India has been conducting research in biotechnology without having a national policy in place. A Public Interest Litigation filed by Gene Campaign in the Supreme Court created sufficient pressure for the government to set up an Expert Committee to frame a national biotechnology policy. The Expert Committee was stacked with members from the industry and government; I was the solitary NGO member. Protests by Gene Campaign that the Committee should be expanded to include concerned stakeholders were not heeded. The Expert Committee met twice. One was at its inaugural meeting, followed by one other meeting. There was one sub-committee meeting where stakeholders were invited to accommodate Gene Campaign's protests. No minutes of any of the meetings were circulated to the Expert Committee.
With such little and desultory preparation, suddenly a draft "National Biotechnology Development Strategy" appeared on the Department of Biotechnology's website, with a six-week period for comments.
I had protested at the appearance of the draft strategy, asking where it had come from, who had written it, since nothing of any substance was discussed by the Expert Committee in the first meeting. The Chairman, Dr M K Bhan, who is the DBT secretary, promised to have another meeting incorporating the suggestions made with respect to the draft, so as to start a proper discussion. That meeting never happened. Gene Campaign's protests continued, so finally the chairman agreed to have public consultations. One was held in Chennai, another in Delhi. No minutes were circulated from either meeting. For a long period there has been no news about the policy.
The Department of Biotechnology and its Secretary seem to be in a terrible rush to get a policy in place with as little public intervention as possible. There is an informed rumor that the draft Biotechnology Policy is going to be in Parliament in the coming session. That is far too premature since it has not been adequately discussed by stakeholders, and even the Expert Committee that was established to frame the policy has not been informed of the content of the draft to be presented to Parliament. This is not how policy should be made.
The draft report makes an assertion that the existing regulatory system is sound and adequate, a laughable claim. It also states that "there is consensus" that existing legislation is efficient, when nothing could be further from the truth. India's regulatory system for biotechnology has been criticised by a large number of stakeholders as being ad hoc, lacking in the technical skills required, and without adequate provisions to deal with violations and unexpected situations. The uncontrolled spread of Bt cotton and the failure of the regulatory system to deal with it is sufficient proof of its inefficiency. A consultative process leading to a thorough overhaul of the regulatory system is crucial if India is to adopt GM technology with any degree of responsibility and maturity.
The Policy, whenever it is submitted to Parliament, must also take into account socio-economic concerns in addition to science based evidence when doing risk assessment. This is provided for in the Convention on Biological Diversity and the Biosafety Protocol. The Precautionary Principle - especially relating to the centres of origin for crop plants, socio-economic concerns relating to small farmers and consumers, and the right of the public to participate in decision making - must form an integral part of our biotechnology policy.
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 in 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. The draft biotech report is silent on this crucial issue of particular relevance to India and ultimately to the world, since rice is the staple food of almost half of mankind. Invoking the precautionary principle, India should not allow research on GM rice, nor allow it to be imported or planted.
Ignoring the science
Biosafety and risk assessment need to be thoroughly revised. The draft makes recommendations that are irresponsible and potentially dangerous to the environment and human health. Far from adopting a precautionary approach, as advocated even by international treaties like the Biosafety Protocol, the report makes a departure from the established principles of biosafety and risk assessment that are practiced in other countries. A truly alarming recommendation is to do with the introduction of foreign genes into different kinds of crop plants. The draft strategy document recommends that "an event that has already undergone extensive biosafety tests should not be treated as a new event even if it is in a changed background."
This kind of carte blanche to the producers of GM products, putting at risk not just farmers' livelihoods but also the environment and the health of consumers, is unprecedented and should be revoked immediately. Following the principles of good science and principled biosafety assessment, all events in new backgrounds must be subjected to full biosafety tests.
Further, the biotech policy document states that even if the foreign gene has been changed and modified and then inserted into a new host plant, there is no requirement to conduct tests for allergenicity and toxicity if there is 'no significant modifications in protein conformation'. This is unacceptable and dangerous and must be revoked. Complete biosafety testing must be required if the gene is altered in any way:
Nothing in such a context can be considered 'insignificant' because a change that is not radical can have radical outcomes. Especially with respect to allergens and toxins in crop plants, it is well understood that the creation of new allergens and toxins is a complex affair influenced by a number of micro factors. Acknowledging this, the WHO and FAO are compiling an atlas of the known allergens in food plants so that these can be monitored when genetically modified plants are created and used as food. It is insupportable that the national strategy report makes the astonishing recommendation of dispensing with testing for the presence of allergens and toxins.
The Policy must take a clear position on crops and traits that are permissible and those that are not. GM crops that could have harmful social or economic impacts for farmers and consumers, those that are frivolous and those that will displace labor and impact rural livelihoods must be banned in this country. Herbicide tolerance should not be used in this country for it brings no significant advantages but would destroy sources of supplementary nutrition and underutilized food sources, it would destroy vegetation that is used as supplementary fodder for livestock and it would destroy flora used as medicinal plants, in addition to taking away a significant source of wages, especially for rural women.
The Policy must apply to the country as a whole, and not differentiate between public and private sector. The draft policy merely says that "public funding should be avoided to research areas of low priority or those that could reduce employment and impinge the livelihood of rural families". Why should just the public sector be restrained? Why not the private sector as well? Why does the draft policy pander to the GM seed industry? Can they go ahead and produce crops that reduce employment and impinge the livelihood of rural families?
The biotechnology policy must take a clear position on crucial issues like fixing liability for biotech products that end up causing damage otherwise the signal to the biotechnology industry will be that it is open season in India and producers of biotechnology seeds and other products can come and do things here that no other country will allow. Liability and Redress is part of the Cartagena Protocol and we must develop and implement a comprehensive domestic regime so that if something goes wrong the owner of the GM crop can be held liable. The biotech policy must ensure that this is in place before any further release of GM crops is allowed. The Food and Feed Safety testing regimes that are currently ad hoc must be brought up to the highest international standards.
GM foods should not be allowed until sufficiently high standards of testing and adequate quality control are put in place, and data on this is publicly available. The recent report of the Monsanto study on the organ damage and compromised immune system of rats fed with GM corn, should be an eye opener. The biotech policy must place the highest emphasis on ethical practices. We need to take a position on what we consider ethical science and what would not be considered permissible. Transparency, the precautionary principle and public interest must constitute the cornerstones of our national policy, implemented with the highest levels of technical competence. And there must be sufficient time for an open discussion for people to understand the contents of the document and express their views on it. This draft policy is in need of a comprehensive revision if it is to contribute to a safe and equitable development of this sector.