Fast Facts

One of EPA's chemical assessment programs maintains a database of chemicals' toxicity and effects on human health. This information contributes to the development of policies and regulations.

EPA's IRIS Program has not produced timely chemical assessments, and most of its ongoing assessments have experienced delays. Although EPA began soliciting nominations in an annual survey, starting in December 2019, EPA didn't provide sufficient guidance on how to prioritize and submit nominations to meet user needs.

We recommended issuing guidance and criteria for nominating and selecting chemicals for assessment.

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Highlights

What GAO Found

The Environmental Protection Agency's (EPA) Integrated Risk Information System (IRIS) Program has not produced timely chemical assessments, and most of its 15 ongoing assessments have experienced delays. As we reported in March 2019, the IRIS Program has taken some actions to make the assessment process more transparent, such as increasing communication with EPA offices and releasing supporting documentation for review earlier in the draft development process, but the need for greater transparency in some steps of the assessment process remains. Specifically, the IRIS Program does not publicly announce when assessment drafts move to certain steps in their development process or announce reasons for delays in producing specific assessments. Without such information, stakeholders who may be able to help fill data and analytical gaps are unable to contribute. This could leave EPA without potential support that could help overcome delays.

Delays of Milestones by Quarter for a Selection of the Integrated Risk information System's Assessments in Development 2019 - 2024

Delays of Milestones by Quarter for a Selection of the Integrated Risk information System's Assessments in Development 2019 - 2024

In mid-2018, EPA's Office of Research and Development (ORD) instituted changes to the way it solicits nominations for chemical assessments prepared by the IRIS Program but did so without providing sufficient guidance or criteria, raising questions about its ability to meet EPA user needs. For example, ORD issued a new survey to EPA program and regional offices but did not provide them with guidance for selecting chemicals for nomination, and ORD did not make explicit the criteria it was using for selecting nominations to include in the IRIS Program's list of assessments in development. Furthermore, despite a significant decline in survey participation between 2018 and 2019, EPA did not indicate whether the agency has assessed the quality of information generated by the survey. Leading program management practices state that agency management should internally communicate the necessary, quality information to achieve the entity's objectives and should monitor and evaluate program activities. Without evaluating the quality of the information produced by the survey, ORD cannot know if the survey is achieving its intended purpose and whether ORD has the information necessary to meet user needs.

Why GAO Did This Study

EPA's IRIS Program prepares chemical toxicity assessments that contain EPA's scientific position on the potential human health effects of exposure to chemicals; at present, the IRIS database contains more than 570 chemical assessments. In March 2019, GAO reported on the IRIS Program's changes to increase transparency about its processes and methodologies, including the use of systematic review. However, GAO also found that EPA decreased the number of ongoing assessments in December 2018 from 22 to 13 and continued to face challenges in producing timely assessments.

This report evaluates (1) EPA's progress in completing IRIS chemical assessments since 2018; and (2) EPA's recent actions to manage the IRIS Program, and the extent to which these actions help the Program meet EPA user needs.

GAO reviewed and analyzed EPA documents and interviewed officials from EPA; GAO also selected three standards for program management, found commonalities among them, and compared ORD's management of the IRIS Program against these leading practices.

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Recommendations

GAO is making five recommendations, including that EPA provide more information publicly about where chemical assessments are in the development process; and issue guidance for selecting chemicals for nomination and criteria for selecting nominations for assessment. EPA partially agreed with two of our recommendations and disagreed with the other three.

Recommendations for Executive Action

Agency Affected Recommendation Status
Environmental Protection Agency
Priority Rec.
Priority recommendations are those that GAO believes warrant priority attention from heads of key departments or agencies.
The Administrator should direct the Assistant Administrator of the Office of Research and Development to provide more information publicly about where chemical assessments are in the development process, including internal and external steps in the process, and changes to assessment milestones. (Recommendation 1)
Open
In April 2021, officials from EPA's Office of Research and Development (ORD) indicated that they partially agree with this recommendation and committed to implementing enhancements to ensure programmatic transparency. While EPA officials indicated concern that providing more information could create an additional reporting and management burden that would slow the development of assessments, we believe additional efforts are important. As we stated in our December 2020 report, internal steps of the assessment (agency review, interagency science consultation, revising the assessment based on peer review, and final agency review and interagency science consultation--steps 2, 3, 5 and 6) are not announced publicly, leaving the public, including industry and environmental stakeholders, without information to track assessment status. Nonetheless, EPA officials told us they believe the agency already maintains a high level of transparency via the IRIS Program Outlook, webpages, list serve announcements, and public engagement opportunities. We will keep this recommendation open and monitor ORD's implementation efforts.
Environmental Protection Agency The Administrator should direct the Assistant Administrators of program offices and Regional Administrators to develop and make available guidance for chemical assessment nominations. Such guidance could include information such as how to select chemicals for IRIS assessment nomination or for high priority needs, criteria explaining how Assistant and Regional Administrators determine which nominations to support and which they may choose not to support, and how to document these decisions. (Recommendation 2)
Open
As of April 2021, this recommendation remains open. In its comments on our report, EPA disagreed with this recommendation because it believed the agency had already taken the actions we recommended. EPA provided GAO with information on changes made to the latest nominations process as articulated in a September 2020 memorandum that described the two-phase process for regional offices and National Program Managers. We do not believe the memorandum addresses our recommendation. As we describe in our report, Assistant Administrators and Regional Administrators have not issued criteria or other information to guide their staff as they select chemicals to nominate for assessment. We continue to believe that providing such guidance to program and regional office staff would help them plan their chemical nominations to align with their office's goals as well as facilitate ORD's understanding about their office's current and future assessment needs.
Environmental Protection Agency
Priority Rec.
Priority recommendations are those that GAO believes warrant priority attention from heads of key departments or agencies.
The Administrator should direct the Assistant Administrator of the Office of Research and Development to issue criteria for how chemical assessment nominations are selected for inclusion in the IRIS Program's list of assessments in development and provide quality information about such topics as defining high-priority chemicals, prioritizing assessment work, and determining the IRIS Program's capacity to undertake work. (Recommendation 3)
Open
As of April 2021, this recommendation remains open. In its comments on our report, EPA partially agreed with this recommendation but did not believe it merited immediate attention because agency officials stated that they have not rejected any formal nomination that has been submitted since initiating its new process in 2018. As we describe in our report, an understanding of the criteria used for prioritizing chemicals for assessment development can inform staff as they consider which chemicals to nominate. Without information on such things as the program's capacity or how decisions are made for prioritizing assessments, it was difficult for program and regional offices to determine how the Office of Research and Development (ORD) viewed their high-priority needs, and for stakeholders to understand how ORD defines its priorities.
Environmental Protection Agency The Administrator of EPA should direct the Office of Research and Development to continue evaluating the survey process used to solicit IRIS user needs and assess key elements, such as its purpose and timing, to facilitate the collection of quality information. (Recommendation 4)
Open
As of April 2021, this recommendation remains open. In its comments on our report, EPA disagreed with this recommendation because it believes the agency has already taken the actions we recommended. EPA indicated that it already obtained useful feedback on ways to improve the clarity and transparency of its nominations process from program and regional office senior leadership, as reflected in its September 2020 memorandum. We believe that ongoing assessment of the annual survey process is warranted. As we state in our report, leading program management practices, as well as Standards for Internal Control in the Federal Government, state that agency management should monitor and evaluate program activities. Without evaluating the quality of the information produced by the survey, ORD cannot know if the survey is achieving its intended purpose and whether ORD has the information necessary to evaluate the extent to which the IRIS Program is meeting its users' needs.
Environmental Protection Agency
Priority Rec.
Priority recommendations are those that GAO believes warrant priority attention from heads of key departments or agencies.
The Administrator of EPA should include in ORD's strategic plan (or subsidiary strategic plans) identification of EPA's universe of chemical assessment needs; how the IRIS Program is being resourced to meet user needs; and specific implementation steps that indicate how IRIS will achieve the plan's objectives, such as specific metrics to define progress in meeting user needs. (Recommendation 5)
Open
As of April 2021, EPA officials indicated that the agency is considering a range of options for improving the nomination of chemicals for IRIS assessments. As we discuss in our December 2020 report, a review of EPA's draft strategic plan, released by the Board of Scientific Counselors in August 2020 showed that it was difficult to determine how the goals outlined in the plan would be accomplished through specific research projects and deliverables. It further noted that the plan did not include a detailed implementation strategy or metrics to define progress in the draft strategic plan. Therefore, we continue to believe that EPA's Office of Research and Development should include in a strategic plan information about the IRIS Program's resources and capacity. We will keep this recommendation open and monitor EPA's implementation efforts.

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