How EPA + NIH + Open Innovation Are Transforming How We Measure Chemical Toxicity

Thousands of chemicals are in use today, but few have been fully evaluated for potential health risks. One big gap are cases in which toxicity can develop from the way our bodies process chemicals in our livers and kidneys.

On July 8th, the U.S. Environmental Protection Agency (EPA) and National Institutes of Health (NIH) will convene participants of their Transform Tox Testing Challenge in a public workshop in Research Triangle Park, NC to discuss how we can fill that gap.

As an example, take acetaminophen, commonly known as Tylenol. In the last decade, more than 1,500 people have died from inadvertently taking too much acetaminophen.

What is happening that makes acetaminophen harmful at high doses?

Acetaminophen is a medicine that almost all of us have taken. In appropriate doses, it can relieve pain, headaches, and soreness. The body naturally removes it through the liver by transforming (i.e. metabolizing) acetaminophen into two harmless substances. But in high doses, the liver triggers a new process that transforms acetaminophen into a toxin. The toxin, or metabolite in this case, is called NAPQI, and can potentially cause severe liver damage. When our bodies process drugs or chemicals, they can produce new chemicals that are toxic to us. (Don’t just take our word for it – This American Life even talked about it.)

In the past, scientists measured toxicity by exposing them to animals, which was a slow process and raised ethical concerns. Now, scientists use what’s called high-throughput screening (HTS) that expose toxins directly to a set of cells or proteins and look for a variety of adverse effects simultaneously. These tests, however, don’t take into account the actions of your livers or kidneys – that is, they don’t directly test the toxic chemicals called metabolites – like NAPQI that acetaminophen produces – that the liver and kidneys can produce from chemicals.

The EPA, the NIH’s National Center for Advancing Translational Sciences (NCATS), and the National Toxicology Program, headquartered at the National Institute of Environmental Health Sciences (NIEHS) has formed a partnership to change that.

With the goal of evaluating the safety of chemicals and better protect human health, the Partnership put a call out to industry, academia, and the Public to design technologies that could evaluate the toxicity of chemicals and their metabolites.

The challenge – called Transform Tox Testing Challenge – launched January 8th, and by April 8th, the Federal partnership received 26 submissions from individuals, companies, and Universities around the world. On  May 16, they selected 10 promising approaches to continue on to Stage 2 of the three-stage challenge.

The 10 semi-finalists will attend the upcoming workshop so they can meet experts and other innovators, as well as develop criteria and requirements for Stage 2 and 3 of the challenge. The agencies have committed up to $1 million in prize money for the challenge.

The 10 semi-finalists, who are being awarded $10,000 each from the EPA, are:

  • Hongbing Wang, University of Maryland School of Pharmacy
  • Remco HS Westerink, Institute for Risk Assessment Sciences (IRAS) at Utrecht University
  • Albert P. Li, In Vitro ADMET Laboratories LLC
  • Stéphane C. Corgié, ZYMtronix Catalytic Systems, Inc.
  • James F. Rusling, University of Connecticut
  • Chris Vulpe, University of Florida
  • Brian Johnson, Onexio Biosystems LLC
  • Moo-Yeal Lee, Cleveland State University and Rayton Gerald, Solidus Biosciences, Inc.
  • David Thompson, MilliporeSigma
  • Lawrence Vernetti, HanKayTox Consulting

For more information:

HHS Competes, an HHS IDEA Lab program, supports the use of prizes, challenges, and crowdsourcing to more effectively leverage the intelligence of the crowd to solve our nation’s toughest problems.  Learn more.