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Tox21 Welcomes FDA as Partner

By Robin Mackar
August 2010

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A powerful federal agency collaboration welcomed a new partner this summer. The U.S. Food and Drug Administration (FDA) officially joined the NIEHS/NTP, the National Institutes of Health Chemical Genomics Center (NCGC), and the U.S. Environmental Protection Agency (EPA) July 20 as a partner in Tox21 - the interagency consortium to advance toxicology in the 21st century.

Tox21 merges federal agency resources (research, funding and testing tools) to develop ways to more effectively predict how chemicals will affect human health and the environment. Tox21 was established in 2008 with a Memorandum of Understanding (MOU) ( that was expanded this summer to include FDA.

"Using the best science to protect human health and the environment is the ultimate goal of this collaboration," said Linda Birnbaum, Ph.D., director of the NIEHS and NTP. "The addition of FDA to this effort allows biomedical researchers and regulatory scientists to work together to more rapidly screen chemicals and find more effective ways for protecting the health of the public. The NTP is pleased to bring its toxicology and coordination expertise to bear on making Tox21 a reality."

Along with Christopher Austin, M.D., director of the NCGC and Robert Kavlock, Ph.D., director of EPA's National Center for Computational Toxicology, Raymond Tice, Ph.D., chief of the Biomolecular Screening Branch at NIEHS/NTP was instrumental in working with FDA staff to achieve this new MOU. "FDA brings not only its experience in human health effects to the MOU, but the capabilities of the FDA National Center for Toxicological Research will also be key in accelerating our progress in this unique effort," Tice stated.

FDA will provide additional expertise and chemical safety information to improve current chemical testing methods. "This partnership builds upon FDA's commitment to developing new methods to evaluate the toxicity of the substances we regulate," said Janet Woodcock, M.D., director of FDA's Center for Drug Evaluation and Research.

"This collaboration is revolutionizing the current approach to chemical risk assessment by sharing expertise, capabilities, and chemical information, which will lead to both a faster and deeper understanding of chemical hazards," said Paul Anastas, Ph.D., assistant administrator for EPA's Office of Research and Development. "Through the Tox21 collaboration, 2,000 chemicals have already been screened against dozens of biological targets and we are working to increase the number of chemicals to 10,000 by the end of the year."

A critical part of the Tox21 partnership is the robotic screening and informatics platform at the NCGC that uses fast, automated tests to screen thousands of chemicals a day for toxicological activity in cells.

"Our robots screen in a day what would take one person a year to do by hand, allowing a fundamentally different approach to toxicology, which is comprehensive and based on molecular mechanisms," said Austin.

(Robin Mackar is the news director in the NIEHS Office of Communications and Public Liaison and a regular contributor to the Environmental Factor.)

What is Tox21?

Tox21 is a collaboration among federal agency partners striving to develop a new paradigm of predictive toxicology by pursuing seven enabling objectives:

  • Research, develop, validate, and translate innovative chemical testing methods that characterize toxicity pathways.
  • Investigate ways to use new tools to identify chemically induced biological activity mechanisms.
  • Prioritize which chemicals need more extensive toxicological evaluation.
  • Develop models that can be used to more effectively predict how chemicals will affect biological responses.
  • Identify chemicals, assays, computational platforms, and targeted testing needed for the innovative testing methods.
  • Complete acquisition in 2010 for a library of more than 10,000 chemicals for quantitative high-throughput screening (qHTS) at the NCGC.
  • Implement Phase II of EPA's ToxCast™ program, which will include the screening of a 700-compound subset of the 10,000 compound library in various mid- and high-throughput assays. ToxCast™ is an initiative launched in 2007 by EPA to revolutionize the agency's chemical toxicity evaluation procedures. ToxCast™ will use advances in computers, genomics, and cellular biology to speed up toxicity testing and enhance capacity to screen new compounds.

The data generated from the innovative chemical testing methods by the Tox21 partnership will be public and provided to risk assessors to use when making decisions about protecting human health and the environment.

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