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Biotechnology in the Global Economy:
Science and the Precautionary Principle

22-23 September, Kennedy School of Government at Harvard University


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

National Experiences: Case Studies from Brazil, India and Kenya
Dr. Luiz Antonio Barreto de Castro, The Brazilian Enterprise of Agriculture Research, Aarti Gupta, School of Forestry and Environmental Studies, Yale University, and Dr. John Mugabe, African Centre for Technology Studies, Kenya

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. (

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. (

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. (

International Experiences

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. (

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. (


In the ensuing debate, several participants stressed concern with the EU's position, especially as expressed in a recent communication claiming that the principle could easily be employed as a non-tariff trade barrier. In this regard, participants requested more explicit definition of the EU's use of the term "sufficient certainty," while others inquired about the principle's relevance to the EU's Common Agricultural Policy and fisheries policies. One participant called for more attention to trade concerns within the debate and suggested a creative competition between trade and environmental goals. Others noted that the European system will simply take more time to work through the process given complexities of internal policy formulation, and that one of the points expressed in its communication was to avoid the principle's use for trade protectionism.

Policy and Institutional Implications

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. (

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. (


Dr. Gary Comstock, Bioethics Institute, Iowa State University, suggested that the principle's formulation in the Rio Declaration implies that new technologies should not be advanced unless there is certainty that it will be safe for humans and the environment. He suggested that this is society's expression of risk aversion and that is why it has been codified into international law and why the EU has invoked the principle to justify its current moratorium on GM crops. He asserted that a logical analysis of the principle reveals two contradicting propositions: (i) We must not develop GM crops, as some in the EU propose and (ii) We must develop GM crops. He therefore suggested that the burden of proof is on the principle's defenders to explain why its policy implications are not incoherent. He stated that discussion should not focus on the principle, but rather on the obstacles standing in the way of delivering the potential benefits (e.g., improved nutritional content and decreased environmental and health impacts). He proposed the following questions: if biotechnology advocates want to feed the world's hungry, why aren't they putting more resources into alternative methods proven to increase production; and what gives biotechnology's opponents the right to take away the choice of using the technology from people in other countries? (

Regulatory Implications

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. (

Andrew Apel, AgBiotech Reporter, presented his ideas to unify the concepts of substantial equivalence and the precautionary principle. Noting recent criticism of both principles, he stressed the need to develop a mutual compromise among interested stakeholders. He noted that substantial equivalence generally embodies the idea that existing organisms used as food can be the comparative basis for assessing the safety of a similar product or variety that is modified or new. Apel did note that substantial equivalence is not equipped to address developments that are so new that they cannot be interpreted in terms of the status quo, at which point the potential risks could be assessed through the precautionary principle. He noted that the principle would thus be subsidiary to substantial equivalence and that this is consistent with the Cartagena Protocol. Finally, he called for an assessment of the risks and dangers of existing non-GM controls to their GM alternatives, suggesting the need for further research on the impacts of herbicide applications on monarchs in addition to work on Bt maize. (

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