EPA Health Risk Assessments:

Sustained Management and Oversight Key to Overcoming Challenges

GAO-11-824T: Published: Jul 14, 2011. Publicly Released: Jul 14, 2011.

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David C. Trimble
(202) 512-9338


Office of Public Affairs
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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 540 chemicals in the environment and is a critical component of EPA's capacity to support its mission. 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. The 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. These shortcomings contributed to our decision to designate the IRIS program as a high-risk area. Specifically, beginning in 2004, OMB began requiring and managing two interagency reviews of IRIS assessments by OMB and other federal agencies with an interest in these assessments, such as the Departments of Defense and Energy. These reviews contributed to concerns about the timeliness and credibility of IRIS assessments. In particular, EPA was not allowed to move forward with an assessment until OMB determined that EPA had satisfactorily addressed all OMB and other federal agency comments. As a result, IRIS assessments were frequently delayed. In addition, the content of the OMB-required reviews was not publicly available, thus limiting the transparency and the credibility of IRIS assessments. The credibility of the assessments was further limited by the involvement of other federal agencies that could be affected by the assessments if they led to regulatory actions. That is, if EPA issued an IRIS assessment that resulted in a decision to regulate a chemical to protect the public, some of the agencies participating in these reviews, such as the Department of Defense, could face increased cleanup costs and other legal liabilities. The IRIS assessment process reforms instituted by EPA in May 2009 appeared to represent a significant improvement over the previous IRIS process and, if implemented effectively, with sustained management and oversight, could help EPA restore the credibility and increase the timeliness of this important program. The reforms included the following: (1) Restored EPA control, (2) Established transparency, and (3) Streamlined process.

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