Currently, the IRIS database contains assessments of  more than 540 chemicals. Findings and Recommendations from Our March 2008 Report on the Productivity and Credibility of EPA’s Integrated Risk Information System

The IRIS database is at serious risk of becoming obsolete because the  agency has not been able to routinely complete timely, credible  assessments or decrease a backlog of 70 ongoing assessments. Specifically, although EPA has taken important steps to improve the IRIS  program and productivity since 2000 and has developed a number of draft  assessments for external review, its efforts to finalize the assessments  have been thwarted by a combination of factors including the imposition  of external requirements, the growing complexity and scope of risk  assessments, and certain EPA management decisions. In addition, the  changes to the IRIS assessment process that EPA was considering at the  time of our review would have added to the already unacceptable level of  delays in completing IRIS assessments and further limited the credibility  of the assessments. Several key factors have contributed to EPA’s inability to achieve a level  of productivity that is needed to sustain the IRIS program and database:  new OMB-required reviews of IRIS assessments by OMB and other federal  agencies; the growing complexity and scope of risk assessments; certain  EPA management decisions and issues, including delaying completion of  some assessments to await new research or to develop enhanced analyses  of uncertainty in the assessments; and the compounding effect of delays. In addition, the OMB/interagency reviews have hindered  EPA’s ability to independently manage its IRIS assessments. Specifically, despite the OMB/interagency review process that  OMB required EPA to incorporate into the IRIS assessment process in  2005, certain federal agencies continued to believe they should have  greater and more formal roles in EPA’s development of IRIS assessments. These  additional process steps, which would have lengthened assessment times  considerably, include    giving federal agencies and the public 45 days to identify additional  information on a chemical for EPA’s consideration in its assessment or to  correct any errors on an additional assessment draft that would provide  qualitative information;   giving potentially affected federal agencies 30 days to review the public  comments EPA received and initiate a meeting with EPA if they want to  discuss a particular set of comments;   allowing potentially affected federal agencies to have assessments  suspended for up to 18 months to fill a data gap or eliminate an  uncertainty factor that EPA plans to use in its assessment; and   allowing other federal agencies to weigh in on (1) the level of independent  peer review that would be sought (that is, whether the peer reviews would  be conducted by EPA Science Advisory Board panels, National Academies’  panels, or panels organized by an EPA contractor); (2) the areas of  scientific expertise needed on the panel; and (3) the scope of the peer  reviews and the specific issues they would address. In its February 21, 2008, letter providing comments on our  draft report, EPA said it would consider each of our recommendations in  light of the new IRIS process the agency was developing. Key Changes to the IRIS Assessment Process That EPA Implemented in April 2008

On April 10, 2008, EPA issued a revised IRIS assessment process, effective  immediately (see app. While the revised process is largely the same as the  draft proposed process we evaluated in our March 2008 report, there are  several key differences that are likely to further exacerbate the  productivity and credibility issues we identified in our report. Given the importance and sensitivity of IRIS  assessments, we believe it is critical that input from all parties, particularly  agencies that may be affected by the outcome of IRIS assessments, be  publicly available. The newly implemented IRIS assessment process broadens EPA’s  characterization of IRIS assessments from “the Agency’s scientific  positions on human health effects that may result from exposure to  environmental contaminants” to “the Agency’s science and science policy  positions” on such effects. To effectively maintain IRIS,  EPA must streamline its lengthy assessment process and adopt  transparency practices that provide assurance that IRIS assessments are  appropriately based on the best available science and that they are not  inappropriately biased by policy issues and considerations. Matter for Congressional Consideration

In light of the importance of the IRIS program to EPA’s ability to protect  the public health and the environment, the Congress should consider  requiring EPA to suspend implementation of its new IRIS assessment  process and develop a process that is responsive to our recommendations  for a streamlined process that is transparent and otherwise responsive to  our recommendations aimed at improving the timeliness and credibility of  IRIS assessments. This series of delays has limited EPA’s ability to conduct its mission. However, as of December 2007, the draft  assessment had not yet been provided to the National Academies. Appendix II: Summary of Two GAO Reports on EPA’s Toxic Substances Control Act and Chemical Control Regulations in the EU

This appendix summarizes information presented in two prior GAO  reports and related work on EPA’s regulation of toxic chemicals. Appendix III: EPA’s IRIS Assessment Process as of April 10, 2008

No, it is not mission critical. critical?
Why GAO Did This Study

The Environmental Protection Agency's (EPA) mission includes evaluating and regulating toxic chemicals. EPA's Integrated Risk Information System (IRIS) program is a chemical evaluation program that is a critical component of EPA's capacity to support scientifically sound environmental regulations and policies. The IRIS database contains EPA's scientific position on the potential human health effects of exposure to more than 540 chemicals. This testimony highlights GAO's work on toxic substances, focusing on (1) its March 2008 report, Chemical Assessments: Low Productivity and New Interagency Review Process Limit the Usefulness and Credibility of EPA's Integrated Risk Information System and (2) key changes to the IRIS assessment process EPA included in its revised IRIS assessment process released on April 10, 2008. It also highlights the findings of two GAO reports on EPA's regulation of toxic chemicals. For the IRIS report, GAO analyzed EPA data and interviewed officials at relevant agencies, including the Office of Management and Budget (OMB). For this testimony, GAO supplemented the IRIS report with a review of EPA's revised IRIS assessment process announced earlier this month. Given the importance of the IRIS program to EPA's ability to protect public health and the environment, Congress should consider requiring EPA to suspend its new process and develop one that is responsive to GAO's recommendations.

What GAO Found

The IRIS database is at serious risk of becoming obsolete because EPA has not been able to routinely complete timely, credible assessments or decrease its backlog of 70 ongoing assessments--a total of 4 were completed in fiscal years 2006 and 2007. In addition, recent assessment process changes, as well as other changes EPA was considering at the time of GAO's review, further reduce the timeliness and credibility of IRIS assessments. Although EPA has taken steps to improve the IRIS program since 2000 and has developed a number of draft assessments for external review, its efforts to finalize assessments have been thwarted by a combination of factors, including two new OMB-required reviews of IRIS assessments by OMB and other federal agencies; EPA management decisions, such as delaying some assessments to await new research; and the compounding effect of delays--even one delay can have a domino effect, requiring the process to essentially be repeated to incorporate changing science and methods. The 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, the OMB/interagency reviews lack transparency, and OMB required EPA to terminate five assessments EPA had initiated 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 GAO's review, would have added to the already unacceptable level of delays in completing IRIS assessments and further limited the credibility of the assessments. On April 10, 2008, EPA issued a revised IRIS assessment process, effective immediately. In its February 2008 comments on GAO's draft report, EPA said it would consider the report's recommendations, which were aimed at streamlining the process and better ensuring that EPA has the ability to develop transparent, credible assessments. However, EPA's new process is largely the same as the draft GAO evaluated, and some key changes also are likely to further exacerbate the productivity and credibility concerns GAO identified. For example, while the draft process would have made comments on IRIS assessments from other federal agencies part of the public record, EPA's new process expressly defines such comments as "deliberative" and excludes them from the public record. GAO continues to believe it is critical that input from all parties--particularly agencies that may be affected by the outcome of IRIS assessments--be publicly available. As recommended in GAO's March 2008 report, to effectively maintain IRIS, EPA must, among other things, streamline its lengthy assessment process and adopt transparency practices that provide assurance that IRIS assessments are appropriately based on the best available science and that they are not inappropriately biased by policy considerations. Since EPA's new process is not responsive to GAO's recommendations, the viability of this critical database has been further jeopardized.