|Supreme Court moves against reckless trials in India (1/8/2006)|
EXCERPTS: This biosafety study [on Bt brinjal (eggplant)] is nothing more than an ill-conceived PR exercise by Mahyco [Monsanto's Indian subsidiary], masquerading as a scientific document, with little supporting data to verify the claims.
There is an outcry by leading international scientists, (many of whom have provided affidavits for the Court), who are aghast at the new depths being plumbed and allowed by the Indian Regulator, of abysmal standards in so-called biosafety studies, not yet observed elsewhere. The repercussions of the Regulator's releases of GM foods in India will be global.
Dr. Arpad Pusztai, the world renowned toxicologist and leading expert in protein lectins... said that in all these years of scrutinising industry studies, (and most of these have passed through his hands), he has never seen anything quite like this.
Prof. David Schubert of the prestigious Salk Institute says, the safety testing data on the Ministry (GEAC) website is "very poorly done and in the absence of REAL DATA it is impossible to make any assessment of the validity of their claims".
Dr. Doug Gurian Sherman, Senior Scientist at the Centre For Food Safety [and a former EPA scientist] concurs. Dr. Robert Mann formerly senior lecturer in biochemistry at the University of Auckland and Advisor to successive Ministries of Health in NZ, says, "I regard the 'Bt'-brinjal field-trial proposal as one of the most ill-conceived I have encountered in my three decades of critical appraisal of GM. The risks and hazards, while not exactly known or indeed precisely foreseeable, appear to be so grave that the proposed field-trials should be enjoined pending a thorough assessment such as has yet to be performed."
Genetic engineering if allowed to proceed unchecked will change the molecular structure of the world's food. In India, if the GEAC's reckless rush into GM foods is not checked, this process will be the fastest and riskiest experiment anywhere, with irreversible impacts on our farmers, their crop choices, our food and health, our wild places and our countryside.
Truly we need sense and it would appear, an uncommon sense: sound science must prevail in the debate over GE to ensure the safety of consumers and the environment. It truly presents the gravest global threat alongside 'climate change'.
THE INTENDED APPROVAL OF BT BRINJAL BY THE GEAC PROMPTS AN URGENT APPEAL IN THE SUPREME COURT
In continuation of the PIL [Public Interest Litigation] filed in July 2005 in the Supreme Court for a moratorium pending a comprehensive biosafety protocol, this is an emergency response by the Petitioners, in view of the intended plans by the Union of India to subject India to the riskiest experiment faced anywhere in the world and at a pace which will contaminate our food supply and food chain within months. This is the most serious challenge that India faces. We must succeed in reigning in the Government and its Regulator, the GEAC, for the profoundly serious reason that transgenic contamination means, CONTAMINATION AT THE MOLECULAR LEVEL OF OUR FOOD AND ENVIRONMENT FOR ALL TIME. The Indian nation has been put on notice by the GEAC that it intends to give Mahyco (Monsanto Partner and Indian Collaborator) permission for large-scale field trials of Bt brinjal, preliminary to its commercialisation. In the meanwhile we have also learnt that limited field trials have been carried out all over the country on every conceivable food crop including rice, an array of vegetables, and oilseeds. The Regulator plans to give staged approvals for these for large-scale field trials and their eventual commercialisation, on an unprecedented and short timescale. And as if this were not enough, it also intends to change the basis of approvals, to quite simply make them easier, to an Event-based system, (as opposed to a case-by-case basis see below), a uniquely irresponsible and unscientific departure not yet a part of any approval process internationally, for GM.
The urgency of this Application in the Supreme Court which was filed today, is guided by the fact that if the Court refuses to step in and apply the Precautionary Principle at this point in time, then the situation will be so serious with regard to the irrevocable contamination of India that the PIL will be rendered infructuous. The Petitioners have therefore prayed the following:
(i) Direct the Respondents to stop all field trials, for all GM products anywhere and everywhere in the country with immediate effect;
(ii) Direct Respondents to institute a autonomous panel of Independent scientific and credible experts mandated to protect public health and the environment, as an ombudsman, to oversee GM biosafety and GM policy;
(iii) Direct the Respondents that environmental releases of GMOs will not be permitted till each GMO to be released is cleared by such a panel as above, of independent scientific and credible experts, having first been subjected to a comprehensive, rigorous biosafety test protocol in the public domain as prayed for in the WP
Mahyco has also been bold enough to file for a patent for this important vegetable, a major presence on every table in the country, most so the poor, urban and rural. This clearly demonstrates an unwavering eye for commercial advantage. It is also clear that the concerns with GE and its handling in India have reached such a crisis that it can no longer be entrusted to a Regulator that is betraying the national trust. Encouraged by its power and ability to disregard all dissent based on farmer-feedback on the failure of Bt cotton and the increasing incidence of health hazards, it is now emboldened to pursue a major phase 2 thrust into Bt Foods, as opposed to animal feed, in support of the biotech agenda and the American Indo-US Agricultural Initiative. The evidence before the SC shows the involvement of USAID in the development of GM crops and Bt brinjal in India.
It is completely unacceptable that public policy with regard to the unique risks of genetic engineering is based on the crop developers (Mahyco) studies and assurance, termed by the Regulators as biosafety studies. As a matter of principle, which must be upheld for rigorous, independent and honest science, such a bias is indefensible and invalidates the test protocol, which must now be held to be void. The crop developer cannot be expected to prove that his own crop is allergenic and unsafe. This biosafety study is nothing more than an ill-conceived PR exercise by Mahyco, masquerading as a scientific document, with little supporting data to verify the claims.
There is an outcry by leading international scientists, (many of whom have provided affidavits for the Court), who are aghast at the new depths being plumbed and allowed by the Indian Regulator, of abysmal standards in so-called biosafety studies, not yet observed elsewhere. The repercussions of the Regulators releases of GM foods in India will be global. Dr. Arpad Pusztai, the world renowned toxicologist and leading expert in protein lectins in a telephone conversation with Petitioner No 1, Aruna Rodrigues, said that in all these years of scrutinising industry studies, (and most of these have passed through his hands), he has never seen anything quite like this. Prof. David Schubert of the prestigious Salk Institute says, the safety testing data on the Ministry (GEAC) website is "very poorly done and in the absence of REAL DATA it is impossible to make any assessment of the validity of their claims". Dr. Doug Gurian Sherman, Senior Scientist at the Centre For Food Safety concurs. Dr. Robert Mann formerly senior lecturer in biochemistry at the University of Auckland and Advisor to successive Ministrys of Health in NZ, says, "I regard the 'Bt'-brinjal field-trial proposal as one of the most ill-conceived I have encountered in my three decades of critical appraisal of GM. The risks and hazards, while not exactly known or indeed precisely foreseeable, appear to be so grave that the proposed field-trials should be enjoined pending a thorough assessment such as has yet to be performed."
While various Bt toxins have been incorporated into GE corn and cotton for animal feed, it has NEVER BEFORE BEEN EXPRESSED IN A VEGETABLE CROP FOR COMMERCIAL PRODUCTION ANYWHERE. Bt brinjal in India if approved, will be the FIRST internationally, widely grown vegetable/food product with a Bt toxin. It is a major source of calories in India, because of its fat content, it is widespread, is part of the diet of most Indians, is eaten in significant quantities and while cooked, there is less processing, and therefore more hazardous. In Ayurvedha preparations, it is eaten raw, where the purity of the product is critical.
Broadly, there are at least 5 major concerns about the safety of Bt Brinjal and why it would be a grave mistake to introduce Bt brinjal in India:
i. Its hazardous potential for effecting human health: GM FOODS HAVE NOT BEEN SAFETY TESTED ANYWHERE, LEAST OF ALL BT FOOD CROPS AND VEGETABLES. Bt crops are toxic. No toxicology testing has ever been done. Furthermore, serious limitations of current allergy-testing procedures for GMO proteins, is widely recognised. For example, the recent case in Australia, revealed that a protein previously consumed safely in beans had become immunogenic (allergic reaction), when engineered into GMO peas. In other words when the transgenic DNA from a GM plant/food is taken up, integrated and expressed in vertebrate organisms, like the alpha-amylase inhibitor gene from beans, when expressed in peas they exhibited altered functions and allergenic properties. Other forms of unintended effects are possible which would confer unanticipated activities to cry genes (Bt proteins like in Bt cotton). It took 10 years to discover the bean altered effect in peas and the tests were abandoned. The immunogenicity of the GMO peas would not have been detected by currently used tests - the tests that revealed the problem are not currently part of required protocols for any regulatory agency. This means that new allergy tests and careful long-term tests are needed to assure the safety of all Bt crops and particularly food crops like Bt brinjal. It also demonstrates unequivocally, the problems that emerge with the process of genetic engineering, that they are intrinsic to the technology.
"GE crops present unique and irreversible risks, no new GM crops should be allowed to be cultivated, commercially traded or incorporated into human food or animal feeds without the minimum required testing methods referred to." (Dr A Pusztai)
ii. It will certainly contaminate the many varieties of brinjal currently grown in India as well as its wild relatives: the implications of the introduction of Bt Brinjal in India are extremely serious as India is a centre of origin and domestication of brinjal. Because Brinjal originated in India, there are many varieties of both wild, such as Solanum Incanum, and cultivated plants. Therefore it is likely that the Bt gene will be transferred from the crop to those wild relatives. If the gene confers an advantage to the wild plants, it will spread in those plants and cause possible harm. "This is a very different risk than for the crop itself, since most crops, unlike their wild relatives, cannot survive without cultivation" (Doug G-Sherman) When risk assessments were done in the US and EU for these crops, no evaluations of possible impacts on centres of origin were even conducted. These questions were never ever considered.
Farmers in traditional agriculture as in India play a markedly different role from farmers in industrial agriculture whose role is limited to the production of crops. In traditional agriculture, farmers play a role in conservation, development of new cultivars, actively maintaining crop landraces (domesticated from wild varieties). Since transgenic crops have the potential to reduce genetic diversity, Bt brinjal varieties could displace local brinjal landraces that hold genetic diversity important to local farmers and the world, as sources of important traits. Once GM brinjal is cultivated on a large scale these tremendously important sources of genetic diversity will be lost forever due to transgenic contamination. The genetic diversity is important because some of the strains will be naturally resistant to lethal pathogens, which would be fatal to crops in the future. Once lost, this lack of diversity can lead to the complete loss of the crop. The most recent example is the demise of the banana due to the loss of fungus resistant wild relatives. It is to be expected that like any new technology, (microwaves, mobiles for example) farmers will experiment with GE crops, especially in India, where the government, sarkari, endorsement through approval carries great weight that the transgenic seed is indeed better than their own, when in fact it is not.
iii. Potential environmental harm from the Bt Cry1Ac gene: Bt crops are not sufficiently selective and specific for pests and by inflicting damage to beneficial insects they destroy the natural balance between pests and useful organisms. Environments in centres of domestication are quite different from those where GE crops are grown. Both pests and non-target organisms are different. If the gene spreads in wild relatives of brinjal, its escape into the environment will likely be permanent. The toxin produced by the gene may then kill insects that feed on the wild plants. These insects, in turn provide food for other organisms such as birds and mammals, which may then suffer harm.
iv. It will evoke dissemination of mutant insects resistant to Bacillus thuringiensis: the natural bacterium B. t. is very important in advanced organic agriculture, so insects resistant to this pesticide would be a serious threat to many types of agriculture on which a country such as India inevitably & rightly relies.
v. It will eliminate a current and potential export market once it is known that it is a GM product that is being sold. In the US, farmers rejected GM wheat (HT, herbicide tolerant) for this reason and it is not grown in that country. Within India, non-GM farms including organic farms will be contaminated. This will be largely surreptitious and therefore un-known, will not be labelled and will therefore affect both farmers rights and consumers and their food and health choices.
The GEAC Changes to Event-based System
There is no scientific evidence published or otherwise to show that event-based regulation is scientific and therefore acceptable. Quite the contrary, evidence shows that "splicing the same transgene into different crops can lead to different unforeseen and unpredictable consequences" known as 'unintended effects', an accepted euphemism for scientific ignorance: totally "un-predicable changes unrelated to the nature of the transgene can occur, because of the complexity of interactions between genes, as well as the more obvious problems of gene disruption by insertion of the transgene itself". Furthermore, the bean-pea experiment described above "formally proves that the assumptions underlying the 'event based' approval process are fundamentally wrong" (Prof David Schubert).
Prompt toxicity of a GM product might be rapidly detected once the product entered the marketplace if it caused a unique disease, and if the food were labelled for traceability, as were the GM batches of tryptophan, the famous case of a GM food supplement, amino acid, which killed hundreds of Americans. HOWEVER, CANCER OR OTHER COMMON DISEASES WITH DELAYED ONSET WOULD TAKE DECADES TO DETECT, AND MIGHT NEVER BE TRACED TO THEIR CAUSE.
The Prayer to the SC for a Status Quo: The Writ Petition may not be made infructuous It is abundantly clear that the GEAC is quite lacking in commitment to the methods involved in the serious business of test protocols, in their design, their processes, execution and independence, or the critical need for "sceptical analyses" of GM proposals to assess their hazards. All of these are conspicuous by their absence in the Bt brinjal study. Instead, the Regulator is resorting to tweaking the Mahyco study here and there, as if it can be strained of weaknesses. The GEACs regulatory performance is a sad commentary on Indian regulation. The attempt to pass off the Mahyco-sponsored Bt brinjal testing as legitimate biosafety tests is a new low in Indian standards and integrity. Furthermore, the insidious move to event-based regulation is unparalleled anywhere. At best, the Regulator may be accused of ignorance in which case it stands disqualified to carry out its mandate under the EPA.
It has also become clear that civil society cannot reign in a Regulator that is malfunctioning with intent and deliberation. We just do not have the resources, the expertise and experience to do so. IT WOULD THEREFORE BE EXTREMELY UNWISE FOR THESE REASONS TO RISK THE NATIONS BIOSAFETY AND SOVEREIGN INTERESTS. Furthermore, the GEAC has no credibility left in the eyes of civil society. Thus, it has become both necessary and urgent to institute the office of an Ombudsman, autonomous, independent, free of government interference, or the presence of bureaucrats in its management: WITH THE SPECIFIC MANDATE TO PROTECT INDIAS BIOSAFETY, STARTING AS A FIRST ORDER OF PRIORITY WITH ASSESSING THE UNIQUE RISKS POSED BY GE AND ITS IMPACTS. SUCH A WATCHDOG WILL OVERSEE THE WORK OF THE GOVERNMENT REGULATOR IN WHATEVER FORM. A panel of independent scientists of eminence from India and abroad, need to be deployed to work out sound processes for safety testing protocols, who have the experience to fill the current gaps in safety testing procedures and assessment.
It is of profound concern that a regulator and a department of government can abuse its powers by subverting democratic processes to such an degree, that it is able to subject India to the incalculable consequences of its hubris and extreme folly for evermore, in perpetuity, impacting the many dimensions of the problem in India, and globally, presented by the unique risks of genetic engineering and GM crops.
There are two major and far reaching crises facing mankind. The first is undoubtedly climate change. The second is the profound truth that the unique risks of GE and GM crops have potential impacts of many magnitudes that are still not understood and would affect our world in ways unimaginable. Arguably, it stands with climate change as two of the most serious crises to be challenged and overcome; However, its threats (GE) are not perceived or recognised by peoples, because it is still a new technology and is being subjected to the same spin and swift boating as climate change was for years and indeed still is, with the support of the White House. We are only now waking up to the realisation of the fallout of this immense folly. The interventions required globally for reductions in CO2 emissions to be effected by national governments are both complex and structural. On the other hand, with GM crops, the intervention necessary is still remarkably simple, within the powers of National Governments, given the political will, honesty to recognise the risks and ability to withstand US pressure. Not all African Nations are capitulating to this inordinate pressure. Furthermore, the scope for correction and redemption that lies within the powers of the Indian justice system makes the possibility of such an intervention, timely, effective and full of hope. It is the Petitioners case that this Writ Petition cannot be allowed to fall by the way side because of the utter irresponsibility and recklessness of a Regulator-turned-approver of GM. Approvals have already been given for an astonishing array of 91 field trials. This is of the greatest concern. The timescale during which the Regulator plans approvals for large-scale field trials of Bt brinjal is in August 2006 with further plans for other crops later in the year. Therefore, time is of the essence for remedial action. Based on the evidence in this Application and this is the reason for filing it, we are at a crossroads now. In the time that it takes for this Honble Court to be seized of the debate and evidence before it, India will be irreversibly contaminated and this WP will become infructuous. Genetic engineering if allowed to proceed unchecked will change the molecular structure of the worlds food. In India, if the GEACs reckless rush into GM foods is not checked, this process will be the fastest and riskiest experiment anywhere, with irreversible impacts on our farmers, their crop choices, our food and health, our wild places and our countryside. Truly we need sense and it would appear, an uncommon sense: sound science must prevail in the debate over GE to ensure the safety of consumers and the environment. It truly presents the gravest global threat alongside ‘climate change’.