Use of biotechnology in sectors such as agriculture and medicine has produced a growing number of genetically modified organisms (GMOs) and products from them. The rapid diffusion of transgenic crops illustrates the pace at which biotechnology is transforming the commercial landscape (see figure). The potential ecological, human health, and socioeconomic effects of such use have become the focus of widespread debate at national and international levels. These debates are rooted in different cultural approaches to risk acceptance and management, and their outcomes will reshape existing policies and institutions dealing with the safe use of biotechnology.
Efforts to ensure the safe use of biotechnology to date, especially in the United States, include undertaking scientifically based, case-by-case hazard identification and risk assessment; regulating the end product rather than the production process; developing a regulatory framework that builds upon existing institutions rather than establishing new ones; and building flexibility into biosafety systems to reduce regulation of products perceived to be low-risk. Biosafety risk assessment focuses on characteristics of the organism being assessed, intended use of the organism, and features of the recipient environment. The concept of substantial equivalence between new and traditional products has been used as a basis for determining what safety tests are needed before putting a genetically modified product on the market and whether product labeling is required.
Given that risk assessment and management decisions have been based on experience gained with a particular organism, its intended use, and its receiving environment, familiarity has emerged as a key biosafety principle in some countries. Although familiarity cannot be equated with safety, it has provided the basis for applying existing management practices to new products. Furthermore, case-by-case and step-by-step risk analysis underpin the use of familiarity to assess and manage risk. The Organisation for Economic Cooperation and Development (OECD) recommends this approach to biosafety and the U.S. regulatory system relies on it.
Partly in response to negative public reaction to growing use of genetically modified crops in agriculture, some countries, especially in Europe and recently Japan, have introduced labeling for some or all biotechnology-based products. The perceived need to base biosafety policies on the precautionary principle has also justified labeling. This approach acknowledges that not enough may be known about the long-term adverse effects of GMOs. It thus requires prior evidence that biotechnology-based products are safe for human health and the environment.
As a reflection of the need to regulate potential risks posed by transnational transfers of GMOs, efforts are currently under way to negotiate a legally binding biosafety protocol under the Convention on Biological Diversity. Lack of agreement on a number of critical issues prevented the adoption of the protocol in Cartagena, Colombia, in February 1999. The centerpiece of the draft protocol is an advance informed agreement (AIA) procedure to be followed prior to the transboundary transfer of GMOs (called living modified organisms or LMOs in the protocol). Exactly which categories of LMOs will be covered under this AIA procedure remains a subject of disagreement. All agree that LMOs that will come into contact with the environment of an importing country should be covered under the AIA, in order to assess for potential adverse impacts on biodiversity. A key point of disagreement centers on whether LMOs that are “intended for food, feed, or processing” rather than for deliberate release into the environment should also be covered under the AIA. LMOs not intended for release into the environment are called commodities. A group of major agricultural exporting countries (the Miami group, including Argentina, Australia, Canada, Chile, the United States, and Uruguay) argues that agricultural commodities should be excluded from the AIA procedure because they cannot pose a threat to biological diversity. These countries point out that providing detailed information on LMOs in bulk agricultural commodity shipments is not feasible, because genetically modified and nonmodified seeds commingle and no direct business link exists between seed growers and exporters. Other countries, especially developing countries, call for all first-time transfers of LMOs, including commodities, to be covered by AIA. This is seen as necessary in order to monitor entry of LMOs, as well as to assess human health impacts. These countries also point out that the “intended use” of LMOs for processing (rather than for planting) cannot always be guaranteed once the organisms have entered a country’s borders.
Negotiators also disagree on whether decisions taken under AIA should be based upon sound science or precaution. Those calling for sound science note that reliance upon the precautionary approach could result in discriminatory or unjustifiable barriers to international trade in LMOs. Those favoring precautionary approaches note that unambiguous scientific evidence of harm relating to LMOs may not be forthcoming in the short term. They argue, therefore, for precaution in the face of scientific uncertainty, in order to ensure that genetically modified products are safe for human health and the environment. Another key conflict involves the exact nature of the relationship between a country’s obligations under the protocol and its rights and obligations under World Trade Organization (WTO) agreements. A standoff on this issue was one of the main reasons for the deadlock in Cartagena. Countries also disagree about whether issues such as socioeconomic effects of LMOs, liability and compensation, and pharmaceutical products should be included in the protocol. Further negotiations are under way in an attempt to finalize a protocol in 2000–2001.
Biosafety measures cannot be effectively implemented without adequate institutional and human capacity at the national level. In most countries with regulatory regimes, existing institutional arrangements have been adjusted to accommodate biosafety needs. Many developing countries are now in the process of developing biosafety regulations. In some poorer countries, discussions about the introduction of these regulations have been accompanied by concerns about their expense. As a way to address these concerns, the last decade has seen an increase in the number of formal and informal programs aimed at creating human resource capacity for biosafety regulation. The programs have focused on risk assessment and regulatory oversight. Training, workshops, seminars, and technical meetings have helped to build capacity in biosafety. International organizations have played a key role in supporting such activities. The draft biosafety protocol also identifies capacity building as a key area for international cooperation.
Current public debate on the commercialization of agricultural biotechnology products, especially in Europe, has underscored the importance of public participation in risk assessment and decisionmaking pertaining to GMOs. The rapid pace of technological change and the wide-ranging nature of the perceived effects of biotechnology necessitate much greater public participation in policymaking. A number of industrialized countries have launched programs aimed at including the public in technology assessment and decisions involving the use of biotechnology in agriculture. The issue is not simply one of providing scientific information to the public, but rather of building trust between science and society. Intermediary programs and institutions concerned with the social aspects of biotechnology could be established to build such trust. While informed and effective public participation remain crucial requirements in this arena, the need to maintain confidentiality about proprietary commercial information constrains the nature and extent of this participation. Where the boundary should lie between privately and publicly held information pertaining to GMOs continues to be an area of debate in determining the appropriate level of public participation in decisionmaking.
For information without proprietary constraints, national and international agencies are increasingly using modern communication technologies, such as the internet, to disseminate information on regulations and risk assessments of genetically modified organisms. While such communication technologies are important mechanisms for sharing information and experiences, and their use is likely to grow in the future, excessive reliance on them could prevent those countries with the least capacity and the greatest need for risk-related information from having timely access to the latest knowledge about biosafety. Measures adopted to complement information dissemination through the internet include the establishment of biosafety clearing houses within national and international agencies. The use of such intermediary institutions as bridges for sharing information and experience between various sections of society and across countries needs to be enhanced. In particular, intermediary institutions could facilitate the task of monitoring risk assessments and decisions pertaining to biotechnology products as an important means of accumulating knowledge. While a number of national agencies have begun monitoring activities, the results of these efforts have not been consolidated into global biosafety assessments. Such assessments could be useful in disseminating the lessons learned about different genetically modified organisms and in facilitating experience and information sharing among countries.
For more information see John Doyle and Gabrielle Persley, Enabling the Safe Use of Biotechnology: Principles and Practice (Washington, D.C.: World Bank, 1996); G. Tzotzos, Genetically Modified Organisms: A Guide to Biosafety (Wallingford, U.K.: CABI, 1995); and Aarti Gupta, Biosafety in an International Context (Cambridge, Mass., U.S.A.: Harvard University, 1999) (http://environment.harvard.edu/gea).
Calestous Juma is a special adviser and research fellow at the Center for International Development at Harvard University and a former executive secretary of the United Nations Convention on Biological Diversity (e-mail: calestous_juma@harvard.edu). Aarti Gupta is a research fellow at the Kennedy School of Government, Harvard University (e-mail: aarti_gupta@harvard.edu).