Journal or Publishing Institution: Tapir Academic Press
Study: http://bch.cbd.int/database/attachment/?id=11414
Author(s): Traavik, T. and Lim, L.C.
Article Type: Book
Record ID: 2005
Abstract: The history of this book is closely related to the origins of the international biosafety course ‘Holistic Foundations for Assessment and Regulation of Genetic Engineering and Genetically Modified Organisms’. It started at a breakfast conversation between the Third World Network (TWN) director Martin Khor, TWN’s coordinator of its environment programme Chee Yoke Ling, and GenØk director Terje Traavik during a regional biosafety meeting in Kuala Lumpur in early February 2001. The TWN representatives made the point that during international biosafety meetings and negotiations, representatives of developing countries were often brushed off and intimidated by the claim that ‘you do not know anything about the science behind this’, and that this claim was often correct. They then inquired whether GenØk would be able and willing to launch biosafety courses for scientists, regulators and NGO/ civil society leaders from developing countries. The main basis and core of such
courses would have to be the functional genomics and molecular biology behind genetic engineering (GE) and genetically modified organisms (GMOs). Following internal meetings and discussions in both TWN and GenØk, a decision was made in the autumn of 2001 to go ahead with a joint planning process spearheaded by Lim Li Lin and Terje Traavik, and to invite NZIGE (New Zealand Institute of Gene Ecology, now Centre for Integrated Research in Biosafety (INBI)) director Jack Heinemann to participate in the process. By early 2002 the biosafety course idea had grown into a ‘Biosafety Capacity Building Package’. In addition to biosafety courses for the aforementioned target groups, the package included a Biosafety Forecast Service (BFS) and a Biosafety Book/CD-ROM project. The latter ‘seed’ has developed into the book that you are now reading, while the former has become the BFS/Biosafety Assessment Tool (BAT) service, which is described in Chapter 35.
An application for funds to make the Biosafety Capacity Building Package a reality was submitted to the Norwegian Royal Ministry of International Cooperation and Development in September 2002. Minister Hilde Frafjord Johnson subsequently invited Terje Traavik to deliver a talk to her staff about the need for GE/GMO biosafety capacity building, with particular reference to developing countries. The talk was delivered on 9 December 2002. Afterwards, Terje Traavik was invited to coffee and to sign his name on the last page of a pile of papers, which was the contract for a grant that made the realization of the Biosafety Capacity Building Package possible, and for that we are eternally grateful to Hilde Frafjord Johnson and her staff, particularly Ms Inger Marie Bjønness.
We then started to plan the details for the first course to be launched in Tromsø (Norway) in August 2003, which was targeted at regulators. However, as this would have been just before the Cartagena Protocol on Biosafety came into force the organizing committee felt that it was important to give all three target groups some basic and urgently needed biosafety training, and therefore decided to open the first course to all groups. The professional and social benefits of this turned out to be so overwhelmingly obvious that the common course mode has been used ever since, i.e. for five consecutive years, and this has also strongly influenced the design, pedagogical principles and contents of this book.
This book is intended as background reading for our annual Biosafety Course, as well as for the regional courses that we are now launching in conjunction with partners from all continents. It is, however, a regrettable fact that admission to these courses is very limited, mainly by the capacity of the laboratory training facilities. We therefore sincerely hope that the book will be a useful resource for all the highly qualified and motivated applicants that are not admitted, and also for citizens with an interest in the biosafety aspects of some of the most powerful technologies humankind has ever created.
The book is based on a holistic design which embraces the new scientific field of ‘gene ecology’ and a Precautionary Principle based approach to risk identification, assessment and management. The holistic concept is approached by the inclusion of all potential risk areas (human, animal and ecosystem health; socioeconomic; cultural, ethical, etc.) within the same contextual framework. Moreover, it integrates the legal, regulatory and policy issues, as well as public participation issues, providing a solid foundation on which genetic engineering and GMOs can be assessed.
Gene ecology is the study of interactions between hereditary materials (DNA, RNA, proteins) and their surrounding environment in the broadest sense. This includes the organization, function and transmission of genes and nucleic acid fragments in different ecosystems and in the context of varying ecological parameters. Hence, gene ecological research must be based on knowledge from functional genomics and other modern biosciences, combined with ecology, evolutionary sciences, bioethics, social sciences, and the philosophy of science. Since humanmade changes crucially influence the ecosystems, and there is also a social context in which scientific interventions occur, social scientific approaches must be included in the working hypotheses, research designs and impact analyses of gene ecology. Gene ecology is hence, at the same time, a basic and biosafety applied scientific field.
Employing the Precautionary Principle as a basis for creative thinking, research hypotheses and experimental designs leads us to the science of ‘What if?’ This is important in view of the fact that real GE/GMO biosafety can only be achieved if we are able to anticipate, prevent and attack the causes of ecosystem, human and animal health degradation. The Precautionary Principle and its scientific and regulatory applications are further discussed in a number of chapters, among them 7, 17, and 29.
As mentioned earlier, the need for genomics and molecular biology knowledge and training was the basis for the Biosafety Course and hence for this book. These subjects are presented and discussed from many different angles and viewpoints in Parts 1 and 2. The intention of Part 1 is to present the basic genomic knowledge behind GE/GMOs in an unbiased way, but with clear distinctions between what we know, what we think we know, and what we do not know. If the authors have succeeded, the chapters in Part 1 should turn the reader’s mind to the most burning issues of biosafety: hazard and risk identification, the known unknowns and the unknown unknowns. The section of Part 2 of the book dealing with the potential biological impacts, builds on the scientific knowledge provided in Part 1, and aims to identify areas where scientific ignorance and lack of knowledge may render credible risk assessment impossible, irrelevant or too large-meshed. The latter half of Part 2 then deals with areas of social, cultural and ethical concern. The chapters present new ideas and ways of thinking and approaching science, bringing in social perspectives. This includes learning from indigenous peoples and farmers. Viewed in this way, socio-economic considerations, the implications of scientific uncertainty and the limitations of risk assessment are squarely placed within the concept of biosafety.
While a biosafety regulatory framework attempts to regulate and manage the risks of GMOs and is important in its own right, many challenges remain. Part 3 of the book provides an understanding of the current regulatory and policy approaches to biosafety, touching in particular on the only legal instrument to specifically regulate GE/GMOs, the Cartagena Protocol on Biosafety. Yet, this in itself is not adequate, and other considerations come into play, including ensuring coordination and coherence in the national implementation of biosafety regulations based on national development needs, navigating the international mesh of regulations that deal with and impact on biosafety policy and law, applying the Precautionary Principle and sustainable development considerations, and addressing the issue of liability and redress for when damage occurs. Moreover, the testing and monitoring of GMOs, and ensuring public participation in biosafety issues, are critical components of a precautionary approach to managing risks and uncertainty.
The authors of this book advocate a very cautious and precautionary approach to modern biotechnologies, in order to harness the benefits and leave the risks behind. For the sake of biosafety it is necessary to admit that the central core of the living is not at all well understood. We cannot explain how gene regulation starts; we cannot explain the differentiation in multicellular organisms, nor the timing of gene expression programmes that secure the homeostasis of organisms.
Keywords: New Technologies, Genetic Engineering, Genetically Modified Organisms (GMO), Human Health, Environment, Socio-Economic, Biosafety, Precaution, Prior Informed Consent, Holistic Approach, Commercial Interests, Gene Ecology
Citation: Traavik, T. and Lim, L.C. (eds.) Biosafety First: Holistic Approaches to Risk and Uncertainty in Genetic Engineering and Genetically Modified Organisms. Trondheim: Tapir Academic Press.
