Science and policy in risk assessments of chlorinated ethenes

In this article the use of data obtained from standardized experimental methods, for example, as specified in OECD guidelines for the testing of chemicals, epidemiology data, and mechanism data obtained from nonstandardized experimental methods in carcinogen risk assessment is scrutinized using the most recent risk assessments made by International Agency for Research on Cancer (IARC), the MAK(MAK)-Kommission, World Health Organization (WHO), European Centre for Ecotoxicology and Toxicology of Chemicals (ECETOC), and American Conference of Governmental Industrial Hygienists (ACGIH) for the four chlorinated ethenes as examples. The analysis shows that there was little controversy among these risk assessors about the interpretation of standardized animal data. On the other hand, they differ in their interpretation of epidemiology data, in particular in their assessment of statistical significance including the use of meta-analyses, and in quality evaluation of studies initiated on the basis of a priori concerns for carcinogenicity. The selection of mechanism data for species extrapolation is diverse among these risk assessors. Furthermore, in some cases they refrain from transparently motivating significant claims about mechanisms of toxicity by avoiding to give (explicit) references to the sources of information forming the basis of these claims or conclusions. This practice is not according to the scientific standards that should be required of a risk assessment document, and it makes it difficult to follow the argumentation and consequently to scrutinize the scientific accuracy of the conclusions drawn. In this article it is concluded that in some of these risk assessment documents, the use of mechanism data is not according to the scientific standards that should be required. It is furthermore concluded that if the use of mechanism data in these documents are representative of risk assessments in general, then there is an urgent need for further development and implementation of quality criteria for the use of mechanism data in species extrapolation.