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 Credibility and Usefulness 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. 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. One of the factors that has contributed to EPA’s inability to complete  assessments in a timely manner—the new OMB-directed OMB/interagency  review process—also limits the credibility of the assessments because it  lacks transparency. 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. The Expansion of Agencies’ Roles in IRIS Assessments That EPA Was Considering at the Time of Our Review Would Have Caused Further Delays and Limited the Assessments’ Credibility

For our March 2008 report, we reviewed the additional assessment  process changes EPA was planning and concluded that they would likely  exacerbate delays in completing IRIS assessments and further affect their  credibility. 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. Recommendations Made in Our March 2008 Report

To address the productivity and credibility issues we identified, we  recommended that the EPA Administrator require the Office of Research  and Development to re-evaluate its draft proposed changes to the IRIS  assessment process in light of the issues raised in our report and ensure  that any revised process, among other things, clearly defines and  documents an IRIS assessment process that will enable the agency to  develop the timely chemical risk information it needs to effectively  conduct its mission. Key Aspects of the Revised IRIS Assessment Process Implemented in April 2008 Which Is Not Responsive to Our 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, the dialogue should not bias or otherwise color the  risk assessment conducted, and the activities should remain distinct; that  is, risk assessors should not be performing risk management activities.”

	EPA’s Progress in Completing Assessments in Fiscal Year 2008

EPA’s progress in completing assessments continues to be slow—only  four final assessments have been completed in fiscal year 2008. Moreover, little or no progress has been made on assessments of the key  chemicals highlighted in our report—naphthalene, formaldehyde, Royal  Demolition Explosive (RDX), trichloroethylene (TCE), tetrachloroethylene  (perc), and 2,3,7,8-tetrachlorodibenzo-p-dioxin (dioxin). Examples include the  following:  Naphthalene. 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; (2) key aspects of EPA's revised IRIS assessment process, released on April 10, 2008; and (3) progress EPA has made in completing assessments in fiscal year 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. We also updated our information on EPA's assessment productivity through September 12, 2008.

What GAO Found

In March 2008, GAO concluded that the IRIS database was at serious risk of becoming obsolete because EPA had not been able to 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, assessment process changes EPA had recently made, as well as other changes EPA was considering at the time of GAO's review, would further reduce the credibility and timeliness of IRIS assessments. We concluded the following: 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 and by EPA management decisions, such as delaying some assessments to await 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, 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. EPA issued its revised IRIS assessment process in April 2008. The new process is largely the same as the draft GAO evaluated and does not respond to the recommendations in GAO's March 2008 report. Moreover, 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 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 streamlining the process, as GAO recommended, EPA has institutionalized a process that from the outset is estimated to take 6 to 8 years. This is problematic because of the substantial rework such cases often require to take into account changing science and methodologies. EPA's progress in completing assessments continues to be slow--only four assessments have been completed in fiscal year 2008. Further, these assessments cover a group of four related chemicals that were processed and peer reviewed together but finalized individually. Little or no progress has been made on assessments of chemicals highlighted in our report, including naphthalene, formaldehyde, and trichloroethylene (TCE).