By Lynn L. Bergeson and Carla N. Hutton
 
On May 16, 2023, the U.S. Government Accountability Office (GAO) released publicly a report on its priority open recommendations for the U.S. Environmental Protection Agency (EPA). GAO’s priority recommendations include three in the area of “assessing and controlling toxic chemicals.” According to GAO, EPA’s ability to protect effectively public health and the environment depends on credible and timely assessments of the risks posed by toxic chemicals, including per- and polyfluoroalkyl substances (PFAS). GAO states that implementing the following three priority recommendations in this area, such as by establishing an ongoing process to assess the resources required to complete successfully Integrated Risk Information System (IRIS) chemical assessments, would improve EPA’s ability to prepare and issue the assessments:

• To develop the timely chemical risk information that EPA needs to conduct its mission effectively, the EPA Administrator should require the Office of Research and Development (ORD) to reevaluate its draft proposed changes to the IRIS assessment process in light of the issues raised in the 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. According to GAO, as of February 2023, officials from ORD’s Chemical and Pollutant Assessment Division (CPAD) had conducted an analysis of the resources needed to produce chemical assessments, including IRIS assessments and Provisional Peer-Reviewed Toxicity Values. The analysis concluded by noting that CPAD is under-resourced and expects to experience a continued increase in its workload in coming years, thereby worsening the gap between what EPA offices need and what CPAD is able to produce. GAO states that CPAD’s analysis did not identify specific metrics for assessing the effectiveness of EPA’s staff recruitment and retention strategies or whether current resource allocations are helping CPAD meet the targets established in various EPA strategic action plans. GAO will keep the recommendation open until CPAD updates its analysis to include more specific metrics, which will help EPA determine the effectiveness of its recruitment and retention strategies.
   
• To ensure better the credibility of IRIS assessments by enhancing their timeliness and certainty, the EPA Administrator should require ORD to establish a written policy that clearly describes the applicability of the timeframes for each type of IRIS assessment and ensures that the timeframes are realistic and provide greater predictability to stakeholders. According to GAO, as of March 2023, EPA officials were considering ways to provide additional documentation to help stakeholders better understand the timeframes for completing IRIS assessments. GAO “encourage[s] EPA to provide its program offices with documentation of how long it takes to complete each of these different types of assessments to reduce uncertainty for stakeholders with significant interests in IRIS assessments.”
   
• The EPA Administrator 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. GAO states that it will keep this recommendation open until CPAD updates its analysis to include such specific metrics and more information is available for GAO to determine the extent to which EPA management has used CPAD’s analysis to balance its workload with available resources. This would ensure EPA and CPAD can better identify and meet user needs.

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By Lynn L. Bergeson and Carla N. Hutton
 
On April 20, 2023, the U.S. Government Accountability Office (GAO) issued its updated High Risk List, which highlights 37 areas across the federal government that are vulnerable to waste, fraud, abuse, and mismanagement, or that need broad reform. The High Risk List includes “Transforming EPA’s Process for Assessing and Controlling Toxic Chemicals.” GAO states that the U.S. Environmental Protection Agency’s (EPA) ability to implement its mission of protecting public health and the environment effectively depends on its assessing the risks posed by chemicals in commerce and those that have yet to enter commerce in a credible and timely manner. EPA supports the evaluation of such risks through its Integrated Risk Information System (IRIS) and by implementing the Toxic Substances Control Act (TSCA). According to GAO, because EPA had not developed sufficient chemical assessment and risk information under these programs to limit exposure to many chemicals that may pose substantial health risks, GAO added this issue to the High-Risk List in 2009. GAO reports that overall ratings for four criteria -- leadership commitment, capacity, action plan, and demonstrated progress -- remain unchanged since 2021. The overall rating for monitoring increased to partially met. For IRIS, leadership commitment, monitoring, and demonstrated progress increased to partially met. For TSCA, leadership commitment increased to met, and action plan and monitoring increased to partially met. GAO notes that as of February 2023, five recommendations related to the management of toxic chemicals remain open, such as:

• Periodically assessing the demand for chemical assessments and the resources needed to produce IRIS assessments; and
• Developing a process and timeline to ensure EPA’s workforce planning efforts fully align with relevant planning principles and incorporating the results, as appropriate, into EPA’s annual plan for chemical risk evaluations under TSCA. According to GAO, this will help ensure EPA can effectively implement its TSCA review responsibilities. In February 2023, GAO reported that strategic workforce planning is essential in helping agencies align their workforces with their current and emerging missions and that it also helps them develop long-term strategies for recruiting, developing, and retaining staff. More information on GAO’s February 2023 report is available in our February 24, 2023, memorandum.

GAO states that continued congressional oversight of EPA’s workforce planning efforts is needed to help ensure EPA identifies the resources it needs to assess and control toxic chemicals. According to GAO, this area has realized more than ten benefits since it was added to the High-Risk List in 2009, including:

• The IRIS Program increased its coordination with other EPA offices and external federal entities. This will help ensure the offices avoid duplicative work on chemical assessments, can assist each other with obtaining chemical data, and use many of the same chemical evaluation tools and techniques for greater consistency in final products; and
• The Office of Pollution Prevention and Toxics (OPPT) completed a skills gap assessment in March 2021 that included hiring targets and anticipated attrition counts for various years. This helped EPA better understand its future workforce needs for implementing TSCA and informed its budget request for fiscal year 2023.

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By Lynn L. Bergeson and Carla N. Hutton
 
On July 8, 2022, the U.S. Government Accountability Office (GAO) publicly released its 2022 update on its priority open recommendations for the U.S. Environmental Protection Agency (EPA). In June 2021, GAO identified 22 priority recommendations for EPA. According to GAO, EPA has since implemented ten of those recommendations by requiring states to report quarterly to EPA on the number of lead service lines in each public water system in the state and providing direction to staff on integrating climate change information into risk assessments at nonfederal Superfund sites, as well as other actions. GAO states that it is not adding any additional priority recommendations this year. The total number of priority recommendations remaining is 12. These recommendations involve the following areas:

• Assessing and controlling toxic chemicals;
• Reducing pollution in the nation’s waters;
• Ensuring cybersecurity at EPA;
• Addressing data and risk communication issues for drinking water and wastewater infrastructure;
• Managing climate change risks; and
• Protecting the nation’s air quality.

According to GAO, EPA’s continued attention to these issues could lead to significant improvements in government operations.
 
Regarding assessing and controlling toxic chemicals, GAO states that EPA’s ability to help protect public health and the environment effectively “depends on credible and timely assessments of risks posed by toxic chemicals,” including per- and polyfluoroalkyl substances (PFAS). According to GAO, by implementing the following four priority recommendations in this area, EPA would improve its ability to prepare and issue Integrated Risk Information System (IRIS) chemical assessments:

• To develop the timely chemical risk information that EPA needs to conduct its mission effectively, the EPA Administrator should require the Office of Research and Development (ORD) to re-evaluate its draft proposed changes to the IRIS assessment process in light of the issues raised in GAO’s 2008 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.”
• To ensure better the credibility of IRIS assessments by enhancing their timeliness and certainty, the EPA Administrator should require ORD to establish a written policy that clearly describes the applicability of the timeframes for each type of IRIS assessment and ensures that the timeframes are realistic and provide greater predictability to stakeholders.
• The EPA Administrator should direct the Assistant Administrator of ORD 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.
• The EPA Administrator 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.

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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on November 30, 2021, the release of the National Academies of Sciences, Engineering, and Medicine’s (NASEM) external peer review report of the Office of Research and Development (ORD) Staff Handbook for Developing Integrated Risk Information System (IRIS) Assessments (IRIS Handbook). EPA states that the IRIS Handbook provides standard operating procedures for staffers developing IRIS assessments and includes systematic review approaches that promote consistency and ensure that contributors understand how the assessment components are developed.
 
The NASEM committee found that the IRIS Handbook “reflects the significant improvements that EPA has made in its IRIS assessment process.” For instance, according to the report, the IRIS Handbook describes the inclusion of “sophisticated, state-of-the-art methods that use systematic evidence maps to summarize literature characteristics for scoping and systematic review methods for hazard identification.” The committee acknowledges that the IRIS program is “clearly helping” to advance the science of systematic review as applied to hazard identification. The report states that the committee “recognizes that EPA faces challenges in implementing many of the methods for the IRIS assessment process and is impressed and encouraged by the progress that the IRIS program has made to date.” The committee suggests that the methods for developing IRIS assessments can serve as a model for other EPA programs implementing systematic review methods.
 
The committee found that the Handbook does not consistently convey the strengths and advances in methodology for the IRIS assessment process in an even and clear manner, however. The report includes the committee’s recommendations to ensure the IRIS Handbook meets its objectives of providing transparency about the IRIS assessment process and providing operational instructions for those conducting the assessments.

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By Lynn L. Bergeson and Carla N. Hutton
 
On March 3, 2021, Representatives Frank Lucas (R-OK), Ranking Member of the House Science, Space, and Technology Committee; Stephanie Bice (R-OK), Ranking Member of the Environment Subcommittee; and Jay Obernolte (R-CA), Ranking Member of the Investigations and Oversight Subcommittee, sent a letter to the U.S. Environmental Protection Agency (EPA) urging EPA to expedite any reevaluation of the Toxic Substances Control Act’s (TSCA) systematic review methods.  As reported in our February 17, 2021, blog item, on February 16, 2021, the National Academies of Sciences, Engineering, and Medicine (National Academies) announced the availability of a report entitled The Use of Systematic Review in EPA’s Toxic Substances Control Act Risk Evaluations.  In its final report, the Committee to Review EPA’s TSCA Systematic Review Guidance Document states that it “was in strong consensus that the processes used by [the Office of Pollution Prevention and Toxics (OPPT)] do not meet the evaluation criteria specified in the Statement of Task (i.e., comprehensive, workable, objective, and transparent).”  EPA published a press release on February 16, 2021, in response to the Committee’s report, announcing that it “will refine its approach to selecting and reviewing the scientific studies that are used to inform” TSCA chemical risk evaluations.  According to the press release, EPA has already begun to develop a TSCA systematic review protocol in collaboration with its Office of Research and Development to incorporate approaches from the Integrated Risk Information System (IRIS) Program.  In their March 4, 2021, press release, the Republicans state that the IRIS Program “has come under fire from Congress and independent reviewers like the National Academies for its inconsistent process, lack of transparency, and failure to complete assessments in a timely fashion.”  The Republicans ask for EPA’s commitment that, “in accordance with congressional intent to operate with flexibility and speed, TSCA does not fully or consistently adopt program processes or procedures implemented by IRIS.”  If EPA incorporates elements developed by the IRIS Program into TSCA, the Republicans “expect the Agency to assess their benefits and impacts thoroughly, while also adhering to the statutorily prescribed deadlines and scientific standards mandated.”

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By Lynn L. Bergeson and Carla N. Hutton
 
On March 2, 2021, the U.S. Government Accountability Office (GAO) published its latest High Risk List, which includes 36 areas across the federal government vulnerable to waste, fraud, abuse, and mismanagement or needing broad-based transformation.  According to GAO, five areas have regressed since 2019, including the U.S. Environmental Protection Agency’s (EPA) process for assessing and controlling toxic chemicals.  GAO’s report, High-Risk Series: Dedicated Leadership Needed to Address Limited Progress in Most High-Risk Areas, states that this high-risk area declined in the monitoring criterion from a partially met rating in 2019 to a not met rating in 2021; three criteria in each of the two segments declined to a not met rating in 2021.  GAO notes that the Integrated Risk Information System (IRIS) Program did not issue a completed chemical assessment between August 2018 and December 2020, and EPA (1) did not indicate how it was monitoring its assessment nomination process to ensure it was generating quality information about chemical assessment needs; and (2) lacked implementation steps and resource information in its strategic plan and metrics to define progress in the IRIS Program.  Additionally, according to GAO, EPA’s programs supporting the Toxic Substances Control Act (TSCA) (1) did not complete workforce or workload planning to ensure the agency can meet TSCA deadlines; and (2) did not meet initial statutory deadlines for releasing its first ten chemical risk evaluations.

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By Lynn L. Bergeson and Carla N. Hutton
 
On February 16, 2021, the National Academies of Sciences, Engineering, and Medicine (National Academies) announced the availability of a report entitled The Use of Systematic Review in EPA’s Toxic Substances Control Act Risk Evaluations.  The U.S. Environmental Protection Agency (EPA) requested that the National Academies convene a committee to review EPA’s 2018 guidance document on Application of Systematic Review in TSCA Risk Evaluations and associated materials.  In its final report, the Committee to Review EPA’s Toxic Substances Control Act (TSCA) Systematic Review Guidance Document states that it “was in strong consensus that the processes used by [the Office of Pollution Prevention and Toxics (OPPT)] do not meet the evaluation criteria specified in the Statement of Task (i.e., comprehensive, workable, objective, and transparent).”  The Committee recognizes the “substantial challenges in implementing review methods on the schedule required by” the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act), but concluded that those challenges “have not yet been successfully met.”  The final report includes the following summary of the Committee’s general recommendations:

• OPPT’s approach to systematic review does not adequately meet the state of the practice.  The Committee suggests that OPPT comprehensively reevaluate its approach to systematic review methods, addressing the comments and recommendations provided in Chapter 2 of the final report.
   
• With regard to hazard assessment for human and ecological receptors, the Committee comments that “OPPT should step back from the approach that it has taken and consider components” of the Office of Health Assessment and Translation (OHAT) of the National Toxicology Program, EPA’s Integrated Risk Information System (IRIS), and Navigation Guide methods that could be incorporated directly and specifically into hazard assessment.
   
• The Committee finds that OPPT’s use of systematic review for the evidence streams, for which systematic review has not been previously adapted, “to be particularly unsuccessful.”  The Committee suggests that OPPT elaborate plans for continuing the refinement of methods, ideally in collaboration with internal and external stakeholders.  The Committee also suggests that OPPT evaluate how the existing OHAT, IRIS, and Navigation Guide methods could be modified for the other evidence streams.  In addition, according to the Committee, OPPT should use existing EPA guidance, such as the Guidelines for Human Exposure Assessment, the Guidelines for Ecological Risk Assessment, and the operating procedures for the use of the ECOTOXicology knowledgebase (ECOTOX).  Following these existing guidelines would improve transparency of the assessments.
   
• The Committee recommends that EPA put together a handbook for TSCA review and evidence integration methodology that details the steps in the process.  Throughout the final report, the Committee points to problems of documentation.  The Committee “believes that the effort of developing and publicly vetting a handbook will pay off in the long run by making the process more straightforward, transparent, and easier to follow.”

The final report states that “[t]here is an ongoing cross-sector effort to develop and validate new tools and approaches for exposure, environmental health, and other new areas of application of systematic review,” and the Committee “strongly recommends that OPPT staff engage in these efforts.”  According to the final report, the approaches used for TSCA evaluation “would benefit from the substantial external expertise available,” as well as additional transparency and acceptance by the different stakeholders as these tools are developed.
 
EPA published a press release on February 16, 2021, in response to the Committee’s report, announcing that it “will refine its approach to selecting and reviewing the scientific studies that are used to inform” TSCA chemical risk evaluations.  According to EPA, its “ongoing effort to update its systematic review approach” is also part of its “broader efforts” to review the first ten TSCA risk evaluations.  EPA states that it “is not using, and will not again use, the systematic review approach that was reviewed by the Academies.”  The 2018 Application of Systematic Review document “represented EPA’s practices at that time.”  According to the press release, EPA has already begun to develop a TSCA systematic review protocol in collaboration with its Office of Research and Development to incorporate approaches from the IRIS Program.  EPA “expects to publish and take public comment on a TSCA systematic review protocol that will adopt many of the recommendations in the Academies’ report later this year.”

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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on November 10, 2020, that the Integrated Risk Information System (IRIS) Program released the ORD Staff Handbook for Developing IRIS Assessments (IRIS Handbook) for public comment.  EPA states that the IRIS Handbook provides operating procedures for developing IRIS assessments, including problem formulation approaches and methods for conducting systematic review, dose response analysis, and developing toxicity values.  The IRIS Handbook notes that it does not supersede existing EPA guidance and does not serve as guidance for other EPA programs.  EPA will publish a Federal Register notice announcing the beginning of a 90-day public comment period on the IRIS Handbook and on the draft charge questions for reviewers in advance of a National Academies of Sciences, Engineering, and Medicine (NASEM) peer review.  EPA will summarize comments received and provide them to the committee conducting the peer review.  EPA has posted a pre-publication version of the Federal Register notice.

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By Lynn L. Bergeson, Charles M. Auer, and Carla N. Hutton

On March 27, 2019, the House Science, Space, and Technology Subcommittee on Investigations and Oversight and Subcommittee on Environment held a hearing on “EPA’s IRIS Program:  Reviewing its Progress and Roadblocks Ahead.”  The hearing focused on issues with the U.S. Environmental Protection Agency’s (EPA) Integrated Risk Information System (IRIS) Program, as described in two recent reports issued by the U.S. Government Accountability Office (GAO), Chemical Assessments:  Status of EPA’s Efforts to Produce Assessments and Implement the Toxic Substances Control Act (Chemical Assessments Report) and High-Risk Series:  Substantial Efforts Needed to Achieve Greater Progress on High-Risk Areas (High-Risk Report).  Please see our full memorandum for more information on what transpired at the hearing, including some background and commentary. 

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By Lynn L. Bergeson, Charles M. Auer, and Carla N. Hutton

GAO released on March 6, 2019, a report entitled High-Risk Series:  Substantial Efforts Needed to Achieve Greater Progress on High-Risk Areas.  GAO’s high-risk program identifies government operations with vulnerabilities to fraud, waste, abuse, and mismanagement, or in need of transformation to address economy, efficiency, or effectiveness challenges.  GAO’s report describes the status of high-risk areas and outlines actions necessary to assure further progress.  GAO states that in the two years since its last high-risk report, three areas, including “Transforming EPA’s Process for Assessing and Controlling Toxic Chemicals,” have regressed in their ratings against GAO’s criteria for removal from the High-Risk List.  GAO notes that since adding this area to its High-Risk List in 2009, it has made 12 recommendations to EPA related to the IRIS Program and TSCA.  According to GAO, while EPA has taken steps to manage chemicals that pose risks to human health and the environment, leadership and implementation challenges remain.  More information is available in B&C’s March 8, 2019, memorandum, “EPA’s Process for Assessing and Controlling Toxic Chemicals Remains on GAO’s High-Risk List.”

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