Introduction

In previous chapters the many applications of biotechnology can be divided into the traditional domains of fermentation for the production of various potable beverages, bread, cheese, organic acids, antibiotics and waste treatment, and the new biotechnologies. The new biotechnologies include production and use of genetically modified organisms for the large-scale production of vaccines and therapeutic proteins; their use in plant and animal agriculture and in environmental clean-up; the use of hybridomas for the production of monoclonal antibodies for diagnostic and therapeutic end-points; and, of course, the controversial embryonic stem cells. As such, biotechnology spans a vast range of activities, and considerations of biosafety can potentially encompass activities within the research laboratory, the process plant, the final product and in many cases the environment. The term ‘biosafety’ has evolved as a new area of corporate activity created as an inevitable response generated by an expanding biotechnology industry and its increasing influence upon many aspects of commercial and public life. In particular, the many public issues recently generated, especially in Europe, concerning genetically modified (GM) crop trials has done much to raise the profile of this subject.

In all biotechnology processes, however, safety is of paramount importance. Table 14.1 lists the main areas of consideration for safety aspects of biotechnology.

Concepts of hazard and risk

Essential to the understanding of biosafety is the recognition and appreciation of the terms ‘hazard’ and ‘risk’.