The chairperson of the Genetic Engineering Approval Committee (GEAC), the apex regulatory body for biotechnology products like GM crops, is not a person of the highest technical competence, as one would expect, but whichever bureaucrat happens to be posted as the Additional Secretary in the Ministry of Environment and Forests. The rest of the GEAC is not trained in the core area of bio safety assessment either. The mixture of bureaucrats and representatives of scientific bodies are there ex officio; almost no one brings the specific skills required by the job.
India must radically change the composition and functions of the bodies that are designated to manage GM technology otherwise, ignorance could lead to wrong decisions that could end up hurting Indian farmers and pose a danger to the environment of this country and the health of its people. The unbridled spread of the illegal Bt cotton, Navbharat 151 and the complete failure of the GEAC to control the situation even three years down the line, do not inspire confidence in its capabilities. The GEAC’s resolute refusal to engage with public concerns or provide any information on the handling and trial of GM crops is anachronistic in this day and age and raises suspicions about its motivations. The fact that GEAC authorised commercial cultivation of Monsanto’s Bt cotton even when there were no legally mandated State Level Committees or District Level Committees, in any of the six states, raises disquiet about its flagrant disregard of the law.
The GEAC should be a technically competent body, strong on Risk assessment and Risk Management of GM crops as also on Monitoring. At present members of the GEAC are not qualified to understand the process of Bio safety Assessment, Environmental Assessment or Environmental Impact Assessment, which are central to their functioning. This means that they are not qualified to interpret the data that is placed before them for evaluation. The regulatory structure must be competent and independent to inspire confidence. It should be able not just to assess Biosafety but also other aspects like social and economic impacts, particularly the impact on small farmers, of the introduction of a particular GM crop. In western nations these aspects may not have a central position but in the context of Indian agriculture, it is important to evaluate such impacts before taking a final decision.
The UNEP International Technical guidelines for safety in Biotechnology outline the following steps for identifying potential impacts and assessment of risks:
- Identify potential adverse effects on human health and/or the environment
- Estimate the likelihood of these adverse effects being realized
- Evaluate the consequences should the risks materialize
- Consider appropriate risk management strategies
- Estimate the overall potential impacts that may be beneficial to human health or the environment.
In my view, it would be best to divide the regulatory function into two parts, one Advisory, the other Statutory.
The Advisory body should have a broad based multidisciplinary membership that includes all relevant scientific disciplines, social scientists, environmentalists, civil society groups, members of farming and adivasi communities, representatives of panchayati raj institutions, and legal experts. A person of the highest technical calibre who has experience in the regulation of GM crops should head the GEAC.
The statutory body should be an independent body staffed by people skilled in Bio safety Assessment, Environmental Assessment and Environmental Impact Assessment. This body should have overall responsibility for all aspects of risk assessment, risk management, risk communication leading up to decision-making about the safety of a GM crop for the environment, human and animal health and post release monitoring. It is important to ensure that there is no conflict of interest and rules should be framed in a clear and unambiguous manner so that it is not possible to stack the Agency with any particular kind of people.
The regulatory process should be transparent, accountable and technically competent. Data from field trials and the rationale for decision-making should be available to the public. A cost benefit and a risk benefit analysis should be conducted before decisions are taken and clear-cut channels should be created for the public to participate in the decision-making process and to voice concerns. There should be an annual review of the decisions taken on GM products and the rationale for these decisions. This review should be presented to Parliament.