Chemical Assessments:

Challenges Remain with EPA's Integrated Risk Information System Program

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

Additional Materials:

Contact:

David C. Trimble
202-512-9338
trimbled@gao.gov

 

Office of Public Affairs
(202) 512-4800
youngc1@gao.gov

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

    Comments: In June 2016 we reviewed information provided by EPA related to this recommendation. In July 2013, the EPA issued "enhancements" to the IRIS process. EPA stated that the Program introduced the idea that different timelines are needed for different types of assessments based on criteria such as complexity (i.e., large database, many endpoints, complex questions about dose-response, multiple science issues, and novel approaches), potential public health impact, and the amount of new research that needs to be considered. Consequently, two sets of timelines for the IRIS assessment process were developed, one set for "standard" assessments and one set for "complex" assessments. GAO believes that this is an important first step, but that EPA still needs to assess the feasibility and appropriateness of the established time frames for each step in the IRIS assessment process. This can only be done as the program works to complete assessments and determines the time it takes to complete an IRIS assessment.

    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

    Comments: In June 2016 we reviewed information provided by EPA related to this recommendation. In July 2013, the EPA issued "enhancements" to the IRIS process. EPA stated that the Program introduced the idea that different timelines are needed for different types of assessments based on criteria such as complexity (i.e., large database, many endpoints, complex questions about dose-response, multiple science issues, and novel approaches), potential public health impact, and the amount of new research that needs to be considered. Consequently, two sets of timelines for the IRIS assessment process were developed, one set for "standard" assessments and one set for "complex" assessments. GAO believes that this is an important first step, but that EPA still needs 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

    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 independent entities 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: In June 2016, EPA provided an update to GAO and said they believe they have met the intent of this GAO recommendation by publishing an IRIS Multi-Year Agenda in December 2015. According to EPA, the Multi-Year Agenda provides detailed information on near-term agency priorities including IRIS assessments that are ongoing and those that will be initiated over the next few years. GAO still believes that annually providing current and accurate information on chemicals that EPA plans to assess through the IRIS program is critical 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 annually publish the IRIS agenda in the Federal Register each fiscal year.

    Agency Affected: Environmental Protection Agency

  5. Status: Open

    Comments: In June 2016, EPA provided an update to GAO and said they believe they have met the intent of this GAO recommendation by publishing an IRIS Multi-Year Agenda in December 2015. According to EPA, the Multi-Year Agenda provides detailed information on near-term agency priorities including IRIS assessments that are ongoing and those that will be initiated over the next few years. GAO still believes that annually providing current and accurate information on chemicals that EPA plans to assess through the IRIS program is critical 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 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

    Comments: In June 2016, EPA provided an update to GAO and said they believe they have met the intent of this GAO recommendation by publishing an IRIS Multi-Year Agenda in December 2015. According to EPA, the Multi-Year Agenda provides detailed information on near-term agency priorities including IRIS assessments that are ongoing and those that will be initiated over the next few years. GAO still believes that annually providing current and accurate information on chemicals that EPA plans to assess through the IRIS program is critical for IRIS users. In addition, The Agenda does not identify projected start dates for new assessments, and therefore is not ensuring that current and accurate information on chemicals that EPA plans to assess through IRIS is available to 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

 

Explore the full database of GAO's Open Recommendations »

Jul 26, 2016

Jul 21, 2016

Jul 14, 2016

Jul 7, 2016

Jun 14, 2016

Jun 13, 2016

Jun 2, 2016

Apr 29, 2016

Looking for more? Browse all our products here