Highlights from Parallel Sessions on: national experiences; international experiences; policy and institutional implications; and regulatory implications

Aarti Gupta, School of Forestry and Environmental Studies, Yale University, presented her field study on the Precautionary decision-making for biosafety in India. Her main theme was that despite the inclusion of precautionary decision-making in the Cartagena Protocol on Biosafety, the relevance for developing countries of precautionary decision-making for biosafety remains under-examined. In India, Biosafety data is being generated by the private sector and provided to public regulators who are themselves scientists engaged in transgenic research. There was, however, still the concern related to sharing of confidential information and the credibility of the information. She also highlighted the Cross-checks in biosafety governance monitoring & evaluation Committee. (aarti_gupta@harvard.edu)

Dr. John Mugabe, African Centre for Technology Studies, Kenya, gave an overall assessment of different levels of biotechnology development in Africa, noting that many African countries do not have the time or choices to reduce scientific uncertainty. He said the debate on perceptions of risk and precaution assumes that society perceives of risks in a homogeneous way, highlighting the issue of values and choices. He observed that debate seems to have confused products of biotechnology and the system through which they would be distributed, and that addressing food production in most African countries requires technological as well as structural solutions and thus the view that biotechnology does not figure into food production is false. (j.mugabe@cgiar.org)

Dr. Luiz Antonio Barreto de Castro, Director General of Genetic and Biotechnological Resources, The Brazilian Enterprise of Agriculture Research (EMBRAPA), illustrated Brazil's complex history of biotechnology and biosafety. He emphasized that new technologies soon will only be limited by those boundaries set by regulators and ethicists. Noting the increase in biosafety regulations, he described a complex web of interactions and consequences that reached beyond biosafety issues to include worldwide agrochemical markets, noting that the global fertilizer market is rising while herbicide use is declining, which affects decisions made about GM crops. (labc@cenargen.embrapa.br)

Dr. Piet Van der Meer, Ministry of the Environment, the Netherlands, highlighted his work with Central and Eastern European countries seeking entry into the EU and in the process of adjusting their regulatory frameworks to abide with EU directives on biotechnology. He noted that biosafety frameworks need to include a regulatory framework, an administrative system, decision-making procedures and means for information dissemination. Further, the process of decision-making is key to implementing the precautionary principle and must address three steps: assessment of whether procedural requirements have been met; risk assessment on a scientific basis; and taking a decision, which is a political issue. Van der Meer highlighted the need to find a common understanding of the principle's application, recognizing that participants in the debate have been approaching the issue from different domains, levels of generality, stages in the regulatory process and terminological lexicons. He called for assessment of the impacts and conceivable hazards of existing alternatives, as well as further discussion to clarify different conceptions of the principle's purpose, who should be involved in the discussions and its practical use, including how it should be triggered. (PietvanderMeer@cs.com)

Diego Malpede, Ministry of Foreign Affairs, Argentina, discussed the national context of biotechnology in Argentina, as well as its perspective on international trade and environmental discussions relating to the precautionary principle. In the area of international policy, Malpede noted common fears that the precautionary principle could be used for protectionist measures, thereby restricting access to foreign markets. He stated that effective capacity-building in developing countries is essential for the Cartagena Protocol's success. He further reviewed the principle's inclusion within the WTO's Agreement on Sanitary and Phytosanitary Standards (SPS) and that precautionary action only take place: where relevant scientific information is insufficient; on the basis of available pertinent information; through efforts to obtain additional information necessary for a more objective assessment of risk; and within reasonable timeframes for review. He concluded by noting that regulatory guidelines for the principle should consider: internationally agreed principles for its operation; open and transparent functioning; rigorous research, especially by independent bodies; no more restrictions on trade than necessary; recognition that ignorance is not equivalent to lack of scientific certainty; and reasonable timeframes for decision making. (dma@mrecic.gov.ar)

Professor Ed Soule, McDonough School of Business, Georgetown University, spoke about regulatory legitimacy and distinguished between weak and strong versions of the precautionary principle. He defined the weak version as being highly pragmatic, providing regulators with some flexibility in determining relevant factors and deciding on the importance of environmental risks. The strong version is risk averse, limits regulators to consideration of environmental risks and urges prohibition of the commercialization of novel technologies until they are proven safe. He suggested that in the weak version, risk is a valid concern in domestic settings and may necessitate preventing or regulating particular technologies. He suggested that the Cartagena Protocol introduced weak precautionary language into an international trade agreement and was concerned that this would encourage production of environmentally risky agrochemicals. In the case of the strong version, risk is expected to trump all other concerns. It is sometimes argued that uncertainty of risks supports the principle's risk-averse stance. He rejected this proposal, stating that one can know enough about GM crops to prevent their commercialization, while not knowing enough to compare their risks to agrochemicals in order to decide which technology is preferable. He suggested that the choice of risks is a political or moral decision and that to preclude either on the grounds of such uncertainty would be very arbitrary. (ed.soule@msb.edu)

Professor Philip Bereano, Department of Technical Communication, University of Washington, characterized this conference as an expression of the political reality of the precautionary principle. Focusing specifically on the US, he noted that risk assessment, management and communication are political because definitions are not clear or obvious and costs and benefits do not fall equally on everyone. He reminded participants that risks are subjective, and arise not because scientists try to discover them but because the public encounters them. He emphasized that people will react strongly if they believe the risks of GMOs are being imposed upon them without their consent, knowledge or an open and transparent process. As for the ambiguity of the precautionary principle, he reminded participants that the "reasonable man" standard has been elaborated in the US legal system to accommodate and employ many different interpretations quite effectively. He stated that it is necessary to allow the organic nature of law to define and perfect the meaning of terms like environment and precautionary principle. (phil@uwtc.washington.edu)

Mario Rodriguez, AgroBio Mexico, noted the tendency for the debate to marginalize developing countries, by presuming that they do not have expertise in ethics, applying technologies, or developing regulatory frameworks. He also noted that developing countries should not be treated as a homogenous block, given the diverse range of economic development and interest in biotechnology. He stated that there is no precautionary principle as there is no general consensus on its formulation, and instead supported the use of longstanding principles such as comparative advantage, non-discrimination and most-favored nation status. He stated that technology is an important indicator of a country's ability to derive national benefits and suggested that using the precautionary principle to curtail technological development would leave developing countries disadvantaged in the global economy. (mrodrigu@pulsar.com.mx)