Contributions from
the Column
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Martin Menski: GM crops in India: Caution on precautionary principle

Corinna Kreidler: Risk of corruption in humanitarian aid

Romeo Bertolini, Olaf Nielinger and Monika Muylkens: Prospects for African telecom markets


12/2006
 

[ GM crops ]

Caution on
precautionary principle


India’s emerging biosafety regime has run into trouble. Genetically modified crops have been introduced illegally, with small-scale producers becoming impatient as field trials were repeated again and again. Pressure groups have led the government to include socio-economic effects in biosafety assessment. The Indian experience has global implications.


[ By Martin Menski ]

The uncertainty and controversy surrounding the ecological impact of genetically-modified (GM) crops has made global environmental policy-making focus on the precautionary principle. This principle, which was defined at the UN Conference on Enviroment and Development in Rio de Janeiro in 1992, states that the lack of full scientific certainty shall not be used as a reason for postponing measures to prevent environmental degradation. Applied in the context of regulating biosafety, it means that a GM crop should not be introduced into the environment unless it has been established beyond reasonable scientific doubt that it shall not have an adverse impact.
Internationally, there is no agreement as to how, if at all, this principle should be applied, given that GM risks are unquantifiable and may become apparent several decades after release. Many European countries have placed a temporary moratorium on introducing GM crops. Few other countries have taken a similar stand, however, and the US successfully challenged the moratorium policy in the World Trade Organisation in 2005. The US opposes the idea that a technology should be denied simply because its risks cannot be ruled out completely. It advocates the principle of “substantial equivalence”, namely that there is no scientific basis for denying GM crop introduction if it is substantially equivalent in terms of its observable characteristics and interaction with the environment to non-GM crops.

The Biosafety Protocol, formed in 1998 pursuant to the UN Convention on Biological Diversity (1992), stipulates application of the precautionary principle on the somewhat vague basis of “sound science”. This approach is emphsised by two WTO treaties, the Sanitary and Phytosanitary Agreement and Technical Barriers to Trade Agreement. This emerging global standard may appear logical and sensible at first sight; but it raises fundamental problems when implemented in practice.

India’s experience with governing GM crops is an example. This is one of the developing countries that have pioneered biotech research. Contrary to popular perception, however, biotechnology is not a monopoly of multinationals. Public research institutes have enjoyed considerable funding since the establishment of India’s Department of Biotechnology in 1986. While multinationals have spearheaded the commercial sale of GM crop products in India, beginning in 2002, it is far from certain that they will remain the leading players in this market, given the large number of domestic seed companies and biotechnology firms.

With the rapid growth of the biotech industry, an increasingly complex and sophisticated legal and policy regime to regulate it emerged. In 1989, the Genetic Engineering Approval Committee (GEAC) was established in the Ministry of Environment and Forests. It was designed to monitor the application of the precautionary principle at all stages of GM-product development, ensuring that no modified organism be released without full scientific certainty. This approach, however, ran into trouble, when field trials of a Bt. cotton variety developed jointly by Monsanto and Mahyco, an Indian company, began in the late 1990s.


Challenging policy

At the time, environmental NGOs and activists, most notably Vandana Shiva, claimed that Monsanto-Mahyco and the authorities had not sufficiently tested Bt. cotton. Arguing that there was no scientific certainty that it would not have adverse effects in India, including socio-economic ones, they demanded further repeat studies, many of which involved replicating research already done in other countries.

Even though scientists were quite satisfied with the existing data, field trials went on. They were meant to generate public trust in the regulatory system and to achieve scientific certainty, but they had the opposite effect. The delays to introducing the crop gave small-scale seed producers an incentive to sell illegal varieties of Bt. cotton. In 2000-2001 the Indian Government discovered that farmers had been growing such varieties in three different states. There is a shroud of mystery over when, where and how these illegal growings began. Officially, the blame was placed on Navbharat Seeds, a company in Ahmedabad, which was prosecuted in Indian courts. Some NGOs and rival domestic seed companies allege that Monsanto secretly encouraged the illegal spread of its Bt. cotton. However, that seems doubtful, given the considerable loss of revenue to Monsanto and bad publicity.

Of course, illegal cultivation created chaos within the regulatory framework. The authorities were unable to enforce an order from the GEAC to destroy the crops. It would have been far too controversial politically to burn the crops and too burdensome financially to compensate farmers. The Government of India found itself unable to guarantee proper assessment of GM crops prior to their release into the environment, despite the precautionary approach of its regulatory framework.

The Bt. cotton drama and the realisation of government impotency has precipitated a recent shift in Indian policy-making towards broadening the concept of the precautionary principle to include socio-economic aspects. India is thus moving beyond conventional European approaches. Indian officials now believe that the commercial performance of all GM crops must be tested as part of the biosafety assessment. Even if GM crops are environmentally safe, the reasoning goes, India cannot risk allowing economically unsuitable crops to be sold. Officials argue that if the yields of GM crops fail to perform better than conventional hybrids, the GEAC may become the target of farmers’ demands for compensation.

As a result, Indian regulations now require that all GM crops be assessed for their socio-economic suitability. Guidelines issued by the Department of Biotechnology in 1998 stipulate that the GEAC is to monitor the “comparative agronomic advantages” of transgenic plants so as to evaluate their “risks and benefits”. The National Seeds Policy of 2002 has now strengthened this by providing that all transgenic varieties “will be tested to determine their agronomic value for at least two seasons (…) in coordination with the tests for environment and biosafety clearance” and “before any variety is commercially released in the market”. It also requires the authorities at national and state levels to monitor the in-field performance of a transgenic plant variety “for at least three to five years” after its commercial release. These mechanisms will have legal effect when the new Seeds Bill, which is currently under preparation, comes into force.

Unsurprisingly, the biotechnology industry has criticised these developments as unnecessary regulatory interference in commercial activities and is deeply concerned about the extension of “unscientific” bureaucratic power. Indeed, the question does arise whether there are sufficient checks and balances in place to ensure that the broad notion of the precautionary principle does not create scope for corruption and abuse.

A 2004 report by the Commission on Agricultural Biotechnology recommended establishing a separate regulatory body with representatives from industry and civil society. It remains to be seen to what extent this will be translated into official policy. Although the Department of Biotechnology is preparing a draft Biotechnology Strategy Paper that advocates greater public and stakeholder participation in biosafety assessments, intra-ministerial battles over bureaucratic authority may undermine attempts to infuse greater transparency and accountability in the emerging regulatory framework.

What is certain, however, is that current global discourse on the precautionary principle needs to move beyond conceptualising the risk of GM crops in terms of establishing scientific certainty. The global emphasis on “sound science” must recognise that national developmental and socio-economic needs will always be a contentious issue in poor countries.

Moreover, what constitutes “sound science” will always be disputed by stakeholders in the GM debate. The Indian scenario questions the alleged benefits of pursuing a purely scientific conception of the precautionary principle. The challenge before global policy-makers is to adopt a more inclusive public-centred approach to decision-making. GM acceptance critically depends on creating sufficient safeguards and involving various stakeholders. Approaches that recognise the social and economic interests must be explicitly included and debated openly in devising a global regime on biosafety. To meet the challenges of governing GM crops in the developing world, it is necessary to find new ways of bringing together scientific and non-scientific considerations, rather than asserting the primacy of science alone.





Dr. Martin Menski
is a lawyer at Clifford Chance LLP,
an international law firm based in London.
martin.menski@cliffordchance.com