FDA and Other Federal Agencies Collaborate to Improve Chemical Screening

WASHINGTON - 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 (NCGC) welcome the U.S. Food and Drug Administration (FDA) to the Tox21 collaboration. The Tox21 collaboration 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. The collaboration was established in 2008 to develop models that will be able to better predict how chemicals will affect humans. FDA will provide additional expertise and chemical safety information to improve current chemical testing methods.

For Immediate Release: July 19, 2010
Media Inquiries: Latisha Petteway, petteway.latisha@epa.gov, 202-564-3191, 202-564-4355
Consumer Inquiries: 888-INFO-FDA

FDA and Other Federal Agencies Collaborate to Improve Chemical Screening

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 (NCGC) welcome the U.S. Food and Drug Administration (FDA) to the Tox21 collaboration. The Tox21 collaboration 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. The collaboration was established in 2008 to develop models that will be able to better predict how chemicals will affect humans. FDA will provide additional expertise and chemical safety information to improve current chemical testing methods.

“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. “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 chemical testing is expensive and time consuming.

“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.

FDA will collaborate with other Tox21 members to prioritize chemicals that need more extensive toxicological evaluation and develop models that can better predict human response to chemicals.

EPA contributes to Tox21 through the ToxCast program and by providing chemicals and additional fast, automated tests to NCGC. ToxCast 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, Ph.D., director of the National Institute of Environmental Health Sciences and the NTP. "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. The NTP is pleased to bring its toxicology and coordination expertise to bear on making Tox21 a reality."


A major part of the Tox21 partnership is the robotic screening and informatics platform at 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 that is comprehensive and based on molecular mechanisms,” said Dr. Christopher Austin, director of the NIH NCGC.

For more information:

► Tox21 collaboration
http://epa.gov/ncct/Tox21/

► ToxCast [see below]
http://epa.gov/ncct/toxcast/


► National Toxicology Program

http://www.ntp.niehs.nih.gov/




► National Institute of Health Chemical Genomics Center

http://www.ncgc.nih.gov/


open here please:
FDA and Other Federal Agencies Collaborate to Improve Chemical Screening




ToxCast™
Predicting Hazard, Characterizing Toxicity Pathways, and Prioritizing the Toxicity Testing of Environmental Chemicals
In 2007, EPA launched ToxCast™ to develop a cost-effective approach for efficiently prioritizing the toxicity testing of thousands of chemicals.

Uses data from state-of-the-art high-throughput screening (HTS) bioassays.
Builds statistical and computational models to forecast potential chemical toxicity in humans.
In 2007, Phase I provided EPA regulatory programs with science-based information helpful in prioritizing chemicals for more detailed toxicological evaluations and more efficient use of animal testing.



Phase I profiled over 300 well-characterized chemicals (primarily pesticides) in over 400 HTS endpoints. Endpoints include biochemical assays of protein function, cell-based transcriptional reporter and gene expression, cell line and primary cell functional, and developmental endpoints in zebrafish embryos and embryonic stem cells.

Phase 1 chemicals have already been tested using traditional toxicology methods including developmental toxicity, multi-generation reproductive studies, and sub-chronic and chronic rodent bioassays. ToxRefDB is the relational database storing this information- nearly $2 billion worth of animal toxicity studies.

In 2010, Phase II of ToxCast will screen additional chemical compounds representing broader chemical structure and use classes to evaluate the predictive toxicity signatures developed in Phase I.

Toxicity signatures from ToxCast will be defined and evaluated by how well they predict outcomes from mammalian toxicity tests and identify toxicity pathways relevant to human health effects.

Provides the Tox21 collaboration access to ToxCast high-throughput screening assays and chemical library to increase the data available on the nearly 10,000 chemicals being studied.