American Chemistry Matters: Driving Innovation, Creating Jobs and Enhancing Safety

Public input is critical to successfully move forward on IRIS reform

Sound science and transparency should be at the core of how the federal government evaluates the safety of chemicals — and they are critical elements to successfully reforming the U.S. Environmental Protection Agency’s (EPA) Integrated Risk Information System (IRIS).

We strongly believe that the implementation of key enhancements to IRIS will greatly improve the program and offer more clarity into how risk assessment conclusions are reached.

These key enhancements include:adopting a transparent weight-of-evidence framework, allowing for meaningful stakeholder input and early engagement, and implementing a robust, objective peer review processes.

Update on IRIS reform

In a comprehensive 2011 review of the Agency’s draft IRIS assessment of Formaldehyde, the National Research Council (NRC) of the National Academy of Sciences (NAS) provided EPA with specific recommendations for fixing its broken chemical risk assessment program.

In an effort to address these concerns and comply with a directive from Congress, EPA submitted a “progress report” to the NRC just this past January that reveals the steps it has recently taken, and plans to take still, to help bring IRIS up to speed.

In addition to outlining several improvements to the program, the report included a draft “IRIS handbook” that provides significant “how-to” guidance for staff to incorporate these recent improvements when developing a risk assessment.

Outstanding issues with IRIS

We commend EPA’s latest efforts to improve the IRIS program, including enhancements to documentation and the consistency of the Agency’s approach to developing hazard assessments.

While the improvements EPA outlined are encouraging, we identified several outstanding issues that we raised in comments that ACC, along with ACC’s Center for Advancing Risk Assessment Science and Policy (ARASP), submitted to the NRC and EPA.

For instance, EPA has neither adopted consistent nor transparent study evaluation methods to determine quality and reliability for the different types of studies that are involved in every IRIS assessment.

In addition, the IRIS program has yet to put forward a scientifically-grounded framework for integrating study results based on a weight-of-evidence approach to establish cause and effect, which incorporates modern knowledge of mode of action to determine potential risks to humans at environmentally relevant exposures.

A path forward

The work that EPA outlined to the NRC could have a profound impact on IRIS, and the Agency should not miss out on an important opportunity to solicit valuable outside expertise and perspectives.

As Dr. Kenneth Olden, director of EPA’s National Center for Environmental Assessment, told a crowd of stakeholders attending an EPA-sponsored public dialogue last November:

The best way to deal with complex issues, whether they be scientific or otherwise, is through public dialogue and transparency.

To help the Agency move forward we recommend that EPA provide the public with a more robust process to provide input on latest round of proposed improvements to ensure the enhancements it implemented were done so correctly, and that progress on future enhancements will not unnecessarily be delayed.

EPA should also treat the IRIS handbook that was included in latest round of improvements as economically significant guidance that should be subject to review by OMB in accordance with several Executive Orders.

Finally, other Agencies that conduct and use risk assessments should be given a chance to weigh in with EPA as well.

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