Transforming EPA's Process for Assessing and Controlling Toxic Chemicals

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Since our 2019 High-Risk Report, four criteria remain unchanged. However, the rating for monitoring decreased from partially met to not met in 2021. Furthermore, ratings for three criteria in the Integrated Risk Information System (IRIS) Program and four criteria in the Toxic Substances Control Act (TSCA) segments declined.

Integrated Risk Information System (IRIS)

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Since 2019, ratings for capacity and action plan remain unchanged, as partially met. However, ratings for leadership commitment, monitoring, and demonstrated progress declined to not met.

Leadership commitment: not met. This rating declined from partially met in 2019. We reported in March 2019 that the Environmental Protection Agency (EPA) Administrator had not identified the IRIS Program as among his top priorities for the agency. Furthermore, the Administrator’s congressional budget justification for fiscal year 2021 proposed a 34 percent ($12.7 million) cut to the Health and Environmental Risk Assessment area’s budget, approximately half of which is the IRIS Program’s budget. This is the fourth year in a row that the Administrator has proposed such a reduction. Although Congress in prior years directed that funding remain at fiscal year 2017 enacted levels, the Administrator’s proposed budget cut contributed to the decline in rating for leadership to not met.

Additionally, EPA’s agency-wide strategic plan for fiscal years 2018 through 2022 does not mention the IRIS Program. Although the strategic plan has a section focused on human health risk assessments, it does not explain how the IRIS Program’s work supports EPA’s goals of protecting human health and the environment.

In our December 2020 report, we found that EPA would benefit from increasing transparency about the IRIS Program’s processes and work. For example, EPA did not publicly explain continued delays in chemical assessment production, and program and regional offices’ processes for nominating chemicals for assessment lacked transparency and structure. We recommended that EPA provide more information publicly about where chemical assessments are in the development process, internal and external steps in the process, and changes to assessment milestones.

Capacity: partially met. According to officials, EPA’s workforce has remained fairly stable since 2018 but the agency could not provide us with documents indicating any workforce planning or analysis. Although the workforce remained stable, in December 2018 EPA decreased the number of assessments the IRIS Program was working on from 22 to 13 (two more assessments were started in 2019 bringing the total to 15 ongoing assessments as of December 2020). EPA did not indicate why there was a reduction in the number of assessments in development. In addition, EPA has not made public any information about the program’s current or future resource capacity for meeting EPA-wide needs for chemical assessments.

Action plan: partially met. We reported in December 2020 that EPA has a draft strategic research action plan for the Health and Environmental Risk Assessment National Research Area, of which the IRIS Program is a part. Although this plan does not address our May 2013 recommendation that EPA develop an agency-wide strategy to address unmet needs internally and to coordinate externally, it calls for coordinating the work of several Office of Research and Development (ORD) programs—including IRIS—that produce chemical assessments. Planning for such coordination of the various assessments ORD produces is encouraging, but reviews of the plan found that it lacks important details.

For example, it did not include an implementation strategy or metrics to define progress or mention the resources the IRIS Program needs to produce chemical assessments to meet user needs. EPA neither provided an update about the plan’s status nor information on the agency’s plans for implementation.

Monitoring: not met. This rating declined from met for two reasons. First, as we reported in December 2020, despite a decline in participation in the assessment nomination process from 2018 to 2019, EPA has not assessed whether this survey is achieving its intended purpose and is generating quality information. While EPA reported that it gathered feedback from its senior leadership about the nomination process, it did not have information on how feedback informed future monitoring efforts. Second, ORD’s advisory committee review of the Health and Environmental Risk Assessment strategic research action plan found that the plan did not include an implementation strategy or metrics to define progress and allow for monitoring.

To make progress in this area, EPA needs to include implementation steps in its strategic plan, define clear metrics for assessing program progress in meeting objectives, and show that it is monitoring the IRIS Program as a whole as well as continuing to assess specific activities—such as the survey—to ensure they are achieving stated objectives.

Demonstrated progress: not met. The IRIS Program’s objective is to issue chemical assessments for use in EPA’s risk evaluation and management activities. However, the program did not issue any completed assessments between August 2018 and December 2020. We also found that since December 2018, the IRIS Program had publicly released nine supporting documents for ongoing chemical assessments—primarily documents that indicate how assessments will be developed—but few chemical assessments had progressed through the assessment development process.

For example, two assessments completed peer review in February 2019—the fourth of seven steps in the assessment development process—but have yet to be finalized and released publicly as of December 2020. For most chemical assessments the program is developing, projected milestone dates have been delayed at least a quarter.

EPA told us that changes in IRIS assessment schedules are typically due to the scientific complexities of each assessment and availability of staff with the appropriate expertise. However, EPA did not identify the scientific complexities associated with any specific assessment or explain why it did not anticipate and resolve these unspecified complexities.

Toxic Substances Control Act (TSCA)

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Since our 2019 High-Risk Report, ratings for demonstrated progress remained unchanged. However, ratings for leadership commitment declined from met to partially met; ratings for capacity, action plan, and monitoring declined from partially met to not met.

Leadership commitment: partially met. TSCA remains an agency priority as noted in testimony by the Administrator and in the most recent budget request. The EPA budget request for fiscal year 2021 includes an increase of $8.5 million for TSCA implementation and $4 million for TSCA records digitization. But in May 2020, the Administrator stated that EPA would not meet its deadlines for releasing the first 10 chemical risk evaluations; EPA stated that it would complete them by the end of 2020. The Administrator also stated in May 2020 that EPA had identified the next 20 high-priority chemicals for risk evaluation and that scoping documents that include information to be included in the risk evaluations, such as the chemical hazards and exposures, would be released in mid-2020.

Capacity: not met. The 2016 Lautenberg Act provided EPA with greater authority to address chemical risks, which consequently increased EPA’s responsibility for regulating chemicals and increased its workload. However, the Office of Pollution Prevention and Toxics (OPPT), which implements TSCA, did not meet statutory deadlines for its first 10 high-priority risk evaluations, according to the EPA Office of the Inspector General’s (OIG) August 2020 report. Furthermore, OIG found that OPPT would be required to produce double the number of risk evaluations by the end of 2022 with only a slight increase in the number of staff.

Additionally, as of December 2020, EPA had not implemented the recommendation we made in 2013 regarding TSCA’s ability to identify resources needed to conduct risk assessments. Specifically, EPA program offices have not identified workforce needs for budget justification purposes since 1987, according to the August 2020 OIG report.

The OIG report also stated that OPPT expected to hire more than 50 staff members in fiscal year 2020 but had not conducted a workforce and workload analysis to demonstrate that, even with 50 additional staff, it would have the capacity to successfully implement the TSCA requirements by the statutory deadlines. Although EPA officials said they are preparing a workforce analysis, they did not provide a draft to us.

In addition to the challenges of meeting existing deadlines, EPA has to incorporate a recent court ruling into its ongoing risk evaluations. Under this ruling, EPA must evaluate the risks associated with the use and disposal of chemicals that are not being, and are not expected to be, manufactured, processed, or distributed—called legacy uses. For example, polychlorinated biphenyls (PCBs) were produced until the late 1970s, when their production was banned in the United States. But older products such as fluorescent lights, caulking, and paints may contain PCBs, and remain a concern for workers and consumers. According to EPA’s OIG, the resulting expansion of the scope of EPA’s risk evaluation process will require the agency to devote more staffing and resources to existing chemical risk evaluations.

Action plan: not met. The TSCA amendments require EPA to publish a plan at the beginning of each calendar year for completing risk evaluations of chemicals already in commerce. The plan must identify (1) risk evaluations to be initiated or completed that year, (2) necessary resources, and (3) an updated schedule for completing risk evaluations.

However, the August 2020 OIG report found that OPPT’s annual plans did not meet the statutory requirement. The plans did not identify steps to complete future work or specify the financial and staff resources needed to initiate or complete the risk evaluations for that year. EPA partially agreed with the OIG’s recommendation to include anticipated implementation efforts and financial and staff resources in its annual reports to Congress, beginning in 2021.

Monitoring: not met. Although OPPT has developed annual performance goals that correspond to EPA’s long-term performance goals, the agency did not provide us with the underlying metrics or information on how they influenced changes to improve performance. The August 2020 OIG report indicates that OPPT has done no workforce or workload planning to ensure it can meet TSCA deadlines. EPA agreed with the OIG’s recommendations to perform a workforce analysis—as mentioned above—and a skills gap analysis.

Demonstrated progress: partially met. EPA took regulatory actions, including finalizing a rule that requires EPA to, for example, review certain new uses of per- and polyfluoroalkyl substances in surface coatings, such as apparel and carpet, before these products can be imported into the U.S.

As required by TSCA, as amended, EPA was due to release its first 10 high-priority risk evaluations in December 2019, but the agency was unable to meet that deadline and required a 6-month extension for all 10 risk evaluations. EPA did not meet the original or extended deadline; they had released nine of 10 risk evaluations by the end of December 2020.

However, EPA did not (1) publicly release scoping documents for its next 20 risk evaluations by the June 2020 deadline, or (2) include in its annual plans updates on its progress in completing the risk evaluations that are due by the end of 2022. And as noted above, a 2019 court ruling will require EPA to revise its risk evaluation process; EPA has not released information about incorporating these changes into its risk evaluations.