WASHINGTON-- E.P.A. is proposing to use ground-breaking tools developed in the ToxCast plan to enhance testing for chemicals that have the potential to disrupt hormone function in the human body.
E.P.A. uses automated chemical screening technologies to rapidly and simultaneously perform tests on thousands of chemicals and feed the results into computational models to predict hormone-related, endocrine activity. Some of these automated chemical screenings have been performed using robots from the federal Toxicology in the 21
st Century, ("Tox21") consortium, a collaboration among EPA, the National Institutes of Health (NIH) and the Food and Drug Administration (FDA). The new technology enables faster and less costly screening than conventional methods.
"This is the beginning of a new day for testing chemicals for safety," said Jim Jones, assistant administrator for the Office of Chemical Safety and Pollution Prevention. "These new technologies allow us to screen more chemicals in less time, use fewer animals and reduce costs for everyone."
This new endocrine screening approach reliably identifies the potential for chemicals to mimic estrogen in hormone physiology. The method provides an alternative to 3 of the 11 current screening tests, most of which require animals. The Tox21 consortium is rapidly developing additional models to predict androgen and thyroid activity, which will provide alternatives for the other 8 tests. Thus far, E.P.A. has estrogen screening results for 1,800 chemicals; by FY2016, we expect results for almost 3,000 chemicals.
E.P.A. has coordinated with other governmental entities, industry and environmental groups in the development of these methods. They have been peer-reviewed via multiple publications in the scientific literature and by the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), Scientific Advisory Panel (SAP).
The endocrine system is comprised of glands that are spread across an organism's body. The glands secrete hormones when triggered and can affect an organism in a variety of ways. In the 1990's, scientists suggested that certain chemicals might disrupt the endocrine system in humans and wildlife.
There is compelling evidence of developmental and reproductive problems in certain fish and wildlife following exposure to chemical contaminants. Based on this and other data, Congress passed the Food Quality Protection Act and the Safe Drinking Water Act Amendments in 1996. These required E.P.A. to screen pesticide chemicals for their potential to produce effects similar to the hormone estrogen in humans, and gave E.P.A. the authority to screen additional chemicals for other endocrine effects.
In 2006, E.P.A. acknowledged the need for a comprehensive review of current toxicity testing approaches. The agency also requested that the National Research Council (NRC) conduct a review and propose a vision and strategy for toxicity testing incorporating new methods and technologies. The NRC provided a bold, new vision of toxicology in 2007 entitled, "Toxicity Testing in the 21st Century: A Vision and A Strategy", affirming EPA's Computational Toxicology research program, and inspiring the Tox21 partnership between EPA, NIH and FDA.
The alternative, cutting-edge equipment that E.P.A. is presenting today for endocrine screening, represent the 1st steps in a paradigm shift for chemical safety testing. These new tools provide a robust scientific basis for assessing and managing chemical safety and efficiently quantifying risk to human health and the environment for thousands of chemicals.
E.P.A. is requesting review on the suggested approach. Comments must be received on or before August 17, 2015: https://www.federalregister.gov/articles/2015/06/19/2015-15182/endocrine-disruptor-screening-program-use-of-high-throughput-assays-and-computational-tools.
For more information on this approach: http://www.epa.gov/scipoly/oscpendo/index.htm
