Biotechnology Regulatory Authority Bill of India

• 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.

A number of people and organizations are opposed to BRAI, including Greenpeace. Reasons given for opposition include:

• The bill bypasses the Right to Information
• The technical expert committee recommends that the regulatory body be located in the MoEF and the Ministry of Health and Family Welfare. The BRAI under the Ministry of Science and Technology will clearly result in a conflict of interest.
• Deviation from task force report
• Authority of state government is undermined because agriculture is a state subject under Indian constitution.

The key areas of controversy related to GMO food are whether such food should be labeled, the role of government regulators, the objectivity of scientific research and publication, the effect of genetically modified crops on health and the environment, the effect on pesticide resistance, the impact of such crops for farmers, and the role of the crops in feeding the world population.

The release of transgenic crops in India is governed by the Indian Environment Protection Act, which was enacted in 1986. The Institutional Biosafety Committee (IBSC), Review Committee on Genetic Manipulation (RCGM) and Genetic Engineering Approval Committee (GEAC) all review any genetically modified organism to be released, with transgenic crops also needing permission from the Ministry of Agriculture. India regulators cleared the Bt brinjal, a genetically modified eggplant, for commercialization in October 2009. Following opposition from some scientists, farmers and environmental groups a moratorium was imposed on its release in February 2010.

Biofortification- Biofortification is the process by which the nutritional quality of staple crops is enhanced. This is done through conventional plant breeding and/or modern technology. More research is needed, but it is hoped that people who consume biofortified crops will have an improved nutritional intake.

Various Biofortification projects are underway, including:

• iron-Biofortification of rice, beans and sweet potato
• zinc-Biofortification of wheat, rice, beans, sweet potato and maize
• Provitamin A carotenoid-biofortification of sweet potato, maize and cassava.

Biofortification capitalizes on the consistent daily intake of food staples, thus indirectly targeting low-income households who cannot afford a more diverse diet. Biofortified crops, either by conventional breeding methods or by modern biotechnological tools, are not a panacea. The ultimate aim in global nutrition remains a sufficient and diverse diet for the world’s population. However, biofortified crops can complement existing micronutrients interventions, can have a significant impact on the lives and health of millions of people, especially those most in need.