EPA’s initial gains in productivity under the  revised process have not been sustained. Initial Gains in Productivity under the Revised Process Have Not Been Sustained

Shortly after it implemented its revised IRIS assessment process in May  2009, EPA experienced a surge of productivity in terms of the number of  IRIS assessments it issued. The increased productivity occurring after May 2009 does not appear to  be entirely attributable to the revised IRIS assessment process. Beyond  the 55 ongoing IRIS assessments and 14 on hold, the demand for  additional IRIS assessments is unclear. With existing resources devoted  to addressing its current workload of ongoing assessments, EPA has not  been in a position to routinely start new assessments. EPA Faces Long- standing and New Challenges in Implementing the IRIS Program

EPA faces both long-standing and new challenges in implementing the  IRIS Program. In July 2011, EPA announced that it planned to respond to the National  Academies’ suggestions by implementing changes to the way it develops  draft IRIS assessments. Therefore, current and accurate  information regarding when an assessment will be started, which  assessments are currently ongoing, and when an assessment is  projected to be completed is presently not publicly available. Conclusions

The IRIS process reforms EPA began implementing in May 2009 have  restored EPA’s control of the process and increased its transparency. Notably, EPA has addressed concerns we raised in our March 2008  report regarding the transparency of comments from both the interagency  science consultation and discussion steps in the IRIS process. Progress in other areas, however, has been more limited. For example,  even for its less challenging assessments, EPA took longer than its  established time frames for accomplishing steps in the revised process— calling into question the feasibility and appropriateness of the established  time frames in the IRIS assessment process for standard assessments. We note that EPA has not analyzed the time frames to determine whether  the actual time taken for each step of the overall 23-month process is  realistic. Consequently, as part of its independent scientific  review of EPA’s draft IRIS assessment of formaldehyde, the National  Academies also provided suggestions in a “roadmap for revision” that  included suggestions for improving EPA’s development and presentation  of draft IRIS assessments in general. Many of the issues raised in  the National Academies’ report have been brought to the agency’s  attention previously. It is unclear whether any independent entity with  scientific and technical credibility, such as EPA’s Board of Scientific  Counselors, will have a role in reviewing EPA’s planned response to the  National Academies’ suggestions to ensure that EPA addresses these  long-standing issues. To better ensure the credibility of IRIS assessments by enhancing their  clarity and transparency, we recommend that the EPA Administrator  require the Office of Research and Development to submit for  independent review to an independent entity with scientific and technical  credibility, such as EPA’s Board of Scientific Counselors, a plan for how  EPA will implement the National Academies’ suggestions for improving  IRIS assessments in the “roadmap for revision” presented in the National  Academies’ peer review report on the draft formaldehyde assessment. To ensure that current and accurate information on chemicals that EPA  plans to assess through IRIS is available to IRIS users—including  stakeholders such as EPA program and regional offices, other federal  agencies, and the public—we recommend that the EPA Administrator  direct the Office of Research and Development to    annually publish the IRIS agenda in the Federal Register each fiscal  indicate in published IRIS agendas which chemicals EPA is actively  assessing and when EPA plans to start assessments of the other  listed chemicals; and    update IRISTrack to display all current information on the status of  assessments of chemicals on the IRIS agenda, including projected  and actual start dates, and projected and actual dates for completion  of steps in the IRIS process, and keep this information current. Specifically, EPA agreed that it should (1) assess the feasibility and  appropriateness of the established time frames for each step in the IRIS  assessment process by using available program performance measures  collected since the current IRIS process was established to evaluate  determine whether different time frames should be established, based on  complexity or other criteria, for different types of IRIS assessments, (2)  determine if different time frames are necessary, establish a written policy  that clearly describes the applicability of the time frames for each type of  IRIS assessment and ensures that the time frames are realistic and provide  greater predictability to stakeholders, (3) continue to implement the 2011  suggestions for improving IRIS assessments in the “roadmap for revision”  presented in the National Academies’ peer review report on the draft  formaldehyde assessment and seek independent review through the  Science Advisory Board to ensure that the agency is addressing the  recommendations, (4) annually publish the IRIS agenda in the Federal  Register each fiscal year, (5) indicate in published IRIS agendas which  chemicals EPA is actively assessing and when EPA plans to start  assessments of the other listed chemicals, and (6) update IRISTrack to  display all current information on the status of assessments of chemicals  on the IRIS agenda, including projected and actual start dates, and  projected and actual dates for completion of steps in the IRIS process, and  keep this information current. Appendix I: Scope and Methodology

This appendix details the methods we used to assess the Environmental  Protection Agency’s (EPA) management of its Integrated Risk Information  System (IRIS). For this review, our objectives were to evaluate (1) EPA’s  progress in completing IRIS assessments under the May 2009 process and  (2) the challenges, if any, that EPA faces in implementing the IRIS Program. In addition, we  interviewed officials from EPA’s National Center for Environmental  Assessment (NCEA) who manage the IRIS Program, including the Acting  Center Director, the Associate Director for Health, and the IRIS Program  Acting Director, to obtain their perspectives on, among other things, the  May 2009 IRIS process and the effects of changes from the April 2008 IRIS  process, the extent to which EPA has made progress in completing timely,  credible chemical assessments, challenges EPA faces in completing  assessments, and EPA’s process for responding to Data Quality Act  challenges.
Why GAO Did This Study

The Environmental Protection Agency's (EPA) Integrated Risk Information System (IRIS) Program supports EPA's mission to protect human health and the environment by providing the agency's scientific position on the potential human health effects from exposure to various chemicals in the environment. The IRIS database contains quantitative toxicity assessments of more than 550 chemicals and provides fundamental scientific components of human health risk assessments. In response to a March 2008 GAO report on the IRIS program, EPA revised its IRIS assessment process in May 2009. GAO was asked to evaluate (1) EPA's progress in completing IRIS assessments under the May 2009 process and (2) the challenges, if any, that EPA faces in implementing the IRIS program. To do this work, GAO reviewed and analyzed EPA productivity data, among other things, and interviewed EPA officials.

What GAO Found

EPA's May 2009 revisions to the IRIS process have restored EPA's control of the process, increased its transparency, and established a new 23-month time frame for its less challenging assessments. Notably, EPA has addressed concerns GAO raised in its March 2008 report and now makes the determination of when to move an assessment to external peer review and issuance--decisions that were made by the Office of Management and Budget (OMB) under the prior IRIS process. In addition, EPA has increased the transparency of the IRIS process by making comments provided by other federal agencies during the interagency science consultation and discussion steps of the IRIS process available to the public. Progress in other areas, however, has been limited. EPA's initial gains in productivity under the revised process have not been sustained. After completing 16 assessments within the first year and a half of implementing the revised process, EPA completed 4 assessments in fiscal year 2011. Further, the increase in productivity does not appear to be entirely attributable to the revised IRIS assessment process and instead came largely from (1) clearing the backlog of IRIS assessments that had undergone work under the previous IRIS process and (2) issuing assessments that were less challenging to complete. EPA has taken longer than the established time frames for completing steps in the revised process for most of its less challenging assessments. However, EPA has not analyzed its established time frames to assess the feasibility of the time frame for each step or the overall 23-month process. The agency's progress has also been limited in completing assessments that it classifies as exceptionally complex and reducing its ongoing assessments workload. Beyond the 55 ongoing IRIS assessments, the backlog of demand for additional IRIS assessments is unclear. With existing resources devoted to addressing its current workload of ongoing assessments, EPA has not been in a position to routinely start new assessments.
EPA faces both long-standing and new challenges in implementing the IRIS program. First, EPA has not fully addressed recurring issues concerning the clarity and transparency of its development and presentation of draft IRIS assessments. For example, as part of its independent scientific review of EPA's draft IRIS assessment of formaldehyde, the National Academies provided suggestions for improving EPA's development and presentation of draft IRIS assessments in general, including that EPA use a standardized approach to evaluate and describe study strengths and weaknesses and the weight of evidence. EPA announced that it planned to respond to the National Academies' suggestions by implementing changes to the way it develops draft IRIS assessments. Given that many of the issues raised by the National Academies have been long-standing, it is unclear whether any entity with scientific and technical credibility, such as an EPA advisory committee, will have a role in conducting an independent review of EPA's planned response to the suggestions. In addition, EPA has not addressed other long-standing issues regarding the availability and accuracy of current information to users of IRIS information, such as EPA program offices, on the status of IRIS assessments, including when an assessment will be started, which assessments are ongoing, and when an assessment is projected to be completed. GAO recommends, among other things, that EPA assess the feasibility of the established time frames for each step in the IRIS assessment process and make changes if necessary, submit for independent review to an entity with scientific and technical credibility a plan for how EPA will implement the National Academies' suggestions, and ensure that current and accurate information on chemicals that EPA plans to assess through IRIS is available to IRIS users. EPA agreed with GAO's recommendations and noted specific actions it will take to implement them.

What GAO Recommends

GAO recommends, among other things, that EPA assess the feasibility of the established time frames for each step in the IRIS assessment process and make changes if necessary, submit for independent review to an entity with scientific and technical credibility a plan for how EPA will implement the National Academies suggestions, and ensure that current and accurate information on chemicals that EPA plans to assess through IRIS is available to IRIS users. EPA agreed with GAOs recommendations and noted specific actions it will take to implement them.