To GE or not?

by Shalini Bhutani | September 28, 2011

A sense of deja vu dawns as one reads the opening lines of the Biotechnology Regulatory Authority of India Bill, 2011 (“the Bill”) – yet another version of a bill covering genetic engineering (“GE”) and more. The text of the Bill was only made open in mid-August literally hours before it was to be tabled in the Lok Sabha.


As per due parliamentary procedures, the Minister of Science and Technology and Earth Sciences informed the Secretary General of the Lok Sabha about the Bill on July 27, 2011. It was listed for being introduced by the Minister on August 17, 2011. The issue has never been debated in Parliament. Many Parliamentarians still stay blissfully unaware of the implications of modern biotechnology in agriculture and the making of a law on the subject.


The only other law that talks about biosafety is the Biological Diversity Act, 2002 (“the Act”), using which Central Government shall regulate, manage, or control the risks associated with the use and release of living modified organisms resulting from biotechnology likely to have adverse impact on the conservation and sustainable use of biological diversity and human health. (See, Section 36(4)(ii) of the Act). This provision however, has never been invoked.


The idea of having a new regulatory regime and a law for the purpose goes back to 2003 when theCartagena Protocol on Biosafety (under the Convention on Biological Diversity) came into force. The very same year, the Ministry of Agriculture constituted the Task Force on the Application of Agriculture Biotechnology in India (“the Task Force). As mentioned in the Statement of Objects and Reasons of the Bill, the Task Force recommended the establishment of an “autonomous, statutory, and professionally-led National Biotechnology Regulatory Authority.”



Sharad Pawar and M.S. Swaminathan

Dr. M.S. Swaminathan, the Chairman of the task force on the applications of biotechnology in agriculture, presents the report of the task force to the Union Minister of Agriculture, Sharad Pawar, on June 2, 2004.

Image above is from the website of the PRess Information Bureau here.

Previous attempts to table bills on this issue have been futile. The first legislative draft was the National Biotechnology Regulatory Authority Bill, 2008 (“the NBRA Bill”). Widespread protests from farmer groups, agriculture activists, and concerned individuals led to the NBRA Bill being dropped. In its proposed form (tagged to the very ministry that has the function to promote biotechnology), the regulatory authority was evidently not so independent. The bill was subsequently reincarnated in 2009 by the Department of Biotechnology (“the DBT”) that comes under the purview of the Ministry of Science and Technology. Even the current Bill does not correct the situation of autonomy. In fact, a provision in the Bill expressly gives the Central Government powers to supersede the proposed Biotechnology Regulatory Authority. The decision of the Government of India would be final. (See, Sections 75 and 76 of the Bill)

In the coming days many critiques and analyses of the Bill’s eighty-eight sections will emerge. The very gist of the Bill lies in its expanded title.



“A Bill to promote the safe use of modern biotechnology by enhancing the effectiveness and efficiency of the regulatory procedures and provide for establishment of the Biotechnology Regulatory Authority of India and to regulate the research, transport, import, manufacture, and use of organisms and products of modern biotechnology and for matters connected therewith or incidental thereto.”

There are certain products, processes, and procedures of modern biotechnology, such as GE that warrant special handling. The technology is yet to be proven ‘safe’ by independent scientific assessment. In such a situation, its promotion is unwarranted. Clearly the Government of India, or at least the Ministry of Science and Technology, believes that our current knowledge of GE is sufficient. It is now official that its makers believe in the application of modern biotechnology in agriculture, food, forests, and animal health care. India however, is yet to develop expertise and technical know-how to be able to test for GE.


As regards “enhancing the effectiveness and efficiency of the regulatory procedures”, no matter how “efficient” the regulatory procedures may be, the fact is that the very nature of the technology makes it impossible to contain or recall. A crop variety, an animal breed, or a microorganism interacts with its environment by the laws of nature and not the laws of Parliament. Genetic material foreign to the natural structure of a living organism can also pass on to unintended species or contaminate the soil, water, or cattle in contact with it. It is near impossible to localise and clean up such a (bio) spill in the open environment.


Nonetheless, the DBT has been very keen to turn this law into reality. The Association of Biotechnology Led Enterprises – Agriculture Group (ABLE-AG) has supported of the Bill. The industry seeks predictability in decision-making on approvals for GE clearances and favours a single-window clearance for GE applications. The Bill clearly centralises the decision-making.


The Monsoon Session of Parliament closed on September 8, 2011 without Bill being tabled. In the Winter Session, it might again make an appearance on the Lok Sabha’s list for business. Whether it will see the light of day is anyone’s guess. There is some obvious confusion in the re-writing of the Bill that needs to be sorted out. For example, Section 81 of the Bill proposes overriding effect for the law. Section 86 however, suggests that states that the provisions do not derogate from any other law in forceThe biggest confusion to sort out before pushing such a Bill however, is whether GE is to be or not to be.

Shalini BhutaniShalini Bhutani is a Delhi-based lawyer working independently on issues of trade, agriculture, and biodiversity.


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