New regulatory science in system toxicology: is an update needed, what would be the critical elements and by when?
Regulatory toxicology is used to control about $10 trillion (£6.2 trillion) worth of worldwide trade in chemicals, drugs, pesticides, food and consumer products.
While Europe has been pursuing change under the label of alternative methods and the 3Rs (reduce, replace, refine) for more than two decades, it was only a 2007 National Research Council report on the subject that prompted serious efforts to change the US system. The 3Rs approach had suggested either optimising animal tests (fewer animals or less pain and distress) or replacing traditional tests with in vitro or in silico models for harmonization.
The answer emerging in Europe is to combine various information sources in integrated (or intelligent) testing strategies (ITS). Despite the enormous possible impact this could have with EU legislations like REACH or the testing ban for cosmetic ingredients, efforts to further this are still limited. The answer emerging in the US is to adopt a new, molecular description of toxic action based on pathways of toxicity (PoT) – the biomolecular pathways that lead to a cell being harmed. This approach represents a paradigm shift in toxicity testing – identifying a substances effect on harmful cellular pathways, rather than interpreting effects on cell lines or entire organisms.
Synergies exist between these two approaches and two economic partners. Joint efforts to keep
leadership and achieve results are seek.
