Chemical Assessments: An Agencywide Strategy May Help EPA Address Unmet Needs for Integrated Risk Information System Assessments
Highlights
What GAO Found
The Environmental Protection Agency (EPA) has not conducted a recent evaluation of demand for Integrated Risk Information System (IRIS) toxicity assessments with input from users inside and outside EPA. Specifically, EPA issued a needs assessment report in 2003, which estimated that 50 new or updated IRIS toxicity assessments were needed each year to meet users' needs. However, GAO did not find sufficient support for the estimate. In addition, IRIS Program officials recognize that the 2003 estimate does not reflect current conditions, but the agency does not plan to perform another evaluation of demand. Without a clear understanding of current demand for IRIS toxicity assessments, EPA cannot adequately measure the program's performance; effectively determine the number of IRIS toxicity assessments required to meet the needs of IRIS users; or know the extent of unmet demand.
The IRIS Program's chemical nomination and selection process, which the agency uses to gauge interest in the IRIS Program from users inside and outside of EPA, may not accurately reflect current demand for IRIS toxicity assessments. The 75 chemicals that were nominated in response to EPA's most recent 2011 nomination period may not reflect demand for a number of reasons. For example, given the long-standing challenges the IRIS Program has had in routinely starting new assessments, according to some EPA IRIS users, they chose not to nominate new chemicals for assessment. Also, EPA has not clearly articulated how the IRIS Program applies the criteria it uses to prioritize the selection of chemicals for IRIS toxicity assessment--including how it determines the circumstances under which an IRIS toxicity assessment is or is not needed. Consequently, for chemicals that were nominated but not selected for assessment, it is not clear how many, if any, were excluded from consideration because they did not meet the IRIS Program's selection criteria because the IRIS Program determined that an IRIS toxicity assessment was not needed--or, alternatively, if they were not selected due to resource constraints or other reasons.
EPA has not implemented an agencywide strategy for addressing the unmet needs of EPA program offices and regions when IRIS toxicity assessments are not available, applicable, or current. Specifically, EPA does not have a strategy for identifying and filling data gaps that would enable it to conduct IRIS toxicity assessments for nominated chemicals that are not selected for assessment because sufficient data from health studies are not available. IRIS Program officials stated that no agencywide mechanism exists for EPA to ensure that chemicals without sufficient scientific data during one nomination period will have such information by the next nomination period or even the one after that. These officials acknowledged that better coordination across EPA and with other federal agencies could help address the issue. EPA also does not have agencywide guidance for addressing unmet needs when IRIS toxicity assessments are not available, applicable, or current. In the absence of agencywide guidance, officials from select EPA offices stated that they used a variety of alternatives to IRIS toxicity assessments to meet their needs, including using toxicity information from other EPA offices or other federal agencies.
Why GAO Did This Study
EPA created the IRIS database in 1985 to help develop consensus opinions within the agency about the health effects from chronic exposure to chemicals. The health effects information in IRIS--referred to as IRIS toxicity assessments--provides fundamental scientific information EPA needs to develop human health risk assessments. GAO was asked to review the effectiveness of EPA's implementation of its IRIS toxicity assessment process. This report determines the extent to which (1) EPA has evaluated demand for IRIS toxicity assessments from users inside and outside EPA; (2) EPA's process for nominating and selecting chemicals for IRIS toxicity assessment accurately reflects demand; and (3) EPA has implemented a strategy for addressing any unmet agency needs when IRIS toxicity assessments are not available, applicable, or current. To do this work, GAO reviewed and analyzed IRIS nomination data, among other things, and interviewed EPA officials. GAO did not evaluate the scientific content or quality of IRIS toxicity assessments.
Recommendations
GAO recommends that EPA evaluate demand for IRIS assessments; document how the agency applies its selection criteria, including the circumstances under which an IRIS toxicity assessment is or is not needed and; develop an agencywide strategy including, at a minimum, coordination across EPA offices, as well as with other federal agencies, to identify and fill data gaps, and providing guidance that describes alternative sources of toxicity information. EPA agreed with the first two recommendations and partially agreed with the third.
Recommendations for Executive Action
| Agency Affected | Recommendation | Status |
|---|---|---|
| Environmental Protection Agency |
Priority Rec.
To ensure that the Environmental Protection Agency (EPA) can measure the Integrated Risk Information System (IRIS) program's performance and determine the number of IRIS toxicity assessments required to meet the statutory, regulatory, and programmatic needs of IRIS users, the EPA Administrator should direct the Office of Research and Development to identify and evaluate demand for the IRIS Program to determine the number of IRIS toxicity assessments and resources required to meet users' needs. |
As of October 2016, EPA provided documentation showing that the agency evaluated user needs for toxicity assessments as part of its process for developing the Multi-Year Agenda it issued in December 2015, and provided GAO with information about resources required to meet user needs.
|
| Environmental Protection Agency |
Priority Rec.
To ensure that EPA can measure the IRIS program's performance and determine the number of IRIS toxicity assessments required to meet the statutory, regulatory, and programmatic needs of IRIS users, the EPA Administrator should direct the Office of Research and Development to document how EPA applies its IRIS toxicity assessment selection criteria, including the circumstances under which program offices and regions may or may not need an IRIS toxicity assessment. |
As of October 2016, EPA indicated that the agency evaluated user needs for toxicity assessments as part of its process for developing the Multi-Year Agenda it issued in December 2015. The agency indicated that EPA used six general criteria to inform the selection of chemicals for assessment or reassessment and documented this process in an internal working table as part of its Agenda process.
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| Environmental Protection Agency |
Priority Rec.
To ensure that EPA maximizes its limited resources and addresses the statutory, regulatory, and programmatic needs of EPA program offices and regions when IRIS toxicity assessments are not available, and once demand for the IRIS Program is determined, the EPA Administrator should direct the Deputy Administrator, in coordination with EPA's Science Advisor, to develop an agencywide strategy to address the unmet needs of EPA program offices and regions that includes, at a minimum: (1) coordination across EPA offices and with other federal research agencies to help identify and fill data gaps that preclude the agency from conducting IRIS toxicity assessments, and (2) guidance that describes alternative sources of toxicity information and when it would be appropriate to use them when IRIS values are not available, applicable, or current. |
As of March 2022, this recommendation has been closed as implemented. In September 2021, IRIS staff outlined several actions underway that addressed the intent of this recommendation. First, to show coordination across EPA offices to fill data gaps, IRIS officials identified a variety of tools, processes, and methodologies they developed, including for example, methodologies for deriving toxicity values for data-poor chemicals. IRIS officials, from EPA's Center for Public Health and Environmental Assessment, in March 2022 provided documentation of internal coordination through meetings twice a year with other EPA offices that produce assessments, such as the Office of Pesticide Programs and the Office of Pollution Prevention and Toxics; officials also provided examples of external coordination, such as memoranda with the Agency for Toxic Substances and Disease Registry and the National Toxicology Program. The purpose of these coordination meetings and memoranda are to exchange information on specific chemicals IRIS is assessing, as well as methods and tools they are employing. These interactions facilitate coordination across EPA offices and with other federal agencies to help identify and fill data gaps that preclude EPA from drafting or finalizing IRIS toxicity assessments. Second, to identify alternative sources of toxicity information when EPA values are unavailable, officials also outlined several actions underway for determining when IRIS values are most appropriate. For example, in August 2021, officials provided information that they meet with every office that uses IRIS assessments to determine which chemical assessment requests would be best met by an IRIS assessment, and which might be better addressed through another product. EPA also provided information on the criteria IRIS officials used for determining whether to accept a chemical assessment nomination into their workflow (e.g. whether an IRIS assessment is the most appropriate product; whether another health agency assessment exists (or is in development)). Based on these actions, we are closing this recommendation as implemented.
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