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IRIS: Bad Science, Real World Consequences

This week, the U.S. House Committee on Science, Space, and Technology will be holding a hearing on EPA’s troubled Integrated Risk Information System (IRIS) program. Given the attention it will be receiving, we wanted to provide you with some important information about IRIS’s problematic track record.

What is IRIS?

EPA originally designed the IRIS program to support the agency’s mission to protect human health and the environment by identifying and characterizing health hazards of specific chemicals, which internal EPA offices would prioritize. This is an important distinction: IRIS assesses hazard only. It is not a risk-based system—its assessments do not take exposure into account and do not characterize actual risks to human health and the environment. And, unfortunately, the IRIS program has repeatedly demonstrated an inability to meet the scientific standards necessary to produce reliable hazard assessments. There are long-standing and well documented concerns from government and non-governmental organizations regarding the program’s lack of transparency, productivity, and inability to produce scientifically sound hazard assessments that meet EPA’s needs on a consistent basis.

A Program Plagued with Problems

Bad science has real-world implications that can lead to unwarranted restrictions including product de-selection, unfounded public alarm, and unnecessary costs for consumers and businesses. When EPA relies on questionable science, it undermines public confidence in government decision making.

In February 2019 the Competitive Enterprise Institute (CEI) provided some important perspective on those real world implications:

“Thanks to IRIS’ junk science, medical sterilization plants may close, putting people out of work and imperiling public health with the potential of increased disease transmission. Because there are no good substitutes, the elimination of [EO] for medical product sterilization would be ‘significant, and likely disastrous’ for public health and ‘would introduce the real risks of increased morbidity and mortality,’ according to the Ethylene Oxide Sterilization Association.”

That CEI publication is referring to the IRIS assessment of ethylene oxide (EO) that created concerns about EO exposures 19,000 times lower than occur naturally in the human body. So, according to IRIS, the natural production of EO from our own bodies represents a hazard to human health and the environment. That’s bad science.

EPA’s Responsibility to Ensure Program’s Scientific Credibility

The agency’s leadership, under any administration, has a duty to ensure that all of its programs are working efficiently, effectively and that they are actually serving the American people. The IRIS program has been plagued by serious issues for years as noted on many occasions by the National Academy of Sciences (NAS), the Government Accountability Office (GAO), congressional committees (Democrats have scrubbed the House Science Committee website of any previous information regarding IRIS oversight hearings), members of Congress and other stakeholders. The program’s failure to address those issues means that IRIS hazard assessments cause unnecessary alarm and misstate the potential impact of a given substance on public health.

Given its problematic history, it should come as no surprise that EPA leadership decided last year to pause, take a closer look and reevaluate the IRIS program and how it functions. Part of that process, according to a recent GAO report, was for EPA program offices (e.g., Office of Air and Radiation; Office of Water; Office of Land and Emergency Management ) to reconfirm which ongoing chemical hazard assessments they consider as priorities for their programs. That’s exactly what we should expect from our leaders in government.

Hoping for the Best

While we agree that some progress has been made to improve the IRIS program, there are still many recommendations that were made years ago by GAO, NAS and others that have not been addressed, such as releasing a finalized IRIS handbook. IRIS program leaders have repeatedly promised but failed to deliver a completed handbook, which would detail the step-by-step guidance to selecting, evaluating and integrating evidence for developing IRIS hazard assessment values.

We hope that the IRIS program will one day be able to produce high-quality, scientifically sound toxicity values, but there is  still a great deal of work to be done to get to that point.

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