Regulatory and political perspectives in reproductive and developmental hazard assessment

The World Health Organisation is attempting to harmonise the processes of risk assessment worldwide in the hope that assessments performed in one country will be acceptable to other countries. This would reduce not only duplication of work by scientists, but would also reduce to a minimum the need for animal studies. There are differences in the scientific approaches used in different countries to the process of hazard and risk assessment. For example, in the USA risk assessment is focusing on development of mathematical models to describe dose-response relationships to define, for example, a benchmark dose. In Europe much less use is made of such models. More dependence is placed on no-effect levels, and the use of safety factors is much more highly developed. Political considerations come into play when one looks at the use, or misuse, that may be made of such hazard and risk assessments. Once a chemical has been classified and placed on a 'list' of reprotoxic chemicals, the underlying criteria may be ignored and actions taken which are quite unjustified by the original scientific evidence.