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April 20, 2012

George Washington University Regulatory Studies Center Convenes Panel Discussion on Moving Forward with IRIS Reform

Bergeson & Campbell, P.C.

On April 18, 2012, the George Washington University Regulatory Studies Center convened a panel discussion entitled Moving Forward With IRIS Reform: Implementing National Academies’ Roadmap for Revisions. Panelists included Dr. Lynn R. Goldman, Dean of the School of Public Health and Health Services and former Assistant Administrator for Toxic Substances at the U.S. Environmental Protection Agency (EPA); Rebecca Clark, M.P.H., Acting Director of EPA’s National Center for Environmental Assessment (NCEA); Chuck Elkins, former Director of EPA’s Toxic Substances Program; Dr. Yiliang Zhu, Professor of Epidemiology and Biostatistics at the University of South Florida and member of the National Academy of Sciences’ (NAS) Institute of Medicine Committee on Shipboard Hazard and Defense; and Heidi R. King, Chief Economist on the U.S. House of Representatives Committee on Energy and Commerce. The panel discussion focused on how EPA could effectively implement suggested improvements found in Chapter 7 of the NAS National Research Council’s (NRC) assessment of the draft Integrated Risk Information System (IRIS) assessment of formaldehyde, which can be found online.

Panelists agreed that the IRIS assessment process currently suffers from lack of public engagement and accountability for EPA staff developing the assessments leading to a lack of transparency and clarity in the IRIS assessments issued. There was also concern expressed that the current IRIS peer review process is flawed in that EPA sometimes selects panelists and “cherry-picks” the recommendations that appear to fit the assessment’s goals with no oversight from independent brokers of issues. All participants agreed that the IRIS process takes entirely too long to produce a final assessment and that the resulting data are often used for unproductive ends, such as product deselection and misleading the public and regulators about exaggerated and unsupported health risks of the chemicals subject to IRIS assessments.

To improve the IRIS assessment process, the panelists engaged in a spirited discussion that yielded numerous suggestions on how EPA could implement NRC’s recommendations. They recommended a more open and transparent public dialogue before EPA issues draft assessments to make itself more engaged and accountable, making more risk data publicly available so risk assessments can be produced by various groups, improving the current peer review process by adopting the peer-reviewed journal model of actual independent review and honest responses to panel questions, more dedicated funding for the IRIS program, and improving timeliness by producing quicker initial assessments with caveats about the reliability of the information prior to publishing a full rigorous IRIS assessment.

EPA panelist Rebecca Clark did an admirable job of comforting fellow panelists and attendees that EPA is moving forward to improve the IRIS process and implement the NRC recommendations in a phased approach. Initially, EPA is focused on implementing short-term recommendations, such as streamlining documents, increasing transparency and clarity, and using more tables and figures to present information and data in assessments. Upcoming IRIS assessments will also include a detailed description of the literature search strategy and study evaluation process used in developing the assessment. EPA is also developing a formal framework to establish conclusions about the weight of evidence for health effects other than cancer that includes standardized classification of causality. Finally, EPA is planning on supplementing existing public listening sessions and comment periods with public peer consultation workshops to enhance the input of the scientific community earlier in the process as assessments are designed. EPA also announced the establishment of a dedicated Chemical Assessment Advisory Committee (CAAC), under the auspices of EPA’s Science Advisory Board (SAB), to provide advice on draft IRIS toxicological reviews and the IRIS program in general. In conclusion, EPA reiterated its commitment to reforming the IRIS assessment process while also ensuring it produces rigorous, credible assessments.

More information on the panel discussion, including discussion materials, will be posted online.