New technologies could build better regulation

A variety of new technologies are allowing researchers to study how genes are expressed, the function of proteins, metabolism and genetic differences in unprecedented detail within populations and between individuals. These scientific advances are making a major impact on medical diagnosis, treatment and the prevention of disease. They also hold great promise for improving the scientific basis for understanding the potential impact of chemicals on health and the environment.

Today, human health risks are deduced from toxicity studies that use very large doses, much greater than those that are environmentally relevant for us. The use of the new molecular biology techniques in risk assessment could lead to better, more reliable understanding of relationships between dose, exposure and risk from substances (natural and manufactured) found at low levels in the environment.

Cefic position on new risk assessment technologies

An enormous amount of toxicogenomic data is being generated on chemical substances.  But techniques for comprehensive interpretation of this data still need to be developed.

Through its Long-range Research Initiative (LRI), the European chemical industry is working towards a better understanding of dose, exposure and risk from a variety of environmental stressors using toxicogenomic data generated by the new molecular biology techniques. Such techniques are not currently part of regulatory processes.  LRI will support the development of an appropriate interpretive framework to allow the input of this data into science-based risk assessment, regulation and policy making. The Cefic-LRI programme launched its first project in this area in 2007.

This work will highlight the industry’s engagement, activity and impact in this developing scientific and regulatory area. It will also demonstrate its role as a provider of research for the relevance of molecular biology technologies – in particular in better understanding the impact of complex environments on health.

Cefic’s contribution to new technique development

Cefic was an early participant in discussions on how these new technologies might be implemented within risk assessment and regulatory environments in a useful and appropriate way. It is pursuing the development of the techniques by organisation of scientific workshops through the global International Council of Chemical Associations (ICCA) LRI programme and participation in the OECD expert group.

The OECD Expert Group, led by the US Environmental Protection Agency (EPA), first met in May 2007 to support and harmonise activities in this area – in particular the EPA’s ToxCast initiative that involved a programme of tests on about 300 substances including toxicogenomic and in-vitro methods.

A number of European Commission research projects are also working in this area (for example ToxicoGenomics, NewGeneris). These are being monitored by Cefic-LRI.

A major ICCA LRI workshop was organized mid June 2010 in conjunction with the European Commission’s Joint Research Centre (JRC) on ‘Integrating New Advancements in Exposure Science and Testing’ in Italy. This will discuss the need for innovations in exposure science and how to incorporate these innovations with the results of the ‘new’ toxicity testing.