CHARLESTON, W.Va. -- AFTER a chemical spill into the Elk River affected the water supply for 300,000 people in West Virginia, some are calling on Congress to reauthorize the 1976 Toxic Substances Control Act.
Here's another idea: Revamp how we define a hazard and determine risks to humans and the environment for the 80,000 or more chemicals in commerce today. This would require less political wrangling and would follow the 2007 recommendations of a National Research Council expert panel.
Limited safety data are available to the federal government for regulating these chemicals: only 500 chemicals have been subjected to the standard animal test for carcinogenicity in the past 50 years. Furthermore, such tests are of limited relevance to human risk.
In 2004, the FDA reported 92 percent of new drugs that passed animal trials failed in human clinical trials because of lack of effect or unexpected toxicity. A 2000 report found that animal data predicted human outcomes only around half of the time. Animal testing is also time-consuming and expensive. Testing just one chemical thoroughly costs about $5 million and takes four to five years. Safety testing for drugs and pesticides costs more and takes longer.
The National Research Council on toxicity testing argued that continuing animal testing is not the answer. We need to embrace a new approach based on three core technologies -- high throughput robotic testing systems that produce a much larger amount of biological data per dollar/time compared to animal tests; new human cell systems based on developments in stem cell biology and bioengineering; and sophisticated new computer modeling algorithms and databases for interpreting this flood of new data.
As an example, the European Union has established a system to collect safety information on about 30,000 chemicals. If these chemicals were tested in animals to assess likely risks in humans, it would cost billions of dollars and take 300 or more years to complete. Using the types of robotic systems in place at the National Chemical Genomics Center of the NIH, we could put these chemicals through hundreds of tests at 15 different chemical concentrations at much reduced costs in just a few years.
The Humane Society of the United States estimates approximately $200 million a year is already devoted to the technologies that would underpin new hazard identification and risk assessment approaches. In the United States, the NIH, the EPA, the National Toxicology Program and the FDA signed a memorandum of understanding to support these new approaches, and related efforts are occurring in the EU, Japan and elsewhere. However, there is still a lack of coordination and political will to target resources and track results.
The Humane Society has teamed with multi-national corporations such as Dow, DuPont, Procter & Gamble and Unilever and a number of independent research institutions to accelerate the realization of the transition away from animal testing and toward the 21st-century approaches recommended by the National Research Council in a project we call the Human Toxicology Project Consortium.
We now call on Congress and U.S. research and regulatory agencies to do for toxicity testing and safety assessment what was done for human genome science and formally coordinate these efforts. The formal launch of this approach is likely to have tremendous scientific and economic impacts, as with the Human Genome Project. That project cost $3.8 billion but has led to almost $800 billion in new jobs, economic activity and a much deeper understanding of human biology. In addition to economic benefits, new testing approaches will lead to a safer world for people, animals and our environment.
Andrew Rowan is chief scientific officer for The Humane Society of the United States, and Melvin Andersen is chief science officer of The Hamner Institutes for Health Sciences.