STEPS Centre GM archive regulation

Biotechnology Research Archive

Theme 2 - Regulating GM Crops

Overview

Effective regulation is an essential component of any innovation process. This is particularly the case for GM crops, where potential risks remain unknown. Impacts arise through the interaction of particular technologies in particular environments. Therefore a case-by-case approach to regulatory control is essential. This section includes research on the negotiation and implementation of the Cartegena Protocol – an international agreement focused on the transboundary movement of genetically-modified organisms – and the intersection of international legal frameworks with national biosafety regulations, with case studies from China, India, Zimbabwe and Argentina.

Key findings include:

Arguing that GM products are ‘safe’ based on principles such as ‘substantial equivalence’ is not sound science. Nor is the argument that lack of recorded deleterious consequences recorded in one place means that it is safe somewhere else.

A precautionary approach is not ‘anti-science’. In fact, the opposite is true, as a broad approach to precaution means that uncertainty and ignorance are dealt with, avoiding the danger of reducing complex assessments to simplistic risk management.

Biosafety regulations need to be developed in response to local settings and demands. Transferring regulations from OECD settings to the developing world through top-down capacity-building efforts can undermine the effectiveness of regulatory systems.

Disputes in the WTO have highlighted the differing constructions of risk management and policy across the world. The resolution of trade disputes must grapple with this, as there may be a number of valid scientific perspectives on risk at play.

Intellectual property restrictions have major impacts on access to new technologies, especially for the poor. Brokering arrangements where patent limitations are removed or selective licenses are issued may improve this, but explorations of a more open-source model for innovation will result in greater benefits for a wider group.

Regulations need to be built from the bottom-up, incorporating diverse views and assuring trust and accountability. Without this, they will not work and will not be trusted by key stakeholders.

Limited regulatory reach – and the capacity to implement any regulations even if agreed – is a major constraint in most of the developing world. But few approaches exist which allow for a flexible development of regulatory capacity based on real – rather than ideal-type – settings.

Investments in regulatory processes by the corporate sector, or allied bodies, should be viewed with extreme caution. Discussions of ‘red tape’, ‘bureaucratic hurdles’ and restrictions on ‘freedom’ should be understood in the context of the broader political economy of GM technology, including the associated business interests.

Theme 2 Archive

General

Ely, A. V. et al (forthcoming) Chapters 1-5 in Dreyer, M. and O. Renn (Eds.) (2009) ‘Food Safety Governance: Integrating Science, Precaution and Public Involvement’, (including a chapter on GM Bt maize in Europe). Springer

Ely, A. (2008) “Risk: safety is just the start if we want good regulation”, Food Ethics 3, 3, 6-8

Millstone, E., van Zwanenberg, P., Levidow, L., Spök, A., Hirakawa H. and Matsuo, M. (2008) ‘Risk-assessment policies: differences across jurisdictions’, Institute for Prospective Technological Studies, Seville, Spain, EUR Number: 23259 EN.

Burgess, J., Stirling, A., Clark, J., Davies, G., Eames, M., Staley, K., and Williamson, S. (2007) Deliberative mapping: a novel analytic-deliberative methodology to support contested science-policy decisions - Public Understanding of Science, Vol. 16, No. 3, 299-322

Millstone, E. (2007). Can food safety policy-making be both scientifically and democratically legitimated? If so, how?', Journal of Agricultural and Environmental Ethics, Vol. 20, pp. 483-508
Download a pre-publication version of this paper

Stirling, A. (2007) Risk, precaution and science: towards a more constructive policy debate. Talking point on the precautionary principle EMBO reports 8, 4, 309–315,

Ely, A. (2006) Regulatory Appraisals of Bt maize: A study of science in governance, DPhil Thesis, SPRU-Science and Technology Policy Research, University of Sussex

Ely, A. V. (2005) "Austrian Biosafety Policy: Founded on Ignorance?" in Yearbook of the Institute for Advanced Studies on Science, Technology and Society (IAS-STS), 2005, Graz, Austria

Stirling, A., and Mayer, S. (2005) ‘Confronting Risk with Precaution: A Multi-Criteria Mapping of Genetically Modified Crops’, in Getzner, M, Clive L. Spash and Sigrid Stagl (eds) Alternatives for Environmental Valuation, Routledge

Ely, A. V. (2004) "Nur so können wir in Europa etwas verändern" Soziale Technik December 2004, 9-10

Mayer, S. and Stirling, A. (2004), GM crops: good or bad? EMBO Reports, 5(11): 1021–1024

Newell, P. and MacKenzie, R, (2004) ‘Whose rules rule? Development and the global governance of biotechnology’ IDS Bulletin Vol. 35 No.1 pp.82-92.

Scoones, I (2004) Debating GM crops (editorial), Insights 52

Glover, D. (2003) GMOs and the politics of international trade. Democratising Biotechnology: Genetically Modified Crops in Developing Countries Briefing Series, Briefing 5. Brighton, UK: IDS

Glover, D. and Yamin, F. (2003), Intellectual property rights, biotechnology and development, Democratising Biotechnology: Genetically Modified Crops in Developing Countries Briefing Series, Briefing 4. Brighton, UK: IDS

Mackenzie, R. (2003), The international regulation of modern biotechnology: finding space for food security?, Biotechnology Policy Series 18. Brighton, UK: IDS

Mackenzie, R. with Glover, D. (2003), Harmonisation, diversity and uncertainty in international biosafety regulation, Democratising Biotechnology: Genetically Modified Crops in Developing Countries Briefing Series, Briefing 6. Brighton, UK: IDS

Millstone, E. (2003), 'The EU-US Dispute over the introduction of agricultural biotechnology: an analysis and prognosis', Soziale Technik, Vol.4, pp. 19-20

Newell, P. (2003), Regulating biotechnology for the poor?, Democratising Biotechnology: Genetically Modified Crops in Developing Countries Briefing Series, Briefing 7. Brighton, UK: IDS

Stirling, A. (2003), ‘Risk, Uncertainty and Precaution: some instrumental implications from the social sciences' in I. Scoones, M. Leach, F. Berkhout, Negotiating Change: perspectives in environmental social science, Edward Elgar, London, 2003 pp.33-76

Yamin, F. (2003), Intellectual property rights, biotechnology and food security, IDS Working Paper 203, Biotechnology Policy Series 22. Brighton, UK: IDS

Mayer, S. and Stirling, A. (2002), ‘Finding a Precautionary Approach to Technological Developments – Lessons for the Evaluation of GM Crops’ Journal of agricultural and environmental ethics, Vol 15, 1, 57–71

Newell, P. (2002), Biotechnology and the politics of regulation, IDS Working Paper 146, Biotechnology Policy Series 2. Brighton, UK: IDS

Scoones, I. (2002), Science, policy and regulation: challenges for agricultural biotechnology in developing countries, IDS Working Paper 147, Biotechnology Policy Series 3. Brighton, UK: IDS

Mayer, S. and Stirling, A. (2001), ‘A Novel Approach to the Appraisal of Technological Risk’ Environment and Planning C, 19, 529-555, 2001

Newell, P. and MacKenzie, R, (2000) `The 2000 Cartagena Protocol on Biosafety: Legal and Political Dimensions’, Global Environmental Change, Vol.10.

Newell, P. and Mackenzie, R. (2000), The 2000 Cartagena protocol on biosafety: legal and political dimensions, Global Environmental Change 10: 313-7

Mayer, S. and Stirling, A. (1999), ‘Rethinking Risk: a pilot multicriteria mapping of a genetically modified crop in agricultural systems in the UK’, report for the UK Roundtable on Genetic Modification, SPRU, University of Sussex,

Millstone, E., Brunner, E., and Mayer, S. (1999), 'Beyond the "substantial equivalence" of GM foods', Nature, Vol 401, 7, pp. 525-526

Millstone, E., Brunner, E., and White, I. (1994), 'Plagiarism or protecting public health?', Nature, Vol. 371, No 6499, pp. 647-8

Africa

Ely, A. V. (2003) ‘Evaluation of Environmental Risks of Bt Maize in the US and EU: Lessons and Challenges for Kenya’ produced for the Institute of Development Studies, Brighton, UK

Keeley, J. and Scoones, I. (2003), Contexts for Regulations: GMOs in Zimbabwe, IDS Working Paper 190, Biotechnology Policy Series 9. Brighton, UK: IDS

Odame, H., Kameri-Mbote, P., and Wafula, D. (2003), Globalisation and the international governance of modern biotechnology: implications for food security in Kenya, IDS Working Paper 199, Biotechnology Policy Series 20. Brighton, UK: IDS

Mwangi, P. and Ely, A. (2001) 'Assessing risks and benefits: Bt maize in Kenya' Biotechnology and Development Monitor 48, 6-9

China

Keeley, J. (2006) Balancing Technological Innovation and Environmental Regulation: an Analysis of Chinese Agricultural Biotechnology Governance. Environmental Politics, Vol. 15, No. 2, 293 – 309

Huang, J. and Wang, Q. (2003), Biotechnology policy and regulation in China, IDS Working Paper 195, Biotechnology Policy Series 4. Brighton, UK: IDS

Keeley, J. (2003), Regulating biotechnology in China: the politics of biosafety, IDS Working Paper 208, Biotechnology Policy Series 7. Brighton, UK: IDS

India

Scoones, I (2006) Science, Agriculture and the Politics of Policy: the case of biotechnology in India. Orient Longman: Delhi

Dhar, B. (2003) ‘Regulating biotechnology in India’, Background paper, Globalisation and the International Governance of Modern Biotechnology project, Brighton: IDS

Ramakrishna, T. (2003), The development of the IPR regime in India with reference to agricultural biotechnology, Background paper, Globalisation and the International Governance of Modern Biotechnology Project, Brighton, UK: IDS.

Scoones, I. (2003), Regulatory manoeuvres: The Bt cotton controversy in India, IDS Working Paper 197, Biotechnology Policy Series 14. Brighton, UK: IDS

Scoones, I. (2003), Science, policy and biotechnology regulation, Democratising Biotechnology: Genetically Modified Crops in Developing Countries Briefing Series, Briefing 8. Brighton, UK: IDS

Seshia, S. (2002), Plant Variety Protection and Farmers' Rights: Law Making and the Cultivation of Varietal Control, Economic and Political Weekly [India] 37 (27) (Review of Science Studies), 6-12 July: 2741-7