Close up on toxicity tests
Every year, millions of animals are poisoned in EU labs to test the toxicity of chemicals, pharmaceuticals, household products and – except in the UK – toiletries.
Of all animal experiments, toxicity tests certainly rank among the most cruel. The reason is not hard to find: the endpoint of many of them is to wait and see how many animals will die after receiving a given test substance. Symptoms can include nausea, convulsions and bleeding.
Yet traditional animal toxicity testing could be replaced very quickly by far more reliable science-based toxicology. The problem is that political forces are currently holding back the scientific ones. These powerful interests are operating both within the EU and in the US. The seed of hope, however, is that political power can sometimes be moved by public opinion - as well as by legal challenges. A good example of the latter is the enlightened Swedish government's rebellion against the EU's continued use of the highly toxic pesticide, Paraquat. Sweden outlawed its use in 1983.
Unreliable animal tests
There are also very good historical reasons why animal tests should be eliminated. The New York Times put it very succinctly just over a decade ago, in March 1993: "So much evidence has accumulated that chemicals frequently have wholly different effects in animals and humans that officials throughout government and industry often do not act on the studies' findings."
If this is the case - as indeed it would appear to be - then the public is owed an explanation as to why progress to end animal experiments is so slow. Why have regulatory authorities hesitated and equivocated for the past decade, rather than simply rectifying the situation by adopting science-based, non-animal toxicological methods?
Despite all the evidence to the contrary, the EU cannot seem to follow a logical policy. For example, even ECVAM (European Centre for the Validation of Alternative Methods) - the EU's main advisory authority on alternatives to animal testing - often simply defines alternatives as replacing live animals with animal cells. But by using animal cells, the results of the alternative test methods can only be compared with existing animal data, rather than with the relevant target species, human beings. ECVAM has thus become a victim of its own alternatives testing strategy, since the 'gold standard' against which alternatives must be measured are animal tests. Indirectly, it is still encouraging animal research by legitimising it as a valid method.
It remains a mystery why ECVAM continues to rely on previous animal data in the light of the US Food and Drug Administration's (FDA's) admission in 1998 that "most of the animal tests we (the FDA) accept have never been validated. They evolved over the past 20 years and the FDA is comfortable with them". (Validation is defined as "the process by which the reliability and relevance of a procedure are established for a specific purpose".)
Completion of the validation process is key to regulatory acceptance (in this case, by the EU). Once an alternative method has achieved the status of regulatory acceptance, it may then be adopted by industry to replace a particular set of live animal tests.
The average timespan for the validation process is ten years per test method. Such a strategy will obviously not eliminate animal testing, nor embrace more scientifically relevant toxicology anytime soon. However, as the saying goes, there is no stopping an idea whose time has come. Animal toxicity testing is as outdated as it is cruel.
The concept of a human-based approach has now been launched through what is known as science-based toxicology (SBT). SBT is now being recognised and indeed encouraged by some government authorities, most notably the NIEHS (US National Institute of Environmental Health Sciences). Initiatives are already underway to encourage collaboration between government, industry and academia to assess non-animal models of molecular toxicology. This research would lead to the elimination of such standard testing as the current method to assess carcinogenicity - normally carried out over long periods on mice and rats.
The implementation of SBT systems is of particular importance and urgency in the world in which we live today, surrounded by 100,000 chemicals, most of which have never been assessed for their toxic risk to humans and to the environment. Whereas SBT methods can provide an initial toxic risk assessment within 24-48 hours, the traditional animal tests typically take up to two years. And all that they achieve - apart from suffering and death - is to provide information upon which we cannot rely.