Chapter: National Issues

Topic: Unconstitutional, Unethical, Unscientific

Q. What are the flaws and deficiencies of proposed BRAI Bill?

Ans. It is now widely accepted that the existing procedure in India (and even elsewhere) for regulation of genetic engineering technology is faulty and insufficient. It was for this reason that Jairam Ramesh, then Minister for Environment and Forests, put an indefinite moratorium on the open release of genetically engineered Bt brinjal, which was approved by the Genetic Engineering Approval Committee of the Ministry on October 14, 2009.

The Biotechnology Regulatory Authority of India (BRAI) Bill, proposed to be put up to Parliament, claims to take care of the deficiencies in the existing system of approval of genetically modified (GM) crops.

As it turns out, the Bill is unconstitutional, unethical, unscientific, self- contradictory, and not people-oriented. It suffers from greater flaws and deficiencies than the present system. If passed, it will seriously and adversely affect agriculture, health of humans and animals, and the environment, causing unparalleled harm.

• Article 28 of the Bill states the information declared by BRAI “confidential commercial information” will not come under the RTI Act, and there is no way civil society can challenge its decision to declare any information confidential. In spite of the fact that BRAI encompasses activities that would virtually affect every Indian, there is no mention in the Bill of public consultation.

• Articles 81, 86 and 87.2, which allow BRAI to override any existing law in the areas covered by BRAI, contradict Article 86, which says “the provisions [of BRAI] shall be in addition to, and not in derogation of, any other law for the time being in force.”

• The definition of modern biotechnology in Article 3 (r) is absurd as it excludes a large number (over 25) of areas such as peptide synthesis, immuno-technology, tissue culture, stem cells and nano-biotechnology that are an integral part of today’s biotechnology. Not only that, it would make techniques that are used in everyday research in modern biology such as isolation or sequencing of DNA and the PCR technique illegal, unless approved by BRAI in every specific case. So every university in the country teaching these extremely widely used techniques will have to get BRAI permission for teaching them to undergraduate and postgraduate students.

• Funnier is the inclusion in Schedule I (which lists organisms and products “which should be regulated by the Authority”) of cloned animals, DNA vaccines, and stem cell-based products. There is no mention of them in the main text of the Bill. Schedule 1 also includes “products of synthetic biology for human or animal use.” I have been in the business of modern biology for six decades and seen the modern biological evolution from very close quarters with more than 20 of my friends having won Nobel prizes but, for the life of me, I cannot make out what is meant by “products of synthetic biology.”

• In fact, if one strictly followed item 2(d) of Schedule 1, no organ transplantation would be possible in the country without BRAI permission!

• There is no provision in the Bill for an independent testing laboratory for GM crops, in which civil society would have confidence. There is no mention of mandatory labelling of GM food products, and there is no protection provided to, say, farmers whose fields growing, for example products of organic agriculture, get contaminated with a GM product of the neighbouring farm.

• Article 62 under “Offences and Penalties” is unprecedented. It implies that anyone making a statement about a GM crop which BRAI decides is false or misleading, shall be punished with imprisonment for a term which may extend up to three months and also with a fine which may extend to Rs. 5 lakh. BRAI will not be obliged to state the basis of its decision which is not challengeable by any member of civil society. The Bill thus assumes that all the wisdom of biotechnology lies with the five members of the Authority, and what thousands of leading scientists say will cut no ice with the members of BRAI.

As of today, at least five States (Bihar, Madhya Pradesh, Kerala, Karnataka and Himachal Pradesh) have formally declared that they will not allow field trials and/or open release of any GM crop. So, the present system had to be disabled, and roadblocks to fulfilling the ambition of the U.S. and the seed MNCs removed.

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