Advocacy to Regulate GM Crops

Background

Globally, genetic engineering has received far greater acceptance in the field of medicine and healthcare than in the field of food and agriculture. The prospect of obtaining medicines and diagnostic kits using recombinant DNA technology is more acceptable because it is seen as having the potential to save lives, and has demonstrated direct and tangible consumer benefits.

In the case of food, the benefits so far have not been seen as direct nor visible. There is great scepticism and opposition to transgenic crops in many parts of the world because the manner in which the crops have been put into the market, make it appear that the primary beneficiary are the Life science corporations that manufacture genetically engineers (GE) seeds themselves and not consumers.

Stating its position, the Government of India (GoI) in a communication through the Department of Biotechnology, 2007 acknowledged agri-biotechnology as a powerful enabling technology that can revolutionise agriculture. Agriculture, today, faces the formidable challenge of having to produce more farm commodities from diminishing per capita arable land and water resources for a growing human and livestock population.

The government also admits that that there are several social concerns that need to be addressed to regulate the emergence of agri-biotechnology innovation. These concerns are about conserving bioresources, and ensuring safety of products and processes using genetic modification. However, despite the admission, little is done to address these concerns and civil society continues on a collision course on issues of biosafety with the biotechnology regulatory bodies as well as the Department of Biotechnology.

Many refer to agri-biotechnology as the ‘Evergreen Revolution’ or the ‘Gene Revolution’. Both terms are an attempt to link agri-biotechnology with the Green Revolution, which raised food production in Asia in a short time. This is a much debated comparison as there are some obvious differences. The Green Revolution (GR) was a publicly owned technology. The research was conducted with public money to fulfil a public need—improve inadequate food production—and it created public goods to which everyone had access. There were no Intellectual Property Rights (IPR), no patents vested in multinational companies, no proprietary technologies or products. If there was ownership of the GR, it was vested in the farmer. The GR addressed farmers needs and Asia’s food production showed an upward curve.

The Gene Revolution is largely a privately owned technology. Six corporations (Monsanto, Syngenta, Bayer CropScience, DuPont , Dow and BASF Plant Science) control practically the entire research and output in the field of transgenic plants. Processes and products, including research methodologies are shackled in patents and the farmer has no say, let alone any control.

Gene technology creates private goods that can be accessed only at significant cost (a bag of Mahyco- Monsanto’s Bt cotton seeds in India began at Rs 1600 as compared to between Rs 300 to Rs 400 for superior varieties produced locally). The seed belongs to the company, which strictly controls its movement. With the development of the popularly termed ‘terminator’ or sterile seed technology (farmers cannot save seed from one harvest for planting in the next. They have to buy it from the market) the farmer is reduced to a helpless consumer, not a partner as was in the case of the Green Revolution.

The Gene Revolution has not yet, in its 20 years, produced a single crop variety that has any direct connection to hunger and nutritional needs. The most prevalent crops remain corn, soya, cotton and canola and the dominant traits are ‘herbicide tolerance and insect resistance’. Whereas, despite its other faults, the Green Revolution was able to put out a number of crop varieties in a short span of time that enabled direct yield increases, which brought immediate benefits to farmers.

Gene Campaign’s Position

India must develop its own national biotech priorities, not be driven by other’s agendas: India, as it is with most developing countries, inducts the concepts and structures of regulatory and oversight systems from the industrial countries, without any effort to incorporate its own perspectives and sensitivities towards how it can best use GM crops to address the food crisis. Even India’s research priorities in agricultural biotechnology are based on what the industrial countries have developed, and very little has been done to evolve an indigenous set of priorities based on the needs of small farmers and local agricultural production systems.
If Genetically Modified (GM) crops entering India intend to address the needs of the poor then the biotechnology industry needs to radically change the scientific priorities of its research and technology development to address the direct welfare of people. It must do a needs assessment of what the poor need and it must ensure safety for the environment, and an equitable distribution of the benefits accruing from the technology. But, in the absence of any dialogue with farmers, the real consumers of this technology, it is not clear to what extent this technology will fulfil the needs of small farmers facing an agrarian crisis.

India, therefore, has a situation where over 40% of the GM crop research in India is based on Monsanto’s Bt gene. GM crops in the pipeline are Bt brinjal, chilli, cabbage and cauliflower rather than urgently needed pulses such as lathyrus, oilseeds or fodder grasses that the large livestock population needs.

Asian countries are predominantly agricultural, with significant concerns about food security and the livelihoods of millions of small and subsistence farmers. A targeted and informed biotechnology policy may help to solve some of their agricultural problems. However, if policy is ad hoc and ill informed, as is the case now, it could end up hurting rather than helping farmers.

Social and economical concerns of unregulated entry of GM foods: Since a few MNCs almost entirely control the GM technology through their patents, global concerns include the weak social and institutional structures for measuring and addressing risks of putting GM agricultural products out there for the public. This is underscored by the inability of most developing countries to properly steward biotechnology and its products.

With respect to safety of GM technology, in the early 90s, civil society groups in the European Union (EU) began to question the unhindered proliferation of GM crops and products by big life science corporations, without much research on its safety (human & animal health and environmental) aspects. These voices backed by clear scientific evidence began to influence policy making in the EU. By mid to ate 1990s the EU began to formulate stringent rules to regulate the release of GM crops. Simultaneously, the international community was influenced and began to frame international rules for trade in Genetically Modified Organisms (GMOs). The development of such rules was also mandated in the Convention of Biological Diversity (CBD).

Despite strong opposition from the US, the international community negotiated such rules in the form of the Biosafety Protocol (also called the Cartagena Protocol on Biosafety). The Protocol was adopted in January 2000 and came into force on 11 September 2003. India is a signatory and is bound by its provisions.

The Biosafety Protocol is predominantly an enabling agreement which does not question the relevance or suitability of GM crops for food needs in developing countries; it essentially provides a framework for trade in GM products. Developed countries are not pushing this issue because they are not greatly affected by it. Neither is the US (backed by the agri-biotech industry) keen to allow a strong regime for Liability and Redress to develop for GM crops.

There is however an urgent need in developing countries, should they adopt GM crops, to develop a liability regime to protect the interests of small farmers and poor consumers, if something should go wrong.

Need to promote open discussions and greater understanding of GM crops: India is on its way to embrace the Gene revolution. Yet there is little debate in the country about the path agri-biotechnology should take in India. There is no consultation with the public as it is done in many European countries or any sharing of information, as is done in almost all countries that are implementing GM technology.

The media is largely uninformed and political leaders remain unaware of the direction this new and controversial technology is taking in India. They have no say in determining what the technology should or should not do. As a result, civil society is uneasy with the lack of transparency and the lack of competence in the decision and regulatory bodies.

The Department of Biotechnology promotes research projects randomly in universities and research institutions, without any assessment of farmers’ needs or deliberations on the best way to fulfil them. This is taking place since governments of India and most other Asian countries rarely allow public participation in the decision-making process nor do they explain the basis of their decisions. Since scientists too, by and large, work for the government, regulatory review processes remain secretive with the public having no mechanism by which to understand the rationale of decisions.

Demands by civil society to have a dialogue and know more about the decision making process go unheeded. Indeed, the public’s demands are seen as illegitimate and hostile by definition. This needs to change because such a situation breeds suspicion and opposition to biotechnology.

Need for more competent policy making: Most administrators, policy makers, politicians, legislators, the bar, and the judiciary have little comprehension of biotechnology, and are often overwhelmed by it. This ignorance is compounded by their consistent refusal to include as advisors members from the scientific community (Science Academies) in any biotechnology policy development. Equally, most scientific experts are unaware of public perceptions of risk and safety in the field of agriculture and food production, which are often at variance to their own, more clinical understandings. To add to this, most of the decision-making on this complex and controversial technology is ad hoc, influenced neither by sound scientific research nor by genuine consumer concern but by various pressure groups and extraneous factors.

For more informed policy making there is need to have more deliberations on issues such as the impact of GM crops in centres of origin & diversity, what are the desirable traits/ relevant crops for India and other Asian countries, evaluating the socio-economic impact of GM crops, cost and risk-benefit analysis of GM crops, evaluating alternatives to GM approaches, public participation in decision-making on GM crops and foods, understanding public attitudes & perceptions about GM crops, improving regulatory and oversight mechanisms, ethical aspects of GM technology, public awareness and capacity building on GM issues

Need for a more transparent and informed regulatory authority: The role of any regulatory authority is to oversee the conduct of a business or a practice according to statutory provisions and an application of the ethical construct to prevent exploitation. In India —a democratic, welfare state— the responsibility of all regulatory bodies, therefore, is to ensure that the nothing threatens the physical, social, economical and environmental welfare of substantial segments of its population in the conduct of an particular activity or policy.

India’s regulatory mechanism for GM crops is based on rules formulated in 1989 under the Environment Protection Act, 1986. Since then, there have been dramatic developments throughout the world on understanding and implementing GM technology and its risks. In response to this, many countries have either amended their existing regimes or developed new ones. Unfortunately, Indian policy makers have not made any movement to upgrade the country’s regulatory systems. Rather, the regulatory system which is slated for an overhaul plans to introduce a single window clearance system instead of the multi-agency system in place today. The old regulatory framework will be replaced by a National Biotechnology Regulatory Authority which is being introduced through the National Biotechnology Regulatory Bill. It is awaiting enactment by Parliament. Once this happens, there will be lesser checks and balances on the way regulation and oversight of GM crops are done in the country. What is needed is a consultative process leading to a thorough overhaul of the regulatory system if India is to adopt GM technology with any degree of responsibility and maturity.

While Gene Campaign has not taken a ‘for’ or ‘against’ position on the issue of GM crops it continues to advocating for responsible and vigilant regulatory systems, evidence of success of GM crops from third party conducted trials, and transparent and democratic decision making as it has significant implications for food, livelihoods and environmental security. Unless the regulatory systems are demonstrably more competent, transparent and responsive to public concerns, it is Gene Campaign’s demand is that there be a moratorium on the commercial release of GM crops.

Question the coexistence of GM crops with non-GM crops: Coexistence of GM and non-GM crops is being promoted as a way to resolve the conflict over genetically modified crops and create space for both in the same agricultural system. Studies conducted in the US assert that co-existence is possible and that most organic farmers have neither incurred extra costs nor suffered any disadvantages due to the cultivation of GM crops in their vicinity.

Since the subject of GM crops is already internationalized through the Bio-Safety Protocol of the Convention on Biological Diversity, concepts like coexistence, labeling, identity preservation and traceability can become international policies that developing countries are compelled to implement. But would such an implementation be possible? Do developing countries have the capacity to segregate GM crops from non–GM crops, preserve the individual identity of each category, introduce mechanisms to trace food backwards from the store to the farm, and introduce meaningful labeling? In short, is coexistence of GM and non-GM crops feasible in the agricultural conditions prevailing in developing countries? Before India can begin to consider co-existence of GM and non-GM crops, it needs to put in place a number of policies and laws to regulate aspects like labeling, traceability, liability and redress. Labelling of GM foods is proposed under the Prevention of Food Adulteration Act but the provisions have not yet been implemented.
Presently there are no rules or guidelines to enable the coexistence of non-GM and GM crops, and even if there were, it would be impossible to avoid contamination under Indian cultivation conditions. This effectively means that the adoption of GM crops is almost certain to result in contamination of non-GM and organic crops. India is a biodiversity-rich region from where major crop plants like rice have originated. It is, therefore, an important center of origin, where unique genetic wealth and diversity is found. There is global concern on GM crops being grown at their centers of origin and diversity because of the threat to this unique gene pool from contamination by foreign genes. Such contamination has already been found in Mexico’s corn, and the authorities there are scrambling to find a way to contain the problem.

Gene Campaign’s Activities

1. 2003 – National Symposium on the Relevance of GM technology to Indian Agriculture and Food security
Though there was an increasing interest in the subject of GM crops there had been no comprehensive discussion on the subject at the National level that involved all stakeholders. Gene Campaign organised a two-day national symposium in Delhi in November 2003. Titled the ‘The Relevance of GM Technology to Indian Agriculture and Food Security,’ the symposium brought together a range of stakeholders of differing views to discuss what genetic modification technology offered Indian agriculture and whether it was relevant to ensuring the food security of the nation. The speakers and participants represented both viewpoints – those in favor of GM crops as well as those who were opposed to them. Participants included scientists, academics, social scientists, farmers, members of parliament, lawyers and judges, representatives of government, including the regulatory agencies, various policy makers, the National Academy of Agricultural Sciences (NAAS), the Indian seed industry, the multinational seed industry, food processing and retailing industries, environmentalists, consumer organizations, organic farmer organizations, international organizations, representatives of foreign embassies and missions, and a number of civil society organizations.

The symposium recognized that the field of biotechnology is advancing rapidly and the Indian regulatory system is grossly inadequate to provide any meaningful oversight. A common feature of all the presentations was the urgent need to change the structure and composition of the regulatory agencies, particularly the Genetic Engineering Appraisal Committee (GEAC), India’s apex regulatory body.
A series of recommendations emerged from the two-day deliberations which were finalized into a comprehensive 20 recommendations and then sent to the Department of Biotechnology.

The 20 recommendations:

• A distinct law should be enacted to oversee Genetic Modification Technology and its implementation. This law must harmonise with other national laws and international agreements.

• A comprehensive biotechnology policy should be developed in consultation with all stakeholders.

• A statutory National Bioethics Commission must be set up.

• There should be a consultative and participatory process to prioritise crops and traits for genetic improvement through biotechnology with the goal of addressing the needs of small farmers and Indian agriculture.

• Investment in public sector research should be increased and strengthened. Novel gene discovery in crops of relevance to India should get highest priority.

• India must develop a policy for transgenic varieties of crops for which it is a Centre of Origin and Diversity. Commercial cultivation of GM rice should not be allowed until the nature of gene flow and its impact is understood.

• The herbicide-tolerance trait should be subject to rigorous cost and risk benefit analysis before being considered for adoption.

• Alternatives to the GM approach must be carefully evaluated in each case before deciding on the GM route. A cost and risk benefit analysis must be conducted before deciding on a GM product.

• Protocol for food safety tests must be vastly improved and mechanisms for long term monitoring of human health (post GM food release) be put in place.

• A stringent protocol to assess environmental and ecological impact must be developed.

• There should be provisions for post-market surveillance and monitoring of GM products.

• India must exercise caution in the IPR regime that it adopts. The PPVFR Act of 2001 should be retained since it balances Breeders and Farmers’ Rights.

• A new statutory, independent National Biotechnology Regulatory Authority must be established.

• The GEAC must be made more competent, transparent and accountable. Data on research and development of GM crops and products must be posted on websites and local newspapers.

• An annual review of all decisions on GM products must be presented to Parliament.

• Conduct a scientifically sound study to assess attitudes and perceptions about GM technology among stakeholders in India.

• Undertake a program of awareness about GM technology to educate the public.

• Organize a series of public debates across the country to elicit the views of the people, to channel it into policy making. The government should fund this exercise.

• There should be a moratorium on commercial cultivation of GM crops until the regulatory system is demonstrably improved. Research on GM crops, however, should continue.

These 20 recommendations were sent to the Department of Biotechnology (DBT) for their responses. On their part, the DBT opposed almost all the recommendations. Given below are some of the DBT’s rebuttals to the recommendations made.