Theme 2: Regulating agricultural biotechnology

This theme is part of the Biotechnology Research Archive.

Effective and well-designed regulation is essential to any innovation process. This is particularly the case for novel genetic techniques, where uncertainty is high and potential risks remain unknown. Impacts arise through the interaction of particular technologies with particular environments. A case-by-case approach to regulatory control is essential.

This section of the Biotechnology Research Archive includes research on the negotiation and implementation of the Cartagena Protocol – an international agreement focused on the transboundary movement of GMOs – and the intersection of international legal frameworks with national biosafety regulations, with case studies from China, India, Zimbabwe and Argentina.

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Key findings include:

  • Arguing that biotech crops are ‘safe’ based on principles such as ‘substantial equivalence’ is not sound science. Nor is the lack of recorded deleterious consequences recorded in one place evidence 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 acknowledged and addressed directly, instead of reducing complex assessments to simplistic risk management.
  • Biosafety regulations should (and often will) respond to local settings, needs and demands. Trying to transfer regulations from OECD settings to the developing world through top-down capacity-building efforts can undermine the appropriateness and effectiveness of national regulatory systems. Efforts to impose international norms on countries will often meet resistance from local policy elites or popular forces, and fail to produce the standardised and effective regulatory regimes that were expected.
  • Intellectual property restrictions have major impacts on access to new technologies, especially for the poor and for public sector research. Explorations of a more open-source model of knowledge sharing for innovation, such as ‘copyleft’, will likely result in easier access and greater benefits for a wider group.
  • 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 should incorporate diverse views from various stakeholders, in order to assure trust and accountability.
  • Lobbying against ‘red tape’, ‘bureaucratic hurdles’ and restrictions on corporate ‘freedom’ should be understood in the context of the broader political economy of modern agricultural biotechnology, including business interests and the professional interests of scientists.

Theme 2 Archive

General

Ely, A. (2020) What can past dynamics of agbiotech regulation teach us about transatlantic divergences in genome editing?, [Video], Presentation to the conference Gene Editing in Agriculture and Food: Social Concerns, Public Engagement, and Governance. Iowa State University, October 20-21, 2020

Kashani, E. S., and Millstone, E. (2016) Experts against precaution: analyzing the process of biosafety regulation in Iran, New Genetics and Society, Vol. 35, No. 1, 29-48.

Millstone, E., Stirling, A., and Glover, D. (2015) Regulating Genetic Engineering: The Limits and Politics of Knowledge, Issues in Science and Technology, Vol. XXXI, No. 4, 23-26.

Millstone, E. (2015) For or against GM crops? Other positions are available, STEPS Blog.

Kashani, E. S., and Millstone, E. (2013) Contested framings and policy controversies: analysing biosafety policy making in Iran, Science and Public Policy, Vol. 40, No. 5, 616-627.

van Zwanenberg, P., and Arza, V. (2013) Biotechnology and its configurations: GM cotton production on large and small farms in Argentina, Technology in Society, Vol. 35, No. 2, 105-117.

Dreyer, M., and Renn, O. (2009) The process of evaluation and management, in Dreyer, M., and Renn, O. (eds.) Food Safety Governance: Integrating Science, Precaution and Public Involvement, Berlin, DE: Springer.

Ely, A., Stirling, A., Dreyer, M., Renn, O., Vos, E., & Wendler, F. (2009) The need for change, in Dreyer, M., and Renn, O. (eds.) Food Safety Governance: Integrating Science, Precaution and Public Involvement, Berlin, DE: Springer.

Ely, A., Stirling, A., Dreyer, M., Renn, O., Vos, E., & Wendler, F. (2009) Overview of general framework, in Dreyer, M., and Renn, O. (eds.) Food Safety Governance: Integrating Science, Precaution and Public Involvement, Berlin, DE: Springer.

Ely, A., Stirling, A., Vos, E., & Wendler, F. (2009) The process of framing, in Dreyer, M., and Renn, O. (eds.) Food Safety Governance: Integrating Science, Precaution and Public Involvement, Berlin, DE: Springer.

Ely, A., and Stirling, A. (2009) The process of assessment, in Dreyer, M., and Renn, O. (eds.) Food Safety Governance: Integrating Science, Precaution and Public Involvement, Berlin, DE: Springer.

Ely, A. (2008) Risk: safety is just the start if we want good regulation, Food Ethics, Vol. 3, No. 3, 6-8.

Millstone, E., van Zwanenberg, P., Levidow, L., Spök, A., Hirakawa, H., & Matsuo, M. (2008) Risk-assessment policies: differences across jurisdictions, Seville, ESP: Institute for Prospective Technological Studies.

Van Zwanenberg, P., Ely, A., and Smith, A. (2008) Rethinking Regulation: International Harmonisation and Local Realities, STEPS Working Paper 12, Brighton: STEPS Centre.

Burgess, J., Stirling, A., Clark, J., Davies, G., Eames, M., Staley, K., & 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, 483-508.

Stirling, A. (2007) Risk, precaution and science: towards a more constructive policy debate. Talking point on the precautionary principle, EMBO reports, Vol. 8, No. 4, 309–315.

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

Ely, A. (2005) Austrian Biosafety Policy: Founded on ‘Ignorance’? in Institute for Advanced Studies on Science, Technology and Society Yearbook, Graz, AT: IAS.

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

Mayer, S., and Stirling, A. (2004) GM crops: good or bad?, EMBO Reports, Vol. 5, No. 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, 82-92.

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

Stirling, A., and Mayer, S. (2004) Confronting Risk with Precaution: A Multi-Criteria Mapping of Genetically Modified Crops, in Getzner, M., Spash, C. L., and Stagl, S. (eds.) Alternatives for Environmental Valuation, Routledge.

Glover, D. (2003) GMOs and the politics of international trade, in 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, in 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., and Glover, D. (2003) Harmonisation, diversity and uncertainty in international biosafety regulation, in 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, 19-20.

Newell, P. (2003) Regulating biotechnology for the poor?, in 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 Scoones, I., Leach, M., Berkhout, F. (eds.) Negotiating Change: perspectives in environmental social science, London, UK: Edward Elgar, 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, No. 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: Politics and Space, Vol. 19, 529-555.

Newell, P., and Mackenzie, R. (2000) The 2000 Cartagena protocol on biosafety: legal and political dimensions, Global Environmental Change, Vol. 10, No. 4, 313-317.

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

Millstone, E., Brunner, E., and Mayer, S. (1999) Beyond ‘substantial equivalence’, Nature, Vol. 401, No. 7, 525-526.

Millstone, E., Brunner, E., and White, I. (1994) Plagiarism or protecting public health?, Nature, Vol. 371, No. 6499, 647-648.

Africa

Ely, A. (2003) Evaluation of Environmental Risks of Bt Maize in the US and EU: Lessons and Challenges for KenyaGlobalisation and the International Governance of Modern Biotechnology, Brighton, UK: IDS.

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, No. 48, 6-9.

China

Ely, A. (2016) ChemChina-Syngenta deal: why it matters, China Dialogue.

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.

Europe

Ely et al. (2021) STEPS Centre response to the Department for Environment, Food and Rural Affairs (DEFRA) consultation on the regulation of genetic technologies, Brighton, UK: SPRU.

Glover, D., Friedrich, B., Ely, A., Noland, A., & Lidstone, A. (2021) Future Pathways for Genome Editing in Agriculture: Public Policies, Public Debates, Public Goods, GEAP3 Policy Briefing 4, Brighton, UK: IDS.

Ely, A., Friedrich, B., and Glover, D. (2020) Genome Editing in Agriculture: Regulation in the United Kingdom after Brexit, GEAP3 Policy Briefing 3, Brighton, UK: IDS.

Friedrich, B., Glover, D., and Ely, A. (2020) Genome Editing in Agriculture: The Politics of Regulation in the European Union, GEAP3 Policy Briefing 2, Brighton, UK: IDS.

Glover, D., Friedrich, B., and Ely, A. (2020) Genome Editing in Agriculture: Issues for Policy and Regulation, GEAP3 Policy Briefing 1, Brighton, UK: IDS.

Lydgate, E., Anthony, C., and Millstone, E. (2019) Brexit food safety legislation and potential implications for UK trade: the devil in the details, Working Paper, UK Trade Policy Observatory: Brighton, UK.

Millstone, E., and Lang, T. (2018) Hormone-treated beef: should Britain accept it after Brexit?, Technical Report, Food Research Collaboration, London, UK: City University.

Stirling, A. (2018) Is the new European ruling on GM techniques ‘anti-science’?, STEPS Blog.

STEPS Centre. (2015) Some nice recommendations, shame about the spin, STEPS Blog.

Wynne et al. (2014) STEPS Centre submission to the Inquiry by the House of Commons Science and Technology Select Committee on “GM foods and the application of the precautionary principle in Europe”, Brighton, UK: SPRU.

Stirling, A. (2013) Why the precautionary principle matters, The Guardian.

Ely, A. (2009) Implementation of the General Framework: Genetically Modified (Cry1Ab) Maize Case Study, in Dreyer, M., and Renn, O. (eds.) Food Safety Governance: Integrating Science, Precaution and Public Involvement, Springer.

India

Millstone, E. (2014) Science and politics in Indian GM crop regulation: a u-turn down a blind alley, in Moor, R., and Gowda, R. M. V. (eds.) India’s risks: democratizing the management of threats to environment, health and values, Oxford University Press, 205-226.

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

Dhar, B. (2003) Regulating biotechnology in India, Globalisation and the International Governance of Modern Biotechnology, Brighton, UK: IDS

Ramakrishna, T. (2003) The development of the IPR regime in India with reference to agricultural biotechnology, Globalisation and the International Governance of Modern Biotechnology, 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, Vol. 37, No. 27, 2741-2747.


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