Diversity in international biosafety regulation

The Cartagena Biosafety Protocol provides countries with an opportunity to assess the risks associated with GM crops before importing them. Developing countries face particular challenges with this protocol, not least because their capacity to implement, monitor and enforce biosafety laws remains weak. In addition, they need to address the issues in the protocol that are left to national discretion and seek to balance their rights and obligations under the protocol with their commitments under the World Trade Organisation (WTO).

Agreement between different legislations on genetic engineering is usually considered a positive move because it provides greater predictability in international trade. This is promoted by international agreements such as the Biosafety Protocol and the WTO Agreements. Pressure for harmonisation between legislations comes from many sources, including diplomatic channels, bilateral trade, investors and aid negotiations. The relationship between WTO rules and the Biosafety Protocol has become particularly important in the international governance of GM crops.

While the protocol and the WTO agreements are both relevant, their objectives differ and may conflict in some respects. Different agreements under these legislations, such as the General Agreement on Tariffs and Trade, the Agreement on Sanitary and Phytosanitary Measures and the Technical Barriers to Trade Agreement, aim to ensure that measures affecting trade are no more restrictive than necessary.

The WTO Agreements are backed by a compulsory dispute settlement system that can authorise trade sanctions against any WTO member found to have violated WTO rules. There is concern that implementing legislation under the protocol could be overturned if it is deemed to be inconsistent with any of the WTO Agreements. Ambiguities in both regimes make the precise outcome of any dispute unpredictable. Countries may have different opinions about:

• the appropriate level of protection of the environment or human health
• acceptable levels and types of risk
• interpretations of what constitutes risk and of available scientific evidence
• the usefulness and effectiveness of risk management measures
• the significance of socio-economic factors in reaching decisions on the importation and use of GM crops.

The Biosafety Protocol and other international instruments focus primarily on environmental and human health risks. Concerns over the use of biotechnology in agriculture are more far-reaching, however. Ethical and socio-economic issues demand analysis, public consultation and debate. Policies need to consider:

• real world conditions under which GM crops will be used
• how approved GM crops will be monitored and assessed
• risk management measures required to work in the field
• which sections of a community might benefit or lose out from the use of GM crops in place of traditional crop varieties
• how uncertainties will be addressed.

The expansion of national biosafety frameworks represents an important opportunity to consider and address many of these issues. Public consultation is required under the Biosafety Protocol. However, few countries have undertaken the consultations necessary to determine the levels of risk considered acceptable by the public, and consequently the appropriate measures to achieve the desired level of protection. Accommodating national diversity into relatively new technologies represents a huge challenge, not only for the protocol and for national biosafety authorities, but also for the international trade regime.

Ruth MacKenzie
Faculty of Law
UCL
Bentham House
Endsleigh Gardens
London, WC1H 0EG
UK
r.mackenzie@ucl.ac.uk

See also

Mackenzie, R. (2003) Globalisation and the International Governance of Modern Biotechnology: The International Regulation of Modern Biotechnology
www.gapresearch.org/governance/RMregulationfinal.pdf

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