Chemical Assessments:

Challenges Remain with EPA's Integrated Risk Information System Program

GAO-12-42: Published: Dec 9, 2011. Publicly Released: Jan 9, 2012.

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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.

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 GAO’s recommendations and noted specific actions it will take to implement them.

For more information, contact David C. Trimble at (202) 512-3841 or trimbled@gao.gov.

Recommendations for Executive Action

  1. Status: Open

    Priority recommendation

    Comments: As of Fall 2017, EPA's Integrated Risk Information System (IRIS) Program officials told GAO that IRIS assessments that support policy and regulatory decisions for EPA's programs and regions, and state agencies, are being consolidated into a new portfolio to optimize the application of best available science and technology. According to IRIS Program officials, the IRIS workflow will be reoriented and timelines and resources will be tailored to fit the intended purpose of the IRIS assessment. This approach was presented to EPA's Science and Technology Policy Council in July 2017 and was presented to the Science Advisory Board's Chemical Assessment Advisory Committee in September 2017 for their consideration and evaluation. In addition, according to EPA IRIS officials, there were improvements in project management for IRIS assessments, such as working with IRIS assessment chemical managers individuals who manage IRIS assessments to develop timelines and a system that tracks the portfolio of IRIS products in development, to allow the IRIS Program to more effectively use resources across assessment projects and ensure timely delivery of products. GAO continues to believe that these efforts show important progress, but that EPA needs to continue to determine whether different time frames should be established for different types of assessments, and the feasibility and appropriateness of the established time frames.

    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.

    Agency Affected: Environmental Protection Agency

  2. Status: Open

    Priority recommendation

    Comments: As of Fall 2017, EPA's Integrated Risk Information System (IRIS) Program officials told GAO that they met with the Science Advisory Board's Chemical Assessment Advisory Committee in September 2017 to discuss responses to this recommendation. After the meeting, EPA's IRIS Program officials expect to issue a public statement that will emphasize the new portfolio approach to chemical evaluation and reflect that IRIS milestones will be varying based on the scale and type of assessment needed. EPA's IRIS Program officials told GAO that these activities will also provide the Program an opportunity to evaluate whether additional training on project management has provided the consistency in planning and delivery that was expected. GAO continues to believe that EPA has made progress and we will continue to review information provided by EPA as the agency works to ensure that the time frames are realistic and provide greater predictability to stakeholders.

    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.

    Agency Affected: Environmental Protection Agency

  3. Status: Closed - Implemented

    Priority recommendation

    Comments: 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.

    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.

    Agency Affected: Environmental Protection Agency

  4. Status: Open

    Comments: As of Fall 2017, EPA's Integrated Risk Information System (IRIS) Program officials told GAO that starting in 2017, on an annual basis, the IRIS Program is reviewing the information in the December 2015 Multi-Year Agenda to ensure that it remains responsive to GAO's recommendation. According to IRIS Program officials, this process was informal in 2017 but will be formalized starting in 2018 and updates to the Multi-Year Agenda will be published on the IRIS website and disseminated appropriately. GAO continues to believe that current and accurate information on the chemicals EPA plans to assess through IRIS should be made available to IRIS users. As the program continues its work, GAO will monitor EPA's progress to determine if information is provided annually in the Federal Register.

    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 annually publish the IRIS agenda in the Federal Register each fiscal year.

    Agency Affected: Environmental Protection Agency

  5. Status: Open

    Priority recommendation

    Comments: As of Fall 2017, EPA's Integrated Risk Information System (IRIS) Program officials told GAO that starting in 2017, on an annual basis, the IRIS Program is reviewing the information in the December 2015 Multi-Year Agenda to ensure that it remains responsive to GAO's recommendation. According to IRIS Program officials, this process was informal in 2017, but will be formalized starting in 2018, and updates to the Multi-Year Agenda will be published on the IRIS website and disseminated appropriately. EPA IRIS Program officials stated that they received feedback from the Science Advisory Board's Chemical Assessment Advisory Committee in September 2017. IRIS officials intend to publish an updated Agenda that will list which chemicals EPA is actively assessing and when EPA plans to start assessments of the other listed chemicals. GAO continues to believe that annually providing current and accurate information on chemicals that EPA plans to assess through the IRIS program is critical for IRIS users as well as specifically identifying which chemicals EPA is actively assessing and when EPA plans to start assessments of the other listed chemicals.

    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.

    Agency Affected: Environmental Protection Agency

  6. Status: Open

    Priority recommendation

    Comments: As of August 2017, EPA's Integrated Risk Information System (IRIS) Program officials stated that starting in 2017, on an annual basis, the IRIS Program is reviewing the information in the December 2015 Multi-Year Agenda to ensure that it remains responsive to GAO's recommendation. According to EPA IRIS Program officials, this process was informal in 2017 but will be formalized starting in 2018, and updates to the Multi-Year Agenda will be published on the IRIS website and disseminated appropriately. EPA IRIS Program officials stated that they received feedback from the Science Advisory Board's Chemical Assessment Advisory Committee in September 2017. Officials indicated that after the feedback is received, the IRIS website will be updated with information consistent with GAO's recommendation, such as projected and actual start dates. GAO will monitor EPA's progress, and consider whether updates are annually providing current and accurate information on chemicals that EPA plans to assess through the IRIS program, as necessary for IRIS users.

    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.

    Agency Affected: Environmental Protection Agency

 

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