EPA Health Risk Assessments:

Oversight and Sustained Management Key to Overcoming Challenges

GAO-12-148T: Published: Oct 6, 2011. Publicly Released: Oct 6, 2011.

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David C. Trimble
(202) 512-9338


Office of Public Affairs
(202) 512-4800

This testimony discusses our prior work on the Environmental Protection Agency's (EPA) Integrated Risk Information System (IRIS) program and database. IRIS is one of the most significant tools that EPA has developed to support its mission to protect people and the environment from harmful chemical exposures. The IRIS database contains EPA's scientific position on the potential human health effects that may result from exposure to more than 550 chemicals in the environment and is a critical component of EPA's capacity to support its mission. IRIS assessments provide the scientific input to risk management decisions, such as whether EPA should establish air and water quality standards to protect the public from exposure to toxic chemicals or set cleanup standards for hazardous waste sites. Consequently, IRIS assessments are a critical component of EPA's capacity to support scientifically sound decisions, policies, and regulations. EPA created IRIS in 1985 to help the agency develop consensus opinions within the agency about the health effects from chronic exposure to chemicals. Over time, the importance of the program has increased as EPA program offices, state and local environmental programs, and some international regulatory bodies have increasingly relied on IRIS health risk assessment information to support risk-based decision making to protect public health and the environment. As the IRIS database became more widely used and accepted, EPA took steps, beginning in the early 1990s, to improve and maintain the IRIS program and database. Over the years, the agency has implemented a variety of new operational procedures aimed at improving the IRIS program and database--with the most recent change to its IRIS assessment process occurring in May 2009. Because of the potential for EPA's health risk assessments to lead to regulations that can significantly affect certain industries or federal agencies, IRIS assessments have frequently received considerable attention. For example, in recent months, much attention has been focused on EPA's draft health risk assessment of formaldehyde and the National Academies' review of the draft assessment. In addition to reviewing the draft assessment of formaldehyde, the National Academies' report also offered some suggestions for improving the preparation and presentation of draft health risk assessments in general. Our work to date has not focused on these aspects of IRIS assessments. Instead, our body of work on the IRIS program has more broadly evaluated the overall IRIS assessment process and the challenges the program has faced in implementing it. In March 2008, we reported that the IRIS database was at serious risk of becoming obsolete because EPA had not been able to routinely complete timely, credible assessments. After subsequent reports, in January 2009 we added EPA's processes for assessing and controlling toxic chemicals to our list of areas at high risk for waste, fraud, abuse, and mismanagement or in need of broad-based transformation. We are currently undertaking a review of EPA's revised 2009 IRIS assessment process and the agency's progress in implementing it and plan to issue a report later this year. In this context, this testimony today discusses our past work on (1) the timeliness and credibility of IRIS assessments and (2) EPA's May 2009 IRIS assessment process.

From March through September 2008, we reported on shortcomings in EPA's IRIS process that limited the agency's ability to complete timely and credible IRIS assessments. For example, the Office of Management and Budget (OMB) required and managed interagency reviews of IRIS assessments, and OMB determined when assessments could proceed to the next process step, frequently resulting in delayed IRIS assessments. Such shortcomings contributed to our decision to designate the IRIS program as a high-risk area in January 2009. In June 2009 and July 2011, we testified that EPA's May 2009 IRIS assessment process reforms, if implemented effectively, would represent a significant improvement over the previous IRIS process by restoring EPA control, establishing transparency, and streamlining the process. We are currently undertaking a review of EPA's revised 2009 IRIS assessment process and the agency's progress in implementing it and plan to issue a report later this year.

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