Biotechnology Regulatory Authority Bill 2013 | Science & Technology for UPSC CSE PDF Download

The Biotechnology Regulatory Authority of India Bill, 2013

Ministry

Science and Technology

• Introduced
  Lok Sabha
  Apr 22, 2013
• Referred
  Standing Committee
  May 17, 2013
• Report
  Standing Committee
  Extn upto June 03, 2014

Highlights of the Bill

• The Bill sets up an independent authority, the Biotechnology Regulatory Authority of India (BRAI), to regulate organisms and products of modern biotechnology.
• BRAI will regulate the research, transport, import, containment, environmental release, manufacture, and use of biotechnology products.
• Regulatory approval by BRAI will be granted through a multi-level process of assessment undertaken by scientific experts. 
• BRAI will certify that the product developed is safe for its intended use.  All other laws governing the product will continue to apply. 
• A Biotechnology Regulatory Appellate Tribunal will hear civil cases that involve a substantial question relating to modern biotechnology and hear appeals on the decisions and orders of BRAI.
• Penalties are specified for providing false information to BRAI, conducting unapproved field trials, obstructing or impersonating an officer of BRAI and for contravening any other provisions of the Bill.

Key Issues and Analysis

• The Tribunal has jurisdiction over a ‘substantial question relating to modern biotechnology’. However, the Bill does not define this term.  Leaving a term undefined could allow for flexibility but could also increase ambiguity.
• The Tribunal will consist of one judicial member and five technical members.  This is not in conformity with a Supreme Court decision that the number of technical members on a bench of a Tribunal cannot exceed the number of judicial members.
• The Tribunal’s technical members shall be eminent scientists or government officials with experience in the field.  It is unclear whether the technical expertise of the latter can be equated with the former.
• The Bill does not specify any liability for damage caused by a product of biotechnology.  Therefore, it will remain open to the courts to determine liability arising out of any adverse impact of modern biotechnology.
• Various committees have recommended that an autonomous statutory regulator having members with expertise in biotechnology be set up.

Us Imperialism and The Brai Bill

• Just as the greatest support for BRAI comes from corporations and a section technocrats and agricultural scientists, US imperialism also has a direct role in the matter. One of the major goals of US imperialistic interests is to fundamentally change the nature of Indian agriculture, and make it subservient to the interests of multinational corporations, especially US multinational corporations. The inception of this process was on the 18th of July 2005, when the Ex- Prime Minister Dr. Manmohan Singh and the then US president George Bush signed the “US-India Knowledge Initiative on Agricultural Education, Teaching, Research, Services and Commercial linkages” or the KIA agreement. 
• As a result of this treaty, the control of the US based multi-nationals was consolidated on all areas of agriculture in India, from agricultural research to the marketing and retail sale of agricultural products. As a part of this treaty, a board was established whose main objective was to implement the different aims of the agreement, and thereby usher in the “second green revolution”. The greatest emphasis in KIA was laid upon the massive application of biotechnology in Indian agriculture. 
• Under the KIA, one of the approaches that these multi-nationals would be taking to establish their hold over Indian agriculture is to take control of the huge agricultural research system in India and use it for research and commercialization of biotechnology products. Their main target is the huge research infrastructure of the Indian Council for Agricultural Research (ICAR) consisting of 59 institutes, 17 national labs and 78 research projects spread all over the country. Besides this, there are also grants for several hundred research projects in the 50 agricultural universities across India. In all, a huge infrastructure to be potentially used for agri-biotechnology. 
• The KIA effectively ensures the control of the US based multi-nationals over this infrastructure. But even then, the issue of government regulations on the commercialization and marketing of GM-crops remained. And because of this, in order to fully implement the Indo-US agricultural knowledge treaty, it became necessary to establish the BRAI, which will make the commercialization process of GM crops simple and amenable to the interests of multinational corporations.
• It is worth noting that at the time when the new BRAI draft act was published in 2009, unknown to the Parliament, an US-India memorandum-of-understanding (MOU) related to “cooperation in agriculture and food security” was signed during the visit of the US foreign secretary Hillary Clinton to India. The objective of the MOU was to increase US investment in the Indian food and agriculture sector. 
• Under the guise of “cooperation in agriculture”, this MOU opened the door for privatization of the agricultural research system and flooding the Indian food market with GM food crops under “food security”. It is easily understandable that the passing of the BRAI bill is intimately linked with the interests of US imperialism in India and with the interests of the multinational corporations, whose interests are served by US imperialism[xviii].

What Does India Need Instead?

India needs a Biosafety Protection Legislation. Any regulatory regime around GMOs should have the primary mandate of protecting health of people and the environment from the risks of modern biotechnology and should also realize that transgenic technology is being actively rejected by citizens and governments all over the world and is not a fait accompli. 

It should necessarily have the following components as cornerstones of the legislation[xix]:

• Precautionary Principle as the central guiding principle.
• Going in for GM option only in case other alternatives are missing and only if proven safe, including in the long-term.
• Separating out very clearly the phases of contained research and deliberate release and distinct regulatory mechanisms for both, in a sequential fashion.
• No conflict of interest to be allowed anywhere in the regulation and decision-making.
• Transparent functioning: information disclosure and public/independent scrutiny.
• Democratic functioning including public participation.
• 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 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; Liability Regime to cover both crop developers and regulators.
• Labeling regime for informed choices covering traceability requirements, including for imports.
• Oversight and appellate mechanisms that are simple, affordable and accessible by affected parties and ones who can approach in public interest, without time limit set.
• Given India’s federal structure with Agriculture as a state subject, special clauses to allow state governments to form their own regulatory systems and mechanisms; similarly, protection of the constitutional authority of Gram Sabhas over their natural resources.

Conclusion

The BRAI bill would do no good if it comes into force in its present structure. If it is passed by the government as it is, then Bt Brinjal, Bt Rice and some 40-odd food crops would be at risk. The bill attacks the very constitutional rights of the citizens, including their right to information, their right to choose, even their right to seek redressal under court. The bill envisages a limited role for the state government. The choice of safe food along with the right to ask for it would be crushed underneath the multinational giants, who would then take over the agricultural sector of this country. The farmers would be left at their mercy and very soon out country would witness another advent of mass suicides by farmers if this bill comes into force. The legislation should be made to enhance biosafety and ensure democracy in the country and not otherwise.