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July 14, 2011

House Subcommittee on Investigations and Oversight Holds Hearing on IRIS Program

Bergeson & Campbell, P.C.

On July 14, 2011, the House Science, Space, and Technology Subcommittee on Investigations and Oversight held a hearing on the U.S. Environmental Protection Agency’s (EPA) Integrated Risk Information System (IRIS) Program. According to the hearing charter, the hearing was prompted in part by the recent National Academy of Sciences (NAS) report on EPA’s formaldehyde assessment, which focused on the process EPA uses to develop initially draft IRIS assessments and which is separate from the overall process that includes multiple layers of review. The charter states that, in light of those criticisms, and recognizing that this is not the first time NAS has articulated them, the Committee’s goal is to better understand the process behind the development of IRIS assessments, whether EPA plans on adopting NAS’s recommendations, and whether EPA assessments are based on the best available evidence and evaluated in accordance with established protocols. The charter is available online.

The hearing consisted of two panels — the first comprised of witnesses from EPA, the U.S. Government Accountability Office (GAO), and the National Academies National Research Council, and the second of individuals and experts who presented their perspectives on IRIS. The hearing witnesses included:

Panel 1

  • The Honorable Paul Anastas, Assistant Administrator, Office of Research and Development, EPA;
  • Mr. David Trimble, Director, Natural Resources and Environment, GAO; and
  • Dr. Jonathan M. Samet, M.D., M.S., Professor and Flora L. Thornton Chair, Department of Preventive Medicine, Keck School of Medicine, University of Southern California; and Chair, Committee to Review EPA’s Draft IRIS Assessment of Formaldehyde, NRC.

Panel 2

  • The Honorable Calvin Dooley, President and Chief Executive Officer, American Chemistry Council (ACC);
  • Ms. Rena Steinzor, Professor, University of Maryland School of Law, and President, Center for Progressive Reform;
  • Dr. Gail Charnley, Principal, HealthRisk Strategies; and
  • The Honorable J. Christian Bollwage, Mayor, City of Elizabeth, New Jersey.

The witness testimony is available online.

During the hearing, the discussion was sharply divided along party lines. Discussion touched on issues raised by NAS, both in its recent report on formaldehyde as well as earlier ones, as well as concerns expressed previously by the GAO. The fact that earlier this week, on July 12, 2011, EPA announced plans to improve IRIS blunted some of the criticism towards EPA. According to EPA, all new IRIS assessment documents will be shorter, clearer, and more visual, concise, and transparent. EPA states that users can expect to see a reduced volume of text and increased clarity and transparency of data, methods, and decision criteria. EPA will “rigorously edit” documents to eliminate inconsistencies and address redundancies and include more graphical and tabular representations of data. Related discussions will also be consolidated into concise narrative descriptions. EPA is “working closely” with the Science Advisory Board (SAB) “on how to bring to bear its expertise on an ongoing basis to focus on the quality, transparency and scientific rigor of IRIS assessments and guide EPA’s response to the NAS recommendations.” As part of the IRIS Program improvements, EPA intends to create a new peer consultation step early in the development of “major” IRIS assessments “to enhance the input of the scientific community as assessments are designed.” EPA’s press release, which is available online, states that this latest overhaul of the IRIS Program is “in direct response” to the recent NAS recommendations.

Testimony during the hearing focused on the NAS recommendations and whether EPA is capable of addressing criticisms of the IRIS Program and providing scientifically supported IRIS assessments in a timely manner. According to Anastas, EPA welcomes and accepts NAS’s recommendations, and will incorporate the recommendations in assessments going forward. Anastas’s written testimony states that the recommendations will be incorporated as follows:

  • Assessments that have already been peer-reviewed or released for peer review: We are revising these assessments to address peer review comments, especially those that call for increased transparency of study selection and evidence evaluation;
  • Assessments currently under development but not yet released for peer review: We are re-examining these assessments to ensure that the rationale for study selection and evidence evaluation is clear. These assessments will also be edited to reduce redundancy; and
  • New assessments that have not yet been started: We will fully implement the NAS recommendations for new assessments, including a tighter document structure, evidence tables to summarize details from pertinent studies, greater transparency in study selection and evaluation criteria, and greater emphasis on clear analysis and synthesis.

During questioning, Anastas stated that IRIS assessments are not risk assessments and are not risk management documents. Rather, the IRIS Program reviews the toxicity and underlying hazards of substances. Charnley noted in her testimony that state and local governments and other countries rely on IRIS assessments and, because of their influence, the quality of IRIS assessments is critical.