Biosafety in Biotechnology (original) (raw)

Resulting from a historical wedding with the traditional agro-food and pharmaceutical sectors, the discrete world of modern biology and genetics has still to stabilise ways of communication and behavioural and ethical practices in the real world. In such interactive and real-time evolving situation, any summary should appear, at the best, as a flashed picture. Biosafety is an emerging discipline built from traditional risk assessment and risk management rationale originating from chemistry, toxicology, microbiology, epidemiology, ecology, human and veterinary medicines, agronomy and all related basic or engineering sciences. It is composed of a spectrum of ways of thinking from the pure scientific analytical way to the most global conceptual way merging regulatory science, ethical issues, economics, and sociology. Biosafety is basically a case by case methodology exploiting pertinent safety criteria embedded in the history of sciences and of human practices. Risk assessment is and must be science-based only. However risk-assessment is evaluating multi-factorial situations and necessarily only leads to a set of certainties but also of uncertainties. Risk management leads to a binary decision: should an activity or a product be authorised or not, given a certainties/uncertainties ratio. Risk communication motivates the final decision and is a complex mixture of local and transboundary education, information and public interaction, dialectics, democratic respect, and transparency. These three aspects of biosafety are complementary and mutually beneficial if properly managed. To illustrate such a concept and its complexity, the present article gathers examples of the biosafety management of present biotechnological key developments. As it might be understood further, biosafety meets the challenge to be at the boundary of hard and soft sciences, the place where, in many societies, skill requires wisdom, on top of expertise.