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FDA Joins Effort to Improve Chemical Screening

The U.S. Food and Drug Administration (FDA) joined a multiagency effort this week to improve the federal government’s ability to predict how chemicals will affect human health and the environment.

Earlier this week, the U.S. Environmental Protection Agency (EPA), the National Institute of Environmental Health Sciences National Toxicology Program (NTP), and the National Institute of Health Chemical Genomics Center welcomed the FDA to the so-called Tox21 collaboration.

Established in 2008, the Tox21 initiative attempts to coordinate research, funding and testing tools dedicated to figuring out how chemicals, widely used in drugs, food, industry, agriculture, and in the household, affect humans.

According to a statement from the agencies earlier this week, FDA will provide additional chemical safety expertise to the project.

“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 Dr. Paul Anastas, assistant administrator for EPA’s Office of Research and Development, in a statement Monday. “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.”

There are tens of thousands of chemicals currently in commerce and current modes of safety testing are expensive and time consuming, according to FDA.

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

Working with other federal agencies, FDA will work to “prioritize chemicals that need more extensive toxicological evaluation” and create models for actually predicting the human health response to chemicals. The program currently includes 500 chemical screening tests that have assessed over 300 environmental chemicals.

“Using the best science to protect human health and the environment is the ultimate goal of this collaboration,” said Linda Birnbaum, director of the National Institute of Environmental Health Sciences and the National Toxicology Program (NTP) in a statement.  

“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,” added Birnbaum.  “The NTP is pleased to bring its toxicology and coordination expertise to bear on making Tox21 a reality.”

The agencies also noted that the Tox21 partnership is using robotic screening and an informatics platform that uses automated tests for chemicals with 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 that is comprehensive and based on molecular mechanisms,” said Dr. Christopher Austin, director of the National Institute of Health Chemical Genomics Center.

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