ABSTRACT
In this chapter, I will cover the examination of studies concerned with defining hazard to humans. Formally, two stages of risk assessment are covered: hazard identification (determining what adverse effects may be caused) and hazard characterisation (determining dose-response or dose-effect relationships for the key effects). Outside labelling requirements for chemicals, hazard characterisation is combined with either risk evaluation or exposure assessment. Normally, the first objective is to examine what constitutes a ‘broadly acceptable’ risk (a ‘safe’ exposure) for health effects, either by defining the maximum ‘broadly acceptable’ risk (standard setting) or by determining whether there is a sufficient margin of exposure that the risk is ‘broadly acceptable’.
