Currently, the IRIS database contains assessments of  more than 540 chemicals. While the process used to  develop IRIS chemical assessments includes numerous individual steps or  activities, major assessment steps include (1) a review of the scientific  literature; (2) preparation of a draft IRIS assessment; (3) internal EPA  reviews of draft assessments; (4) two OMB/interagency reviews, managed  by OMB, that provide input from OMB as well as from other federal  agencies, including those that may be affected by the IRIS assessments if  they lead to regulatory or other actions; (5) an independent peer review  conducted by a panel of experts; and (6) the completion of a final  assessment that is posted to the IRIS Web site. 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. 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. These time frames are  problematic because of the substantial rework such cases often require to  take into account changing science and methodologies before they can be  completed. In addition, the OMB/interagency reviews have hindered  EPA’s ability to independently manage its IRIS assessments. For example,  without communicating its rationale for doing so, OMB directed EPA to  terminate five IRIS assessments that for the first time addressed acute,  rather than chronic exposure—even though EPA initiated this type of  assessment to help it implement the Clean Air Act. 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. Actions that are key to this  ability include ensuring that EPA can (1) determine the types of  assessments it needs to support EPA programs and (2) define the  appropriate role of external federal agencies in EPA’s IRIS assessment  process, and (3) manage an interagency review process in a manner that  enhances the quality, transparency, timeliness, and credibility of IRIS  assessments. Key Aspects of the Revised IRIS Assessment Process Implemented in April 2008 Which Is Not Responsive to GAO’s Recommendations

On April 10, 2008, EPA issued a revised IRIS assessment process, effective  immediately. Overall, EPA’s revised process is not responsive to the  recommendations made in our March 2008 report—it is largely the same  as the draft proposed process we evaluated in our March 2008 report (see  app. Moreover, changes EPA did incorporate into the final  process are likely to further exacerbate the productivity and credibility  issues we identified in our report. However, EPA’s revised process institutionalizes a process  that the agency estimates will take up to 6 years to complete. 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. However, under the new IRIS assessment process, EPA has further  introduced policy considerations into the IRIS assessment process. In fact, it will exacerbate the problems we identified in our  March 2008 report and sought to address with our recommendations—all  of which were aimed at preserving the viability of this critical database,  which is integral to EPA’s mission of protecting the public and the  environment from exposure to toxic chemicals. This series of delays has limited EPA’s ability to conduct its mission. Appendix IV: 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) Integrated Risk Information System (IRIS) contains EPA's scientific position on the potential human health effects of exposure to more than 540 chemicals. Toxicity assessments in the IRIS database constitute the first two critical steps of the risk assessment process, which in turn, provides the foundation for risk management decisions. Thus, IRIS is a critical component of EPA's capacity to support scientifically sound environmental decisions, policies, and regulations. This testimony discusses (1) highlights of GAO's 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 aspects of EPA's revised IRIS assessment process, released on April 10, 2008. For the March 2008 report, GAO reviewed and analyzed EPA data and interviewed officials at relevant agencies, including the Office of Management and Budget (OMB). For this testimony, GAO supplemented the prior audit work with a review of EPA's revised IRIS assessment process announced on April 10, 2008.

What GAO Found

In its March 2008 report, GAO concluded that 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. EPA's 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. 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, 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 our 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 its 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 are likely to further exacerbate the productivity and credibility concerns GAO identified. For example, while the draft process would have made comments from other federal agencies on IRIS assessments 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 that 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, the estimated time frames under the new process, especially for chemicals of key concern, will likely perpetuate the cycle of delays to which the majority of ongoing assessments have been subject. Instead of significantly streamlining the process, which GAO recommended, EPA has institutionalized a process that from the outset is estimated to take 6 to 8 years to complete. This is problematic because of the substantial rework such cases often require to take into account changing science and methodologies. Since EPA's new process is not responsive to GAO's recommendations, the viability of this critical database has been further jeopardized.