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 addition, assessment process changes EPA had recently made, as well as other changes EPA was considering at the time of our review, would have further reduced the credibility, transparency, and timeliness of IRIS assessments. Among other things, we concluded the following: EPA’s efforts to finalize IRIS assessments have been impeded by a combination of factors. These factors include (1) the Office of Management and Budget’s (OMB) requiring two additional reviews of IRIS assessments by OMB and other federal agencies with an interest in the assessments, such as the Department of Defense, and (2) EPA management decisions, such as delaying some assessments to await the results of new research. The two new OMB/interagency reviews of draft assessments involve other federal agencies in EPA’s IRIS assessment process in a manner that limits the credibility of IRIS assessments and hinders EPA’s ability to manage them. For example, some of the agencies participating in these reviews could face increased cleanup costs and other legal liabilities if EPA issued an IRIS assessment for a chemical that resulted in a decision to regulate the chemical to protect the public. Moreover, the input these agencies provide to EPA is treated as “deliberative” and is not released to the public. Regarding EPA’s ability to manage IRIS assessments, without communicating its rationale for doing so, OMB required EPA to terminate five assessments that for the first time addressed acute, rather than chronic, exposure—even though EPA had initiated this type of assessment to help it implement the Clean Air Act. The changes to the IRIS assessment process that EPA was considering, but had not yet issued at the time of our 2008 review, would have added to the already unacceptable level of delays in completing IRIS assessments and would have further limited the credibility of the assessments. For example, the changes would have allowed potentially affected federal agencies to have assessments suspended for up to 18 months to conduct additional research. As we reported in 2008, even one delay can have a domino effect, requiring the assessment process to essentially be repeated to incorporate changing science. In April 2008, EPA issued a revised IRIS assessment process. The process was largely the same as the draft process we had evaluated during our review and did not respond to the recommendations in our March 2008 report. Moreover, some key changes were likely to further exacerbate the productivity and credibility concerns we initially identified. For example, EPA’s revised process formally defined comments on IRIS assessments from OMB and other federal agencies as “deliberative” and excluded them from the public record. As we stated in our report, it is critical that input from all parties—particularly agencies that may be affected by the outcome of IRIS assessments—be publicly available. In addition, we concluded that the estimated time frames under the revised process, especially for chemicals of key concern, would likely perpetuate the cycle of delays to which the majority of ongoing assessments have been subject. Instead of streamlining the process, as we had recommended, EPA institutionalized a process that from the outset was estimated to take 6 to 8 years for some widely used chemicals that are likely to cause cancer or other serious health effects. This was particularly problematic because of the substantial rework such cases often require to take into account changing science and methodologies. 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. She noted that the President’s recent emphasis on the importance of transparency and scientific integrity in government decision making compelled a rethinking of the IRIS process. If effectively implemented, the new process would be largely responsive to the recommendations outlined in our March 2008 report. First, the new process and the memorandum announcing it indicate that the IRIS assessment process will be entirely managed by EPA, including the interagency consultations (formerly called OMB/interagency reviews). 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. The independence restored to EPA under the new process is critical in ensuring that EPA has the ability to develop transparent, credible IRIS chemical assessments that the agency and other IRIS users, such as state and local environmental agencies, need to develop adequate protections for human health and the environment. Second, the new process addresses a key transparency concern highlighted in our 2008 report and testimonies. As we recommended, it expressly requires that all written comments on draft IRIS assessments provided during the interagency consultation process by other federal agencies and White House offices be part of the public record. Third, the new process streamlines the previous one by consolidating and eliminating some steps. Importantly, EPA eliminated the step under which other federal agencies could have IRIS assessments suspended in order to conduct additional research, thus returning to EPA’s practice in the 1990s of developing assessments on the basis of the best available science. As we highlighted in our report, as a general rule, requiring that IRIS assessments be based on the best science available at the time of the assessment is a standard that best supports the goal of completing assessments within reasonable time periods and minimizing the need to conduct significant levels of rework. Fourth, as outlined in the EPA Administrator’s memorandum announcing the new IRIS process, the President’s fiscal year 2010 budget request includes an additional $5 million and 10 full-time-equivalent staff positions for the IRIS program, which is responsive to our recommendation to assess the level of resources that should be dedicated in order to meet user needs and maintain a viable IRIS database. We are encouraged by the efforts EPA has made to adopt most of our recommendations, including those addressing transparency practices and streamlining the lengthy IRIS assessment process. The changes outlined above reflect a significant redirection of the IRIS process that, if implemented effectively, can help EPA restore the integrity and productivity of this important program. Nevertheless, on the basis of our preliminary review of the new IRIS assessment process, we have some initial questions that EPA may wish to consider as it implements its new process. For example, regarding integrity and transparency, it is not clear whether any significant agreements reached among the federal agencies during interagency consultation meetings will be documented in the public record, since the new policy specifies only that written comments provided by other federal agencies will become part of the public record; and why comments from other federal agencies cannot be solicited at the same time the initial draft is sent to independent peer reviewers and public comments are solicited. This change would enhance transparency and would further reduce overall assessment time frames. Specifically, the public and peer reviewers could have greater assurance that the draft had not been inappropriately biased by policy considerations of other agencies, including those that may be affected by the outcome, such as the Department of Defense and the Department of Energy. In addition, the new assessment process states that “White House offices” will be involved in the interagency consultation process but does not indicate which offices. Given that (1) EPA will be performing the coordinating role that OMB exercised under the prior process and (2) the purpose of these consultations is to obtain scientific feedback, it is unclear whether OMB will continue to be involved in the interagency consultation process. 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. Specifically, using peer review, EPA seeks to enhance the quality and credibility of the agency’s highly specialized products. One of the several ways EPA obtains expert peer review is from advice and recommendations it requests of its 24 federal advisory committees comprising independent experts. For example, since its inception in 1978, one of EPA’s largest and most prominent federal advisory committees— the EPA Science Advisory Board—has convened hundreds of peer review panels to assess the scientific and technical rationales underlying a wide range of current or proposed EPA regulations and policies. The IRIS program uses Science Advisory Board panels to peer review some of its particularly complex chemical assessments, and the Board is currently expanding a panel that will review existing IRIS assessment values established more than 10 years ago. Federal advisory committees such as the Science Advisory Board are subject to the requirements of the Federal Advisory Committee Act (FACA), which include broad requirements for balance, independence, and transparency. To be effective, peer review panels must be—and also be perceived to be—free of any significant conflict of interest and uncompromised by bias. Peer review panels should also be properly balanced, allowing for a spectrum of views and appropriate expertise. These standards, reflected in the act, are important because the work of fully competent peer review panels can be undermined by allegations of conflict of interest and bias. 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.