Transforming EPA's Processes for Assessing and Controlling Toxic Chemicals
EPA’s ability to effectively implement its mission of protecting public health and the environment is dependent on assessing the risks posed by chemicals in a credible and timely manner. Such assessments are the cornerstone of scientifically sound environmental decisions, policies, and regulations under a variety of statutes, such as the Safe Drinking Water Act and the Clean Air Act. EPA prepares assessments of chemical hazards to human health under its IRIS Program, among others. The importance of IRIS has increased over time as EPA program offices and regions have relied on the program’s toxicity assessments in making environmental protection and risk management decisions.
EPA is also authorized under TSCA to obtain information on the risks of chemicals and to control chemicals the agency determines pose an unreasonable risk. This act was amended in 2016 by the Frank R. Lautenberg Chemical Safety for the 21st Century Act. The Lautenberg Act provides EPA with greater authority to address chemical risks, but implementation will take years because of the complexity and scope of the legislation.
Because EPA had not developed sufficient chemical assessment information under these programs to limit exposure to many chemicals that may pose substantial health risks, we added this issue to the High-Risk List in 2009 as a government program in need of broad-based transformation.
Since our 2017 High-Risk Report, four criteria remain unchanged. However, the leadership commitment rating decreased from met to partially met in 2019.
For more information on EPA’s recent progress toward producing chemical assessments and implementing TSCA, see our March 2019 chemical assessments report GAO-19-270.
Integrated Risk Information System (IRIS)
Since our 2017 High-Risk Report, ratings for capacity, action plan, monitoring, and demonstrated progress remain unchanged. However, the rating for leadership commitment declined to partially met.
Leadership commitment: partially met. This rating has declined from met in 2017. In our 2017 High-Risk Report, we reported that the EPA Administrator demonstrated leadership commitment to the IRIS Program by identifying action on toxics and chemical safety as one of her top seven priorities for the agency—priorities that included the IRIS Program. However, current EPA leadership has not made a similar statement. While EPA released a document in late December 2018 called the IRIS Program Outlook, identifying ongoing chemical assessments, EPA leadership also proposed significant cuts to the program’s budget. For the past two years, EPA’s budget justification for human health risk assessment work was reduced to about $22 million from its fiscal year 2017 budget of $40.5 million, contributing to a lower rating than we gave in 2017. Congress did not support these reductions. Specifically, according to the joint explanatory statements accompanying the Consolidated Appropriations Act, 2018, and Consolidated Appropriations Act, 2019, Congress has agreed to continue providing funding at fiscal year 2017 enacted levels.
EPA leadership’s long-term accountability for actions has been limited, as demonstrated by four IRIS assessments that were in the later stages of development on the 2015 Multi-Year agenda but have not been released, or included on the December 2018 list of assessments. EPA provided no information on the status of these assessments or whether it plans to discontinue working on them or restart them at another time. As we have previously reported, an overarching factor that affects EPA’s ability to complete IRIS assessments in a timely manner is that once a delay in the assessment process occurs, work that has been completed can become outdated, necessitating rework throughout some or all of the assessment process. Thus, it remains to be seen when these assessments can be expected to move to the next step in the IRIS process or be completed.
Capacity: partially met. As our March 2019 chemical assessments report indicates, the IRIS program has made progress in addressing some challenges to its assessment process, including adopting project management principles, and new software; streamlining the peer review process; implementing systematic review; and making changes to the frequency and type of communication, among others. It will take resources to implement all of these process improvements. We will continue to monitor EPA’s efforts and assess the progress the agency is making. Our previous work has shown that decision makers in the United States and around the world rely on information from IRIS assessments. Because of this key role, we are concerned that without adequate funding, untimely implementation of IRIS assessments could have profound impacts on chemical risk management activities.
Action plan: partially met. As we reported in our 2017 High-Risk Report, EPA had not evaluated the demand for IRIS toxicity assessments with input from users inside and outside EPA. EPA issued an IRIS Multi-Year Agenda in December 2015. According to EPA, the purpose of the 2015 agenda was to: (1) identify IRIS assessments currently under way and their status; (2) prioritize IRIS assessments that will be initiated over the next few years; and (3) evaluate assessment needs and develop an updated process for existing IRIS values. In December 2018, EPA issued the IRIS Program Outlook, but it was missing some key information. The Outlook identifies assessments currently underway and lists the next anticipated step in the IRIS process. However, the Outlook fails to list the projected date for most of the assessments and includes no information regarding assessment prioritization—including how these assessments will meet program and regional office needs. Moreover, we recommended in May 2013 that EPA should develop an Action Plan or strategy, among other things, to address the needs of EPA program offices and regions when IRIS toxicity assessments are not available; the agency is still working to do so.
Monitoring: met. The IRIS Program produced a report to Congress, which offered an overview of progress in January 2018, and took part in a National Academies of Sciences (NAS) review of the program in February 2018, which offered a third-party assessment of the program’s efforts. The resulting NAS report provided a supportive assessment of ongoing transformations aimed at ensuring data quality, new systematic approaches for data analysis and expanded stakeholder engagement efforts, and increasing efficiency of assessments. According to the report, NAS reviewers were impressed with the changes being instituted in the IRIS Program since 2014, including substantive reforms by new IRIS Program leadership, such as the development, implementation, and use of systematic review methods to conduct IRIS assessments. For EPA to sustain the rating for the monitoring criterion, the agency will need to provide clear milestones and metrics for its action plan and monitor progress toward them.
Demonstrated progress: partially met. EPA provided a list of chemicals in the December 2018 IRIS Program Outlook. However, it is not clear what data and priorities EPA used to establish its current priorities or when it will assign time frames and future resources to ensure sustained performance. For example, according to the 2015 IRIS Multi-Year Agenda, the formaldehyde assessment was being revised to incorporate elements of systematic review and was to be released for public comment and external peer review. However, the December 2018 IRIS Program Outlook does not list the formaldehyde assessment and provides no explanation of why the assessment was not included. The IRIS Program issued an assessment of Hexahydro-1,3,5-trinitro-1,3,5-triazine (RDX) in August 2018, although it took almost 2 decades.
Toxic Substances Control Act (TSCA)
Since our 2017 High-Risk Report, ratings for capacity, monitoring, and demonstrated progress progressed to partially met. The rating for leadership commitment remains unchanged at met and for action plan at partially met.
Leadership commitment: met. In January 2019, the Acting Administrator indicated his commitment to fulfill EPA obligations under TSCA. He stated that EPA had, among other things, released guidance and policy on confidential business information, a strategy to reduce animal testing, and a final mercury reporting rule. In addition, EPA's First Year Implementation Plan identified actions taken to meet the deadlines in the new law, such as (1) identifying the initial 10 work plan chemicals to be assessed under TSCA, (2) establishing a process and criteria for identifying high-priority chemicals for risk evaluation under TSCA, and (3) issuing a rule that establishes EPA’s process for evaluating risks from high-priority chemicals under TSCA.
Further, as of December 2018, EPA had implemented two of our recommendations made in 2013 regarding TSCA. As we elaborate in our March 2019 chemical assessments report, EPA has encountered some challenges in implementing the Lautenberg Act and as of mid-February 2019, several lawsuits were pending. In our chemical assessments report, we discuss, for example, EPA's capacity to implement the program, collect appropriate fees, and demonstrate progress. How EPA addresses these matters will be key to continuing to meet the leadership criterion in the future.
Capacity: partially met. The Lautenberg Act provides EPA with greater authority to address chemical risks, but in turn increases both EPA’s responsibility for regulating chemicals and its workload. EPA recently issued a rule under the act to collect fees from certain companies to defray a portion of TSCA implementation costs, but it is unclear whether the fees collected will be sufficient to support relevant parts of the program. According to EPA, the agency will be tracking its costs and use that information to adjust future fees, if appropriate. As required by law, EPA will evaluate and readjust, if necessary, the fees every 3 years.
Action plan: partially met. EPA’s strategic plan discusses general approaches for meeting statutory requirements and mandatory deadlines of TSCA. EPA issued a First Year Implementation Plan in June 2016 noting that this document is intended to be a roadmap of major activities EPA will focus on during the initial year of implementation. As of mid-February 2019, the plan had not been updated, although EPA had indicated that the plan would be further developed over time.
Monitoring: partially met. The Lautenberg Act provided EPA with significant new authorities to regulate chemicals, but EPA's full implementation will take many years. EPA has partially met the criterion for monitoring because it is too soon to determine whether EPA’s approach to managing chemicals within the new TSCA authorities will position the agency to achieve its goal of ensuring the safety of chemicals. We will continue to monitor TSCA as the agency implements this important legislation.
Demonstrated progress: partially met. As our chemical assessments report describes, EPA has responded to many of the new provisions in the Lautenberg Act. For example, EPA has issued rules governing the prioritization and conduct of chemical assessments under TSCA. In addition, EPA told us about efforts to engage EPA offices in a variety of ways to obtain information necessary to conduct risk evaluations and to leverage the expertise and experience of experts within the agency. However, EPA did not provide us with documentation that these activities have occurred. Moreover, EPA has additional Lautenberg Act requirements to address in the years ahead.
Integrated Risk Information System (IRIS)
Since we added the IRIS Program to our High-Risk List in 2009, we have made nine recommendations related to the IRIS segment of this high-risk issue. As of mid-February 2019, six recommendations remain open. EPA will need to implement these recommendations, along with meeting the High-Risk criteria discussed above, to make progress. As noted in several of our recommendations, EPA should, among other things:
- Assess the feasibility and appropriateness of the established time frames for each step in the IRIS assessment process, including whether different time frames should be established for different types of IRIS assessments.
- Publish IRIS agendas on which chemicals EPA is actively assessing and when it plans to start assessments of the other listed chemicals to demonstrate progress.
Develop a strategy to address the needs of EPA Program Offices and regions when IRIS toxicity assessments are not available.
In addition, our March 2019 chemical assessments report provides information on what remains to be done to address challenges, (e.g. producing assessments) in the IRIS Program.
Congressional Action Needed
EPA and Congress should continue to ensure that the resources dedicated to IRIS are sufficient to implement it and to maintain a viable database of chemical assessments.
Toxic Substances Control Act (TSCA)
Since we added TSCA implementation to our High-Risk List in 2009, we have made three recommendations related to this high-risk issue. EPA will need to implement one open recommendation, along with meeting the high-risk criteria discussed above, to make progress. As noted in several criteria above, EPA needs to maintain leadership commitment and ensure that it has the resources and plans in place to facilitate progress. For example, for the demonstrated progress criterion, EPA will need to respond to provisions in the Lautenberg Act, such as having 20 ongoing risk evaluations by December 2019 and making findings on the safety of all new chemicals. In addition, our March 2019 chemical assessments report discusses what remains to be done to address challenges (e.g. process improvements) in implementing the Lautenberg Act.
Congressional Actions Needed
EPA and Congress should consider ensuring that the resources dedicated to TSCA activities are sufficient to implement TSCA reform activities.
GAO-19-270: Published: Mar 4, 2019. Publicly Released: Mar 4, 2019.
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GAO-16-111R: Published: Oct 9, 2015. Publicly Released: Oct 9, 2015.
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GAO-13-369: Published: May 10, 2013. Publicly Released: Jun 10, 2013.
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GAO-13-249: Published: Mar 22, 2013. Publicly Released: Apr 29, 2013.
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GAO-12-41: Published: Dec 9, 2011. Publicly Released: Dec 9, 2011.
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GAO-08-440: Published: Mar 7, 2008. Publicly Released: Apr 29, 2008.
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