Regulatory Developments

GAO Finds Challenges Remain with EPA’s 2009 IRIS Process

January 10, 2012 PRINT

On January 9, 2012, the U.S. Government Accountability Office (GAO) released a report entitled Challenges Remain with EPA's Integrated Risk Information System Program, which evaluates the U.S. Environmental Protection Agency's (EPA) progress in completing Integrated Risk Information System (IRIS) assessments under the May 2009 process. EPA revised its IRIS assessment process in May 2009 in response to a March 2008 GAO report on the IRIS program. EPA most recently revised the IRIS process in July 2011, in response to a National Academy of Sciences (NAS) report on EPA's IRIS assessment for formaldehyde. The GAO report is available online. Information regarding EPA's current IRIS assessment process is available online.

In its report, GAO found that EPA's May 2009 revisions "restored EPA's control of the process, increased its transparency, and established a new 23-month time frame for its less challenging assessments." "Notably," according to GAO, EPA addressed concerns in its March 2008 report and now determines when to move an assessment to external peer review and issuance -- decisions that were previously made by the Office of Management and Budget (OMB). GAO notes that, in addition, EPA has increased transparency by making comments provided by other federal agencies during the interagency science consultation and discussion steps of the IRIS process available to the public.

GAO concluded that progress in other areas, however, was limited. EPA's initial gains in productivity under the revised process have not been sustained. Although EPA completed 16 assessments within the first year and a half of implementing the revised process, EPA completed only four assessments in fiscal year (FY) 2011. Further, according to GAO, "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." Using the revised process, EPA took longer than the established time frames for most of its less challenging assessments. According to GAO, 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. GAO states that, beyond the 55 ongoing IRIS assessments, the backlog of demand for additional IRIS assessments is unclear. GAO found that, with existing resources devoted to ongoing assessments, EPA has not been in a position to start new assessments routinely.

EPA, in its July 2011 fact sheet concerning the IRIS process, notes that, since the new process was instituted in 2009, EPA has completed 16 assessments, "significantly reduced" the IRIS backlog, and has 70 assessments in the IRIS process at various stages. EPA states that, in FY 2011, it anticipated releasing 13 completed assessments, "including a number of major assessments such as trichloroethylene, tetrachloroethylene, arsenic and ethylene oxide." Of those, to date EPA has released only a final assessment for trichloroethylene.

GAO concludes that EPA faces "both long-standing and new challenges" in implementing the IRIS program. First, GAO notes, EPA has not fully addressed recurring issues concerning the clarity and transparency of its development and presentation of draft IRIS assessments. For example, NAS 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. 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 made the following recommendations:

  • To ensure better the credibility of IRIS assessments by enhancing their timeliness and certainty, the EPA Administrator should require the Office of Research and Development (ORD) 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;
  • To ensure better the credibility of IRIS assessments by enhancing their timeliness and certainty, the EPA Administrator should require ORD, 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;
  • To ensure better the credibility of IRIS assessments by enhancing their clarity and transparency, the EPA Administrator should require ORD 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 NAS's suggestions for improving IRIS assessments in the "roadmap for revision" presented in the NAS's 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, the EPA Administrator should direct ORD to publish annually the IRIS agenda in the Federal Register each FY;
  • To ensure that current and accurate information on chemicals that EPA plans to assess through IRIS is available to IRIS users, the EPA Administrator should direct ORD to indicate in published IRIS agendas which chemicals EPA is actively assessing and when EPA plans to start assessments of the other listed chemicals; and
  • To ensure that current and accurate information on chemicals that EPA plans to assess through IRIS is available to IRIS users, the EPA Administrator should direct ORD 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.


With the resignation of Paul Anastas, Ph.D., Assistant Administrator for ORD and the Science Advisor to EPA, it remains to be seen whether EPA will at last succeed in addressing the long-standing issues with the IRIS program. On November 18, 2011, EPA invited public nominations of scientific experts to be considered for appointment to EPA's Science Advisory Board (SAB) Chemical Assessment Advisory Committee to provide advice through the chartered SAB regarding toxicological reviews of environmental chemicals available on IRIS. Nominations were due January 6, 2012, and EPA has not yet announced the Committee members. In the House Report accompanying the nine-bill omnibus appropriations package (H.R. 2055) for FY 2012, Congress directed EPA to incorporate NAS's recommendations and issue a progress report no later than March 1, 2012, describing its implementation. Congress also directed EPA to contract with NAS to conduct up to three reviews of IRIS assessments that EPA seeks to make final.

The omnibus appropriations managers' report language, along with broader concerns in Congress about the basis and impacts of EPA decisions, will likely lead to increased Congressional scrutiny of EPA assessments and assessment procedures. The insertion of NAS specifically to review a number of EPA IRIS assessments belies less confidence on the part of Congress, or at least the Republicans in Congress, in EPA's ability to design and implement its own "objective" peer review process and procedures (notwithstanding the SAB). As assessments become the fodder for increased partisan activity in Congress, the integrity of all science activity of EPA may become a more contentious issue. Historically, Congress has been reluctant to intervene in the kind of directed procedural mandates contained in the appropriations report language. The current legislation may usher in a new era of Congressional oversight of EPA science activities, or certainly of ORD activity, with uncertain implications for the future.

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