Guide to Risk Assessment and Biosafety in Biotechnology, GRABBGuide to Risk Assessment and Biosafety in Biotechnology, GRABBAn Initiative of the United Nations Environment Programme (UNEP)
| SECTION: | INTRODUCTION | |||
| TITLE: | This Guide | |||
| BY: | Gilbert Howe | |||
| LABEL: | INT | UPDATED: | 31 Dec 19D WIDTH="47%">31 Dec 1997 | |
Structure and use of the Guide
IRRO (Information Resource for the Release of Organisms to the Environment) is a non-profit information network, initiated in 1991 by the United Nations Environment Programme (UNEP), which aims to provide access to all types of information relevant to the release of animals, plants and microorganisms into the environment. The information in question may concern both releases of unmodified non-indigenous organisms as well as genetically modified organisms (GMOs), ecological data, regulatory oversight, impacts on biodiversity, or other topics. Central to the concept of IRRO, however, is that it is a network that will facilitate access by all types of user to relevant databases and other sources. Iand other sources. Its secretariat is located in Sheffield, UK, at the Microbial Strain Data Network (MSDN), and the host of its on-line system is at the Base de Dados Tropical (BDT), Campinas, Sao Paulo, Brazil.
There is now a vast resource, much of it readily available on the World Wide Web (WWW), of the type of knowledge to which IRRO's mission is directed (see History and Context of IRRO). The data on GMOs alone encompass releases, projected or accomplished, of plants resistant to viruses, fungi and herbicides, or carrying genes for male sterility, sweetness, or modified sulphur or fatty acid content. Plant gene inactivation projects have focussed on delay of fruit spoilage, prevention of discolouration, reduction of starch content, and modification of flower colour (TA Brown, Gene Cloning: an Introduction, Edn. 3, p. 307. Chapman & Hall, 1995). Much public attention has been directed toirected to the production of cloned animals. In the domain of microbiology, where the earliest genetic modification and release experiments were carried out, numerous organisms have been released or at least considered for release, from modified Rhizobium to bacteria with potential applicability to bioremediation of polluted areas. A range of vaccines for human and animal use employing GMOs is now under development. The marketing of human health products manufactured from GMOs lies beyond the scope of a manual on released organisms, but it should be remarked that any GMO, however high the degree of containment stipulated for laboratory work, becomes a released organism if it escapes.
Knowledge of such possibilities, however, does not equate to information. There is a need for the user to locate where among the mass of data the knowledge of particular use is to be found, and to be clear about the reasons for wishing to acquire it. It might, for instance, be needed for scientific purposes in cposes in construction of a vector / cloned gene combination suited to a specified product, for the framing of a proposal for a release to a regulatory body, for the writing of a patent or other legal instrument to protect intellectual property, or to substantiate or refute a concerned voiced by the public. Demands for all of these purposes have increased in recent years in parallel with the corpus of scientific data itself. The ability to gain meaningful access to the data should be the aim of the searcher needing real information; a skill in doing so must be counted among those needed by scientists and others working in the area, pointing to a need for training.
Much of the rationale for seeking an understanding of these issues lies in the call for assessment and management of the conjectural risks, and sometimes benefits, of releases to the environment. This has been recognized by the Federation of European Microbiological Societies (FEMS) among other bodies: "Not only should scientists and technici technicians be trained to a high degree as specialists, they should also be trained in risk assessment and safety procedures" (Gene Technology in Microbiology: Benefits and Risks, FEMS, 1966). FEMS pointed to the need for training programmes to encompass ethical as well as safety guidelines, and for professional societies to initiate training programmes.
Several organizations have worked towards meeting this demand. For example the International Centre for Genetic Engineering and Biotechnology (ICGEB) has accepted each year since 1991 around forty workers in scientific or regulatory positions, mainly from developing countries, for one-week intensive courses and workshops. Some of those who have taken part have risen to positions of importance in biotechnology practice and regulation in their home countries. These courses with time have tended to focus on plant releases, and to adopt a case study approach where appropriate (see links at http://www.shef.ac.uk/~doe;)
The present Guide is intended to contribute to this training need by providing a series of interlinked chapters, accessible on the WWW, that can be updated regularly in line with the rapid developments in biotechnology thinking and practice.