Shortcuts always lead to problems, and nowhere is this more evident than in the biotechnology sector. Research in genetically modified organisms (GMOs) crops was permitted, both in the public and private sectors, even before a clear policy was in place and before any guidelines had been formulated on the priority areas for Indian agriculture. Nor was any socio-economic survey, vital for understanding the implications of introducing such high-tech crops, ever conducted before releasing the first GM crop, the Bt cotton. And the regulatory system, manned mostly by bureaucrats till recently, was clearly not up to the task of tackling the complex issues related to the sector because of their limited understanding of the technicalities. The result: A host of concerns about the environmental and health effects of GM crops that have not been addressed clearly.
However, the remedy that the government is proposing in the form of the Biotechnology Regulatory Authority of India (BRAI) Bill, 2009, promises to compound the problems. What the government wants to set up in place of the Genetic Engineering Approvals Committee (GEAC), the apex regulatory body with representation from several ministries, is a three-member regulator that will act as single-window clearing house for all GM commercial applications. With the processing of such applications as its primary mandate, the Bill, scheduled to be introduced in the current Budget session of Parliament, ignores the basic premise for biotech regulation.
| REVIEWING RISK MANAGEMENT | |
| CRITICAL OMISSIONS | DANGEROUS PROVISIONS |
| Not a broad-based body representing diverse fields | Act to have overriding effect on other laws |
| No participation of state governments, stakeholders (farmers & consumers groups) or public interest groups | Jail and stiff fines for those who mislead the public about the safety of GMOs* and products |
| Risk management neglected | No disclosure of confidential commercial information but this information not defined |
| No provision for liability, redressal or recall of products | Union government can give directions to the Authority |
| No clear provision for revocation of approval to prevent harm to public or environment | Union government can amend Schedule I (list of specified organisms and products) |
| Post-marketing surveillance and monitoring absent | Permits delegation of authority to the chairman |
| Statutory Bioethics Commission
* Genetically modified organisms | |
This was articulated clearly in the 2004 Task Force Report on Agricultural Biotechnology, which was accepted by the Union government in 2005. The task force, headed by M S Swaminathan, the grey eminence of Indian agriculture, had said: “The bottom line of our national agricultural biotechnology policy should be 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 in farm commodities.” In keeping with this guiding principle, the task force had recommended a statutory and autonomous National Biotechnology Regulatory Authority (NBRA) with two wings: One for agricultural and food biotechnology and the other for medical and pharmaceutical biotechnology. Agriculture Minister Sharad Pawar had promised then that the NBRA would be set up within a year.
The primary reason for the delay in setting up NBRA, which has morphed into BRAI, is the turf war. While the GEAC, which the BRAI replaces, is under the jurisdiction of the Ministry of Environment and Forests (MoEF), the Department of Biotechnology (DBT), which come under the Ministry of Science and Technology, has formulated the Bill while the Ministry of Agriculture is nowhere in the picture. This, in fact, is the biggest sticking point and critics of the Bill say there would be a serious conflict of interest if BRAI is housed under the Ministry of Science and Technology. The recent controversy over the Science & Technology Minister Prithviraj Chavan quoting large tracts from a report prepared by the global GM seeds and biotech industry to make the case for the introduction of Bt brinjal has not helped inspire confidence in the DBT-sponsored Bill.
Environment Minister Jairam Ramesh, who describes the provisions of the proposed regulation as “unacceptable”, claims that his ministry or the Ministry of Health is better suited to be the nodal department for the autonomous authority. Experts, however, say this is a deflection from the core concerns over the Bill. Plant geneticist Suman Sahai, who was on the Planning Commission’s Task Force on Biodiversity and Genetically Modified Organisms (GMOs) for the XIth Plan, says the problem with the regulatory system is that “it lacks technical competence, transparency and stringency”, and that new Bill does nothing to set right these shortcomings. Worse, “there is utter confusion in the way the different bodies are constructed in the new Bill with no understanding of their different functions and responsibilities”.
Sifting through the expert views on the issue, a key concern appears to be the lack of guidelines in the BRAI Bill — the principles that will shape the functioning of the regulatory authority in deciding the biosafety of GM crops. In short, the nuts and bolts are missing from this structure.
Instead, the Bill attempts to impose an undemocratic, secretive system that cannot be challenged under the laws of the country. The most egregious of these provisions is Section 63 which allows for imprisonment and hefty fines for “whoever, without any evidence or scientific record, misleads the public about the safety of the organisms and products in Schedule I”. Besides, the proposed law will override other statutes like the Right to Information (RTI) Act and the Environment Protection Act. In sum, details of BRAI’s decisions cannot be sought by the public, nor can these be legally challenged. In all other spheres of government and regulatory activity, it is the Central Information Commission that decides what information can or cannot be disclosed, and even its ruling can be challenged in the courts.
In fact, there is no provision for public participation in the regulatory process, which is expressly mandated under the Cartagena Protocol on Biosafety to which India is a signatory under the Convention on Biosafety. According to this global treaty, any statutes on biotech issue must include a systemic mechanism to ensure public participation in decision-making by representatives of farmers’ lobbies and consumer groups.
Equally undemocratic and violative of the Constitution is the fact that states have been kept out of the regulatory process although agriculture — and health, for that matter — is a state subject. The Bill envisages only an advisory role through the State Biotechnology Regulatory Advisory Committee. Apart from hitting at the federal structure on agriculture and health issues, the BRAI will impinge on, if not override, other laws like the better designed Biological Diversity Act which gives equal play to the states and Union government. Official sources are not forthcoming on the reasons for the draconian provisions on stifling public dissent or on the sidelining of states. “The regulations have been in the making since 2008 and everyone was aware of the provisions,” is the explanation from one source.
That hardly justifies the reasons for the flawed architecture of the legislation, where some of the provisions are in seeming conflict with one or the other regulation. Take, for instance, Sections 24 and 26 which relate to the procedure for risk assessment for the research, transport, import, organism and product and the procedure for grant of authorisation for manufacture or use of organism and products, respectively. It is not clear whether the Product Rulings Committee will be the final arbiter of risk assessment or whether its reports will form the basis for such evaluation by the risk assessment unit.
But, of more concern is the fact that independence, impartiality or autonomy of this three-member body can be easily undermined. Under Section 75, the Central government is allowed to give directions to the regulatory authority, allowing it to “interfere with matters that are scientific and technical in nature.” Sahai, who is convener of the farmers’ rights group Gene Campaign, has been fighting a long battle in the Supreme Court — her PIL was filed in 2004 — to ensure stringent and transparent regulations for GM crops, and she says it’s high time a credible authority was in place.
The larger issue with the BRAI is that risk management is almost absent from its agenda. Not only is there is no stipulation for revocation of approval by the authority to prevent any possible harm to the environment or public health, there is also no strong provisions for liability. Missing here are express clauses for redressal or compensation and measures for remediation and clean up in the event of an ecological disaster, says Kavitha Kuruganti of the Kheti Virasat Mission, a civil society organisation working for sustainable agriculture.
The general verdict is that BRAI is the wrong Bill drafted by the wrong people for the wrong reasons. Given the old saw that no good product can came out of a bad system, the Bill spells bad news for the GM industry — and the country.
