that emerges from this court filing and the brief quotes above is that Monsanto and other GE multinationals are running circles around the national regulators that are supposed to keep our food supply healthy and our environment clean and protected.

We can only hope that actions like this one in India and others around the world will force the legislators and regulators will be made to take a hard look at what is happening and act to curb a technology that has obviously become a killing machine with the potential to wipe out more than a just butterflies.

The relief asked of the Indian Supreme Court is that imports should be certified GMO free, and that the release of any GMO into the environment should be suspended subject to proper bio-safety tests.

Too much to ask? I should say no - those things should have been required long ago.

Read the whole court filing (Rejoinder Affidavit) to the Indian Supreme Court...

See also related:

Agriculture: Chemicals GMO Failing - Try Organic, Sustainable

GM Watch Org

Monsanto's cotton has deficiencies: study

GM Foods: Endangering India's Health

Organic farming to boost Punjab�s kharif season
NEW DELHI, JUNE 5: �Organic farming, particularly in cotton, in Punjab is set to get a boost in the ensuing kharif (summer) season. A local NGO, Kheti Virasat Mission has conducted several orientation camps amongst farmers, convincing them about the efficacy of organic farming...

Film: The Future of Food
"The Future of Food provides an excellent overview of the key questions raised by consumers as they become aware of GM foods... [The film] draws questions to critical attention about food production that need more public debate."