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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.

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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.
Closed - Implemented
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.
Environmental Protection Agency
Priority Rec.
This is a priority recommendation.
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.
Closed - Implemented
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.
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.
Closed - Implemented
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.
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.
Closed - Implemented
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.
Environmental Protection Agency
Priority Rec.
This is a priority recommendation.
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.
Open
As of April 2021, this recommendation remains open. EPA officials indicated that agency leadership is working to initiate the new cycle of strategic planning and will use the nomination process to understand the Agency's assessment needs as the starting point for making informed decisions on resources. EPA re-administered the September 2020 request for FY 2021 nominations using a modified process that the agency believes better engages the Regions and other offices in EPA that do not oversee statutory decision making, i.e., the Office of Children's Health Protection. A workforce plan that includes both staff and budget resources consistent with user needs is necessary. The IRIS Program is currently working to further clarify the process for its FY 2022 nomination request and GAO will keep this recommendation open and continue to monitor EPA's efforts and reevaluate its progress
Environmental Protection Agency
Priority Rec.
This is a priority recommendation.
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.
Closed - Implemented
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.
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.
Closed - Implemented
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.
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.
Closed - Implemented
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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