Farmers' rights in India : The way it always was

Suman Sahai

Indian law recognises strong farmers’ rights. For instance, they are entitled to sell seed of protected varieties from their harvest, though not under the registered brand name. [ By Suman Sahai ]

 

In August 2001, India’s Parliament passed the Plant Variety Protection and Farmers’ Rights Act. This is the “sui generis” legislation of India, defining intellectual property rights (IPRs) according to Indian standards rather than adopting a model from elsewhere in the world.

Before the Act was passed, there was a long and heated debate. As a WTO member, India had to comply with TRIPS, the agreement on Trade Related Intellectual Property Rights. Among other things, TRIPS applies to plant variety protection (PVP). WTO members must protect IPRs either by patents, a sui generis system or a combination of the two.

Initially, India’s government leaned towards patents. It launched a large-scale public relations campaign propagating seed patenting as the harbinger of prosperity for rural India. But NGOs like Gene Campaign intervened. An important early event was a farmers’ rally in Delhi. Its single point message was: “No patents on seeds”. The event was organised by Gene Campaign and three farmer organisations, showing the government the strength of the opposition.

In the end, the government was persuaded to opt for a sui generis legislation. The WTO offers no references to existing models of plant breeders’ rights (PBR). Therefore, developing countries tend to draft their PVP legislation according to the model of ­UPOV (International Union for the Protection of New Varieties of Plants), partly because of the pressure of the seed corporations and partly due to lack of alternatives.

UPOV provides rights to plant breeders, but does not recognise farmers’ rights. Gene Campaign’s position was clear from the start: if India was to grant PBR, it would have to grant strong rights to farmers too. Gene Campaign insisted that the farming community had to retain control over seed production and use. It would not do to merely allow farmers to save seed from the harvest to sow for the next crop (“plant back rights”).

Plant back rights are called “farmer’s privilege” in many countries. This right, however, is merely an exemption from a right granted to the plant breeder. This kind of exemption is in force in different degrees in various ­UPOV member countries. But after the last amendment in 1991, such exemptions were made subject to the breeder’s consent. Countries that have since joined UPOV have to comply with standards of 1991, whereas those that joined earlier are bound by the less stringent version of 1978.

Selling seed

Gene Campaign always demanded
– that Indian law include clearly defined farmers’ rights,
– that landraces not be used by commercial breeders unless farmers give their consent and are financially rewarded, and
– that farmers be entitled to compensation should poor-quality commercial seeds lead to crop failure.
The most important issue, however, is the farmers’ right to sell seed to other farmers, even if a variety is registered under PBR. This is key to ensuring that farmers stay relevant as seed producers. Not surprisingly, the right to sell seed was most fiercely contested until the law was finally passed.
The seed industry opposed this right. After the patent option fell through, the industry wanted strong UPOV-style PBR in India. Business leaders managed to persuade some government officials, including senior scientists of ICAR (the Indian Council of Agricultural Research) and top bureaucrats at the Agriculture Ministry. The idea was to allow farmers to save, sow and exchange seed, but not to sell seed of protected varieties.
It took seven years of civil-society campaigns and the intervention of two Parliamentary Committees to establish comprehensive farmers’ rights, including the sale of seed, though not under the registered brand name. Breeders thus stay in control of large scale commercial marketing, while farmers have the right to sell seed and mutually support one another the way they always have at the local level.
Generally speaking, there are three focal points to farmers’ rights:
– PBR should not hinder the traditional right of farmers to save, exchange and sell seeds of all varieties that they grow.
– Protection should also be given to landraces bred by farmers and not only to varieties produced by commercial breeders.
– The regime should reward farmers for their contributions to conserving and enhancing plant ­genetic resources, which commercial breeders need in ­order to develop new crop varieties.
Recognising the contribution of farming communities of the developing world to plant genetic ­resources, the Food and Agriculture Organisation (FAO) introduced the concept of farmers’ rights in 1989 in its Undertaking on Plant Genetics Resources. In November 2001, the International Treaty on Plant Genetic Resources for Food and Agriculture (Plant Treaty) was adopted (see essay by Regine Andersen, p. 147).
The Treaty recognises the rights of farmers to save and use, exchange and sell farm-saved seeds or propagating material. There is, however, no international agreement on the design and implementation of farmers’ rights. That responsibility is left to individual countries.

Indian perspectives

India is the birthplace of crops such as rice, millets, red gram, moth bean, jute, pepper, cardamom, many vegetables and fruits. Over millennia, rural and tribal communities identified plants from the wild and developed them into food and cash crops. The result is the cereals, legumes, spices and vegetable species we know today. Farmers incrementally improved these varieties over time.
India’s sui generis law recognises farmers not just as cultivators but also as agricultural gene pool conservers and breeders of several successful varieties (see box). The rights of rural communities are acknowledged as well.
To understand the importance of Indian farmers’ right to sell seed, one must consider the context of seed production in this country. The farming community is the largest seed producer. Until recently, it provided 85 % of the country’s annual requirement of over 6 million tons.
Denying farmers the right to sell seed would have resulted in a substantial loss of rural incomes. In addition, the farmer would lose self reliance in seed and become dependent on outside seed suppliers. In ­Europe, the US, Canada, Australia, New Zealand, Japan and to a lesser extent South Korea and some Latin American countries, the largest seed suppliers are agro-chemical multinationals that have turned into “life science” corporations.
These industry giants have taken control of the international seed market by buying up all smaller seed companies. That strategy, however, would not have worked in India. Since there are not enough large seed corporations and farmers themselves are not a purchasable company, multinational corporations could only gain control of the Indian market if farmers were denied the right to sell seed. That is why there was such heated debate over farmers’ rights. Control over seed production is key to a country’s food independence. A nation that does not produce its own seed – and food – is not secure.

Protection for rural communities

India’s sui generis law not only allows farmers to sell unbranded seed of protected varieties, it protects their rights in other ways too. It acknowledges the role of rural communities as contributors to breeding landraces, which are essential for the creation of commercially valuable new varieties. Breeders who want to use landraces to create what is legally called an “essentially derived variety” (EDV) need the permission of the farmers affected.
EDVs are basically the same as the parent variety except for limited, specific changes. They virtually retain the original genetic structure. Most genetically modified (GM) varieties are EDVs. For example, Bt cotton, Bt corn or any other Bt crop are varieties identical to their parents except that they contain a bacterial gene from the Bacillus thuringiensis.
The Indian law has provisions for benefit-sharing when farmer varieties are used in breeding. A share of profits made from new varieties is required to be paid into the National Gene Fund. For this to happen, farmers’ landraces need to be registered. The Indian law allows any person, governmental or non-­governmental agency to register a community’s claim and have it recorded at an official centre.
Farmers’ rights are also protected in the so-called “passport data”, which people have to submit when applying for a breeders’ certificate. Passport data contain a host of information, including the parentage of the new variety and the names and locations of landraces used. Breeders certificates will be cancelled if such information is found faulty.

Farmers’ rights according to Indian law also prohibit breeders from using sterile seed technologies. Breeders have to submit an affidavit that their variety does not contain Gene Use Restricting Technology (GURT or terminator technology).

Moreover, farmers are exempt from paying fees if they wish to examine PBR-related documents and papers or receive copies of rules and decisions made by various authorities. Fees, however, are applicable to everyone else. Finally, the law states that farmers cannot be prosecuted for infringement of rights specified in the Act if they can prove in court that they were unaware of the existence of that rule. For example, farmers are protected from punishment if they can prove that they only accidentally sold seed under a breeder’s registered name.

MONSANTO CLEARING THE DECKS FOR ITS SECOND BT COTTON

Suman Sahai

The March 5, 2010 statement by Monsanto that Bt cotton in Gujarat is now demonstrating resistance to pink bollworm , does not add up. For one, it has been known for quite some time that the Bt cotton in India, was in fact susceptible to the pink bollworm. Gene Campaign had first made this observation in 2003, after documenting the performance of India’s first ever Bt cotton harvest.

The 2003 study found that Bt cotton hybrids had a mixed response to the bollworm ( Helicoverpa armigera) , but they did not offer protection against pink bollworm (Pectinophora gossypiella). Pink bollworm attack was found to be severe after 60 to 70 days and farmers used several sprays to control the pest. There is a genetic basis to the resistance of pink bollworm . Scientists have shown that field populations of pink bollworm harbour three genetic mutations that confer resistance to Bt toxin. Because the Bt.-resistant pink bollworm larvae mature into adults synchronously and later than the susceptible larvae, they are more likely to mate with each other, rather than with susceptible bollworm .In this way, the resistant pink bollworm not only persists but increases in the population. No surprises therefore that Bt toxin is unable to control the pink bollworm.

In fact the question of resistance build up in the ‘worm’ pests of Bt cotton ( there are more pests of other kinds) , the bollworm, tobacco budworm and the pink bollworm, is a given. No pest can be kept down for ever, as our lifelong experience with pest control demonstrates. Sometimes the host plant comes out on top, sometimes the pest does. But almost always, pests ultimately develop resistance to a single agent used to kill them. Pest resistance in Bt cotton is being reported for some time now. The first reports came from Arkansas in the American cotton belt, where Bt cotton was first introduced.

In 2006, scientists from the Nagpur-based Central Institute of Cotton Research (CICR) had noted pest resistance in Bt cotton fields and sounded the warning against growing resistance developing in the cotton pest, specially marking Gujarat as vulnerable. CICR said that incorrect farm practices like not planting insect refuges and the spread of illegal Bt cotton is accelerating the process of resistance development and it would only be a matter of time till the bollworm develops complete resistance to Bt toxin.

A 2007 study in China led by the Cornell University ,found that six to seven years after adopting Bt cotton, secondary pests had become so dominant , that farmers were spraying heavily to control these. Bt toxin is directed only at leaf-eating bollworms, so other pests remain unaffected. In an effort to keep the Bt cotton strategy alive and the pests vulnerable to the Bt toxin, Chinese scientists have begun implementing a more integrated pest control using natural predators to kill the secondary pests and enforcing the planting of refuge areas where broad-spectrum pesticides are used.

With all this evidence already available, Monsanto owning up that the pink bollworm is now resistant to the Bt toxin, is less a mea culpa than setting the stage for something else. This sounds like a prelude to the push for the promotion of Monsanto’s second generation Bt cotton, the Bollgard II. Granted approval for commercial release some years ago, Bollgard II carrying two Bt toxin genes instead of only one, as in the first generation Bollgard I, is already being cultivated in parts of India. So is Monsanto trashing its first Bollgard to promote its second Bollgard? It would seem so.

Given that there are over 300 Bt cotton hybrids approved by the GEAC, and most companies, barring a few like Nath Seeds ( which use a different Bt construct) , have already paid up their license fees to Monsanto for using its Bt gene, the market is getting saturated . Monsanto has already milked the Bollgard I Bt gene construct substantially. In addition to this, is the problem of the spread of illegal / spurious Bt cotton hybrids flowing out of cottage industries in Andhra Pradesh, particularly Kurnool, which are eating into Monsanto’s profits, so its time to switch to something else.

Introducing Bollgard II ( the 2 gene Bt cotton) will bring in a new period of fresh license fees as companies are forced to license the stacked gene construct with two Bt genes from Monsanto. With stagnating profits from Bollgard I ( the one gene Bt cotton), the next boom in earnings from license fees will happen for Monsanto if Bollgard II is promoted as extensively as Bollgard I was. Monsanto’s statement about resistance is calculated to achieve this goal by persuading GEAC and other policy bodies that the Bollgard I has outlived its utility and it is time to shift to Bollgard II. Monsanto has already been boasting that Bollgard II is ‘ten times better’ than Bollgardd I.

There is however a real problem associated with introducing the Bollgard II cotton in situations like India. Scientific publications point out that the one gene Bt cotton and the two gene Bt cotton cannot be cultivated in the same region, that is, they cannot coexist. If they are made to do so, the development of resistance in the bollworm will be very rapid and the technology will fail even faster than has been estimated. Therefore scientists recommend that if Bollgard II is to be introduced, Bollgard I must be withdrawn from cultivation completely.

It would be practically impossible to do this in India. Where we have failed to check the spread of illegal variants, it is not realistic to expect that the existing legal and illegal one gene Bt cottons can be withdrawn from farmers fields. Then there are the companies who have licensed the expensive Bollgard I technology from Monsanto and have only just brought their hybrids to the market. It is unlikely that they would be prepared to abandon their investments and potential profits and have to license the new gene construct if they want to stay in the Bt cotton business.

In countries like the US , technology change is not difficult since the seed is replaced easily. Farmers do not save seed from their farms, they always buy new seed and are used to dealing with ‘packages’ from the company . The seed and the inputs required for cultivation, come together. In the case of GM crops like Bt cotton, they sign legally binding contracts with Monsanto that they cannot save seed for themselves, even when the seeds are true breeding varieties, and not hybrids, as is the case in India. In such situations, farmers simply receive a new package in which Bollgard I would simply be replaced by Bollgrad II. In the case of India, where there are hundreds of approved Bt cotton hybrids and hundreds of others that are spurious and not approved, getting Bollgard I out of the field before introducing Bollgard II will be near impossible.

Rather than get into the trap of replacing Bollgard I with Bollgard II and ending up with a bigger mess than we have today, we should take a step back and review our Bt cotton strategy. Following China’s example and promoting Integrated Pest Management (IPM) would be a good beginning. IPM was in any case the government policy for pest control until Monsanto came along with its Bt cotton.

Nanotechnology in food : Is it safe ?

Suman Sahai

Nanoparticles used in a variety of sectors are also being used in the processing and packaging of foods. According to a study done by Friends of the Earth, foods which contain nanoscale ingredients and additives are already found on supermarket shelves in Europe and the US. Given the increasing scientific evidence demonstrating the toxicity risks of nanomaterials, this is cause for serious concern.

Firms in Germany producing processed meats like ham and sausage are using already a nanotechnology-based carrier system using 30nm (1 nanometer = 0.0000001 cm) to encapsulate ingredients such as Vitamins C and E and fatty acids, which can be used as preservatives and processing aids. This nano system is reported to increase the potency and bioavailability of the active ingredients enabling faster processing, better colour of the product and the use of cheaper ingredients without compromising on taste. Nestlé and Unilever are said to be developing a nano-emulsion based ice cream which has a rich creamy texture and flavour but is actually low fat. Low fat ice creams otherwise do not taste as good as those made from full fat milk and cream.

Nanoparticles are now being added to many foods to improve flow properties, for example, how well thick liquids pour, colour and stability during processing, or to increase shelf life. For instance, aluminum-silicates are commonly used to prevent clumping in granular or powdered processed foods, and a form of titanium dioxide is routinely used as a food whitener in confectionery, cheeses and sauces to brighten up their colour.

Bread, breakfast cereals, beverages and dairy products like yoghurt drinks, ice cream and cheese are being fortified with vitamins, minerals such as iron, magnesium or zinc, bioactive peptides, and antioxidants. Some of these active ingredients are now being added to foods either as nanoparticles or in nanocapsules to slow their release and make them available for the life of the product.

Nanocapsules in food are used to carry bioactive ingredients like vitamins, isoflavones ( compounds similar to estrogens) , carotenoids, (precursors of vitamin A), essential oils, preservatives and food colouring substances. These are to improve the taste, appearance and nutritional properties of the food. BASF has produced a Vitamin E nano-solution, especially formulated for drinks like sports beverages and flavored waters which are now very popular among the youth.

Nano-sizing or nano-encapsulating active ingredients in nutraceuticals delivers greater bioavailability, improved solubility and increased potency compared to when these substances are simply added in powdered or even micro form. Nutraceuticals are new age compounds that aim to provide nutrition and health benefits. (Nutraceuticals: nutra= nutrition + ceuticals from pharmaceuticals).

The greater potency of nanoparticle additives reduces the quantities of additives required, and so benefit food processors by cutting cost. However the high potential for cellular uptake of nanomaterials, coupled with their greater chemical reactivity, could also introduce new health risks.

Apart from nanomaterials being added to food and food packaging, nanoparticles are also created during food processing. Nanoparticles are found in many foods not because they have been added to enhance taste and appearance but because of the technology used to process the foods. Food processing technologies that produce nanoparticles are not new but the rapidly expanding consumption of highly processed foods is increasing the volume of nanoparticles in human diets, resulting in higher exposure to these particles and raising health risks.

Processing techniques which produce nanoparticles are used in the manufacture of ready to eat foods like salad dressings, chocolate syrups, sweeteners and flavoured oils. Nanoparticles and nanoscale emulsions can be formed as a result of food processing techniques like high pressure homogenisation, dry ball milling, dry jet milling and ultrasound emulsification. It is likely that many food manufacturers particularly in developing countries are unaware that their foods contain nanoparticles. They may have simply licensed a processing technology without being aware of its details and safety implications. Food manufacturers like such processing techniques because the textural changes and flow properties they produce add commercial interest to their products.

In addition to the accidental presence of nanoparticles resulting from processing techniques, they can also enter food as contaminants. Researches have found that many food products contain insoluble, inorganic nanoparticles and microparticles which appear to have contaminated foods unintentionally, for

example as a result of the wear and tear of food processing machines or through environmental pollution.

Before its use in food, nanotechnology has been used in food packaging and food contact materials to extend the shelf-life of packaged foods. One of the earliest commercial applications of nanotechnology in the food sector is in

packaging. It is estimated that between 400 and 500 nano packaging products are in commercial use now, and the projection is that by 2020, nanotechnology will be used in a quarter of all food packaging world wide.

The main purpose of nano material in packaging is to increase the shelf life of packed foods by reducing the rate of deterioration. This is done by using packaging materials that will reduce gas and moisture exchange with the atmosphere and minimize UV light damage. For example, DuPont has produced a nano titanium dioxide plastic additive which can reduce UV damage in foods in transparent packaging. Nano packaging can also be designed to release antimicrobials, antioxidants, enzymes, flavours and nutraceuticals to keep the packaged food tasting ‘fresh’ for a longer period.

Certain kinds of nano packaging materials are made so as to interact with the food to monitor its deterioration. Nano packaging using carbon nanotubes is being developed with the ability to ‘pump’ out oxygen and carbon dioxide that would cause food and beverages to deteriorate as well as undesirable odours that make the food unappealing.

Nano-based antimicrobial packaging

Food packaging and containers are also made incorporating antimicrobial nanomaterials, to prevent or slow down the decay of food due to microbial action. These products commonly use nanoparticles of silver but also nano zinc oxide and nano chlorine dioxide. Packaging materials using magnesium oxide, copper oxide and titanium dioxide in nano form as well as carbon nanotubes are also being developed for use in antimicrobial food packaging.

Nanoscale packaging and containers with antibacterial function
Company/ Institution	Application
SongSing Nano Technology Co., Ltd	Cling wrap treated with nano zinc oxide
Sharper Image	Plastic storage bags treated with nano silver
BlueMoonGoods, A-DO Global, Quan Zhou Hu Zheng Nano Technology Co., Ltd and Sharper Image	Storage containers treated with nano silver
Daewoo, Samsung and LG	Refrigerators treated with nano silver
Baby Dream® Co., Ltd	Baby cup treated with nano silver
A-DO Global	Chopping board treated with nano silver
SongSing Nano Technology Co	Tea pot treated with nano silver
Nano Care Technology Ltd	Kitchenware treated with nano silver

Source: - Friends of the Earth, 2008

Safety

Developing countries have begun to use nanotechnology in the absence of health and safety guidelines. India along with other Asian countries like China, Sri Lanka, Thailand and Vietnam is moving ahead to commercialise nanotechnology but there is as yet no public debate on its impacts, nor a regulatory regime.

In India the government is spending over US$6 million each year on nanotechnology research but regulatory oversight remains weak. Firms are getting ready to put out water filters using nanomaterials for better absorption of contaminants but reportedly, the companies have not performed any toxicology tests because they are not required to do so.

There are outstanding concerns about what happens to nanoparticles once they are inside the body ; do they remain embedded or move freely ? they are known to be highly interactive so what are the immune or inflammatory responses they elicit ? The behavior of a nanoparticle varies according to size, shape, surface area and chemistry with the compounds it interacts with. Exhaustive safety studies are needed before nanotechnology is permitted to be used in the food and beverage sector.

THE BT BRINJAL CASE: OVERHAULING THE REGULATORY SYSTEM MUST BE THE FIRST STEP

Suman Sahai
The Minister for Environment and Forests, Sri Jairam Ramesh deserves congratulations for the effort he is making to hear the public’s views on Bt brinjal. The range of public concerns that are being expressed by diverse stakeholders in different parts of the country will help form the Minister’s opinion about GM crops and the regulatory system in general.

According to the legal framework on GMOs, the 1989 Rules for the Manufacture, Use, Import, Export and Storage of Hazardous Micro organisms, Genetically Modified Organisms and Cells, (and subsequent amendments), the statutory authority to take decisions on the release of GMOs, rests with the Genetic Engineering Approval Committee (GEAC) which is India’s apex decision making body.

In the case of Bt brinjal however, the GEAC has taken the unorthodox step of referring the matter to the government for a final decision. After declaring itself satisfied with the bio safety data on Bt brinjal and giving it clearance in principle, the GEAC has passed the ball into the government’s court. This appears to have been done because the GEAC recognizes that there is opposition to GM crops as well as a trenchant criticism of the manner in which the GEAC itself and the rest of the regulatory system conducts itself, its lack of transparency and its refusal to engage with the public’s concerns.

Gene Campaign had filed a Public Interest Litigation (PIL) in the Supreme Court in 2004, asking for an improved regulatory system incorporating among other things, technical competence, transparency and the involvement of the public in decision making. The case is dragging through the Supreme Court in its sixth year with no signs of any resolution. In the meantime GEAC has preempted everything and given clearance for the cultivation of Bt brinjal. It took this decision despite the fact that there is neither a labeling system in place, nor a law on liability in this country. If some harm were to come from the commercialization of Bt brinjal, either to farmers ( poor crops or contamination of organic crops) or to consumers who ate the vegetable, there is no law according to which the Mahyco seed company could be held responsible and made to pay compensation and recall the offending brinjal from the fields, mandis, retail shops and vendors.

In the absence of a liability law, the Mahyco company would go scot free even if its product were to inflict damage. In the absence of a labeling law , (India’s official position is for mandatory labeling), the consumers would have no way of telling whether they were eating Bt brinjal or not. The freedom of choice guaranteed by the Consumer Protection Act of India has been taken away by the GEAC with its decision to allow Bt brinjal to be commercialized before a system of labeling has been put in place.

The GEAC’s actions, taking a decision in favor of the Mahyco company, at the same time passing the buck to the government to face the public’s opprobrium, reeks not just of cowardice but also manipulation. Quite apart from this unseemly action, a statutory body cannot simply shirk its responsibilities and pass the onus onwards when it does not want to be the bad guy, yet, step in aggressively to take decisions when it thinks it can get away with it. For this reason alone, the GEAC should be disbanded and another structure set up reflecting new scientific developments in the field and principles of good governance.

However it happened, by getting involved, Sri Ramesh has taken the initiative and given himself the opportunity to do something really useful and important. He could do a great public service by forcing an overhaul of the legal framework governing GMOs in India. The Minister should set up a committee including scientists from different disciplines, legal and technical experts, as well as public interest groups. This can be anchored in the Law Ministry particularly since after an evaluation done by them some years ago, they had declared that the current Rules could not with stand a legal challenge.

The mandate of the review committee should be to improve the regulatory system on GMOs, modernize it according to the current stand of knowledge, plug the loopholes and tighten the system to make it inclusive, technically competent and transparent. This would lay the foundation of a system that would enable the development of safe and relevant technologies serving the public interest. A stringent, transparent regulatory system would not allow dubious, poorly tested products to be foisted on the public. Because of the weak and ambiguous nature of the Rules of 1989, agencies wanting the release of their products can avail of shortcuts and pliant regulators assist in this indefensible activity.

Questions of utility and safety will continue to arise till the legal framework and processes remain ad hoc and arbitrary. The following require the attention of the review committee:

1. Improve the overall technical competence of the GEAC. The head of GEAC must be a technically competent person, not whoever happens to be posted as Additional Secretary in the Ministry of Environment and Forests.


2. Divide GEAC into an advisory body of experts from diverse science and social science fields and a statutory body of technically trained people who will do biosafety testing along the lines recommended by the advisory body for each crop variety.


3. Commercial release of GM crops should be held back till a proper regulatory framework with appropriate systems is in place. Research should continue.


4. India must develop a new, stand alone Gene Technology legislation with like other countries have done. We have copied the American system of parking our regulation under the Environmental Protection Act although our situation is entirely different.


5. A thorough Needs Assessment must constitute the first step before starting research on GM crops. Is Bt brinjal really needed? Which problem in agriculture does the transgenic crop attempt to address ? Are there alternative approaches? Has conventional breeding failed to solve the problem? GM seeds require testing, are expensive and raise safety concerns. The GM approach must be justified , not undertaken just because the Bt gene is available for licensing.


6. If the Bt gene is to be used, its use must be selective, only where it will have a clear advantage over other approaches. Currently almost 40 % of Indian transgenic research is based on the Bt gene. Overuse of the Bt gene and the planting of Bt crops in all crop seasons will ensure faster build up of resistance in the pest and collapse of the Bt strategy of pest control.


7. Invest adequate resources in biosafety testing and monitoring at various stages. Public sector agencies complain they get research grants for research on transgenics but not for risk assessment.


8. Create structures to enable public participation in decision making on GMOs. Do this after a stakeholder dialogue to determine the levels and nature of public participation.


9. The regulatory system must have an unequivocal requirement for assessing the socioeconomic impact of a new transgenic crop on traditional agricultural systems, agro biodiversity and the traditional knowledge of communities. This is required by the Biosafety Protocol.


10. There must be an unambiguous definition of what will constitute ‘Confidential Business Information’. Barring this, all other biosafety data must be available for public scrutiny.


11. India must invoke the Precautionary Principle ( as other countries like China, Mexico and Peru have done) and not allow transgenic version of crops for which it is a Center of Origin, most importantly for rice but also other crops like brinjal.


12. Crops in which India has trading interests, like rice, specially basmati rice, soybean, tea, spices etc must not be genetically engineered since this will result in lost export markets.


13. The program to genetically engineer medicinal plants must be stopped. These will be unacceptable in the international market. It is highly likely that rearranging of the genetic material could result in changes in the constitution and profile of plant metabolites that confer the healing properties.


14. Unless the advantage of hybrid vigor can be clearly demonstrated, transgenic crops should be produced as true breeding varieties, not hybrids. This will enable farmers to save seed for planting the next crop and not being dependent on the company.


15. The Herbicide Tolerance trait must not be permitted in India . As a chemical approach to controlling weeds, it will displace agriculture labor, especially women, who earn wages from weeding and other farm activities. Application of herbicides will destroy the surrounding biodiversity which is used by the rural poor as supplementary food, fodder and medicinal plants. It will also make it impossible to practice mixed farming.


16. A clear protocol of mandatory biosafety tests must be prescribed crop wise for agencies producing transgenic crops, so that tests are comprehensive and standardized.


17. A transparent and independent biosafety testing facility must be established under the supervision of scientists in the public sector to verify the data submitted by agencies developing transgenics. The same facility should be available to consumers wanting to have foods tested to confirm the presence of GM ingredients.


18. A state of the art testing facility for food safety testing and a roster of tests that must be conducted, is urgently required. Our current food safety testing procedures are ad hoc and highly inadequate.


19. A system of post release monitoring must be in place before permitting commercial release of GMOs. This will allow the monitoring of long term impacts of the GMO on the environment , human and animal health.


20. Provisions must be made for labeling before any GM food is introduced in the market. This must be preceded by a public education exercise so that the label is not merely a colored sign on the package but offers the opportunity for informed choice to the consumer. Labeling to make any sense, will have to be preceded by a system for segregation, traceability and Identity Preservation of GM crops.


21. The country must enact a law on Liability and Redress before allowing commercial release of GM foods, to put in place provisions for compensation, damage control and recall of the offending GMO.


22. Before any approval is given to a transgenic crop, a risk –benefit analysis should be conducted with public participation.
    

Dr Suman Sahai has a Ph. D in genetics and has several years of research and teaching experience at the Universities of Alberta, Chicago and Heidelberg. She can be reached at mail@genecampaign.org and http://www.genecampaign.org/

GEAC is the decision maker on GMOs

Suman Sahai
The Indian Environment Minister , Sri Jairam Ramesh deserves congratulations for the efforts he is making to hear the public’s views on Bt brinjal. If nothing else, the range of public concerns relating to Bt brinjal will come to the fore and help form the Minister’s opinion about GM crops in general. However the fact of the matter is, that despite his good intentions, the Minister is not in a position to take any action in the matter of Bt brinjal. If he were to decide on the strength of evidence presented to him, that Bt brinjal were indeed undesirable, he would not have the power to act to stop its release. The reason is that in this case, the Minister of Environment and Forests has no locus standii. The statutory authority to take decisions on the release of GMOs, rests with the Genetic Engineering Approval Committee (GEAC) which is India’s apex decision making body.

In India, GMOs (Genetically Modified Organisms) are regulated under the Environment Protection Act 1986 . In addition the Indian biosafety regulatory framework comprises the 1989 Rules for the Manufacture, Use, Import, Export and Storage of Hazardous Micro organisms, genetically Modified Organisms and Cells" , followed by the 1990 "Recombinant DNA Safety Guidelines" (1990 DBT Guidelines) and the 1994 "Revised Guidelines for Safety in Biotechnology" (1994 DBT Guidelines) and the 1998 "Revised Guidelines for Research in Transgenic Plants and Guidelines for Toxicity and Allergenicity Evaluation of Transgenic Seeds, Plants and Plant Parts" (1998 DBT Guidelines). According to this legal framework, the statutory authority vested with the power to take decisions on GMOs, is the GEAC.

The Environment Minister could however make a signal contribution in the matter of GMOs after being informed by the exercise of public consultations. He should take steps to improve the regulatory system on GMOs, plug the loopholes and tighten the system to make it technically competent and transparent. This step alone would sort out half the problems. A stringent, transparent regulatory system would not allow dubious, poorly tested products to be foisted on the public. Because of the weak and ambiguous nature of the Rules of 1989 ( and subsequent amendments) , agencies wanting the release of their products can avail of shortcuts and pliant regulators assist in this indefensible activity.

Gene Campaign had filed a Public Interest Litigation (PIL) in the Supreme Court in 2004, asking for a National Biotechnology Policy and a vastly improved regulatory system incorporating among other things, technical competence, transparency and the involvement of the public in decision making. The case is dragging through the Supreme Court in its sixth year with no signs of any resolution. In the meantime GEAC has preempted everything and given permission for the cultivation of Bt brinjal. This has happened despite the fact that there is neither a labeling system in place, nor a law on liability in this country. If some harm were to come from the commercialization of Bt brinjal, either to farmers ( poor crops) or to consumers who ate the vegetable, there is no law according to which the Mahyco seed company could be held responsible and made to pay compensation . In the absence of a liability law, the Mahyco company would go scot free even if its product were to inflict damage. In the absence of a labeling law , India’s official position is for mandatory labeling, the consumers would have no way of telling whether they were eating Bt brinjal or not. The freedom of choice guaranteed by the Consumer Protection Act of India has been taken away by the GEAC with its decision to allow Bt brinjal to be commercialized before a system of labeling has been put in place.
The GEAC permission for the commercialization of Bt brinjal is highly questionable on these grounds alone.

By getting involved, Mr Jairam Ramesh has taken the initiative and given himself the opportunity to do something worthwhile. He could take the bull by the horns and do a great public service by forcing an overhaul of the legal framework governing GMOs in India. It is high time this was done. The regulatory framework stands on wobbly legal legs. An evaluation done by the Law Ministry a couple of years ago had suggested that the system would not stand scrutiny in a court of law. It is ad hoc and arbitrary and full of opportunities for misuse. Mr Ramesh could certainly get that sorted out.

Food corruption in India and China

Suman Sahai

The list of food scares in China just over the past one year includes drug-tainted fish, industrial dye in egg yolks to colour them red, pork tainted with a banned feed additive and melamine laced milk powder. The melamine scandal which is the most recent, involved the adulterating of infant formula with the industrial chemical melamine, which can cause kidney stones and kidney failure. Melamine, used in the manufacture of plastics, was mixed with milk powder to show higher protein levels on measurement, in order to get higher prices for the allegedly ‘rich’ milk.

The melamine milk powder was discovered just before the Beijing Olympics, but the Chinese government buried the story so as not to create a scandal ahead of the Olympics when China was showcasing its prowess to the world. But soon after, legal proceedings were instituted and just a few days ago, two people were executed for their involvement in the melamine scandal that killed six and sickened over 300,000 people, some critically. Most of those taken ill were babies and children. The two accused received the death penalty for producing and selling toxic food and for endangering public safety. Apart from them, 19 other people have been jailed in this connection.

In another instance a few months ago, China executed a former director of the food and drug agency for approving fake medicine in exchange for cash. During the tenure of the disgraced drug controller, the state food and drug administration had from 1997 to 2006, approved six untested drugs that turned out to be fake. It was also found that some drug-makers had used falsified documents to apply for approvals, with the knowledge of the drug controller, in order to by pass safety tests.

Compare this with the situation in India where it is common knowledge that milk is adulterated with urea and industrial chemicals and made into a lethal brew risking the health and safety of consumers ranging from children to convalescents and pregnant mothers. Spurious drugs are so prevalent that according to newspaper reports it is impossible to ascertain the authenticity of drugs, even life saving drugs, in smaller towns and cities.

Not just this, people die routinely after drinking adulterated alcohol, or go blind or are paralysed. Pictures of wailing women seated next to corpses, victims of ‘hooch tragedies’

are commonplace. Children are periodically taken ill with food poisoning after eating their mid day meal in school, supplied free by the government. Guests at temple feasts ,

weddings and religious ceremonies are regularly found to have been taken violently ill or poisoned because of some adulterant. The adulteration of food in India is on a scale that can only be described as epic.

This is despite the fact that we have a law on food safety which prescribes food standards and heavy penalties for violators. The Food Safety and Standards Act of 2006 spells out in great detail the standards and permissible and banned additives. But all this might as well exist in the ether for all the difference it makes to ensure the safety of food on the market. Contractors and suppliers of food are the worst culprits of breaking the law in ways which are criminal. Government agencies that place such orders are complicit but this malpractice is raging in the private sector as well. Nobody is ever punished.

When talk turns to corruption, there is a large section of the Indian middle class that switches off, saying it is tired of hearing this ‘corruption talk’. Every society is corrupt, so we need not flagellate ourselves. Wasn’t the Prime Minister of this European state charged with corruption, and did not the British MPs inflate their bills? The Chinese are as bad as us they claim, if not worse. This may all be true but the difference is that we in India do not punish our guilty, We condone corruption and let it happen repeatedly and in the case of food adulteration, we over look the fact that innocent lives are lost because of greedy people. The difference between us and them is that when the guilty in other countries pay a severe pricefor their crimes. In the case of China, corrupt people who harm others are executed. In India they wear gold rings on their fingers and go scot free.

Bt brinjal can awaken a sleeping poison

Suman Sahai
What, you may ask, is common between potatoes, tomatoes, brinjal, chilli, datura, tobacco and the deadly nightshade (belladonna)? They all belong to a plant family called Solanaceae. The Solanaceae family contains a number of important agricultural plants as well as many psychoactive and toxic plants. Solanaceae species are rich in complex chemicals called alkaloids and contain some of the most poisonous plants known to mankind. They produce alkaloids in their roots, leaves and flowers. These alkaloids can be hallucinogens, stimulants or outright toxic. For example, when potatoes are exposed to light, a chemical called solanin is produced which appears as a green tinge. Green potatoes can be toxic, damage an unborn foetus and cause abortions. Other plants of this family known for their toxic qualities are belladonna, datura and tobacco.

Farmers have been working for thousands of years to domesticate wild plants like those of the Solanaceae family, to make them safe for eating. Much of this exercise involved breeding out the toxins contained in the wild plants. Scientists too have used careful, selective breeding to "clean up" crop varieties which had good qualities but contained toxins. Now brinjal, a member of this family, has been genetically engineered (GE) to produce a toxin to protect itself against a particular pest. This seems to be a process working to reverse several thousand years of efforts to detoxify natural plants to make them fit for human consumption!

Genetic engineering in plants has not been mastered enough to rule out the creation of dangerous new products in the cells when genes are muddled during the insertion of new, usually foreign genes. Several cases are known when new proteins and toxins were produced in plants which were genetically engineered. For example, when genetically modified (GM) peas were being developed by the Commonwealth Scientific and Industrial Research Organisation (CSIRO) in Australia to protect peas from the pest pea weevil, it was found that newly-formed proteins in the GM peas repeatedly caused immunity problems and lung inflammation when fed to mice. The experiments had to be abandoned. In another case, when mice were fed the genetically engineered Flavr Savr tomato, seven out of 40 experimental animals died within 14 days and the others suffered stomach lesions.

Genetic engineering in plants of the Solanaceae family could be dangerous since disturbing their genetic material through the process of inserting new gene constructs containing a battery of genes - including the toxin producing Bt gene - may trigger off metabolic processes that have been lying dormant. There are apprehensions that not only could new toxins develop but that old toxins that were removed by selective breeding may reappear.

Disturbing the cell metabolism (by genetic engineering) of species that are naturally genetically hardwired to produce toxins, is likely to call up old plant toxins in these species.

Testing for food safety is key in genetically engineered plants; it becomes more so with the Solanaceae family. At present biotechnology companies rely on the concept of "substantial equivalence" to demonstrate the safety of genetically engineered foods. In this method, the overall chemical composition of the genetically engineered food is compared to an equivalent conventional food. If there is no significant difference between the two, the GE plant is considered to be safe.

The Mahyco seed company has also tested its Bt brinjal in the same way. However, substantial equivalence is a highly contested paradigm, favoured by the biotech industry but rejected by most countries. This is because there is no mechanism in such an approach to detect unexpected or unintended changes like new toxic compounds in the cell.

Apart from the critical safety issues, there are other questions that arise with the impending release of India's first genetically engineered food crop. There is no system in place for labelling these foods. Indeed, how can one in the Indian situation label a vegetable that will be sold from farmers' fields, laden into trucks and taken to wholesale mandis? How will the vegetables on the vendor's cart or the corner shop be labelled as GM? The Government of India recognises the need to label GE food, and its position in the meetings of the Codex Alimentarius has been consistently in favour of mandatory labelling.

Accordingly, the ministry of health has drafted rules under the Prevention of Food Adulteration Act to include labelling of GE food and food ingredients. But there is as yet no mechanism in place to label GE food, nor have any awareness programmes been conducted to explain the nature of GE foods and the need for labelling them. For most consumers, especially rural consumers, GE foods are a black box and unless they are made aware of the nature of GE foods, labelling would be meaningless. Despite these big gaps in preparedness, the Genetic Engineering Approval Committee (GEAC) has approved Mahyco's Bt brinjal for commercial production.

Does this mean that the consumer's right to informed choice about their food is about to be trashed? This right is enshrined in India's Consumer Protection Act and the GEAC approval will violate the provisions of this act. Further, labelling is not just about pasting a coloured sticker on a brinjal, it involves a rigorous process of segregation and identity preservation (IP) to keep Bt and non-Bt food segregated. IP is a complex and expensive process requiring separation of a GM food from non-GM food, starting from farmers' fields, all the way to vegetable shops. Without going through this process, labelling cannot be done. Or has the GEAC planned that all brinjals cultivated in this country henceforth will be genetically engineered?

And what about fixing liability for damage? There is no liability law in India. In the event of contamination of organic brinjal with Bt brinjal, what will be the process of recall? Who will be liable to the producers of organic brinjal? There are no provisions for monitoring the long-term impact of GE foods on the health of consumers. In case adverse health impacts are reported from eating Bt brinjal, who would be liable to pay compensation? How would the liability be fixed and what would be the quantum? In the absence of any kind of preparedness or safeguards, what would be the liability of the government for approving such food crops? And in the event of damage caused by Bt brinjal, will Mahyco be put in the dock?