Chemical Assessments: Annual EPA Survey Inconsistent with Leading Practices in Program Management

GAO-21-156 Published: Dec 18, 2020. Publicly Released: Jan 19, 2021.
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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.
This is a priority recommendation.
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
As of March 2022, EPA is providing some information publicly on the status of assessments in the development process, but not the extent of information we recommended. EPA disagreed with this recommendation when our report issued in December 2020, stating that the agency already maintains a high level of transparency. It also said implementing the recommendation would create an additional reporting and management burden and would slow the developments of assessments. However, we believe more information about the timing of all steps in the assessment process is necessary to help the public and stakeholders track assessments, and that our recommendation is warranted. EPA needs to communicate additional information to the public and stakeholders via public documents such as its IRIS Program Outlooks and website. Specifically, EPA should provide more information about where assessments are in the development process, including greater clarity on when EPA initiates steps in the process and expects to complete assessments. ORD has been releasing a quarterly Program Outlook since December 2018 with some milestone dates (primarily draft preparation steps and external review steps) for assessments, as well as making a "Quick Check" available on the IRIS website, but the Quick Check provides no dates for when an assessment entered a step or is expected to complete it; the Outlook likewise provides only some milestone dates.
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 March 2022, this recommendation remains open. In January 2022, IRIS officials indicated that they might be able to assist other EPA program and regional offices with establishment of criteria, but have not provided further evidence of such efforts. We will keep this recommendation open and monitor implementation efforts by program and regional offices.
Environmental Protection Agency
Priority Rec.
This is a priority recommendation.
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)
Closed – Implemented
As of March 2022, this recommendation has been closed as implemented. In June 2021, IRIS Program officials shared with internal EPA IRIS users six acceptance considerations (criteria) that were used to determine which of their March 2021 chemical assessment nominations to add to the IRIS workflow. As part of this process, IRIS officials also identified nominations that would be better served through a different ORD product (e.g. Provisional Peer-Reviewed Toxicity Value) and which they could not accept at this time. The six criteria include: (1) Urgency and public health impact of the nomination for EPA decision making; (2) Have pre-assessment materials already been developed? i.e., IRIS Assessment Plans or Protocols; (3) Size and complexity of evidence base; (is an IRIS assessment the most appropriate product?); (4) Does another health agency assessment exist (or is one in development)?; (5) Does another part of EPA have primary responsibility for conducting the assessment? (e.g., active pesticide); and (6) Resourcing (disciplinary experts, extramural funds) and collaboration opportunities. Since the IRIS Program has identified criteria, communicated with IRIS users about their application, and has demonstrated their use to prioritize future assessment work, we are closing this recommendation as implemented.
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)
Closed – Implemented
As of March 2022, this recommendation has been closed as implemented. In September 2021, IRIS officials told us they were assessing whether to move their formal survey process for nominations to every other year, to be more consistent with the frequency with which assessment needs of most EPA offices change. In March 2022, IRIS officials shared a draft memo to EPA offices stating that they anticipate moving the current annual survey to every other year beginning in fiscal year 2023; they are also testing a new app for collecting and retaining survey data so offices can see a history of nominations, re-nominate chemicals, and support nominations from another office. IRIS officials also said that they are continuing to have regular meetings with offices to ensure that more pressing needs are not missed and users do not need to wait for a formal survey to register need with IRIS. Based on these statements noting the change and the reasoning, and the ensuing memo from IRIS officials to ORD officials stating the same change in frequency of the survey, we are closing this recommendation as implemented.
Environmental Protection Agency
Priority Rec.
This is a priority recommendation.
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 March 2022, this recommendation remains open. We found in January 2022 that EPA had not identified the resources needed to address user needs for chemical assessments, and we continue to believe that ORD should include, in a strategic plan or related document, information about the IRIS Program's resources and capacity. Officials from ORD's IRIS Program told us in January 2022 that they are trying to meet user needs with the resources they have, but have not developed documentation--in a strategic plan or elsewhere--that indicates recognition of the universe of assessment needs, how the IRIS Program is being resourced to meet those needs, and metrics for defining progress in staffing the program appropriately and producing assessments in a timely manner. We will monitor ORD's implementation efforts as they strive to identify the universe of chemical assessment needs, how the IRIS Program is being resourced to meet user needs, and specific implementation steps to achieve the plan's objectives.

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