Current schemes for decision-making in toxicology

In an evaluation of current schemes for decision-making, several areas were identified for improvement. Firstly, regulatory requirements are often inconsistent (e.g., there is no human exposure data requirement for the assessment of agrochemicals). There should be a drive towards standardization so that substances or materials are assessed to a uniform and comparable standard. Secondly, decision-making could be improved by increasing the usage of reported data. Formal voluntary data submission processes should be set up, together with schemes for incorporating the data into the decision-making process. Pharmacovigilance schemes from the pharmaceutical industry may serve as models. Thirdly, the ways in which data are evaluated and integrated may be improved. Klimisch scores provide a good basis for assessing data quality, but additional information is required on the adequacy of studies with regard to specific questions (1). Despite the importance of improved standardization regarding data evaluation (e.g., by more elaborate standards or scoring systems), it is important to allow for a certain flexibility in the way data are interpreted. Fourthly, there is no current link between advances in scientific knowledge and the processes of decision-making. Processes, such as formalized decision analyses, are needed. Finally, uncertainty is not addressed explicitly in decision-making schemes, and uncertainty factors need to be less arbitrary and more evidence-based. There were specific recommendations regarding ecotoxicology. Ecosystem health is a growing concern, and decision-making is increasingly based on in situ diagnostics of low ecological levels of exposure using biomarkers of pollution. A strength of this approach is that biomarkers are measurable in individual organisms, providing early indications of ecotoxicity. Weaknesses include methods of extrapolating mechanistic evidence to the levels of populations and ecosystems. Current decision-making schemes such those of the International Agency for Research on Cancer (IARC), the United States Environmental Protection Agency (EPA), and the Organization for Economic Cooperation and Development (OECD), and the European Union Regulation on Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) legislation are science-based but do to a large extent depend on authority-led judgement. A comparison of the strengths and limitations of individual decision-making schemes may provide the basis for developing an evidence-based toxicological approach. References 1 Klimisch HJ, Andreae M, Tillmann U. A systematic approach for evaluating the quality of experimental toxicological and ecotoxicological data. Regul Toxicol Pharmacol 1997; 25: 1-5.

GRIESINGER Claudius;  HOFFMANN Sebastian;  KINSNER-OVASKAINEN Agnieszka;  COECKE Sandra;  HARTUNG Thomas; 

2010-01-25

SAGE PUBLICATIONS LTD

JRC56782

0960-3271,   

https://publications.jrc.ec.europa.eu/repository/handle/JRC56782,   

10.1177/0960327109105775,