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Debate on Setting up of GMO Authority
Krishan Bir Chaudhary Vrs RK Sinha


Face 2 Face : Do we need a biotech regulatory body? How should it be structured?
GEAC should address health and environmental concerns

http://www.financialexpress.com/news/GEAC-should-address- health-and-environmental- concerns/335290/0

Krishan Bir Chaudary
Monday , July 14, 2008 at 02:46 hrs

The government must clarify why it is setting up the National Biotechnology Regulatory Authority (NBRA), replacing the existing regulator Genetic Engineering Approval Committee (GEAC) which is already acting as a single window clearance for biotech products. If the government feels that the GEAC is incompetent and inefficient, it should bring it to the public knowledge.

The Supreme Court, in the course of hearing a writ petition seeking a moratorium on GM crops, had ordered some improvements for introducing transparency in the functioning of GEAC. The government had always defended the functioning of GEAC in the Supreme Court. Has it got any moral right now to say that GEAC is not functioning well and needs to be replaced by NBRA?

The fact is that the GEAC, without caring for any biosafety norms and transparency, has been very fast in the approval of GM crops with a view to benefit the multinational seed companies. Since 2002, GEAC approved over 175 Bt cotton hybrids, five events and one Bt cotton variety. It has conducted field trials of Bt brinjal, Bt okra, GM mustard, Bt cabbage, GM tomato, GM groundnut and GM potato.

The functioning of GEAC has been questioned by many independent scientists, like the founder director of the Centre for Cellular and Molecular Biology (CCMB), Pushpa Mittra Bhargava. He called for a total review of India's experience with Bt cotton, including how Bt technology was brought into the country. He has also sought a two to three years moratorium on GM crops, unless and until proper independent studies are done on biosafety like pollen flow, seed germination, soil microbial activity, toxicity, allergenicity, DNA finger printing, proteomics analysis, and reproductive interferences.

At the global level, independent scientists like Arpad Pusztai have questioned the safety of GM food. Pusztai has pointed out by saying "Well-designed studies, though few in number, show potentially worrisome biological effects of GM food, which the regulators have largely ignored." In India, there were reports of sheep mortality on account of grazing over Bt cotton fields in Andhra Pradesh, which the GEAC did not consider with seriousness.

There are reported cases of illegal imports of hazardous GM food, which are not approved in the country and the government has remained a mute spectator. Illegal imports of GM food are in violation of the Rules, 1989 of the Environment Protection Act, 1986. The annual amendments to the Foreign Trade Policy made in April 2006 said unlabelled GM food import would attract penal action under Foreign Trade (Development and Regulation) Act, 1992. But this is not implemented in absence of guidelines.

The panel of experts and stakeholders headed by the additional director-general of National Institute of Communicable Diseases, Shiv Lal had recommended mandatory labeling of GM food, irrespective of the threshold level. But the recommendations were not implemented either by the health ministry or GEAC. Rather, the GEAC allowed free imports of oil extracted from GM soybeans without any labeling, tests and restrictions.

The plan to set up NBRA is largely based on the recommendations of the two panels headed by MS Swaminathan and RA Mashelkar. The suggestions made and apprehensions raised by the Indian Council of Medical Research (ICMR) in its paper – Regulatory Regime for Genetically Modified Foods : The Way Ahead – have not been considered.

Monsanto is charging a high technology fee, which has raised the prices of Bt cotton seeds and the issue is subjudice before the MRTP Act. There are fears that pollen flow from GM crops to non-GM crops may cause problems for farmers, who may be asked to pay high technology fee for their own seeds as had been the case with the Canadian farmer Percy Schmeiser. Indian farmers, in many areas have suffered heavy losses on account of failure of Bt cotton. States like Kerala and Uttarakhand have banned GM crops and the Centre, through the NBRA, is planning to override states governments' power to regulate agriculture.

The government should make GEAC more accountable to address health and environmental concerns, rather than set up NBRA.

The writer is president, Bharatiya Krishak Samaj (Indian Farmers' Organisation)

Face 2 Face : Do we need a biotech regulatory body? How should it be structured?
It should create an environment for sound application of biotech


RK Sinha
Monday , July 14, 2008 at 02:44 hrs

The department of biotechnology (DBT) has shown exemplary commitment and sagacity in bringing out the draft of the National Biotechnology Regulatory Authority (NBRA) Bill and the Draft Establishment Plan. The speed with which it has recently concluded a national consultation with the stakeholders across the country, is again an expression of its commitment to the cause.

The evolutionary process started with the enactment of the Environment Protection Act in 1986, followed by rules framed in 1989, to create the Genetic Engineering Approval Committee (GEAC). The string of other regulatory bodies will be culminating now in the creation of a one window clearance system for living modified organisms (LMO), the National Biotechnology Regulatory Authority.

An international parallel can be seen in the Australian Statutory Office of the Gene Technology Regulator (OGTR), established under an Act in 2000. It takes all decisions in dealings with genetically modified organisms (GMOs), including research, manufacture, production, experimental trials, commercial release and importation. The regulator has extensive powers to monitor and enforce the law.

While the Bill and the Establishment Plan have been ably crafted, some valid amendments would be in order. As with the Cartagena Protocol on Biosafety, to which India is a signatory, the NBRA should create an enabling environment. There should be sound application of biotechnology to make it possible to derive maximum benefit from the potential that biotechnology has to offer, while minimising the possible risks to the environment and to human health. A scientific assessment of the risks involved is necessarily limited by the extent of available credible scientific knowledge, and hence only reasonable safety, as in all other fields of human endeavour, can be ensured. The aims and objectives of the Bill would need to be suitably amended to reflect these concepts in a credible and transparent manner.

The composition of the authority appears to be unwieldy for any meaningful decision-making process. Ideally, there should be a smaller core group constituting the NBRA responsible for taking all decisions on the development and regulation of products of modern biotechnology, with an expanded group of scientific and other advisors reflecting all the stakeholders. The Bill, however, has conceived a bigger and expanded NBRA with the Product Rulings Committee as the decision-making body. Relations between the NBRA and the Product Rulings Committee need to be clearly defined in order to avoid unnecessary litigation.

The integrity and autonomy of the body taking the decision should be upheld in the interest of speedy disposal of pending matters. This would mean that as a statutory authority, NBRA should be fully autonomous and be responsible for all science-based decisions that it takes, without any fear or favour from any organisation, including the Central and state governments.

However, matters of domestic and international policies and cooperation would continue to be in the realm of the Central government.

GEAC has played and continues to play a pioneering role in promoting and effectively regulating products of modern biotechnology, while ensuring safety of the environment and human and animal health. It has been ably supported in this effort by the department of biotechnology and other agencies connected with the regulatory regime.

As a sequel to the evolutionary process, NBRA would be replacing GEAC as the one window clearance centre. One only hopes that the rigorous scientific and technological framework for risk assessment and approvals put in place by DBT and GEAC, are carried forward by NBRA in the light of new scientific and technological advances.

The writer is executive director, All India Crop Biotechnology Association

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