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Integrated Risk Information System (IRIS)

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Tom Flanagin
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The U.S. Environmental Protection Agency (EPA) established the Integrated Risk Information System (IRIS) program in 1985 to support EPA’s mission by identifying and characterizing the human health effects that may result from exposure to chemicals in the environment. 

However, the IRIS program has a troubling history of being out of step with the best available science and methods, lacking transparency, and being unresponsive to peer review and stakeholder recommendations.

Members of the scientific community, including the National Academies of Sciences, Engineering, and Medicine, have raised concerns with the IRIS program’s application of the science to draw conclusions regarding human health risk.

Furthermore, the IRIS program has never been authorized by Congress, and since 2009 the program has remained on the GAO’s High-Risk List, which identifies government programs that are vulnerable to fraud, waste, abuse, or mismanagement.

American success relies on American chemistry. Computer chips, national defense, modern healthcare, housing, infrastructure, agriculture, and energy are all made possible by America’s chemical industry.

Unfortunately, EPA’s IRIS program puts many critical chemistries in jeopardy.  Recent examples of where IRIS assessments have led to unwarranted regulatory actions, or threaten to, include:

  • Formaldehyde Risk Evaluation: EPA's final risk evaluation under the Toxic Substances Control Act (TSCA) relies on an IRIS value to propose workplace limits that are significantly lower than the recently updated European Union occupational limits. Formaldehyde is a critical chemistry needed for housing, agriculture, transportation, lifesaving vaccines, and national security. 
  • Ethylene Oxide Air Rules: Rules affecting critical industries like energy development, semiconductors, and healthcare rely on an IRIS value that is 23,000 times lower than naturally occurring levels of ethylene oxide in the human body. 
  • IRIS Review of Hexavalent Chromium: EPA’s recent IRIS assessment fails to adequately consider the weight of evidence and may result in drinking water standards which are far lower than the average background levels of naturally occurring hexavalent chromium in groundwater. This could impose massive costs to water systems nationwide with little to no public health benefit. 
  • IRIS Review of Inorganic Arsenic: The proposed IRIS value could be used to drive new regulatory levels for inorganic arsenic that are significantly lower than the background levels of arsenic in soil and water in many states with impacts to soil remediation programs, drinking water standards, crops and other food supplies. 

Key Points on IRIS

  • IRIS Assessments are plagued with scientific uncertainty, as well as a lack of transparency and accountability. 
  • IRIS Assessments have significant regulatory implications and can threaten American workers and economic competitiveness.
  • The IRIS program is not authorized by Congress and has remained on the "high risk list" for over a decade. 
  • EPA should prohibit the use of IRIS assessments to develop, finalize, or issue a rule or regulation, eliminate duplicative reviews and align hazard assessment responsibilities to EPA agency program offices. 
  • The No IRIS Act, introduced by Senator John Kennedy (R-LA) and Congressman Glenn Grothman (R-WI-06), would protect American manufacturing and help ensure regulations are based on sound science.
  • Smarter chemical management policies can help drive U.S. chemical production and create a stronger, more affordable America.