Science, policy and regulation: challenges for agricultural biotechnology in developing countries

This paper addresses the question of the relationship between science, policy and regulation in the context of debates about the future of agricultural biotechnology. First the paper outlines some of the challenges for biotechnology policy and regulation before exploring the different contexts for biotechnology science and the framing of the policy debate. Next the author examines in more depth notions of ‘sound science’ and ‘precaution’ in the context of risk assessment before the next section examines applications of science in biotechnology policy and regulation through a series of examples. Issues for developing countries are outlined and challenges identified for regulatory policy.The paper concludes by highlighting the importance of a recognition that scientific knowledge – and the regulatory and policy decisions that flow from it – is contextual and socially and politically embedded. From this premise the author suggests that an integrative, precautionary science that acknowledges partial and plural positions and takes uncertainty and ignorance seriously might be more appropriate than conventional ‘sound science’, based as it often is on a rather narrow remit, in this context. Such a redefinition of ‘sound science’ though has some major implications for thinking about regulatory and policy approaches around biotechnology:First, the scope of assessment has necessarily to be expanded beyond narrow technical concerns to a range of strategic economic, socio-cultural, political, ethical and moral issues associated with choices about new technologies. Second, such a shift requires that the methods used need to be expanded beyond narrow risk assessment tools to include systematic assessment and inclusive deliberation techniques Third, this implies that criteria for rigour and trustworthiness be revised to go beyond narrow, technical quantification measures Fourth, this in turn implies that the range of expertises involved in risk assessment and regulatory policy decision-making needs to be expanded. Fifth, if understanding risk and uncertainty requires a located, embedded and context specific assessment then inevitably there will be divergence in emerging assessments and regulatory choices, rather than standardisation and harmonisation.Finally, the institutional contexts for the development of regulatory policy need to be rethought, if they are to encourage the characteristics of openness and transparency and so garner widely held authority and legitimacy for regulatory decisions. In short this requires an institutional innovation process which helps to democratise science and the regulatory decision-making, from local to global contexts