Developers cannot be Regulators
Posted on Thursday, February 18th, 2010
The Biotechnology Regulatory Authority of India Bill 2009 is nothing but a proposal for deepening the Regulatory Chaos and the Crisis Created by Conflict of Interest
By Dr. Vandana Shiva
The proposed Biotechnology Regulatory Authority Bill of India, 2009 (BRAI) which is a new version of the older National Biotechnology Regulatory Bill, 2008 is a recipe for deepening the regulatory chaos as well as deepening the crisis created by conflict of interest issues related to issues of genetic engineering
The conflict of interest issues had become a major concern because the panel which approved the Bt. Brinjal included some of the scientists involved in its development. That is why the public hearings were organized by the Ministry of Environment. As the Minister of Environment observed in his statement justifying the moratorium “while there may be a debate on the nature and number of tests that need to be carried out for establishing human safety, it is incontrovertible that the tests have been carried out by the Bt. Brinjal developers themselves and not in any independent lab. This does raise legitimate doubts on the reliability of the tests.”
The proposed BRAI is an attempt to take the conflict of interest to the structural level by making the department and Ministry that promotes biotechnology, in charge of the regulation of Biosafety. This is equivalent to asking the wolf to protect the sheep. For this reason alone, Parliament should reject the Bill to set up BRAI.
The BRAI will also deepen the regulatory chaos. In response to a case I have filed in the Supreme Court on the safety of GM crops, the Government’s response was that the Food Safety and Standards Act, 2006 would address the lacunae in Biosafety Regulation. We now have another proposed Authority. And this is in addition to the existing Biosafety Law under the Environmental Protection Act 1986 (EPA) titled “The Rules for the Manufacture, Use / Import / Export and storage of hazardous micro-organisms / genetically engineered organisms or cells”, 1989. The substantial parts of what the BRAI will cover are already covered by the EPA rules. These include the regulation of –
- Any genetically engineered plant, animal, microorganism, virus or other animate organism that may have application in agriculture, fisheries (including aquaculture) forestry and food production
- Any genetically engineered plant, animal, microorganism, virus or other animate organism used as food
- Any animal clones that may have application in agriculture, fisheries or food production
It also includes DNA vaccines, transgenic blood, products of synthetic biology etc.
The proposed BRAI is in total denial of the existing Law. The proposed Law pretends we do not have a Law under the EPA. In the opening paragraph of the draft Bill it is stated that the Bill is drafted to implement the Cartagena Protocol on Biosafety to the Convention on Biological Diversity.
Firstly, India had a Biosafety Law put in place in 1989, fourteen years before the Cartagena Protocol came into force. That is why we did not need to create a new Law to implement the Biosafety Protocol. The BRAI is an attempt to dismantle the 1989 Law, and replace it with a Law for fast track promotion of GMOs.
Secondly, the Environment Ministry is the nodal Ministry for the Convention on Biological Diversity and the Cartagena Protocol. Even if we did not have a Biosafety Law under the EPA, which we do, it would be the Ministry of Environment that would be the responsible Ministry to implement International Law. The Department of Biotechnology and the Ministry of Science and Technology cannot usurp this role.
BRAI is the naked attempt by the Biotechnology Department to appropriate to itself the work of regulating biotechnology in addition to promoting biotechnology. Since 1997-98, when Monsanto first brought in Bt. Cotton seeds illegally to the country, the Department of Biotechnology, and the RCGM have been party to covering up the illegal activities of the Biotechnology industry. Its powers were to be restricted to framing guidelines for good lab practices. It has overstepped its powers and used guidelines to undermine clauses of the 1989 EPA Law. When I filed a case in the Supreme Court in 1998 to stop Monsanto’s illegal introduction of Bt. Cotton seeds, it is the DBT/RCGM which gave approval, even though all deliberate release of GMOs is to be approved by GEAC. DBT / RCGM arbitrarily decided to call field trials contained experiments, even though GM crops planted in fields are a deliberate release. DBT has undermined science to rush GMOs to the market. Its track record shows that it cannot be trusted with Biosafety issues. The DBT has been trying to erode the Biosafety structures since 1997-98. Now it is going all the way to hijack and usurp the work of the Environment Ministry and to illegally undermine the 1989 EPA Law, through the proposed BRAI.
Parliament should call for a white paper and an investigation on the role the DBT has played in undermining the independent regulation of Biotechnology and Genetic Engineering. Under no circumstances should the health of the people and the protection of the environment be left in the hands of the agency with a vested interest in promoting genetic engineering. Independent scientific assessment systems need to be put in place.
The 1989 Biosafety Law is an excellent science based legislation. What needs improvement is its implementation, and the working of the GEAC. The Minister of Environment has already announced that the GEAC would become the Genetic Engineering Assessment Committee and not just be a Genetic Engineering Approval Committee.
The Moratorium on Bt. Brinjal should be used to improve the Biosafety Regulatory Process, not dismantle it. The public hearings on Bt. Brinjal made it very clear that the public is seriously concerned about genetic engineering. They also made clear that there is a deep division between biotechnology technicians, rushing to blindly use the tools of genetic engineering, irrespective of their utility and their impact, and scientists from diverse fields who are aware of the ecological and health risks, and the socio-economic costs.
The Minister of Environment has stated that the Moratorium on Bt. Brinjal will stay till a scientific consensus emerges. Such a consensus can only emerge from open dialogue and debate.
The BRAI proposal is an attempt to silence the debate, hijack the policy space and the regulatory process so that those who have subverted science and democracy can have undemocratic power to decide the fate of the nation.
This cannot be allowed. It will lead to a dictatorship of the biotechnology lobby and the biotechnology industry.
The proposed BRAI Bill floated by the DBT must be rejected and our existing Law under the EPA and the Ministry of Environment must be upheld while we make its implementation more robust and more democratic, and more transparent.
It is outrageous that even after the overwhelming stand against Bt brinjal by farmers, civil society, scientists, students etc., the DBT could put forth such a draconian bill that in a totalitarian fashion takes control of our food sovereignty and biodiversity! Supreme authority rests with the NBRA with the proposed Inter-Ministerial Advisory Board being a mere eyewash. I would like to place my support in any way I can behind all efforts mooted to reject this Bill and lobby for upholding the 1989 Biosafety Law.
i woild like to know where to get the copy of the new 2009 Bill. please advise me on i.khan123@yahoo.com
secondly i would like to know if you had forwarded your comments at the time on the Bill in 2008?
thanks.