Regulate Cord Blood Banks

Suman Sahai

India is emerging as one of the leading centres for cord blood banks, which can provide stem cells for regenerative medicine. These are essentially blood banks, which collect, process and store umbilical cord blood for transplants. Umbilical cord blood is blood from the placenta and is rich in stem cells. Cord blood is collected after the umbilical cord has been detached from the newborn, and utilised as a source of stem cells for transplantation. Umbilical cord blood is playing an increasingly important role in the treatment of leukemia and other life-threatening diseases. More easily accessed than embryonic stem cells and more flexible than adult stem cells, the stem cells recovered from the blood in the umbilical cord provide a non-controversial treatment option for a range of diseases.

India opened its first cord blood bank in Chennai in 2004, with a drive to collect and store umbilical cord blood in a private bank. Twelve pregnant women registered with the private bank called Life Cell to store their baby’s umbilical cord blood. LifeCell guarantees that the stem cells gained from the cord blood will be stored for 21 years at a cost ranging from Rs 30,000 to Rs 60,000. Since then, several other cord blood banks have come up in India, many with international collaboration, all with similar price tags. Large private banks like Life Cell, TIFR (Tata Institute of Fundamental Research) and Cryostem Karnataka Pvt Ltd are entering the international market and will bid for international funds to conduct research on embryonal stem cells. All three are recognised by the National Institute of Health (NIH) in the US, which paves the way for their international operations.

India is seen a desirable destination for setting up cord blood banks because of its large, young population of ethnically and genetically diverse potential donors. The use of stem cell therapy in a number of life threatening diseases promises to be a money spinner in the medical sector. The cord blood storage market is currently estimated to be about US$2 billion, with every prospect of substantial growth in the coming years. As in all other fields of medical treatment, the question here is also that of regulation and equitable use. So far, the only countries that have put in place regulations for stem cell research and development, are the US, China, Singapore, Israel, Belgium and UK.

India has prepared some guidelines but these are not official yet. Broadly, these guidelines allow work on cord blood, adult and embryonic stem cells but prohibit the use of adult stem cells to create a new zygote, in other words, a new embryo. A nodal body, the National Apex Committee for Stem Cell Research and Therapy, has been proposed where all researchers and institutions working on stem cells will have to register. Permission from this body will be required for all applications of stem cells, including research. All stem cell lines that have been established, along with the source of the original material, will also have to be registered with the apex body. Given its potential for use and abuse, a regulatory system governing the use of cord blood stem cells will have to be vigilant in ensuring that not just private players but also public banks are set up for cord blood, which can be accessed by the public.

New technologies cannot be such that they shut out the poor because they are expensive and unaffordable. Even with stringent regulations, there are outstanding ethical and practical dilemmas associated with this promising but radical technology. At the simplest level, is the question of the facilities themselves: how reliable is the infrastructure for reliable and safe storage; what will be the accepted methodologies of processing and transport of such materials; and, how will the integrity of the stem cells be ensured. There is no law yet, for instance, to govern ownership of tissues like the umbilical cord or the stem cell line generated from the cord blood. What kind of intellectual property regime will we allow on aterial, which belongs to individuals but has been processed by researchers and institutions? What kind of liability laws will govern this field if things go wrong and accidents happen? How will awareness be created among the public about the availability of this facility, so that its use does not remain restricted to only those who can afford private cord blood banks. Necessary policy will need to be formulated to ensure a sufficient number of public cord blood banks and investment must be made to ensure that the public, specially the poor, can also bring their babies for cord blood storage in the hope of treating future diseases.

Regulate Cord Blood Banks

Suman Sahai

India is emerging as one of the leading centres for cord blood banks, which can provide stem cells for regenerative medicine. These are essentially blood banks, which collect, process and store umbilical cord blood for transplants. Umbilical cord blood is blood from the placenta and is rich in stem cells. Cord blood is collected after the umbilical cord has been detached from the newborn, and utilised as a source of stem cells for transplantation. Umbilical cord blood is playing an increasingly important role in the treatment of leukemia and other life-threatening diseases. More easily accessed than embryonic stem cells and more flexible than adult stem cells, the stem cells recovered from the blood in the umbilical cord provide a non-controversial treatment option for a range of diseases.

India opened its first cord blood bank in Chennai in 2004, with a drive to collect and store umbilical cord blood in a private bank. Twelve pregnant women registered with the private bank called Life Cell to store their baby’s umbilical cord blood. LifeCell guarantees that the stem cells gained from the cord blood will be stored for 21 years at a cost ranging from Rs 30,000 to Rs 60,000. Since then, several other cord blood banks have come up in India, many with international collaboration, all with similar price tags. Large private banks like Life Cell, TIFR (Tata Institute of Fundamental Research) and Cryostem Karnataka Pvt Ltd are entering the international market and will bid for international funds to conduct research on embryonal stem cells. All three are recognised by the National Institute of Health (NIH) in the US, which paves the way for their international operations.

India is seen a desirable destination for setting up cord blood banks because of its large, young population of ethnically and genetically diverse potential donors. The use of stem cell therapy in a number of life threatening diseases promises to be a money spinner in the medical sector. The cord blood storage market is currently estimated to be about US$2 billion, with every prospect of substantial growth in the coming years. As in all other fields of medical treatment, the question here is also that of regulation and equitable use. So far, the only countries that have put in place regulations for stem cell research and development, are the US, China, Singapore, Israel, Belgium and UK.

India has prepared some guidelines but these are not official yet. Broadly, these guidelines allow work on cord blood, adult and embryonic stem cells but prohibit the use of adult stem cells to create a new zygote, in other words, a new embryo. A nodal body, the National Apex Committee for Stem Cell Research and Therapy, has been proposed where all researchers and institutions working on stem cells will have to register. Permission from this body will be required for all applications of stem cells, including research. All stem cell lines that have been established, along with the source of the original material, will also have to be registered with the apex body. Given its potential for use and abuse, a regulatory system governing the use of cord blood stem cells will have to be vigilant in ensuring that not just private players but also public banks are set up for cord blood, which can be accessed by the public.

New technologies cannot be such that they shut out the poor because they are expensive and unaffordable. Even with stringent regulations, there are outstanding ethical and practical dilemmas associated with this promising but radical technology. At the simplest level, is the question of the facilities themselves: how reliable is the infrastructure for reliable and safe storage; what will be the accepted methodologies of processing and transport of such materials; and, how will the integrity of the stem cells be ensured. There is no law yet, for instance, to govern ownership of tissues like the umbilical cord or the stem cell line generated from the cord blood. What kind of intellectual property regime will we allow on aterial, which belongs to individuals but has been processed by researchers and institutions? What kind of liability laws will govern this field if things go wrong and accidents happen? How will awareness be created among the public about the availability of this facility, so that its use does not remain restricted to only those who can afford private cord blood banks. Necessary policy will need to be formulated to ensure a sufficient number of public cord blood banks and investment must be made to ensure that the public, specially the poor, can also bring their babies for cord blood storage in the hope of treating future diseases.

Agricultural Biotechnology Growing, Unregulated

Suman Sahai

The government admits that the regulatory framework is not in consonance with biosafety requirements and the way that biotechnology is being adopted in India, yet , policies andregulatory structures have not changed.

There is no national policy on biotechnology in India to guide the adoption of genetically engineered products. Research and product development is proceeding rapidly in both agriculture and pharmaceuticals in the absence of a guiding policy document. Despite demands from several official and non-official quarters, a national policy for biotechnology has yet to be developed. The legislative framework on agro-biotechnol-ogy is provided under the Environment (Protection) Act. The Rules for the Manufacture, Use/Import/Export and Storage of Hazardous Micro Organisms/Genetically Modified Organisms or Cells formulated under the Environment (Protection) Act provides for a multi-tiered regulatory framework.

The procedures under the Rules for the Manufacture, Use/Import/Export and Storage of Hazardous Micro Organisms/Genetically Modified Organisms or Cells, are lengthy and inadequate regarding biosafety. The govern-ment admits that the regulatory framework is not in consonance with biosafety requirements and the way that biotechnology is being adopted, yet, policies and regula-tory structures have not changed.

Bowing to public demand for better and more trans-parent governance, the government finally constituted two task forces on biotechnology, one to make recom-mendations in agriculture, chaired by Dr MS Swaminathan; the other to make recommendations for streamlining the regulatory framework for recombinant pharma, chaired by Dr RA Mashelkar. The mandate was to formulate a long-term policy on applications of biotechnology in agriculture and pharmaceuticals, and suggest modifications in existing administrative and procedural arrangements. Both task forces have found the regulatory system to be cumbersome, ambiguous and inadequate to deal with the challenges of transgenic technology in agriculture as well as pharmaceuticals. Their recommendations have not yet been acted upon.

The lack of transparency in the execution of agbiotechnology has frustrated civil society organizations for a number of years. The government does not provide any information on transgenic research, field trials or biosafety, despite persistent enquiries. There is neither interface with the public nor any consultations with it. Only after the passage of the Right to Information ( RTI) Act, has it become possible at least for some groups to try to access information. Most often, however relevant information is not provided or it is denied outright under the clause of ‘confidential business information’. Organisations like Gene Campaign and Greenpeace are in the forefront of trying to loosen up the provisions of the RTI Act by contesting and challenging the government’s responses. Progress is slow so far An Expert Committee was constituted in 2004 to frame a National Policy on Biotechnology. The constitution of this Committee and the process it adopted has been widely criticised as unrepresentative and non-trans-parent.

The foremost critic has been this writer (a member of the Expert Committee) who has spoken out against the absence of any consultative process and the presentation of a draft report of which the authorship is unknown. No further consultation has taken place on the draft National Biotechnology Policy, nor is the further course of action known with regard to this document.

The government has not yet implemented a policy for segregation, traceability and labelling of GE crops and foods, although large-scale field trials for brinjal, rice and okra are being conducted as a prelude to commercial cultivation. A number of food imports have been allowed under open

license and several processed foods are being imported, particularly from the US and SE Asia, which could contain GE ingredients. There is no mechanism to regulate imports nor is there a policy for labeling these products. Traders have no idea about GE crops and foods, what labelling is and how or why it should be done. There is very poor aware-ness about the nature of genetic engineering and GE crops and foods across, so labelling is unlikely to be meaningful or an instrument of choice for farmers and consumers.

Agbiotech politics

India has followed the US model of regulation but lacks the scientific experience and stringency of the US system where biosafety is conducted under a voluntary, not mandatory regime. As a member of the US led ABSP I and II programmes (Agriculture Biotechnology Support Programme), India’s agenda and policy is heavily influenced by the US with respect to key concepts like substantial equivalence, precautionary principle, science based evidence vs socio economic impacts, centres of origin, liability and redressal regimes, etc. Even the initial policy on mandatory labelling of transgenic products sometimes shows signs of flagging.

Civil society groups like Gene Campaign have been pressing for a Europe style system based on the precautionary principle and strong public participation in decision making, with little effect so far. The government is even less likely to respond to such suggestions now given that it is strengthening its partnership in this field with the US. Recently (in March 2006), along with the agreement on nuclear technology, India has concluded an agreement on agriculture with the US called the ‘Indo-US Knowledge Initiative in Agricultural Research and Education’ to promote the so-called “Second Green Revolution” with its focus on developing transgenic technologies and products in agriculture. This agreement was concluded in great secrecy and without consultation with even key actors like the National Academy of Agricultural Sciences or the scientific cadre of the Indian Council of Agricultural Research. Political involvement in decision-making in agbiotechnology is practically non-existent. Bureaucrats and technocrats run the programmes arbitrarily, handing out grants and approving projects with no visible peer review process.

Against this, a successful campaign by agbiotech promoters has succeeded in associating the Gene Revolution with the Green Revolution, projecting it as an improved version of the same thing. This results in the political leadership viewing agbiotechnology as favourably as it does the Green Revolution which is perceived very positively for its contribution to end food imports and making India food sufficient. There is little understanding of the critical difference between the two, the former was a public technology, the latter is an entirely private technology, with complex and excluding IPR regimes.

Research agenda

Research on transgenic technology in India is continuing in both private and public sectors. Since there is no biotechnology policy, nor any process for setting research goals, there seems to be little coherence in the research

objectives. For instance, the Cry9c gene known to elicit allergic reactions and the reason why Starlink corn was banned for human use in the US, is allowed for use in research programmes. Approximately 40 per cent of research projects in the public and private sector are based on the Bt gene.

This will result in the presence of Bt containing crops in all sea-sons and it is likely that pest resistance will develop much faster than if a more judicious and restricted use were made of the Bt gene. All Bt cotton in India is being produced by the private sector and all as hybrids so that the farmer cannot save seed. India is the only Bt cotton cultivating country where it is being produced as hybrids; everywhere else, it is produced as true breeding varieties.

Why are the Bees Dying?

Suman Sahai

When I was at my university in Heidelberg this summer, the hot topic of discussion everywhere was the disappearance of honeybees. Media talked incessantly about the impending doom that would befall mankind if honeybees were to die. The quote of the month was Einstein’s …”If the bee disappeared off the surface of the globe, then man would have only four years of life left. . “No more bees, no more pollination, no more plants, no more animals, no more man.” The immediate fact is that millions of bees have simply vanished. Over the last few months bees are dying in the US at an alarming rate. Beehives are emptying out as bees are disappearing in hordes. The problem is so severe that it has been called the Colony Collapse Disorder (CCD).

In most cases, the hives are empty and the dead bees are nowhere to be found .The bees exhibit a set of symptoms, which scientists say does not match anything in the known literature. In many hives, evidence of almost all known bee viruses were found in the few surviving bees. Some had five or six infections at the same time and were infested with fungi -- a sign, experts say, that the insects' immune system may have collapsed. Curiously, other insects that would normally raid abandoned hives for honey and pollen stores, do not go near the hives exhibiting CCD. This suggests that there is something toxic in the colony itself, which is repelling other insects.

The estimated economic value that bees generate, by pollinating fruit and vegetable plants, almond trees and animal feed like clover, is more than $14 billion. Media reports on the extent of damage that will be caused to US agriculture if bees died out, has finally brought national recognition to a problem that beekeepers have been worried about for some time.

There is no understanding why the bees are dying. Several theories are mooted one being the varroa mite, introduced from Asia, another is the widespread practice in agriculture of spraying wildflowers with herbicides and practicing monoculture. Another possible cause, according to beekeepers is the controversial and growing use of genetic engineering in agriculture.

Walter Haefeker, Vice President of the European Professional Beekeepers Association speculates that besides a number of other factors, the fact that genetically modified, insect-resistant plants are now used in 40 percent of cornfields in the United States could be playing a role. The figure is much lower in Germany — only 0.06 percent. So the areas where the bees have disappeared are areas cultivating a lot of Bt crops. This is unlikely to be a coincidence.

A study conducted at the University of Jena from 2001 to 2004 provided evidence that bees infested with parasites and fed with Bt pollen were affected by the pollen and died at a high rate. In the Jena study researchers studied the effects of pollen from a variety of Bt corn on bees. The study found that the pollen of Bt corn had no impact on healthy honeybee populations. But when the bees used in the experiments were infected with a parasite, they died in large numbers. It is possible that the parasitic infection either lowered the immunity of honeybees or altered the surface of the bees’ intestine such that they became vulnerable to the Bt toxin.

The pest control strategy using the Bt gene is based on the action of the Bt endotoxin on the gut of pests like the bollworm. The Bt toxins kill the larvae of certain species of insects after being ingested by the larvae. These Bt toxins cause death by attaching to specific receptors in the larval gut, eventually rupturing the gut and killing the larvae in a few days. Bt toxins are thought to kill only the target pests because only the target pests contain the necessary binding receptors. However the experience of increased mortality in Monarch butterflies and lacewing beetles that were fed Bt pollen , show that what are considered non-target pests can also be susceptible to the Bt toxins.

US scientists working on transgenic crops are less willing to buy the theory of Bt pollen being responsible for the dying honeybees. Tracking the crisis of dying honeybees, scientists at the University of Maryland are of the view that the current use of Bt corn is not associated with CCD but concede that this possibility cannot be ruled out. They further admit that although there is no evidence so far of any lethal or sub-lethal effects of the currently used Bt endotoxins on honey bees, insecticidal products expressed by other transgenes in crops may need extended field testing to assess the longer term consequences of sub-lethal changes in colonies and subtle modifications in bee behavior. This kind of testing should be extended to other kinds of insects as well.

GE Crops and India's Trade Interests

Suman Sahai

A somewhat garbled invitation was sent out by the Department of Biotechnology calling for a Consultation on Guidelines for Regulation of Genetic Modification in Crop Plants and Farm Animals with Reference to Trade Security. Had I not earlier known the purpose of this meeting, I would never have figured out what the consultation intended to achieve.

The purpose as it happened, was to discuss a policy for genetically engineering crops that India was exporting. The immediate impetus for the meeting was the understandable nervousness of the Indian Rice Exporters Association after contamination of US rice stocks with an unapproved genetically engineered herbicide tolerant rice led to the total rejection of US rice and entailed huge costs to recall stocks from the UK, Germany, Italy, New Zealand and Japan where US rice had been exported.

The rice exporters wanted the Indian government to have a policy and safeguards in place to protect rice exports from the country from contamination with GE rice, since as one representative rather imaginatively suggested, "anything to do with GM would be the kiss of death "for India's rice exports.

The gentleman had a point. India exports not just Basmati, but non-Basmati rice as well, largely to Europe and West Asia but also to Africa, both regions that have rejected GE crops and foods. The total annual value of India's rice export is approximately Rs.6000 crores. The importers of Indian rice are countries where there is mounting opposition to GE foods. Producing GE rice in India or even researching and testing it in the fields is bound to result in the escape of GE rice.

The irresponsible and clumsy manner in which the Bt rice field trials were conducted by the Mahyco Seed Company indicate that given the shoddy implementation of GE technology in our country and the lack of accountability on the parts of agencies and regulators, contamination from trial plots and field sites is a certainty. The presence of GE rice in India, will undoubtedly lead to contamination, jeopardizing rice exports to countries that will not accept GE foods.

Soybean is the other crop which India exports which qualifies as a special case for consideration. India is the only country in the world now that is producing GE free soybean. Because of this status it has an assured export market in countries like Japan and South Korea that are sensitive about soybean as food and expressly seek GE free soya. In addition, companies that use soybean meal in food, particularly baby foods and food for convalescents, and which have given undertakings to produce GE free foods, are buyers of GE free soybean. This is a captive market available only to India and it can be expanded several times, creating a growing market for India's soybean farmers many of who are to be found in the distress areas of Vidarbha. Instead of offering inadequate doles, a proper policy introducing GE free, organic soybean may help Vidarbha farmers find their feet and rebuild their agriculture with self respect and dignity.

It is understood that the Review Committee on Genetic Manipulation (RCGM) in the Department of Biotechnology has given permission to conduct research on GE herbicide tolerant soybean. This is extremely undesirable and should be stopped immediately. If India were to allow the cultivation of GE soybean ,or even its research and field trials, it would at once lose its assured export market. Becoming a GE soya producing nation, it would have to compete for markets with gigantic producers like Brazil, USA and Argentina, who are sitting on huge surpluses, unable to sell their produce easily on the world market.

I have no idea whether there was any policy outcome on GE crops and Indian trade interests from the DBT meeting. Both the soybean people and the rice exporters present there held the same view, that genetic engineering of crops in which India had trading interests, was undesirable. The MS Swaminathan led Task Force on Agbiotechnology has made the recommendation that the national policy on GE crops should seek the "economic well-being of farm families, food security of the nation, health security of the consumer, protection of the environment and the security of our national and international trade". Seeing the trend of sharply declining global markets for GE crops and foods, and the rapidly burgeoning market for organic food (currently valued at US $50 billion), it would be wise for India to recognize its USP in agriculture and develop the organic food sector, specially for exports.

Trading in Genetically Engineered Crops

Suman Sahai

The All India Rice Exporters Association has taken a position against GE rice in India, since this would hurt their export markets.

The fact that many countries in the world have chosen to reject genetically engineered (GE) crops and foods must make us alive to the fact that these preferences will reflect in the way that such crops are traded. Countries that are exporters of agricultural produce to nations that do not accept GE products will need to keep this factor in mind when investing in crop development aimed at exports. Despite this obvious reality, there is little visible effort in India to link the research agenda in agriculture biotechnology to India's trade advantages or vulnerabilities. This is not the case in other countries like Australia where an application to run a large-scale trial of genetically engineered canola was substantially diluted by the State Government where the trials were to be held. The Agriculture minister rejected the advice of his expert council which had recommended a 3000 ha trial because the Australian Wheat Board had raised strong objections that such a trial might risk its export markets if contamination occurred with GE canola. On its part, the Australian Wheat Board has successfully opposed genetically engineered wheat, responding to strong indications from the market and trading partners that genetically engineered wheat would not be acceptable.

At present the politics of trade in genetically engineered products is most prominently determined by the widely diverging positions of the United States and the European Union. This difference relates to their attitude to food production. European consumers, on an average, are more conscious of environmental concerns and food safety and tend to be suspicious of genetically engineered foods which they consider potentially unsafe and possibly damaging to the environment. In response to such attitudes, Europe's trading partners do not use genetic engineering in food production, so as not to risk losing markets in the EU. In amibia, where about 80% of the country's meat exports go to the EU, livestock farmers are extremely concerned that GE animal feed could enter the country unofficially and undermine the confidence of European consumers.

During the days of the food shortages in Africa, African governments refused US food aid because it consisted of genetically engineered foods. Zambia rejected the food aid entirely whereas Zimbabwe, Malawi and Mozambique allowed its entry only after the grain had been processed to flour, so that grains could not be used as seeds for planting and contaminating agricultural produce that is exported to the EU. Despite its protestations, the Africans believed that the US used the situation of the African famine to introduce genetically engineered food in the form of food aid so as to force open the African market for its own genetically engineered produce.

International trade in genetically engineered products will be determined by the Cartagena protocol on Biosafety. The central regulatory element of the Biosafety protocol is the Advance Information Agreement (AIA).This applies to the first intentional transboundary movement of a genetically engineered organism that will be released into the environment. These could be seeds or micro organisms, essentially those organisms that can multiply in nature. The AIA provision does not apply to all categories of genetically engineered organisms that are to be traded. For instance, pharmaceuticals for human use do not have to be notified under the AIA. Products (organisms) that will be used directly as food or animal feed or for processing (GE-FFP)also need not be notified under the AIA. The GE-FFP exemptions have been strongly objected to by parties and countries that have a more cautious approach to genetically engineered products but the clause was pushed through at the behest of the US and the countries supporting it in the negotiations of the Biosafety Protocol.

At the level of international trade, the US and EU have just had a major trade spat in the WTO over the fact that the EU had refused to import GE soybean and corn that the US wanted to export to it, because there is strong consumer rejection in the EU of all genetically engineered products that could enter the food chain. The US and its partners, Canada and Argentina, hauled the EU to the WTO dispute settlement court and the verdict was in favour of the US. This does not mean that countries cannot resist forcible exports as in the EU-US case, but it does mean that countries need to exercise all the flexibility available in the Cartagena Protocol and frame firm and clear cut national policies regarding trade in GE products.

In India there is no policy on biotechnology, despite the setting up of two Task Forces on agriculture and pharma biotechnology, nor is there any policy on how trade in GE products, especially food, is to be handled. A long standing restriction on the import of genetically engineered foods was overturned by an ad hoc 2006 decision to allow the import of soybean oil sourced from GE soybean, even though it was not labelled. It is widely believed this was the result of US pressure following the controversial Indo-US deal in agriculture. In any case, this precedence will have implications for future imports of GE products, particularly from the US.

After the global contamination of rice by Bayer's GE rice LL 601, engineered to produce pig vaccine, was detected, US rice consignments had to be recalled from countries as far apart as Japan and Germany. The US rice market crashed, costing millions in losses to traders and ultimately farmers. Responding to this, the All India Rice Exporters Association has taken a position against GE rice in India, since this would hurt their export markets.

In the absence of any policy on the subject, the Commerce Ministry has asked the Genetic Engineering Approval Committee (GEAC) not to approve GE crops in agri export zones. A few weeks later comes the announcement that the National Horticulture Board will invest substantially in genetic engineering and its priority areas will be the export oriented units! This is insane; different arms of government saying different things. To put an end to this confused mess, it is crucial that the country decides on a policy on genetically engineered crops and other products. This policy must be formulated after adequate public consultation and in a transparent manner; so that the country's domestic and trading interests are protected. Till this takes place, it is best to hold all GE crops in abeyance.

WHY PEOPLE OPPOSE GE FOODS

Suman Sahai

Governments all over the world are facing public distrust regarding the safety of GE foods, since the public does not trust the food safety testing procedures, whereas the governments claim them to be safe.

An increasing number of Indian NGOs, farmers’ organizations and common citizens are becoming vocal in their criticism of Genetically Engineered (GE) crops and foods. Farmers have set ablaze fields where trials of genetically engineered crops were being conducted and questions have been asked in Parliament about the status of such crops and foods in India.

Public distrust of GE Foods originated in Europe and it remains strongest there. So far, opposition has not been particularly visible in the US, although consumer concerns have been voiced. Surveys in the US show that most American respondents are willing to eat GE foods and do not feel threatened by it. In India, the ground is fuzzy, the level of awareness is poor except for select groups, but a nascent opposition is building up.

The greater public acceptance of GE foods in the US is anchored in the fact that the scientific community made an attempt to engage with the public on the applications of this technology. When recombinant DNA technology was discovered and its potential for applications in agriculture and pharmaceuticals began to unfold, American scientists organized the Asilomar Conference in the early seventies. These discussions included a risk benefit analysis of this new technology by which genes could be shifted around across the species barrier. The public was, at least to some extent, included in the debate and the scientists decided on a moratorium for a few years on application, to understand the technology better. This engendered confidence in the scientific community.

Unlike the US, European nations did not engage in such an exercise. Discussions with the public were not held. Scientists remained in ivory towers doing science and the public was not aware of what was happening in the laboratories. They feared the worst - perhaps monsters were being hatched in test tubes. The shameful eugenics program of the Nazi regime when "genetically inferior" races like Jews and gypsies were gassed to death, tarred the science of genetics. Understandably, genetics was seen as a tainted science, its manipulation for any purpose, undesirable.

Burdened with this past, people in European countries had to suffer the abominations of the food scandals stemming from the Mad Cow Disease (Bovine Spongiform Encephalopathy ) when infected beef was defended by the British government as perfectly safe for human consumption. Then the link was shown to a human disorder called Jacob- Creuzfeldt syndrome and all hell broke lose. The British government was shown to be lying to its people and engaged in a cover-up exercise to protect beef revenues at the cost of risking the health and lives of its people.

As if this was not enough, close on the heels of the beef scandal came the revelations, long denied, that dioxin laced animal feed was fed to cattle in Belgium. What made everything insupportable was the denial by the government and regulatory authorities that there was no wrongdoing, there was no dioxin. The trust between government and people, if any was left after the Mad Cow terror, vanished. In the eyes of the people, specially the radicals, the government lied routinely to the people and could not be trusted.

Against this backdrop came GE technology and the effort to market GE foods. The government said it was safe. The regulatory authorities said it was safe. Nobody believed a word. Activists and law-abiding citizens applauded as fields with GE crops were destroyed in the UK. In a final blow, the courts let off those charged with tearing up fields planted with GE crops . The protest spread across the world.

In addition to all this, there is resentment at the element of corporate control and the fact that six mega- corporations who have styled themselves the Life Science Corporations control agricultural biotechnology almost entirely. The most notorious of these, Monsanto has so attracted the ire of civil society for its so-called ‘terminator’ technology, that it is facing an anti- trust lawsuit in Washington. The aggressive intellectual property rights regime pushed by the corporations has raised the hackles of even moderate campaigners.

In today’s climate, people tend to be well informed and access data efficiently, they are mindful of special interests, distrustful of governments and disinclined to defer to the opinion of scientists and experts who they do not hold in any special awe. Governments seem to have lost the trust of the people in both developed and developing countries and a government endorsement of food safety is more likely to be met with scorn than trust. Corruption plays a role. Many Indians believe that both bureaucrats and political leaders can be ‘bought’ to make statements and policies favouring vested interests and that it is no different in the food sector.

Apart from this crisis of confidence, there is the angle of consumer attitude. The fact is that GE foods so far do not show any advantage over conventional foods. They are not better tasting or more attractive looking, neither are they more nutritious or cheaper. Whereas there are no visible benefits, there is the very real possibility of risks to the environment and to human health, as numerous studies would indicate.

The reasons for the many strands of resistance to GE foods will have to be understood and taken on board if the dialogue is to continue to some point of resolution and a coherent policy can be made. It is silly for protagonists of the technology in the government and in the private sector to accuse the public of ignorance.

It also serves little purpose to insinuate that there are vested interests behind the lobbying positions of NGOs and that the pesticide lobby is using NGOs to resist Bt cotton so that pesticide sales can continue unabated. This is a juvenile argument and will backfire.

To allow a fair and critical evaluation of genetically engineered crops and foods, policy making in this area will have to be open to public scrutiny. Equity and justice will have to define regimes for intellectual property protection. Risk benefit analysis must be conducted in an open and transparent manner.

Monitoring of field trials should be done by independent experts and include NGOs. The informed public will have to become a partner in the dialogue on GE foods and in decision making. The agenda of research on GE crops will have to be determined after consultations with stakeholders. Who benefits from Roundup Ready soybean except Monsanto and why should the public take on all sorts of real and imagined risks so that Monsanto can line its pockets ? Or Syngenta? Or Bayer?