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Biotechnology Regulatory Authority of India Bill, Unconstitutional, unethical, unscientific

Written By Krishna on Wednesday, December 28, 2011 | 7:57 AM

PUSHPA M. BHARGAVA

The Biotechnology Regulatory Authority of India Bill, if passed, will adversely affect agriculture, health of humans and animals, and the environment, causing unparalleled harm.

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.

BRAI will consist of three full-time and two part-time members. It will have three divisions, each headed by a Chief Regulatory Officer. It will be supported by a Risk Assessment Unit, an Enforcement Unit, a Monitoring Office, a Product Ruling Committee, an Environmental Appraisal Panel, Scientific Advisory Panels, an Inter-ministerial Governing Board, a Biotechnology Advisory Council, and State Biotechnology Regulatory Advisory Committees. These bodies would consist mostly of bureaucrats who are likely to have little knowledge of the highly complex issues that arise in today's biotechnology. No civil society participation is proposed anywhere. Even the proposed Biotechnology Regulatory Appellate Tribunal will not accept complaints from civil society, in spite of the fact that the Bill directly or indirectly affects every citizen. It is not even clear which department of the Government of India will service BRAI.

The Convener of the Selection Committee for members of BRAI will be from the Department of Biotechnology (DBT), which is a vendor of genetic engineering (the technology that BRAI is supposed to regulate) in the country. The Bill says the members of BRAI will be persons of integrity. There is, however, no requirement of integrity for members of any of the other committees mentioned above!

The Bill is unconstitutional as agriculture is a State subject, and it takes away from the State government the authority to take decisions on GM plant products. In this connection, it is noteworthy that more than 10 States cutting across political affiliations formally told Mr. Ramesh in 2009-2010 that they would not permit Bt brinjal to be released in their territories.

No public consultation

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!

One would also have expected that the Bill, if it was people-oriented, to state the procedure to be adopted before approval of a GM product. The first step should be to determine the need for the product through a socio-economic survey and analysis. If there is need, then one should determine if there are cheaper, better and well-established alternatives such as smart or molecular breeding, organic agriculture, or use of Integrated Pest Management or bio-pesticides in the case of GM products containing a foreign pesticidal gene. If it is concluded that there is no alternative to, say, a GM crop, one would need to state a mechanism for deciding what tests the GM crop would need to undergo, and a statement of who will do the tests to ensure public credibility. There is no provision in the Bill for an independent testing laboratory for GM crops, in which civil society would have confidence.
No mention of mandatory labelling

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.

One may justifiably ask why this Bill. The reasons are clear. Food business is the biggest in the world. Whosoever controls it will control the world. To control food production, one needs to control just seed and agrochemicals production. This is what a handful of multinational seed companies, which are also producers of agrochemicals such as pesticides and weedicides, are attempting to do through patented GM crops. These companies are located in the United States, and liaise closely with the U.S. government.

In fact, one of the biggest quarrels between the U.S. and Europe is that Europe, by and large, does not allow GM crops and requires appropriate labelling of all food products that contain more than 0.9 per cent of GM material. No such labelling is required in the U.S. where, therefore, a person today does not know if he is consuming GM food.

Till a few years ago, there was no significant opposition to GM crops in India. In fact, the mechanism set up by the Government of India, ostensibly to regulate GM products, largely worked as a vendor of GM products, serving the interests of seed and agrochemical MNCs.
But, then, people of India became wiser and better-informed. Consequently, against all odds and expectations of the MNCs, and of the U.S. government and the rulers in India, we had an indefinite moratorium on Bt brinjal, and the opposition to GM crops became a force to reckon with. Some components of the existing regulatory system have also begun to assert themselves. 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. What better way to achieve this than by BRAI — so the government thought. But, I believe, the GoI has again underestimated the collective wisdom of the people of India!

(Pushpa M. Bhargava is former Vice-Chairman, National Knowledge Commission.)
http://www.thehindu.com/opinion/lead/article2752711.ece?homepage=true

Note: The Biotechnology Regulatory Authority of India Bill, 2011 is listed for introduction in the Winter Session of the Parliament. It endangers right to safe food for good. This traces its origins in 2005. A 18 page Draft has been in circulation since 2008 which is available at http://dbtindia.nic.in/Draft%20NBR%20Act_%2028may2008.pdf. Its opening sentence reads: "An Act to establish the National Biotechnology Regulatory Authority of India and to regulate the research, manufacture, importation and use of products of modern biotechnology."

The public participation in this matter has been only with business interests. Now a
68 page Bill is proposed without any democratic pretense whatsoever. The Bill is available at: http://www.prsindia.org/uploads/media/Biotech/Biotech%20Regulatory%20Auhority%20Bill,%202011.pdf Its opening sentence reads:"a Bill to promote the safe use of modern biotechnology by enhancing the effectiveness and efficiency of regulatory procedures and provide for establishment of the Biotechnology Regulatory Authority of India to regulate the research, transport, import, manufacture and use of organisms and products of modern biotechnology and for matters connected therewith or incidental thereto." It was listed in the LEGISLATIVE BUSINESS of November 22, 2011. Vilasrao Deshmukh was supposed to move for leave to introduce the Bill.

Biotechnology Regulatory Authority of India(BRAI) will be an autonomous body and statutory agency to regulate the research, transport, import, manufacture and use of organisms and products of modern biotechnology. The Authority will consist of one Chairperson, two full-time members and two part-time members. Each of them will have expertise in life sciences and biotechnology applications in agriculture, health care, environment and general biology. This information was given by the Minister of State for Science and Technology and Earth Sciences Ashwani Kumar in a written reply to a question by E G Sugavanam in Lok Sabha on September 8, 2011.

While the Bill is related to UN's Convention on Biological Diversity and Cartegena Protocol on Bio-Safety and India's The Biological Diversity Act, 2002, proposed BRAI is conflict of interest ridden because it acts both as a regulator and promoter of biotechnology. It APPEARS TO BE EXEMPTED from the provisions of the RTI Act if BRAI decides that certain information submitted by the applicant is “confidential commercial information” as per its Section 28. The is regressive and deserves to be rigorously examined before its entry in the Parliament.

Gopal Krishna
ToxicsWatch Alliance (TWA)
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