Sunday, June 15, 2003

DOES INDIA HAVE A POLICY FOR GM CROPS ?

Suman Sahai

The predominantly agricultural countries of Asia have barely begun to debate the pros and cons of agricultural biotechnology or its relevance to their agricultural and food needs. Information levels are poor and available material is full of scientific and technical jargon that is by and large incomprehensible to most people. Most administrators, policy makers, politicians, legislators, the bar, and the judiciary have very little comprehension of biotechnology, and are either bewildered or overwhelmed by it. Equally, most scientific experts are unaware of public perceptions of risk and safety in the field of agriculture and food production, which are often at variance to their own, more clinical understandings. To add to this, most of the decision-making at the governmental level is ad hoc, influenced neither by sound scientific research nor by genuine consumer concern but by various pressure groups and extraneous factors. A sound public policy framework that takes into account real public concerns is yet to be worked out let alone initiated.

This is since the governments of most Asian countries rarely allow public participation in the decision-making process nor do they explain the basis of their decisions. Since scientists too, by and large, work for the government, regulatory review processes remain secretive with the public having no mechanism by which to understand the rationale of decisions. Demands by civil society to have a dialogue and know more about the decision making process go unheeded. Indeed, the public's demands are seen as illegitimate and hostile by definition. Such a situation breeds suspicion and opposition to biotechnology.

In the prevailing situation, despite the dearth of information, an array of groups are speaking up both for and against biotechnology, making it extremely difficult and challenging for policy makers and administrators to facilitate safe and appropriate technology adoption.

In India, in addition to the poor awareness, no studies have been done that evaluate public understanding and perceptions about biotechnology among the various stakeholders. The recent ISAAA – University of Illinois study (2003) conducted in South East Asia was the first comprehensive study to shed light on the situation in those countries. But the ground reality in the countries of South Asia like India, Pakistan, Bangladesh, Sri Lanka, Nepal and Bhutan, remains largely unknown. At least the first four of the nations mentioned are potential GM nations. India has already cultivated its first commercial transgenic crop (Bt Cotton) amidst a storm of controversy and reports showing field performance to be poor (Frontline June 6, 2003, www.flonnet.com).

The adoption of biotechnology can have far reaching implications for the health and welfare of a country's citizens. There are already serious concerns about the impact of agri-biotechnology on the environment and human and animal health. Yet in India and South Asia, these complex and controversial technologies are being administered by a handful of bureaucrats insensitive to public concerns and lacking the relevant skills and technical competence to assess biotechnology. Equally disconcerting is the fact that academia, and the scientific community (Science Academies) are rarely included in biotechnology policy development.

It is clear that priorities for the development of agricultural biotechnologies must be based on indigenous needs and a thorough needs assessment. Yet most developing countries copy the concepts and structures of regulatory and oversight systems straight from the industrial countries, without any effort to incorporate developing country perspectives and sensitivities. Even the research priorities in agricultural biotechnology are based on what the industrial countries have developed, and very little has been done to evolve an indigenous set of priorities based on the needs of small farmers and local agricultural production systems. Amidst this confusion, a variety of biotechnologies and their products are being considered for commercialisation by regulatory agencies.

The Focus on India

India is an important agricultural country with significant concerns about food security and the livelihoods of millions of small and subsistence farmers. A targeted and informed biotechnology policy can help to solve some of India’s agricultural problems. However, if policy is ad hoc and ill informed, as is the case now, it could end up hurting rather than helping farmers. India can ill afford to be careless or irresponsible in bringing about biotechnology intervention in agricultural development. More so, since Indian decisions are likely to have an impact on the rest of South Asia with respect to the systems they put in place and the decisions they take. If countries in South Asia are on the brink of adopting biotechnology, India has already started the process. The need for transparent and accountable systems is very great otherwise the technology will get mired in controversies to the extent that it could fail to reach those farmers that it has the potential to help.

The Indian Bt cotton case:

In India, the commercial approval granted to Bt cotton, is a good example to demonstrate what can go wrong when ad hoc, ill informed decisions substitute for a sound policy framework.

India permitted commercial release of its first ever GM crop, Bt cotton, in the year 2002-2003. The Bt cotton varieties belonging to Mahyco-Monsanto are reported to have fared poorly in most of the locations where they were grown (Frontline, June 6 2003). The decision to approve these Bt cotton varieties was widely criticised at the time, by civil society groups like Gene Campaign because the varieties were known to be poor performers with respect to yield and would lead to farmer immiseration. But the agencies went ahead, refusing to acknowledge the public’s concerns. Attempts by NGOs to engage the apex regulatory body to address public concerns led to a token dialogue that had no bearing on the ultimate decision.

When the Bt cotton harvest came in, first the government made statements that the harvest was very promising, then it admitted poor performance and has now asked for a state-wise review to assess the reasons for poor performance. On the other hand, Mahyco- Monsanto-continues to present data everywhere showing that their Bt crop has done well by increasing yield by 30%. As all this unfolds, an illegal Bt cotton variety, which was detected over two years ago, continues to be planted season after season making a mockery of the regulatory system’s ability to take any action.

In the absence of credible information and a clear cut policy, some farmer leaders are demanding that there should be no regulation of GM crops and everything should be freely available to farmers. Other farm leaders are virulently opposed to GM crops. Ill informed political leaders have taken positions for and against GM crops. The Agriculture Minister of one state where illegal Bt cotton had to be confiscated declared he would not allow the confiscation. Some farmer’s organisations have set fire to GM crops, others who are pro- GM threatened government regulators when they came to confiscate the illegal Bt cotton seeds. None of the farmer organizations supporting or opposing GM technology can explain their positions.

It is startling to note that the Genetic Engineering Approval Committee (GEAC) of India had approved commercialisation of Bt cotton even though the mandated State Level Committees and District Level Committees (that are required to be put in place to oversee the performance of GM crops in the field), had not been constituted . This kind of violation of the prescribed rules by the regulatory body itself does not inspire public confidence in their ability to regulate biotechnology.

The Indian GM Mustard Case:

In the case of GM mustard, the government first looked like it was going to approve it, and then it suddenly withheld approval. As it stands, GM mustard is neither approved nor rejected and the public has no idea on what basis these decisions are being made, as the process is not transparent and the entire exercise lacks scientific and technical competence.

Friday, June 13, 2003

IS GM POTATO SIX MONTHS AWAY ?

Suman Sahai

There was a startling statement in the press two days ago, that a GM potato variety would be available in India within six months. Curiously, the Genetic Engineering Approval committee (GEAC) has not even received an application to consider approval for the GM potato in question. The chairman of the GEAC has expressed his displeasure at premature pronouncements being made in the press about the release of transgenic crops. His resentment is understandable since it is his turf that is being encroached!

So what is the status of GM potato? Is it six months away? Is it five years away? Who determines these things? What is India’s policy on GM crops? First we had the mess with Mahyco –Monsanto’s Bt cotton that was approved despite several questions about its quality, then its subsequent failure in the field. Then we had the GM mustard, which is in limbo, neither rejected nor approved and now premature announcements on GM potato. India’s policy on GM crops appears to be a bit like the emperor’s new clothes, invisible. Decisions are ad hoc and taken whimsically in the absence of a sound policy framework. The net result is that confusion reigns supreme.

First, the GM potato is quite far away from commercial release. Its promoters appear to be jumping the gun deliberately, in order to pressure the agencies for its release on a human suffering angle. The emotional button for Bt cotton was the farmer suicides in Andhra Pradesh and the need to give them a cotton variety that would slash the heavy expenditures on pesticides and by inference, stop them killing themselves due to debt burdens. We know now that the Bt cotton practically failed in almost all locations it was grown. The emotional button being pressed for GM potato is malnutrioned children susceptible to blindness and how this potato will solve all of that and bring smiles to their well fed little faces. What is not explained is how the potato supposedly with enriched protein will cure night blindness, which is brought about by vitamin A deficiency. Curing night blindness has been entrusted to Golden Rice whenever it sees the light of day, not potato.

In fact the premature announcement made a specific reference to the fact that as soon as the potato was cleared, it would be given free to millions of school children across the country. This is even more worrisome than the fact that at the moment the GM potato is only an experiment, not a product. If the GM potato is improved to the extent that the protein content rises significantly, and it is judged to be safe, we could discuss its merits then. At the moment it will do nothing for school children except expose them to an untested food, which could have harmful effects. Potatoes belong to the botanical family Solanacea, the same family as the poisonous nightshade, a family known to have many plant toxins.

This talk of feeding GM potatoes to schoolchildren is unacceptable adventurism. If there is such an urgent need to save these children, food supplements can be added to their school meals. This will be a safer and more certain path to nutritional enhancement than rushing untested GM potatoes to them. Nutritional enhancement by food supplements is easy to do in schools and has an established tradition. It is difficult to make the case for GM potatoes as a preferred route for enhanced dietary protein, compared for example to pulses or soya blended wheat flour.

As it stands today, even the science done on GM potato is inadequate and we are talking about an incompletely tested product. One thing is clear to everyone that the increase in protein in the GM potato is negligible and will make no real difference nutritionally. This has been emphasised by scientists working at the central Potato Research Institute. What has not been brought out is the fact that this GM potato might not even pan out, not in 2005, not ever. We do not know yet because the appropriate experiments have not been done to test whether this transgenic potato is stable or not.

All the experiments on the GM potato so far have been done only on the vegetative cycle, which means we do not know how the variety behaves when it is sexually reproduced (flowering and setting seed). At present we cannot say anything about the stability of the transgenic potato in the long run since studies on gene insertion have been done only in one vegetative generation, not in several sexual generations, as it should be.

Potato is mostly vegetatively propagated in India , which means , potatoes are cut up into pieces and serve as ‘seed’ for sowing the next crop. The little pieces grow into bigger potatoes and when they are large enough, the crop is harvested and so it goes from crop to crop. During the potato cultivation process in the plains, no flowering takes place, no seed is set and there is no “next generation” as is for example, the case with wheat and rice.

Before any judgement can be passed on the value of the GM potato, studies need to be conducted to evaluate the stability of the gene from one generation to the next generation, to ensure that the amaranth protein gene is actually integrated into the genetic material of the potato. If this is not the case and if the gene is only temporarily lodged somewhere, the protein expression in the potato will be unstable , it may vary in amounts from potato to potato and from crop cycle to crop cycle. It may even disappear altogether. Such an unstable variety cannot be given to farmers.

Stability of gene insertion cannot be tested in the vegetative cycle only, it must be tested through sexual cycles of flowering and setting seed. For this the GM potato variety needs to be grown and tested in the cooler climates of high altitudes where flowering and seed setting takes place. This work has not yet been done for the GM potato that is being promoted. So we have no idea whether the gene is stably integrated, how many copies of the gene have been integrated? One? Many? What else is inserted along with the amaranth gene? Is there foreign genetic material there, which could create problems later? Putting the variety through several crop generations can answer many of these questions.

Apart from protecting the farmers from an unstable variety, there is the question of liability. Whoever markets this variety should be fully aware that if the potato shows itself to be unstable and the genetic function of the protein gene is unreliable, it is likely that legal suits for compensation will be brought against them. If India wants to use agro-biotechnology, its scientific and regulatory establishment will clearly have to demonstrate far greater maturity and responsibility than it is doing at present.

Tuesday, March 4, 2003

BREEDERS RIGHTS VS. COMMUNITY RIGHTS

Dr. Suman Sahai

The rights of communities over bioresources derive from the fact that they maintain and refine these resources and they are the repositories of the knowledge about these resources,their characteristics and their use. The importance of indigenous knowledge can not be understood when one realises that there are no rice or wheat plants nor did cotton or mustard find lying around in the forest. What are found in the forest are wild plants out of which communities of men and women over generations have bred races of several food and cash crops. These communities have bred out of the wild plants of the forests, the thousands of land races which are the basis of the world’s agriculture.

The land races bred by farming communities are the foundation material of modern plant breeding and global food security. These land races are the self-same varieties that plant breeders use to breed other varieties and for which they seek special and exclusive privileges like Plant Breeders Rights.

It needs to be remembered that farm women and men have not only created several thousand races of food and cash crops, they have also identified valuable genes and traits in these crops and maintained them over generations through a highly sophisticated system of crossing and selection. Communities have not only developed complex systems of pest management and biological control, they have identified and managed a series of genes conferring valuable traits for commercial and domestic needs.

So it is that genes for traits as diverse as disease resistance, high salt tolerance, resistance to water logging and drought tolerance have been maintained in the repertoire of

communities. This work of genetic selection, maintenance and cross breeding is the result of innovative and creative scientific experimentation in the field. This work is in no way less than the scientific experimentation conducted by scientists in the experimental plots of agricultural research stations. The fact is that there would be no plant breeders working on experimental farms if it were not for the prior knowledge gained from rural communities.

Indigenous knowledge is not only the foundation of modern science in this and many other fields; it is also what could be described as the reference and referral centre for modern plant breeding.

Today, faced with the threat of global warming and climate changes across agricultural zones, scientists are on the look out for crop varieties that are more heat tolerant. .They acquires this information by going to deserts and hot regions and asking local farming communities to identify varieties that can withstand extreme heat. Armed with this indigenous knowledge, scientists can engage in a breeding and selection program that will result in the combination of traits needed for varieties that are to cope with postglobalwarming agriculture.

If credit had to be apportioned for the breeding of a new crop variety, then it could be shared perhaps as 80:20 or atleast 70:30 between the farming and scientific communities. One could say quite easily that if the breeding of a crop variety entailed 100 steps, then indigenous knowledge contributed the first 80 or 70 steps and laboratory science contributed the next 20 or 30 steps. It stands to reason therefore that credit, reward and recognition for a new variety should be similarly shared. That is the reason why the claim to place Farmers Rights on par with Breeders Rights is such a natural claim.

Farmers have a greater and more innovative share in the creation of new plant varieties than scientists. Their contribution must be recognised with atleast the same degree of enthusiasm, if not more than that accorded to scientists.

We need to address ourselves to a few important aspects in order to lay down a comprehensive national policy with respect to the rights of communities. The first of these is the documentation of the location of biological resources at the regional and national level. If we want to use bioresources as the foundation for national growth, we must at least know where we have what .This documentation which should be compiled as a National Bioresource Register will serve several functions.

a. The first is that of a data bank for people seeking access to information. This access should be made available for a fee accompanied by the conditions governing the use of this information. This is the normal practice with data banks every where.

The fee charged for prospecting for biological material like land races or wild relatives must be paid into a Community Gene / Technology Fund in the dispensation of which, representatives of communities will have a say. A profit sharing formula should be worked out in addition, if a new variety or other commercial product is developed, to pay for the use of community held raw material and indigenous technology.

b. The documentation can be used to stake the claim of communities or individuals for royalty payments for the transfer of indigenous technology. This data base can also be used to identify communities which should be included in the National Authority that will govern the use of bioresources and implement conditions of the Convention on Biological Diversity (CBD) like Prior Informed Consent and Material/ Information Transfer Agreements.

c. Finally, this data bank will serve the important function of establishing community knowledge firmly in the public domain .This will provide the technical basis for rejecting patent claims that derive from indigenous knowledge.

d. We must ensure that the information that is documented is banked in a government owned repository and is legally admissible in a court of law as evidence for prior knowledge. In order to strengthen the claim of indigenous communities over their knowledge base, our laws must admit Oral Tradition as documentation of use. This will be of importance when dealing with knowledge other than that documented in journals and scientific publications, since most of our community knowledge is verbally held.

Drafting of national legislation is the other important aspect. New laws should be drafted quickly to deal with all aspects of bioresources and policy governing their use. These laws are to be drafted primarily in the context of two international treaties, the Convention on Biological Diversity (CBD) signed in Rio in 1992 and the GATT/ 3 TRIPs which was finalised in 1994 .CBD laws are required to establish ownership rights over India’s biological resources and to formulate the guidelines for material and information transfer agreements which will vest all rights with indigenous communities.

Our sui generis legislation should place Farmers Rights on par with Breeders Rights and acknowledge and reward the contribution of farm men and women to the development of land races and therefore to the development of new varieties.

The indigenous knowledge involved in the location of favourable genes needed for successful breeding work should be paid for. The recipient can be the Community Gene / Technology Fund mentioned earlier.

Wednesday, December 4, 2002

GM MUSTARD NOT ADEQUATELY TESTED

But pliant GEAC does not object

Suman Sahai

To ensure that Indian farmers get the best possible seeds, any variety approved for their use must be thoroughly tested by the best institutions under the best possible conditions. This does not seem to be the case with Proagro’s controversial GM mustard variety. The safety of Proagro’s mustard is in question. Safety tests for the GM mustard as human food and as animal feed were conducted by Proagro itself, by feeding seeds and leaves of the transgenic plant to pigeons and rabbits. The company reportedly supplied both the samples to be tested and the controls against which the samples had to be tested, making the tests a farce. Moreover, the tests were not conducted in any government laboratories which are open to scrutiny but in private institutions (FIPPAT in Chennai and Sriram Institute, Delhi). Even in these privately conducted tests, there was no involvement of scientists from the national agricultural system. The safety data were accepted by the GEAC despite this unusual practice.

Equally questionable is the manner in which the field trials were done for Proagro’s GM mustard. The Aventis/Proagro hybrids have not gone through the prescribed procedure of the All India Coordinated Crop trials as crop varieties in India are required to do. In India, all varieties have to undergo rigorous testing in all zones at 40-50 locations and a variety is only notified after this process is completed, a process which lasts over three years. The Aventis/ Proagro mustard has been tested by ICAR ( Indian Council of Agricultural Research ) for only one season, in just 4 locations , in a total of 3 zones!

Curiously enough , like in the food and feed safety tests, it is Proagro itself which has supplied the bulk of the data on field performance to the GEAC, on the basis of tests it has done itself on its own trial variety. The clear cut conflict of interest – the industry providing the data on which its performance will be judged, does not seem to disturb the GEAC. In a deplorable departure from ethical practice, the GEAC does not seem unduly worried either , about the potential for Proagro to manipulate the data both on its field performance and on human and animal safety tests. It has trustingly accepted what Proagro has supplied.

So glaring has been the pro-industry bias of the GEAC , that the Director General of the ICAR has been constrained to criticise it. The ICAR chief has said that the GM mustard data are not sufficient to justify commercial release and that additional tests would have to be done , specially since most of the data provided to the GEAC have been generated by the company itself. The DG of the ICAR also said that “no exceptions can be made in the case of Proagro”, implying that this had indeed been the case.

This is significant in view of the GEAC’s obduracy in insisting that Proagro would not be required to conduct any additional tests. When the decision on release of the mustard variety was deferred from the meeting of 7 November, 2002, to one scheduled for 10 December, the GEAC had categorically stated that the Committee would only review the old data and not ask Proagro for any new data.

One is forced to question this unseemly rush in giving clearance to Aventis’ mustard despite several outstanding and unresolved questions. More so since some Indian labs are on the threshold of releasing high performance non- GM hybrid mustard varieties. Promising hybrid mustard varieties are being developed in the Indian Agricultural research Institute/ Delhi, in Punjab Agricultural University/ Ludhiana and in Haryana Agricultural University/ Hissar. All three labs are very close , about two to three years , from releasing non GM mustard varieties with far better performance than the Aventis variety being pushed by the government.

This great desire to see the Proagro mustard variety through at all costs, has alarmed some NGOs sufficiently to petition the Chief Vigilance Commissioner to investigate the conduct of India’s scientific and regulatory agencies, particularly the GEAC. The known proclivity of the multinational sector to buy influence in governments and decision-making bodies and the complete lack of transparency in the functioning of the GEAC has fuelled suspicions of corruption and irregularities.

It continues to remain a matter of concern that the GEAC resolutely refuses to respond to requests from the NGO community seeking information on the results of field trials of both Bt cotton and GM mustard . Despite repeated requests and several letters requesting information about the results of field trials of transgenic varieties, Sri. A.M. Gokhale, Chairman GEAC, has not responded to the queries made. This evasive conduct would seem to suggest that the GEAC is hiding unpleasant truths that cannot withstand public scrutiny. In addition to the results of test data, Gene Campaign has also been demanding that in the interests of transparency and credibility, independent experts must be allowed to visit test sites and evaluate the performance of GM crops.

If India is to develop as a leading agricultural country capable of absorbing and implementing new technologies, then the scientific and regulatory agencies will have to demonstrate far greater maturity and sensitivity to public concerns than they have been doing so far. This ‘Insider club shrouded in secrecy , taking decisions on who knows what basis’, is not acceptable. Information on Proagro’s mustard and every other GM variety considered for release will have to satisfy all possible health, environmental and ecological criteria, to the satisfaction of the public.

Monday, December 2, 2002

CAN INDIA HANDLE GM TECHNOLOGY ?

Suman Sahai

If proof were needed that India was not ready to absorb and implement a complex technology like GM technology, one only has to watch the performance of the agencies set up to regulate this sensitive technology, the GEAC ( Genetic Engineering Approval Committee ) in particular. The GEAC had convened a meeting on 7 November, 2002 to grant approval to Proagro’s GM mustard varieties. NGOs and farmers organisations raised a storm of protest before and during the meeting, opposing the release of the GM mustard. The committee decided to defer the decision, ostensibly to ‘review’ the data . It is believed that the decision was delayed so as to ride out the protests and clear the variety when things were quiet again. Amidst a barrage of allegations that the GM mustard had not cleared safety tests and not been sufficiently tested in the fields, NGOs like Gene Campaign had been demanding the release of the field data presented by Proagro, and that the company should be required to do new field tests monitored by independent experts . The GEAC has been adamant that no data would be released and no further field trials would be done. Now suddenly, with nothing having changed, it has decided to hold a meeting on 10 December to take a decision on the GM mustard variety.

In the meantime, the conduct and bias of the GEAC has come in for criticism from an unlikely source . Dr. Panjab Singh, Director General of ICAR ( Indian Council of Agricultural Research ) has said that the mustard data are not sufficient to justify commercial release and that additional tests would have to be done , specially since most of the data provided to the GEAC have been generated by the company itself. Dr. Singh added “no exceptions can be made in the case of Proagro”, implying that this had been the case. The clear cut conflict of interest – the industry providing the data on which its performance will be judged, does not seem to disturb the GEAC, so intent are they on granting approval to Proagro.

The GEAC is the regulatory body that is charged with the responsibility of assessing the results of field trials of GM crops and decide whether or not the results are clean and convincing enough to warrant approval for commercial release. This should not be a difficult task . There are supposed to be reference standards for testing GM crops, the field trial results have to be evaluated against these standards and a considered decision taken if the results are convincing . If not, more tests should be done . If even then the results are not clear , the Precautionary Principle should be invoked and the commercial release of the crop should be deferred or denied.

All this naturally needs to be done in an open and transparent manner and with accountability to the public. The laws of countries like the US, Canada, Australia and the EU have statutory provisions for public participation in decision-making, public discussions on risk and benefits of GM crops, the nature and location of field trials, the results of such trials and other aspects of the testing of GM crops. Most information (except some kinds of confidential Business Information ) is in the public domain and access to that information cannot be denied to the public. Here in India however, the GEAC is a law unto itself. It functions like an insider club , cloaked in secrecy and about as transparent as a concrete wall. The GEAC refuses to respond to enquiries from the public. It even refuses to acknowledge phone calls, e mails and registered letters from civil society asking for appointments to discuss public concerns or requests for information about field trials of GM crops ( Bt cotton or GM mustard ) . The question that many are asking is that the if the GEAC has nothing to hide, why is it so secretive, why is it hiding behind its concrete wall ? And should such a secretive, non- transparent (and many would say, incompetent) body be allowed to take decisions of such importance?

Hiding facts about the GM field trials is a violation of India’s Right to Information Act under which, barring sensitive areas like defence, the public has a right to know the basis of government conduct and its decisions. In an area which could so directly impact on the health of humans and their livestock, on the agro-biodiversity and the environment of this region, on the livelihoods of farmers and on the sustainability of agriculture for future generations, withholding information and denying the public the right to participate in taking decisions amounts to a criminal offence. If for nothing else, the GEAC should be called up to explain its conduct on this alone.

But this is not all. The way the scientific administration and the regulatory agencies responsible for evaluating the GM crops on offer from the MNCs (there are no crops yet from public research institutions) are conducting themselves, should be the subject of investigations by the Central Vigilance Commission. In fact, fearing corruption and irregularities, civil society organisations have petitioned the Chief Vigilance Commissioner to institute an enquiry into the behaviour of the regulatory agencies concerned with GM crops.

It is commonly known that when government officials go to monitor the field trials and tests of the GM crop ( in this case , Monsanto’s Bt cotton and Proagro’s GM mustard ) , the entire bill for travel, boarding and lodging and hospitality is paid by the industry whose crop is being evaluated. This is not all. The officials are also paid an honorarium ! Talking about irregularities, to assess whether the GM crop parts like seeds, leaves , oil, oil cake etc are safe for humans and animals, studies have to be conducted to see whether they are toxic or not. The cost of these studies on the safety of GM crop products and crop parts for food and animal feed is borne by the concerned industry. This must be the only instance in the world where the industry in question itself controls the data on which the sanction of its product depends.

The conflict of interest within the government agencies running the GM show does not end here. Within the GEAC, all the members are those who are researching GM crops and hope to have their own GM crops coming up for approval before the same committee. A very ‘I scratch your back- you scratch –mine “ situation. A senior scientist of the ICAR is a member of the GEAC when ICAR itself is an applicant to the GEAC seeking approval for its transgenic crops . What objectivity should one expect in such a situation ? In addition to this, there are no scientists from different fields like social sciences, economics, etc. who would be needed to bring in other perspectives.

The GEAC has no soil scientists or ecologists or entomologists ( to understand insect resistance, as in the case of Bt cotton for example.) , nor experts in any of the environmental sciences. The body is incapable of taking a competent or comprehensive view on the safety and efficiency of the GM crop on the basis of the data provided. Before India’s regulatory agencies precipitate an environmental or human health disaster with their incompetence and their great enchantment of multinational companies, they should be disbanded. India should put on hold the release of GM crops until its regulatory procedure is demonstrably more competent and transparent.

CAN INDIA HANDLE GM TECHNOLOGY ?

Suman Sahai

If proof were needed that India was not ready to absorb and implement a complex technology like GM technology, one only has to watch the performance of the agencies set up to regulate this sensitive technology, the GEAC ( Genetic Engineering Approval Committee ) in particular. The GEAC had convened a meeting on 7 November, 2002 to grant approval to Proagro’s GM mustard varieties. NGOs and farmers organisations raised a storm of protest before and during the meeting, opposing the release of the GM mustard. The committee decided to defer the decision, ostensibly to ‘review’ the data . It is believed that the decision was delayed so as to ride out the protests and clear the variety when things were quiet again. Amidst a barrage of allegations that the GM mustard had not cleared safety tests and not been sufficiently tested in the fields, NGOs like Gene Campaign had been demanding the release of the field data presented by Proagro, and that the company should be required to do new field tests monitored by independent experts . The GEAC has been adamant that no data would be released and no further field trials would be done. Now suddenly, with nothing having changed, it has decided to hold a meeting on 10 December to take a decision on the GM mustard variety.

In the meantime, the conduct and bias of the GEAC has come in for criticism from an unlikely source . Dr. Panjab Singh, Director General of ICAR ( Indian Council of Agricultural Research ) has said that the mustard data are not sufficient to justify commercial release and that additional tests would have to be done , specially since most of the data provided to the GEAC have been generated by the company itself. Dr. Singh added “no exceptions can be made in the case of Proagro”, implying that this had been the case. The clear cut conflict of interest – the industry providing the data on which its performance will be judged, does not seem to disturb the GEAC, so intent are they on granting approval to Proagro.

The GEAC is the regulatory body that is charged with the responsibility of assessing the results of field trials of GM crops and decide whether or not the results are clean and convincing enough to warrant approval for commercial release. This should not be a difficult task . There are supposed to be reference standards for testing GM crops, the field trial results have to be evaluated against these standards and a considered decision taken if the results are convincing . If not, more tests should be done . If even then the results are not clear , the Precautionary Principle should be invoked and the commercial release of the crop should be deferred or denied.

All this naturally needs to be done in an open and transparent manner and with accountability to the public. The laws of countries like the US, Canada, Australia and the EU have statutory provisions for public participation in decision-making, public discussions on risk and benefits of GM crops, the nature and location of field trials, the results of such trials and other aspects of the testing of GM crops. Most information (except some kinds of confidential Business Information ) is in the public domain and access to that information cannot be denied to the public. Here in India however, the GEAC is a law unto itself. It functions like an insider club , cloaked in secrecy and about as transparent as a concrete wall. The GEAC refuses to respond to enquiries from the public. It even refuses to acknowledge phone calls, e mails and registered letters from civil society asking for appointments to discuss public concerns or requests for information about field trials of GM crops ( Bt cotton or GM mustard ) . The question that many are asking is that the if the GEAC has nothing to hide, why is it so secretive, why is it hiding behind its concrete wall ? And should such a secretive, non- transparent (and many would say, incompetent) body be allowed to take decisions of such importance?

Hiding facts about the GM field trials is a violation of India’s Right to Information Act under which, barring sensitive areas like defence, the public has a right to know the basis of government conduct and its decisions. In an area which could so directly impact on the health of humans and their livestock, on the agro-biodiversity and the environment of this region, on the livelihoods of farmers and on the sustainability of agriculture for future generations, withholding information and denying the public the right to participate in taking decisions amounts to a criminal offence. If for nothing else, the GEAC should be called up to explain its conduct on this alone.

But this is not all. The way the scientific administration and the regulatory agencies responsible for evaluating the GM crops on offer from the MNCs (there are no crops yet from public research institutions) are conducting themselves, should be the subject of investigations by the Central Vigilance Commission. In fact, fearing corruption and irregularities, civil society organisations have petitioned the Chief Vigilance Commissioner to institute an enquiry into the behaviour of the regulatory agencies concerned with GM crops.

It is commonly known that when government officials go to monitor the field trials and tests of the GM crop ( in this case , Monsanto’s Bt cotton and Proagro’s GM mustard ) , the entire bill for travel, boarding and lodging and hospitality is paid by the industry whose crop is being evaluated. This is not all. The officials are also paid an honorarium ! Talking about irregularities, to assess whether the GM crop parts like seeds, leaves , oil, oil cake etc are safe for humans and animals, studies have to be conducted to see whether they are toxic or not. The cost of these studies on the safety of GM crop products and crop parts for food and animal feed is borne by the concerned industry. This must be the only instance in the world where the industry in question itself controls the data on which the sanction of its product depends.

The conflict of interest within the government agencies running the GM show does not end here. Within the GEAC, all the members are those who are researching GM crops and hope to have their own GM crops coming up for approval before the same committee. A very ‘I scratch your back- you scratch –mine “ situation. A senior scientist of the ICAR is a member of the GEAC when ICAR itself is an applicant to the GEAC seeking approval for its transgenic crops . What objectivity should one expect in such a situation ? In addition to this, there are no scientists from different fields like social sciences, economics, etc. who would be needed to bring in other perspectives.

The GEAC has no soil scientists or ecologists or entomologists ( to understand insect resistance, as in the case of Bt cotton for example.) , nor experts in any of the environmental sciences. The body is incapable of taking a competent or comprehensive view on the safety and efficiency of the GM crop on the basis of the data provided. Before India’s regulatory agencies precipitate an environmental or human health disaster with their incompetence and their great enchantment of multinational companies, they should be disbanded. India should put on hold the release of GM crops until its regulatory procedure is demonstrably more competent and transparent.

Wednesday, September 18, 2002

POOR QUALITY GM MUSTARD BELONGING TO AVENTIS/PROAGRO TO BE RELEASED SOON

Suman Sahai

Viewing the impending release of Aventis/ Proagro’s GM mustard variety by the Genetic Engineering Approval Committee (GEAC) with great concern, Gene Campaign today demanded that all data pertaining to the field trials of the this GM mustard be made available to the public. There are very serious charges of irregularities being discussed in the scientific community about the bogus nature of the trials conducted by Aventis/Proagro, the high levels of genetic contamination of non-GM mustard varieties and a less than above board approach to securing a favourable verdict for the release of transgenic mustard. These charges must be either admitted or refuted by the company.

Aventis/Proagro’s transgenic mustard is completely unsuited and irrelevant to India because it contains the barnase-bar-barstar genes. Barnase -barstar -bar genes are used in Canada to work specifically with herbicide tolerance. That situation does not obtain in India, so what is the point of using these genes here ?

Bar is a herbicide tolerant gene, barnase is an RNAse gene and can destroy any cell unless controlled. It is known for ‘leaky expression’, which can create unwanted changes, morphological malfunctions and even reduced yields.


1.Most importantly, the efficacy and performance of the Aventis hybrids under trial has been called into question. These varieties do not perform as well as existing Indian varieties , thus giving the farmer absolutely no advantage . All the advantages go to Aventis which seeks to secure a foothold in the Indian seed market, aided by a compliant and compromised scientific bureaucracy.

Gene Campaign demands :

Make the data available on the performance of the Aventis mustard compared to the best Indian mustard varieties.

2. Food and Feed Safety studies for this GM mustard were done by feeding transgenic seeds and leaves to pigeon and rabbits. The reportedly company supplied both the Samples & Controls- for the tests, making the tests a farce.

Safety tests were conducted in private institutions (FIPPAT - Chennai and Sriram Institute, Delhi) without the participation of government scientists. Food and Feed Safety data were cleared without proper testing in Government Institutions/ labs.

Demand :

Let the testing protocol for Food and Feed Safety tests be made public

Identify the source of samples and controls and the testing locations

Make public the safety data on the basis of which the transgenic mustard is getting clearance.

3. Pollen flow & contamination of non-GM mustard

In ICAR conducted tests last year in Pant Nagar, Ludhiana, Kanpur, Mathura and Jabalpur., pollen flow was detected ( in Pantnagar ) up to 75 m. In other locations, officials of the company are rumoured to have influenced the data and shown it to be less on the records than it was.

Even with evidence of pollen flow of 75m. Isolation distance in the Aventis transgenic trials, are recommended as 50m, ensuring genetic contamination of non GM mustard in neighbouring fields.

Demand – Let pollen flow studies be done by public research scientists monitored by an independent panel.

Test all the non-GM mustard in the vicinity of transgenic trials and make the data public. Assess whether or not/how much contamination has taken place.

Specially - Test Proagro 4001 , a non-GM mustard variety already on the market, for contamination with barnase-barstar genes.

4. What is the rush in giving clearance to Aventis’ mustard when Indian labs are on the threshold of releasing high performance non- GM hybrid mustard varieties.

Promising hybrid mustard varieties are being developed by Dr. R K Katiar in IARI, Dr. Banga in PAU, Ludhiana and Dr.Dhiraj Kumar in HAU. All three labs are very close ( 2-3 years ) from releasing non GM mustard varieties with better performance than the Aventis variety being pushed by the government.

Demand : Let there be an investigation into which people or agencies are behind this relentless support for Aventis’ transgenic mustard , at the cost of superior non- GM Indian varieties.

5. Who has borne the cost of the members of the MEC ( Monitoring and Evaluation Committee ) and the government nominees of the GEAC who are supposed to monitor and evaluate the field trials ? Has the government or other designated agency borne the cost of those sent to monitor and evaluate the performance of Aventis’ transgenic mustard ?

It is rumored that the companies themselves (Aventis for this mustard and Monsanto for

Bt cotton ) have paid for the travel and hospitality of the government nominees of the regulatory committees. Not only is this highly irregular and morally questionable, what is even worse, it is said that members have received substantial honorariums from the companies for doing the evaluation of their field trials.

Demand : Let the GEAC and MEC members give undertakings that the companies did not underwrite any costs for government members and that no honorariums were paid by the company to the government nominees .This is necessary to establish the credibility of the MEC and GEAC.

6. According to the procedure and protocol of testing GM varieties, each agency (government laboratory or private company ) is required to disclose the details of the varieties used in breeding the GM variety. This is called the passport data .

Demand : Let Aventis/ Proagro reveal the passport data of their transgenic mustard under trial and imminent release. Let Aventis/ Proagro and the NBPGR give an undertaking that all varieties used have been deposited with the NBPGR as required.

7. The GM hybrids has not gone through the prescribed procedure of the All India Coordinated Crop trials as crop varieties in India are required to do. In India, all varieties have to undergo rigorous testing in all zones at 40-50 locations and a variety is only notified after this process is completed, a process which lasts over three years. The Aventis/ Proagro mustard has been tested for only one season, in just 4 locations , in a total of 3 zones- and it is ready for release !

8. There is talk that several lines of Indian mustard have been sent to the ProAgro headquarters in Belgium. This is in violation of the law. No genetic material can leave the country without proper procedures and in accordance with the Convention on Biological Diversity . This includes Prior Informed Consent, Material Transfer Agreements and Information Transfer Agreements.

Demand : Let Aventis/Proagro give an undertaking that this is not the case. That Indian mustard germplasm has not been sent by them to the company headquarters in Belgium.

9. There is some talk to be heard in certain quarters about how Aventis/Proagro are ‘buying influence’ in government departments to get a favourable decision for the release of Bt mustard. This kind of talk undermines the credibility of the regulatory procedures and casts a shadow on those involved in the testing, monitoring and release of transgenic crops. In the interests of transparency and above board conduct, rumors of this kind should be firmly rebutted by the company.

Dr. Suman Sahai , Convenor of the Gene Campaign said this cloak and dagger approach to GM crops and Ag –biotech is disgusting and demonstrates more than anything else the immaturity and lack of confidence of the scientific administration . Judging by the stealth and secrecy, it seems that the members of the GEAC and the Department of Biotechnology have a lot to hide. Indeed if proof were needed that the decisions on Bt cotton and now GM mustard are detrimental to Indian interests, and that the data can not withstand public scrutiny, the GEAC provides it in ample measure with its ridiculous, almost criminal obduracy in not making the data public.