A number of principles on environmental policy were agreed to at the United Nations Conference on Environment and Development in 1992. One of these is the importance of sustainable development so that we manage our environment not only for the health and economic benefit of today, but also for future generations. The second is adherence to a precautionary approach for environmental protection. Fundamental to our efforts to protect the environment is the establishment of appropriate regulatory mechanisms and the use of the best available science to make decisions, In and of themselves, however, regulations do not ensure safe applications of biotechnologies. We must often make decisions with imperfect knowledge. The precautionary approach suggests that when our knowledge is less than perfect, we will be protective of the environment and human health. Consequently, considerable thought must be given not only to the principles of biosafety, but also the practicalities of what constitutes a functioning programme, what the value of having such a programme is and whether that value balances the cost of establishing and maintaining a programme. The global biosafety regulatory landscape is quickly developing and evolving. The potential of biotechnologies to address national needs and economically attractive possibilities are well known. For practical and philosophical reasons, before countries can take advantage of these technologies, national biosafety mechanisms may be required. Consistent with international acceptance of a moral obligation to protect the environment, the value of having a biosafety programme seems quite high in terms of political capital. This is quite clear in the treatment of biosafety in Agenda 21 and the Convention on Biological Diversity. For the foreseeable future, technology transfer will necessitate concomitant regulatory oversight. While many developing countries are forming regulatory frameworks by adapting regulatory guidance already implemented elsewhere, cost sharing still carries a financial burden. The variety and disparity of potential frameworks necessitates normalization of both information/data requirements and relative stringency of regulatory oversight. Other costs include those for biosafety training, data collection and storage, and monitoring programmes, International guidelines and/or a binding protocol under the Convention on Biological Diversity, may help to assist the harmonization process while providing an overall umbrella for biosafety regulation thus reducing the costs of having to establish biosafety regulatory programmes de novo, Programmed training approaches that create networks of trained individuals on regional and subregional levels may facilitate the acquisition and dissemination of biosafety expertise at reduced costs. Providing useful, relevant information is a non-trivial task and can be expensive. With unique issues to address, developing countries may find limited use for existing assessments done elsewhere. Acquiring new knowledge may carry a high cost in both time and money. There are significant benefits to be derived from having biosafety mechanisms in place, but costs associated with the adoption and implementation of regulations may be substantial. Each country will have to weigh the benefits and costs for themselves to determine the best mechanism to achieve national goals for environmental protection and technology development. International cooperation and assistance can be helpful in this regard and, in many instances, will be necessary if all countries are to have national biosafety regulations.
