	EPA Reforms Have the Potential to Significantly Improve IRIS, but EPA Could Clarify Some Issues

In March 2008, we reported that the IRIS database—a critical component  of EPA’s capacity to support scientifically sound risk management  decisions, policies, and regulations—was at serious risk of becoming  obsolete because the agency had not been able to complete timely,  transparent, and credible chemical assessments or decrease its backlog of  ongoing assessments. In April 2008, EPA issued a revised IRIS assessment process. Largely as a result of EPA’s lack of responsiveness, we added transforming  EPA’s processes for assessing and controlling toxic chemicals as a high- risk area in our January 2009 biennial status report on governmentwide  high-risk areas requiring increased attention by executive agencies and  Congress. Taking positive action, on May 21, 2009, EPA issued a new IRIS  assessment process, effective immediately. In a memorandum announcing  the reforms to the IRIS assessment process, the EPA Administrator  echoed our prior findings that the April 2008 changes to the process  reduced the transparency, timeliness, and scientific integrity of the IRIS  process. Under EPA’s prior process, these two interagency reviews were required  and managed by OMB—and EPA was not allowed to proceed with  assessments at various stages until OMB notified EPA that it had  sufficiently responded to comments from OMB and other agencies. EPA Has Improved the Policies and Procedures of Its Science Advisory Board, but Their Wider Use by Other EPA Scientific Advisory Committees Could Enhance EPA’s Scientific Integrity

Independent, expert peer review of EPA’s scientific and regulatory  products, such as risk assessments and proposed rules, is integral to the  agency’s ability to effectively protect public health and the environment. In 2001, we reported on limitations in the policies and procedures  developed by EPA’s Science Advisory Board to ensure that its panels’ peer  reviewers are independent and that a balance of viewpoints is represented  on each panel. These limitations could reduce the effectiveness of the  Board overall by contributing to its being perceived as biased and could  inadvertently expose some panelists to violations of federal conflict-of- interest laws. Demonstrating a strong commitment to the integrity of its  peer reviews, EPA took a number of actions to implement our report’s  recommendations, including    establishing a standard process for Science Advisory Board panel  formation that includes a requirement to document decisions about  conflicts of interest and balance of viewpoints and expertise in forming  each panel, as well as prospective panelists’ responses to several  standardized questions aimed at assessing impartiality;    developing a new confidential financial disclosure form designed to  capture needed information to evaluate potential conflicts of interest;    allowing the public to review a “short list” of candidates selected for a  specific Science Advisory Board panel and to comment on the  appropriateness of including any of these candidates on the panel; and    developing CD-based conflict-of-interest training for Science Advisory  Board panelists. Regarding the latter issue, we concluded that  the National Academies and the EPA Science Advisory Board have  developed clear processes that, if effectively implemented, can provide  these organizations with an assurance that relevant conflicts of interest  are identified and addressed—and that committees are appropriately  balanced in terms of points of view. Regarding the federal advisory committee policies and procedures at nine  departments and agencies, in 2004 we found that the Departments of  Agriculture, Energy, and the Interior had a long-standing practice of  appointing most or all members of their federal advisory committees as  “representatives”—expected to reflect the views of the entity or group  they are representing and not subject to conflict-of-interest reviews—even  when the departments called upon the members to provide advice on  behalf of the government on the basis of their best judgment and thus  should have appointed them as special government employees. We note that 16 of the 24 EPA federal advisory committees  currently use representative appointments, according to the government’s  database of federal advisory committee information. While EPA may be  appropriately seeking stakeholder advice from some of these advisory  committees, a number of its committees focus on scientific and technical  questions for which EPA is likely to be seeking advice on behalf of the  government on the basis of committee members’ best judgment, rather  than stakeholder advice. As EPA moves forward with actions to enhance its scientific integrity, it  will be appropriate for the agency to review its federal advisory committee  appointments, especially those for which it appoints members as  representatives, to help ensure that committee work is not jeopardized by  allegations of conflict of interest or bias. Among other things, the reforms  appropriately restore EPA’s control of the IRIS process and increase the  transparency of the process. 2009. Chemical Assessments: EPA’s New Assessment Process Will Further  Limit the Productivity and Credibility of Its Integrated Risk  Information System. Toxic Chemicals: EPA’s New Assessment Process Will Increase  Challenges EPA Faces in Evaluating and Regulating Chemicals.
Why GAO Did This Study

The Environmental Protection Agency's (EPA) ability to effectively implement its mission of protecting public health and the environment relies largely on the integrity and transparency of (1) its assessments of the potential human health effects of exposure to chemicals and (2) its federal advisory committees, which are to provide independent, expert reviews of EPA's scientific work, among other functions. EPA's Integrated Risk Information System (IRIS) program is critical in developing the agency's scientific positions on the potential health effects of exposure to toxic chemicals. These positions, used as a basis for environmental risk management decisions by EPA and others, are maintained in IRIS' database of more than 540 chemical assessments. Since 2001, GAO has issued a number of reports addressing the importance of integrity and transparency to EPA's chemical assessments and to EPA's federal advisory committees. GAO work on EPA's advisory committees has focused on its Science Advisory Board--1 of 24 EPA federal advisory committees--which convenes panels to review many of the agency's scientific assessments and proposals. This testimony highlights scientific integrity and transparency issues GAO has reported on and relevant EPA reform efforts regarding (1) the IRIS assessment process and (2) federal advisory committee policies and procedures and appointment mechanisms. GAO has supplemented information from its prior reports with a preliminary review of the IRIS assessment process EPA issued on May 21, 2009, and the current appointment mechanisms for members of EPA's federal advisory committees.

What GAO Found

In March 2008, GAO reported that the database of chemicals assessed under the IRIS program was at serious risk of becoming obsolete because EPA had not been able to complete timely, transparent, and credible assessments or decrease its backlog of ongoing assessments. A revised IRIS assessment process EPA issued in April 2008 did not respond to GAO's recommendations; rather, it made changes likely to further exacerbate concerns GAO had identified. Largely as a result of EPA's lack of responsiveness, GAO added EPA's processes for assessing and controlling toxic chemicals as a high-risk area in its January 2009 biennial status report on governmentwide high-risk areas requiring increased attention by executive agencies and Congress. Taking positive action, EPA issued a new IRIS assessment process on May 21, 2009. In announcing these reforms, EPA echoed GAO's findings that the April 2008 assessment changes reduced the transparency, timeliness, and scientific integrity of the IRIS process. The IRIS reforms, if implemented effectively, will represent significant improvements. Among other things, they restore EPA's control of the process and increase its transparency. For example, under the prior process, interagency reviews were required and managed by the Office of Management and Budget (OMB) and EPA was not allowed to proceed with assessments at various stages until OMB notified EPA that it had sufficiently responded to comments from OMB and other agencies. In contrast, under the recently announced process, EPA is to manage the entire IRIS assessment process, including what are now called interagency consultations. In 2001, GAO reported on limitations in the policies and procedures developed by EPA's Science Advisory Board to ensure that its panels' peer reviewers are independent and that a balance of viewpoints is represented on each panel. These limitations could have reduced the effectiveness of the Board by contributing to its being perceived as biased and could have inadvertently exposed panelists to violations of federal conflict-of-interest laws. EPA revised the Board's policies and procedures, as GAO had recommended. In a broader 2004 report on federal advisory committees, GAO highlighted the Board's revised policies and procedures, and those of the National Academies, which can--if implemented effectively--provide an assurance that relevant conflicts of interest are identified and addressed and that the committees are balanced in terms of points of view. However, EPA currently appoints members to 16 of its federal advisory committees using an appointment mechanism reserved for cases in which members are to speak as representatives of identified entities and are not subject to conflict-of-interest reviews, rather than as individuals speaking on behalf of the government on the basis of their best judgment. While EPA may be appropriately seeking stakeholder advice from some of its advisory committees, a number of these committees focus on scientific and technical questions for which EPA is likely to be seeking advice on behalf of the government. As EPA works to enhance scientific integrity, a review of advisory committee appointments could help ensure that committee work is not jeopardized by allegations of conflicts of interest or bias.