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The HSUS Applauds FDA for Joining Tox21 Project

Federal project expected to reduce reliance on animal testing

On Monday, The Humane Society of the United States and the Humane Society Legislative Fund applauded the U.S. Food and Drug Administration for joining the Tox21 project — a federal effort to modernize the process for assessing the potentially harmful effects of chemicals on human health. This effort is expected to substantially reduce the current reliance on animal testing.

Tox21 was initiated in 2008 by the National Institutes of Health (through its NIH Chemical Genomics Center and the National Toxicology Program) and the Environment Protection Agency, in response to the National Academy of Sciences' 2007 report on "Toxicity Testing in the 21st Century, A Vision and a Strategy." 

Each of the Tox21 partners brings different strengths to the challenge of transforming toxicological methods. For its part, the FDA has considerable experience in evaluating data on the effects of drugs on people, following pre-clinical testing in animals. 

"Such human data should serve as the ultimate yardstick against which to measure the predictive power of cell- and computer-based methods, precluding the need to use unreliable animal data as the default standard of comparison," said Martin Stephens, Ph.D., HSUS vice president for animal research issues and a member of the NAS committee that produced the 2007 report. "The FDA should use its leverage with pharmaceutical companies to encourage them to make their human data available to the Tox21 team."

"The FDA's announcement reflects Commissioner Margaret Hamburg's commitment to modernizing regulatory science, ensuring that the tools for evaluating the safety and efficacy of potential new therapies keep pace with advances in biomedical science that are yielding these therapies," said Sara Amundson, HSLF executive director.

The Tox21 program uses ultra-fast, robot-assisted methods to assess a chemical's effects on cells, often of human origin. The aim is to identify cellular changes that are associated with "downstream," observable effects on animals (e.g. tumor growth). Computer-aided modeling can then translate the results from the cellular tests into predictions about the potential safety of chemicals to people in real-world scenarios. 

In 2008, The HSUS and Procter & Gamble gave the principal scientists involved in the Tox21 project their North American Alternatives Award, which included a $25,000 prize, in recognition of the potential contribution of their work to reducing reliance on animal testing.

The current focus of the Tox21 program is to assess chemicals that have been insufficiently tested for toxicity, and thereby weed out those that should be regarded as low priority for follow-up testing in animals. However, HSUS and HSLF are hopeful that the Tox21 program will evolve into a system for fully predicting the safety of chemicals, without the need for follow-up animal testing.


  • The HSUS estimates that millions of animals are used every year in the United States to evaluate the safety of industrial chemicals, drugs and other consumer products, and this number is likely to increase dramatically as legislative frameworks are revised.
  • These animals include rats, mice, rabbits, dogs, nonhuman primates and other species.
  • The move away from animal testing is being driven by the need for methods that: are faster and cheaper; take advance of opportunities provided by modern scientific advances; overcome the limitations of extrapolating animal data to people; and address animal welfare concerns.
  • The HSUS, HSLF and Humane Society International are pressing authorities in the United States, Europe and elsewhere to devote the necessary resources to implement a "Human Toxicology Project," which would eliminate the need for animal testing and allow the accurate and reliable assessment of human health hazards at a fraction of the cost and time needed for antiquated animal test methods.

More information about the 2008 North American Alternatives Award to the principal scientists of the Tox21 project can be found here.


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The Humane Society of the United States is the nation's largest animal protection organization — backed by 11 million Americans, or one of every 28. For more than a half-century, The HSUS has been fighting for the protection of all animals through advocacy, education and hands-on programs. Celebrating animals and confronting cruelty — On the Web at humanesociety.org.

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