Strengthening IRIS will lead to more informed decisions about the safety of chemicals

The U.S. Environmental Protection Agency (EPA) hosted a public stakeholder meeting last month regarding steps to improve the Agency’s primary chemical safety assessment program, known as the Integrated Risk Information System (IRIS), which acts as a leading source of health risk information for other federal, state and international regulatory bodies.

“The best way to deal with complex issues, whether they be scientific or otherwise, is through public dialogue and transparency,” said Dr. Kenneth Olden, the newly appointed director of EPA’s National Center for Environmental Assessment, who invited ACC and other stakeholders to lead the discussion.

More than 400 participants tuned in both online and in person to the dialogue, signaling that an inclusive stakeholder process will be vital to ensuring the IRIS program can provide the highest quality science-based human health assessments to support the Agency’s regulatory activities.

Dr. Olden’s five-pronged approach to improving IRIS

In his opening remarks, Dr. Olden offered a five-pronged approach to making the assessment process under IRIS more objective and transparent:

  1. Use systematic review methodology and information management tools to review and synthesize data from relevant scientific studies, which will help to prevent “cherry picking” data from the data.
  2. Engage the public early on the IRIS assessment process in order to resolve issues about the data, models scope and definition early on. This will help to identify data gaps and fill them before the process is completed.
  3. Develop strategies to increase IRIS output. EPA is already in the process of discussing systematic improvements, with an ideal output timeline of 23 months or sooner.
  4. Develop stopping rules for rulemaking. There has to be a point at which the Agency makes a decision, “closes the scientific record” and ends the debate.
  5. Continue to find ways to make public forums, like the public stakeholder meeting, more accessible to organizations and stakeholders big and small.

ACC committed to pursuing a more scientifically sound, transparent IRIS program

ACC believes strongly that certain key enhancements to IRIS, if properly implemented, will offer greater clarity into how risk assessment conclusions are reached, including adopting a weight-of-evidence framework, allowing for meaningful stakeholder input and early engagement, and implementing a robust and objective peer review processes.

Adopting weight-of-evidence framework

For all IRIS assessments underway, EPA should apply systematic approaches to data evaluation and weight of evidence.

During its review of formaldehyde, the National Academy of Sciences (NAS) concluded that EPA had not applied a WOE framework in assessing whether the chemical caused a certain type of cancer. Furthermore, more recent assessments do not indicate how EPA assigns weight to studies or how much weight is assigned.

It’s been nearly 20 months since the NAS made its well documented recommendations to the EPA on ways to improve IRIS. Addressing these critical issues will help to make the process of risk assessment, as Dr. Olden intends, more objective and transparent.

Allowing for meaningful stakeholder input and early engagement

In developing strategies in increase IRIS output, EPA should ensure that it builds into the process sufficient time to fully consider public comment and amend the draft assessment before peer review.

EPA has made important strides in converting its listening sessions into active dialogue sessions. The scoping and problem formulation step, however, has yet to be fleshed out and applied to an IRIS assessment. Seeking early input will greatly improve this important procedural step and consequently lead to sound, timely risk assessments.

Robust and objective peer review with an “honest broker”

Making EPA and decision-making bodies more accessible to stakeholders in an important step to improving the transparency of chemical risk assessments, start to finish. We applaud EPA’s commitment to providing stakeholders with an opportunity to contribute to peer review charge questions, and those stakeholders should be afforded sufficient time to present comments to and dialogue with peer reviewers.

ACC recommends that EPA also use the site regulations.gov to post all IRIS assessment documents, comments and peer review drafts for public review. We also encourage EPA to post information regarding where ongoing assessments currently sit in the IRIS process. This will give interested stakeholders more certainty regarding expectations for improvements and more clarity regarding timelines and completion dates.

A meaningful public comment period and objective peer review processes should include an “honest broker” to ensure that scientifically-justified responses and revisions are made to fully address stakeholder and peer review comments. Since EPA should not be in a position to review its own work or dictate how its work is reviewed, an independent referee could step in to ensure that Agency authors have conducted a robust peer review and have transparently and objectively addressed external comments.

Overall, ACC welcomes this new sense of leadership and energy at EPA as it pursues a more robust dialogue and a more scientifically sound, transparent IRIS program. At future stakeholder meetings we encourage EPA to ensure that all dialogue is constructive and productive.

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