India doesn’t need a Biotech Regulatory Authority but a Biosafety Protection Authority

Reacting to reports on the Cabinet clearance given to the Biotechnology Regulatory Authority of India (BRAI) Bill, members of the Coalition for a GM-Free India strongly reiterated that this Bill should be stopped in its tracks. Repeating that the mandate of this Bill is to set up a clearing house for approving GMOs (Genetically Modified Organisms) in our food and farming, they said that they would step up pressure on the Government of India to discard this ‘wrong bill by the wrong people for the wrong reasons’.

“We believe that any law related to regulation of GM crops/foods should have as its basis the protection of the health and environment of Indians from the risks of biotechnology. In fact, that was the basis of the Environment Protection Act’s 1989 Rules which were the basis for the current regulatory regime in India. If this fundamental shift in the statutory approach to regulation of GMOs is happening now, the Government of India should be able to justify the grounds on which this is happening, especially since more and more evidence is emerging on the adverse impacts of the technology”, said Dr G V Ramanjaneyulu, Executive Director, Centre for Sustainable Agriculture.

“Increasingly, we are seeing state governments being bypassed in the law and policy formulation related to various aspects of our agriculture even though Agriculture is a state subject as per the Constitution of India. This is being attempted with the Seeds Bill too, and now the BRAI expressly seeks to supercede such constitutional authority vested with state governments. This is simply not acceptable – obviously, if things go wrong tomorrow, it is the state government’s doors that farmers will be first knocking on tomorrow. This is also against the spirit of local self-governance enshrined in the Constitution starting from the Gram Panchayat”, said Nilesh Desai, Beej Swaraj Abhiyan, Madhya Pradesh. The Madhya Pradesh has already fired the first salvo against the Cabinet approval to the Bill and said that it would fight it tooth and nail.

“We do not believe that tinkering with the existing Bill here and there will do – we need this Bill to be scrapped, to be replaced by a comprehensive, people-friendly biosafety protection legislation. There is just no evidence on the scientific or social fronts to support the government’s complacent pro-GM view”, said Umendra Dutt of Kheti Virasat Mission, Punjab.

Many analysts see this as the government’s and the biotech industry’s attempts to bring in Bt Brinjal, stuck in a moratorium for now, through the backdoor. The BRAI being housed under the Department of Biotechnology is being objected to strongly in addition to the lack of mechanisms for transparent and democratic functioning for protecting health and environment from the hazardous technology of Genetic Engineering. It is worthwhile to remember here that that the need for an independent and credible regulatory regime was articulated by the 2004 Task Force Report on Agricultural Biotechnology and this report clearly pointed out that the following should be the bottom line for any biotechnology regulatory policy: the safety of the environment, the well being of farming families, the ecological and economic sustainability of farming systems, the health and nutrition security of consumers, safeguarding of home and external trade and the biosecurity of the nation”. These important aspects or cornerstones do not find any place in the proposed Bill sought to be introduced.

BRAI bill – some main objections:

  • Mandate is to approve genetically modified (GM) crops and not to safeguard the health of the citizens or the environment. It will become a smooth single window clearance system for GM crops and also poses a question mark on the moratorium imposed on Bt Brinjal on scientific grounds through democratic processes. The approvals also presume that the safety of a GM crop can be best assessed by the company which stands to benefit from the approval.
  • BRAI sits inside the Ministry of Science and technology creating serious conflict of interest. Dept of Biotechnology – under the Ministry of Science &Technology, has the mandate of promotion of GE crops. DBT funds several GE crop development projects using public funds and is the nodal agency for redirecting funds from foreign governments to GE crop development projects.
  • It will leave the decisions in the hands of a few technocrats and neither elected governments nor public will have any say in decisions on GM crops. The bill proposes a centralised, technocratic decision making authority with no scope for democratic intervention. The apex authority is the BRAI with a chairperson and two members, all scientists with either a biotech or a health background.
  • State governments who are constitutionally mandated to take decisions on agriculture will be superceded by BRAI.
  • Removes BRAI from the purview of the Right to information Act.
  • Created through a non-transparent, non consultative process.

What does the Coalition demand instead?

Any regulatory regime around GMOs should have the primary mandate of protecting health of people and the environment from the risks of modern biotechnology. It should necessarily have the following components as cornerstones of the legislation:

  • Precautionary Principle as the central guiding principle
  • Going in for the GM option only in case other alternatives are missing
  • Separating out very clearly the phases of contained research and deliberate release and distinct regulatory mechanisms for both, in a sequential fashion
  • No conflicting interests to be allowed anywhere in the regulation and decision-making
  • Transparent functioning: information disclosure and public/independent scrutiny
  • Democratic functioning including public participation – even here, data to be put out in the public domain and public participation included before the decision-making process and not just informing after a decision is made
  • Risk assessment – (a) prescribing rigorous, scientific protocols and asking the crop developer to take up studies and then do independent analysis of the dossier supplied by the crop developer and evaluate/review of the same; (b) to also take up independent testing by having all facilities and institutional structures in place for the same and evaluating the results
  • Risk management – including monitoring, reviewing, revoking of approvals
  • Liability – including penal clauses, redressal and remediation
  • Labeling regime for informed choices – this covers traceability and identity preservation requirements
  • Oversight and appellate mechanisms
  • In the case of India, given that it is a federal structure and given that Agriculture is a state subject, special clauses which allow the state governments to form their own regulatory systems and mechanisms
  • On-going Post Market monitoring of every GM crop

Further, the law should be governed by principles like Polluter Pays, Inter-generational equity (a key principle in environmental jurisprudence now which covers conservation of options, conservation of quality and conservation of access, for present and future generations) etc. In countries like Norway, the law also has provisions to answer questions like “Is this ethically and socially justifiable?”, before a GMO is cleared. That would automatically include socio-economic and ethical concerns within the regulatory regime.

Pankaj Bhushan, convener, GM Free Bihar Movement said it is disastrous.


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