Indian Bt regulatory process : Explained

India currently has a three-tier regulatory system for GM crops:

a) each research organisation must have an Institutional Biosafety Committee (IBSA), which assesses research proposals;

b) a national Review Committee on Genetic Manipulation (RCGM) assesses field trials for environmental safety and allergic responses;

c) the Genetic Engineering Approval Committee (GEAC) — part of the environment ministry — carries out environmental impact assessment, and approves multi-location field trials and commercial cultivation.

Apart from this system, the Department of Biotechnology (DBT) , under the Ministry of Science and Technology, India plays a vital role in regulating Bt trials as it has laid specific guidelines in doing so.

Recently, DBT has sought constitution of an independent Biotechnology Authority on the lines of the Election commission of India, which would primarily deal with issues concerning the industry.

Problems with the current set-up:

1) A major issue with the current scenario is a clash of interests between stakeholders and regulators. A scientist from the agricultural research system that applies for clearance of a particular seed is part of the GEAC, whose chairman is not a scientist and changes frequently.

2) Also it takes an inordinately long time to get a clearance for commencing field trials. Although this may be perceived as a cautious policy to ensure an informed and educated decision, usually the delay is due to administrative apathy or a conflict between concerned departments.

3) The Indian Bt policy is tilted in favour of the industry and is exclusive in terms of a dialogue with the society at large. The fact that we have not undertaken field trials of GM crops on a large scale is mainly due to a negative perception of the technology. A deterrent which needs to be factored in the policy to assuage relevant vote banks. But, this is about to change by a mass media offensive in favour of the technology.

4) India is lagging by almost a decade with respect to US and China, even though it has equivalent resources and a substantial domestic market. A liberal policy may help in reducing the time induced deficit, but the implication of such a decision would have a 'ripple effect' on almost all sectors of trade, FMCG, domestic markets, processed foods, agriculture, fisheries, etc.

5) A clear demarcation of responsibilities and duties within the structure is necessary to ensure proper regulation.

Relevant to this point, as quoted in the Indian Express:

A task force headed by M. S. Swaminathan, said that India’s approval system was “lengthy and cumbersome” . It recommends creating an autonomous Agricultural Biotechnology Regulatory Authority to consider the approval of GM crops in the country. Under this body, the Indian Council for Agricultural Research (ICAR), not the GEAC, should be authorised to conduct and assess large-scale field trials and approve commercial release of GM crops. He also suggested that the three tiers remain but their responsibilities change.

The major change that they recommend is to limit GEAC’s role to environmental clearance. The ICAR, rather than the GEAC, would decide whether GM crops could be planted for commercial purposes.

The Monitoring cum Evaluation Committee should report to the GEAC on biosafety and environmental issues while post-release monitoring should be responsibility of Union Agriculture ministry and not the ICAR.

It favours strengthening of the existing Seeds Act, 1966 and Environmental Protection Act 1986 to deal with illegal proliferation of GM seeds. It proposes single-window information on all aspects of bioethics and biosafety.

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6) I do not favour the institutionalised structure proposed here. A decentralisation of power is necessary. Through local committees, the citizens themselves, via consensus, must have the right to decide whether a GM crop should or should not enter their market. If a community decides, as a whole, that they do not wish to have GM foods in their locality, then the government or the industry must adhere to the decision.

7) All GM food must be labeled to provide a choice to the citizen. A monitoring committee can be constituted to ensure its implementation and which would penalize industry offenders, by revoking their license to market their product. A monetary compensation here would undermine the necessity of choice.

8) Similarly, the right of conducting field trials on a farm must lie with the farmer and not with a overriding authority. And proper precautions must be taken to ensure containment of the products of these trials to avoid mixing of the crop with the organic varietals.

9) A lack of tranperancy in the trials leads to a general mistrust making it difficult to accept the results of trials. For example, the Bt cotton field trial results were never made public — despite protests. After pressure from civil society, Bt brinjal results have been put on the website this year.