Washington D.C. – Today, the Subcommittee on Investigations and Oversight held a hearing to continue strong oversight of the Environmental Protection Agency’s (EPA) Integrated Risk Information System (IRIS) program, a program established to provide information on risks associated with exposure to chemicals.  The IRIS program has been heavily scrutinized by respected scientific bodies such as the National Research Council, the Government Accountability Office (GAO), as well as industry and stakeholders.  Today’s hearing follows several oversight hearings held in the past two Congresses and was specifically focused on the process EPA uses to initially develop draft IRIS assessments.  In 2009, GAO placed the program on its High Risk Series because EPA was unable to complete timely, credible chemical assessments or decrease its backlog of ongoing assessments.

“While EPA seems to be taking steps to adopt the recommendations of GAO regarding outside review, they have uniformly ignored the recommendations of another body – the National Academy of Sciences (NAS),” said Subcommittee Chairman Paul Broun (R-GA).  “Adopting the NAS recommendations is the first step to restoring the program’s credibility.  EPA’s announcement two days ago is a step in the right direction, but the program’s success hinges on its implementation.”

In March of 2008, GAO reported that the IRIS database was at serious risk of becoming obsolete because EPA had not been able to routinely complete timely, credible assessments.  On April 8 of this year, NAS published its long-awaited study on EPA‘s formaldehyde assessment.  The NAS panel strongly faulted EPA’s methodology in crafting its draft assessment, warning of a pattern of problems in how the agency crafts assessments for its IRIS database that could continue to hamper future risk studies. 

Representing NAS at today’s hearing, Dr. Jonathan M. Samet, Chair of the Committee to Review EPA’s Draft IRIS Assessment of Formaldehyde, said that “Problems with clarity and transparency of the methods appear to be a repeating theme over the years.” He went on to say that “The persistence of the problems encountered with the IRIS assessment methods and reports concerned the committee, particularly in light of the continued evolution of risk-assessment methods and the growing societal and legislative needs to evaluate many more chemicals in an expedient manner.”

Testifying that the IRIS program produces flawed assessments, The Honorable Calvin Dooley, President and Chief Executive Officer of the American Chemistry Council, said that such assessments “create public confusion, unwarranted alarm, unnecessary product de-selection and litigation, all of which ultimately can put jobs at risk without sound scientific basis.”

Dr. Gail Charnley, Principal at HealthRisk Strategies, was also very critical of the Program, stating “Unfortunately, over time the IRIS process has become politicized and, as a result, it no longer has much scientific credibility outside the agency or, importantly, even within the agency.  The process has strayed from science and veered towards advocacy.”  Despite this, Dr. Charnley also said that the guidance provided through the NAS recommendations would greatly increase the program’s scientific credibility

Also testifying at the hearing, Mayor J. Christian Bollwage, of Elizabeth, NJ, stated “[w]hen the IRIS system is used for risk management decisions it must be noted that the compound effect of overly conservative toxicity values with overly conservative exposure scenarios yield a very distorted characterization of risk.”

Acknowledging that the IRIS process is in need of reform, Dr. Paul Anastas, Assistant Administrator at the EPA Office of Research and Development, agreed to implement the NAS recommendations for all new assessments.  “Over the coming months, the IRIS program will fully implement the NAS recommendations and continue to improve the IRIS process to reflect the highest standards of scientific integrity and credibility,” Dr. Anastas said.  “Strengthening and streamlining the IRIS process is a continuing and ongoing priority for EPA.”

Chairman Broun said that “This Committee will continue its oversight of the IRIS program to ensure that EPA not only adopts the NAS recommendations, but that it follows guidelines already in existence, and continuously seeks to employ the most modern, credible methods and protocols to assess chemical risks.”

The following witnesses testified today before the Subcommittee:

Panel 1

The Honorable Paul Anastas, Assistant Administrator, Office of Research and Development, U.S. Environmental Protection Agency.
Mr. David Trimble, Director, Natural Resources and Environment, U.S. Government Accountability Office.
Dr. Jonathan M. Samet, MD, MS, 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, National Research Council, The National Academies.

Panel 2

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