Why We Oppose Biotechnology Regulation Bill

The Union Government has prepared the Biotechnology Regulatory Authority of India Bill, 2001 (BRAI in brief) for the regulation of the biotechnology sector in India. While the need for strong and careful regulation certainly exists keeping in view the serious threats posed to health and environment by the genetically modified (GM) crops, the BRAI can actually increase this threat by paving the way for the rapid spread of GM crops (or their field-trials) and this is the reason why it is being opposed strongly by a wide network of voluntary organisations, farmers’ movements, legal experts and others.

The Coalition for a GM-Free India (CGFI), which includes many such groups and experts, has stated in a recent critique of this Bill that at the time the Bill is being sought to be introduced, at least seven States have said No to GM crop trials; these include Bihar, West Bengal, Orissa, Madhya Pradesh, Chhattisgarh, Karnataka and Kerala. Earlier, during the Bt brinjal debate, 13 States had objected to approval for its commercial cultivation. Hundreds of villages across the country are also declaring themselves GM-free. “The BRAI Bill is a blatant attempt to bulldose through the public (reflected in the State governments’) resistance and genuine concerns about GM crops, and to deny the State governments their constitutional authority over agriculture and health.â€

The CGFI says: “if a technology is inherently unsafe, no amount of regulation can make it safer as is the case with the use of genetic engineering in our food and farming systems†. Nevertheless, keeping in view the existing realities when a regulation system has to be introduced then the main purpose of biotech-nology regulation should be “to protect the health (human and animal) and environment of India from the risks posed by modern biotechnology and its applications†. Therefore, what we need a National Biosafety Protection Authority.

This so-called autonomous regulatory authority should not be housed under the Ministry of Science and Technology, given that this is a Ministry with a mandate to promote biotechnology. This Authority should be under the Ministry of Environment and Forests or under the Ministry of Health and Family Welfare or under both.

A serious objection relates to overcentralisation on the one hand, and significant erosion of the role of State governments on the other. The BRAI proposes to take away the constitutional authority that the State governments have over their agriculture and health in the Indian federal structure. The proposed Bill envisages only an advisory role for the State governments in the form of “State Biotechnology Regulatory Advisory Committees†with no decision-making powers. Section 35 details the constitution of a State Biotechnology Regulatory Advisory Committee where it is provided that it will be headed by the Secretary or head or Commissioner of Biotechnology. “This is again an attempt to keep all the committees under the ambient and control of the Science and Technology Ministry, which reflects that promoters can be regulators.†Section 87 states that if there is any law in any State corresponding to this Act it shall stand repealed when this Act comes into being.

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THE proposed legislation has no clauses on public participation, other than one small mention through Section 27 (5) that public feedback will be obtained. An important part of the CGFI critique relates to absence of transparency in BRAI.
This Bill, despite the enormous criticism being heaped on the current regulatory regime for its opaque functioning, does not have any pro-active measures and mechanisms to institutiona-lise a transparent regulatory regime. It does not pro-actively propose that data at various stages of decision-making would be put out in the public domain for independent scrutiny. Worse yet, this Bill, through Section 28, expressly seeks to classify some information as Confidential Commercial Information and leaves it to the discretion of officials of the Authority to share or not share this information. This is regressive, given that the Bt brinjal controversy saw express Supreme Court orders to the regulators asking them to put out all the biosafety data in the public domain (this and the CIC orders earlier to that have more than established the principle that no biosafety data can be confidential commercial information and such data has to be put out in public interest). Further, the BRAI Bill 2011 has clauses on oath of secrecy.

Another important criticism is related to the very weak panel clauses. As the critique states,

The Bill has very weak penal clauses and in fact does not address liability issues at all: without a liability regime in place, no regulatory regime is complete on this issue. The polluter pays principle has to be an integral part of the regulatory regime for GMOs.

On one hand no mechanisms are provided for prevention of contamination, and on the other, no liability regime is in place. In addition under Sections 67, 68, 69 it is promised to the offender entity that if they can assure that offense was committed “without their knowledge†and “all due diligence was exercised†they will not attract punishment. Combined with the fact that offenses in this category can’t be taken to normal courts (save on a complaint made by the Authority!) and can be tried only with the appellate tribunal and offending entity would be a powerful corporation or government department against a small time farmer or some such complainant (who would be injured party), the scales of justice seem awfully imbalanced.

Various provisions together amount to a situation of denial of justice on critical issues of food security, health and environment. As the critique underscores,

It is unacceptable that the Bill has a clause which says that no court shall take cognisance of any offence punishable under this Act save on a complaint made by the Authority or any officer or person authorised by it! What is the rationale for this other than to protect offenders? Equally objectionable is Section 77 which prevents civil courts to have jurisdiction on any matter which the Appellate Tribunal under the Act is empowered to determine, wherein there is a bar on any injunction to be granted by any court in respect of any action taken by the Authority... All these sections together undermine the right of the public and affected parties to get justice. Again on this count the proposed bill is unconstitutional s in limits the public’s access to justice.

Therefore the CGFI critique concludes: “The Coalition for a GM-Free India rejects the Biotech-nology Regulatory Authority of India Bill 2011 being proposed by the Ministry of Science and Technology—it is a wrong Bill drafted by the wrong people for the wrong reasons.“