Chemical Assessments: Low Productivity and New Interagency Review Process Limit the Usefulness and Credibility of EPA's Integrated Risk Information System
Highlights
The Environmental Protection Agency's (EPA) Integrated Risk Information System (IRIS) contains EPA's scientific position on the potential human health effects of exposure to more than 540 chemicals. IRIS is a critical component of EPA's capacity to support scientifically sound environmental decisions, policies, and regulations. GAO was asked to examine (1) the outcome of steps EPA has taken to ensure that IRIS contains current, credible chemical risk information, to address the backlog of ongoing assessments, and to respond to new requirements from the Office of Management and Budget (OMB); and (2) the potential effects of planned changes to the IRIS assessment process on EPA's ability to ensure that IRIS provides current, credible risk information. To do this work, GAO reviewed and analyzed EPA data and interviewed officials at relevant agencies.
EPA's actions since 2000 to ensure that IRIS contains current, credible risk information, to address its backlog of 70 ongoing assessments, and to respond to new OMB requirements--including increasing funding and revising the assessment process--have not enabled EPA to routinely complete credible IRIS assessments or decrease its backlog. Although in fiscal years 2006 and 2007 EPA sent 32 assessments to OMB for the first of three required external reviews, EPA finalized only 4 assessments during this period. This low level of productivity jeopardizes the viability of the IRIS database. Further, an EPA analysis indicated that many existing assessments may need to be updated, and EPA program offices and other IRIS users have requested assessments of hundreds of chemicals not yet in IRIS. Factors contributing to EPA's inability to complete IRIS assessments in a timely manner include new OMB-required reviews of IRIS assessments by OMB and other federal agencies; certain EPA management decisions, such as delaying some assessments to await new research; and the compounding effect of delays--even one delay can have a domino effect, requiring the process to essentially be repeated to incorporate changing science. As of December 2007, most of the 70 ongoing assessments had been in progress for over 5 years. Regarding new OMB requirements, the IRIS assessment process now includes two OMB/interagency reviews of draft assessments. These reviews have resulted in involvement of other federal agencies in EPA's IRIS assessment process in a manner that limits the credibility of IRIS assessments and hinders EPA's ability to manage them. That is, the OMB/interagency reviews lack transparency--OMB considers agencies' comments on IRIS assessments to be internal executive branch documents that may not be made public. Given the importance of IRIS assessments, it is essential that input from all parties, including other federal agencies, be part of the public record. Transparency is especially important because agencies providing input include those that may be affected by the assessments should they lead to regulatory or other actions. Also, without communicating its rationale for doing so, OMB directed EPA to terminate five assessments that for the first time addressed acute, rather than chronic, exposure--even though EPA initiated this type of assessment to help it implement the Clean Air Act. Most OMB/interagency reviews completed to date have added 6 or more months to the IRIS time frames. Such delays and credibility concerns would likely be exacerbated by further changes EPA is planning to respond to continuing concerns of other federal agencies, such as providing them with an expanded role in EPA's IRIS assessment process and discretion to suspend assessments to develop new studies for some chemicals. EPA estimates that such assessments would take up to 6 years, an estimate GAO believes is conservative in light of the assessment time frames under the current process. Suspending assessments is inefficient; alternatively, with longer-term planning, EPA could provide agencies and the public with more advance notice of assessments, enabling them to complete relevant research before IRIS assessments are started.
Recommendations
Recommendations for Executive Action
| Agency Affected | Recommendation | Status |
|---|---|---|
| Environmental Protection Agency | To develop timely chemical risk information that EPA needs to effectively conduct its mission, the Administrator, EPA, should require the Office of Research and Development to re-evaluate its draft proposed changes to the IRIS assessment process in light of the issues raised in this report and ensure that any revised process clearly defines and documents a streamlined IRIS assessment process that can be conducted within time frames that minimize the need for wasteful rework and carefully considers the trade-off between the benefits of changes that involve additional steps and time--including the development of enhanced uncertainty analyses and other emerging assessment methods--and the impacts of these changes on EPA's ability to complete timely chemical assessments. |
In May 2009, EPA announced comprehensive IRIS assessment reforms it was implementing immediately in response to our 2008 report and January 2009 designation of transforming EPA's processes for assessing and controlling toxic chemicals as a high-risk area. The 2009 IRIS assessment reforms streamline the process by consolidating and eliminating several steps and establishes time frames for each step, including for the internagency reviews which had been open ended under the prior process. IRIS assessments under the new process are estimated to generally take 2 years, compared with the estimated 6 to 8 years outlined under the prior process. The prior time frames were problematic because of the substantial rework such cases often require to take into account changing science and methodologies.
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| Environmental Protection Agency |
Priority Rec.
To develop timely chemical risk information that EPA needs to effectively conduct its mission, the Administrator, EPA, should require the Office of Research and Development to re-evaluate its draft proposed changes to the IRIS assessment process in light of the issues raised in this report and ensure that any revised process establishes a policy that endorses conducting IRIS assessments on the basis of peer-reviewed scientific studies available at the time of the assessment and develops criteria for allowing assessments to be suspended to await the completion of scientific studies only under exceptional circumstances. |
In July 2013, EPA issued IRIS Enhancements-including Stopping Rules-that, among other things were implemented to increase flexibility to revise draft assessments as needed after hearing the public's comments prior to peer review. EPA states that the Stopping Rules are important to the IRIS process to determine how to include new studies in an assessment without introducing delay or cycling through repeated revisions and re-reviews.
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| Environmental Protection Agency | To develop timely chemical risk information that EPA needs to effectively conduct its mission, the Administrator, EPA, should require the Office of Research and Development to re-evaluate its draft proposed changes to the IRIS assessment process in light of the issues raised in this report and ensure that any revised process establishes IRIS assessment needs to provide at least 2 years' notice of assessments that are planned, including criteria for making exceptions to the advance notifications, if needed. |
On May 7, 2012, the IRIS Program published the 2012 IRIS agenda through a Federal Register Notice. The IRIS agenda identifies the status of current assessments and announces assessments that are anticipated to start in the next 2 years. According to EPA, assessments may be started with less than a 2-year notice in instances where there is a pressing public health need, EPA Program Offices or Regions express an immediate need for an IRIS assessment or if Congress mandates an assessment. EPA has stated that changes to the IRIS agenda will be noted on the IRIS website throughout the year. It will be important that EPA routinely update its plans and continue to provide 2 years' notice before starting future assessments.
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| Environmental Protection Agency | To develop timely chemical risk information that EPA needs to effectively conduct its mission, the Administrator, EPA, should require the Office of Research and Development to re-evaluate its draft proposed changes to the IRIS assessment process in light of the issues raised in this report and ensure that any revised process sets time limits for all parties, including OMB and other federal agencies, to provide comments to EPA on draft IRIS assessments. |
As we recommended, the comprehensive IRIS assessment reforms EPA adopted in May 2009 established time frames for each assessment step, including the time for OMB and other federal agencies to provide comments on draft IRIS assessments under the interagency review step. Under the 2009 process, OMB and federal agencies have 45 days to provide comments on draft assessments (1) before the assessments are sent to external scientific peer panels and (2) before the final drafts reflecting external peer review and final EPA intraagency review are completed and posted on EPA's Web site.
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| Environmental Protection Agency |
Priority Rec.
To develop timely chemical risk information that EPA needs to effectively conduct its mission, the Administrator, EPA, should require the Office of Research and Development to re-evaluate its draft proposed changes to the IRIS assessment process in light of the issues raised in this report and ensure that any revised process periodically assesses the level of resources that should be dedicated to this significant program to meet user needs and maintain a viable IRIS database. |
As of April 2024, officials from ORD's Chemical and Pollutant Assessment Division (CPAD) had updated their analysis from February 2023 of the resources needed to produce chemical assessments, including IRIS assessments, Provisional Peer-Reviewed Toxicity Values, and other human health assessment products. The analysis updated the budget and human capital resources allocated to CPAD for producing human health assessments, including the skills and competencies needed to produce different types of chemical assessments, and the current staffing levels under each skill set. CPAD's analysis also examined the role of contractors and how they could assist EPA staff in producing chemical assessments, as well as the impact of unplanned technical assistance to EPA offices on CPAD's production of chemical assessments. The updated analysis concluded by noting that CPAD lacks sufficient resourcing to address assessment needs as they are identified and expects an increase and/or sustained high demand in its workload in the coming years. Because this analysis was updated for FY2024 and included metrics for better understanding workforce effectiveness through recruitment pathways and retention strategies, we believe the intent of this recommendation has been met and we are closing it as implemented. We would encourage CPAD officials to continue updating this analysis at least biennially in order to advocate for the human capital and budgetary resources needed to meet EPA user needs for chemical assessments and technical assistance.
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| Environmental Protection Agency |
Priority Rec.
In addition, the EPA Administrator should take steps to better ensure that EPA has the ability to develop transparent, credible IRIS chemical assessments--an ability that relies in large part on EPA's independence in conducting these important assessments. Actions that are key to this ability include ensuring that EPA can determine the types of IRIS assessments to conduct on the basis of the needs of EPA's program offices and other users. |
In October 2016 we reviewed information provided by EPA related to this recommendation. The issuance of the Integrated Risk Information System (IRIS) Program Multi-Year Agenda in December 2015 demonstrated progress in responding to this recommendation. We see this as a good starting point for EPA's continued process for determining the types of IRIS assessments to conduct on the basis of the needs of EPA's program offices and others.
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| Environmental Protection Agency | In addition, the EPA Administrator should take steps to better ensure that EPA has the ability to develop transparent, credible IRIS chemical assessments--an ability that relies in large part on EPA's independence in conducting these important assessments. Actions that are key to this ability include ensuring that EPA can define the appropriate role of external federal agencies in EPA's IRIS assessment process and manage an interagency review process in a manner that enhances the quality, transparency, timeliness, and credibility of IRIS assessments, including determining when interagency issues have been appropriately addressed. |
In response to our recommendation, under the new 2009 IRIS assessment process, EPA is to manage the entire assessment process, including the interagency reviews--now called interagency consultation. Under EPA's prior process, interagency reviews were required and managed by the Office of Management and Budget (OMB) and, at various stages, EPA was not allowed to proceed with assessments until OMB notified EPA that it had sufficiently responded to comments from OMB and other agencies. The independence restored to EPA under the new process is critical to ensuring that EPA has the ability to develop timely, transparent, credible IRIS chemical assessments.
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| Environmental Protection Agency | In addition, the EPA Administrator should take steps to better ensure that EPA has the ability to develop transparent, credible IRIS chemical assessments--an ability that relies in large part on EPA's independence in conducting these important assessments. Actions that are key to this ability include ensuring that EPA has the ability to provide comments by OMB and other federal agencies on draft IRIS assessments to decision makers, the Congress, and the public. |
As we recommended, the new IRIS assessment process that EPA promulgated in May 2009 expressly requires that all written comments on draft IRIS assessments provided by other federal agencies and White House offices during the interagency consultation process be a part of the public record.
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