FDA Joins Chemical-Screening Collaboration - Pharmaceutical Technology

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FDA Joins Chemical-Screening Collaboration


ePT--the Electronic Newsletter of Pharmaceutical Technology

The US Food and Drug Administration has joined the Tox21 collaboration, which aims to develop ways to more effectively predict how chemicals will affect the body and environment. The collaboration’s founding members include the US Environmental Protection Agency (EPA), the National Institute of Environmental Health Sciences National Toxicology Program (NTP), and the National Institute of Health Chemical Genomics Center (NCGC). The collaboration, established in 2008, combines federal agency resources to carry out its initiatives. “FDA will provide additional expertise and chemical-safety information to improve current chemical-testing methods,” according to a joint press release.

According to Paul Anastas, assistant administrator for EPA’s Office of Research and Development, “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.” EPA provides chemicals to Tox21 as well as fast, automated tests to NCGC to screen thousands of chemicals a day. Specifically, Tox21 focuses on:

  • Finding innovative chemical-testing methods that characterize toxicity pathways
  • Finding ways to use new tools to identify chemical-induced biological-activity mechanisms.
  • Prioritizing which chemicals need more extensive toxicological evaluation
  • Developing models that can be used to more effectively predict how chemicals will affect biological responses
  • Identifying chemicals, assays, informatic analyses, and targeted testing needed for the innovative testing methods
  • Conducting 50 or more ToxCast high-throughput screening assays on an enlarged chemical library every year for the next several years
  • Providing the data generated from the innovative chemical-testing methods to risk assessors to use when making decisions about protecting human health and the environment.

Working under a memorandum of understanding, the Tox21 members already have screened 2000 chemicals against dozens of biological targets. Tox21 aims to increase that number to 10,000 by the end of this year.

“This partnership builds upon FDA’s commitment to developing new methods to evaluate the toxicity of the substances we regulate,” said Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research.

FDA will work with Tox21 members to prioritize chemicals that need more extensive toxicological evaluation and to develop models that can better predict human response to chemicals, according to the press release.

"The addition of FDA to this effort allows biomedical researchers and regulatory scientists to work together side by side to more rapidly screen chemicals and find more effective ways to protect the health of the public,” said Linda Birnbaum, director of the National Institute of Environmental Health Sciences and the NTP, in the release. 

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