Non-animal Methods for Toxicity Testing

The Way Forward: Alternatives – The Future is Now!

Last Updated: December 6, 2007
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By Andrew N. Rowan, Humane Society International

For someone who has spent his career (or over thirty-one years) advocating for the greater use of alternatives, the present moment in history is loaded with exciting potential.

The debate and discussion within biomedical science about the place and use of alternatives has changed in fundamental ways from the patronizing and discouraging comments thirty years ago to encouraging and often even enthusiastic comments today. The number of laboratory animals in research has declined by 50% or more despite a substantial increase in inflation-adjusted research funding. The European Union is home to many "alternatives centers" supported by government funds and both the USA and Japan also have national "alternatives" programs. A few years ago, the European Union (EU) set up the European Partnership for Alternative Approaches to Animal Testing (EPAA) with the support of several key EU Directorates to look to the day when animals would no longer be needed for safety testing and risk assessment. This year in the USA, the National Research Council (NRC) issued a report on the future of toxicity testing that suggested that the time was ripe to develop a new toxicology paradigm not based on animal testing. In fact, the widespread use of alternatives is already being implemented by several large multi-national companies who are faced with eliminating animal testing of cosmetics within the next five years.

As industrial societies face increasing pressure from their citizens to collect more safety data, both the EU and the USA are coming to grips with the problems posed by animal tests. These tests have been developed over the past fifty years and have now become entrenched as the "gold standard" when regulators try to judge whether a new or existing chemical poses unacceptable risks to either humans or the environment. However, these tests are anything but a "gold standard." They are time-consuming, expensive and not particularly relevant to humans. There are many examples of chemicals that produce a toxic response in mice but not in rats and vice-versa leaving regulators to scratch their heads about the level of risk to humans (is the human more like a mouse or a rat in his or her response to the chemical?).

We need a new and better system to identify and assess the level of risk to humans, animals and the environment. The good news here is that the NRC, a number of multinational companies and important European regulators and politicians have recognized that our technology has advanced to the point where it is possible to map out a realistic strategy for developing a new chemical testing approach that does not rely on inadequate and expensive animal tests. Instead, we can do adequate risk assessment using a mix of cell tests, new high through-put "omics" techniques, computer analyses, and modern bio-monitoring technology.

What is needed now is a new "big biology" initiative that takes the model developed for the Human Genome Project and applies it to fulfilling the vision outlined in the NRC report. The Human Genome Project cost $3.8 billion over sixteen years. It has been estimated that about $2 billion of research funding over the next ten years could improve the technology to the point where we would be close to implementing a non-animal safety testing system. This is a large sum of money but not beyond reach in light of the budgets and activities of the National Toxicology Program (with its roadmap and vision for the 21st century), the Environmental Protection Agency (with its ToxCast program), a number of multi-national companies (who are spending $10 million or so each per year on the development of alternatives, the ECVAM, and various European governments that are spending combined at least $5 million a year on alternatives. Counting private and government sources, it should be possible to establish a co-ordinated research program with at least $50 million a year. All we really need now is around $10 million to develop the initiative and then somebody like a Jim Watson or a Francis Collins to get the initiative up and running.

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©2007 Andrew Rowan