Chemical Assessments: Challenges Remain with EPA's Integrated Risk Information System Program

GAO-12-42 Published: Dec 09, 2011. Publicly Released: Jan 09, 2012.
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Highlights

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.

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.

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Recommendations

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.

Recommendations for Executive Action

Agency Affected Recommendation Status
Environmental Protection Agency
Priority Rec.
This is a priority recommendation.
To better ensure the credibility of IRIS assessments by enhancing their timeliness and certainty, the EPA Administrator should require the Office of Research and Development to assess the feasibility and appropriateness of the established time frames for each step in the IRIS assessment process and determine whether different time frames should be established, based on complexity or other criteria, for different types of IRIS assessments.
Closed – Implemented
EPA concurred with our recommendation and has taken action to assess the established time frames for each step in the IRIS assessment process. As confirmed in February 2020, and as we reported in March 2019, the IRIS Program took several actions to evaluate its process. These included assessing the feasibility and appropriateness of established time frames for each step in the IRIS process based on complexity or other criteria, tailoring assessments to meet EPA program office needs using their "fit-for-purpose" approach, and communicating those time frames to internal EPA stakeholders.
Environmental Protection Agency
Priority Rec.
This is a priority recommendation.
To better ensure the credibility of IRIS assessments by enhancing their timeliness and certainty, the EPA Administrator should require the Office of Research and Development, should different time frames be necessary, to 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.
Open
EPA agreed with our recommendation and as of February 2022 EPA officials told us they were considering ways to provide additional documentation to help stakeholders better understand time frames. Since December 2018, EPA has used IRIS Program Outlooks to provide some information about assessment development timelines. EPA has also begun including information in IRIS Assessment Plans (IAPs) and Systematic Review Protocols to help inform stakeholders and the public about the complexity of individual assessments. For example, IAPs document the extent and nature of the evidence, and the Systematic Review Protocols present more advanced literature inventories and summarize methods EPA uses to prepare an assessment. While such information can help the IRIS Program estimate time frames, identify appropriate staff, and contract support where needed, stakeholders have limited information to evaluate whether time frames are realistic. Providing baseline information that elaborates on factors that influence the complexity and time required to complete an assessment would help stakeholders' understanding and better align with our recommendation.
Environmental Protection Agency
Priority Rec.
This is a priority recommendation.
To better ensure the credibility of IRIS assessments by enhancing their clarity and transparency, the EPA Administrator should 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.
Closed – Implemented
EPA has been working to respond to 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. The IRIS Program has sought review and feedback from an independent entity with scientific and technical credibility, and the program has fully embraced the suggestions and has sought to do so in a clear and transparent manner through continuing engagement with internal and external stakeholders.
Environmental Protection Agency 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--the EPA Administrator should direct the Office of Research and Development to annually publish the IRIS agenda in the Federal Register each fiscal year.
Closed – Implemented
The IRIS Program has made public its list of current assessments in development via the IRIS website, and in March 2021 released the latest update to the Program Outlook Document. The IRIS Program Outlook describes assessments that are in development and projected public milestone dates. EPA has released updates at least three times a year since December 2018, and is committed to doing so as indicated on its website. We are satisfied that with this information, stakeholders and the public can ascertain IRIS's priorities for the near-term, thereby meeting the intent of our recommendation. Relatedly, we reiterate our recommendations from GAO-21-156 that direct the Office of Research and Development to provide additional public information about (1) the status of chemical assessments in development including internal and external steps in the process and changes to assessment milestones; and (2) the criteria for determining how chemical assessment nominations are selected for inclusion in the Program's list of assessments in development. Such information would provide stakeholders and the public with greater insight into how IRIS prioritizes its work.
Environmental Protection Agency
Priority Rec.
This is a priority recommendation.
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--the EPA Administrator should direct the Office of Research and Development to indicate in published IRIS agendas which chemicals EPA is actively assessing and when EPA plans to start assessments of the other listed chemicals.
Closed – Implemented
EPA concurred with our recommendation and has taken actions to publish current information about which chemicals EPA is assessing. As EPA officials confirmed in February 2020 from evidence we collected for our March 2019 report, IRIS Program officials have routinely published information for the public. Specifically, every three to four months the IRIS Program is publishing IRIS Program Outlook documents which detail the chemicals they are actively assessing and broad milestone dates for those chemicals. As of February 2020, the program has released information about projected start dates and milestone dates for most of the chemicals currently under assessment
Environmental Protection Agency
Priority Rec.
This is a priority recommendation.
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--the EPA Administrator should direct the Office of Research and Development to update the IRIS Substance Assessment Tracking System (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.
Closed – Implemented
EPA concurred with our recommendation and as of March 2020, the IRIS Program has released information through its IRIS Program Outlook document about projected start dates and milestone dates for most of the chemicals currently under assessment. These updates have been routinely posted every three to four months since December 2018.

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