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Transforming EPA's Processes for Assessing and Controlling Toxic Chemicals

This information appears as published in the 2015 High Risk Report.

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The Environmental Protection Agency’s (EPA) ability to effectively implement its mission of protecting public health and the environment is critically dependent on credible and timely assessments of the risks posed by chemicals. 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, the Toxic Substances Control Act (TSCA), and the Clean Air Act. EPA conducts assessments of chemicals under its Integrated Risk Information System (IRIS) Program. EPA is also authorized under TSCA to obtain information on the risks of chemicals and to control those the agency determines pose an unreasonable risk. 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.

Transforming EPA's Process for Assessing and Controlling Toxic Chemicals

EPA has met the criteria for leadership commitment as its Administrator and top leadership have publicly stated their focus on improving the IRIS program and implementing TSCA as it currently exists. However, because the agency has not assessed the current and future workload of people and resources for these programs, EPA may not have the adequate capacity to resolve this high-risk area. EPA needs to work with Congress to ensure that the resources dedicated to IRIS and TSCA activities are sufficient to maintain a viable IRIS database of chemical assessments and effectively implement TSCA. In addition, EPA has partially met the criteria for having a corrective action plan by starting work on an IRIS multiyear plan that will focus on needs for IRIS assessments during the next 5 years, and making progress since 2009 in implementing its new approach to managing toxic chemicals under its existing TSCA authority. However, EPA has not defined how corrective measures will be implemented and needs to continue to work with Congress to facilitate legislative changes that could provide the agency with sufficient authority to assess and control toxic chemicals. EPA has begun to submit IRIS assessments for independent review to an entity with scientific and technical credibility. But to help ensure that resources dedicated to TSCA are sufficient for effective implementation of the law, EPA needs to institute a program to monitor and independently validate the effectiveness and sustainability of its initiative to use existing TSCA authorities.

EPA's Integrated Risk Information System

EPA's Integrated Risk Information System

EPA’s IRIS database is intended to provide the basic information the agency needs to determine whether it should establish controls to, for example, protect the public from exposure to toxic chemicals in the air, in water, and at hazardous waste sites. In July 2013, the new 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. EPA’s top leadership has also demonstrated support for improving the IRIS program by implementing some recommendations from us, the National Academies, and EPA’s Science Advisory Board.

Because EPA has not issued an analysis of the IRIS program’s need for people and resources, it is unclear if the IRIS program has the capacity to address the issues it faces. In addition, EPA has only partially met the criteria for having an action plan to address the issues. Specifically, in May 2013, we reported that EPA had not conducted a recent evaluation of demand for IRIS toxicity assessments with input from users inside and outside EPA. 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, we did not find sufficient support for the estimate. In addition, IRIS program officials recognize that the 2003 estimate does not reflect current conditions. In response to our report, EPA started work on a multiyear IRIS plan in the summer of 2013. According to EPA, the purpose of the chemical multiyear plan is to help schedule IRIS assessments for specific chemicals over the next 5 years. Specifically, the plan will focus on EPA needs for IRIS assessments during the next 5 years and is based primarily on information solicited from EPA Program Offices and Regions. EPA is currently finalizing the multiyear plan. Until EPA finalizes the plan, the agency does not know how many people and resources to dedicate to the IRIS program. Also, until the plan is made public, there is no way for stakeholders to evaluate if the plan defines the root cause and solutions, and provides for substantially completing corrective measures.

While EPA has not finalized the multiyear IRIS plan, it has begun to monitor the IRIS program. Specifically, the program has begun to implement our recommendation to submit assessments for independent review to an entity with scientific and technical credibility—EPA’s Science Advisory Board. Moreover, EPA presented a plan for how the agency will implement the National Academies’ suggestions for improving IRIS assessments in the “roadmap for revision” included in the National Academies’ peer review report on the draft formaldehyde assessment. The National Academies’ most recent report on the IRIS program, issued in May 2014, independently validates some of the corrective measures the IRIS program is implementing.

EPA has not met the criteria for demonstrating progress in having implemented corrective measures and resolving the IRIS Program as a high-risk area. For example, EPA did not issue any IRIS assessments in fiscal year 2014. In addition, the issuance of the multiyear IRIS plan that EPA indicated will include some corrective measures for the program has repeatedly been delayed. EPA initially indicated the plan would be issued in August 2014 and, then the fall of 2014, and as of January 2015, the new expected release date is the end of the second quarter 2015.

Toxic Substances Control Act

Toxic Substances Control Act

We reported that EPA has found much of TSCA difficult to implement—hampering the agency’s ability to obtain certain chemical data or place limits on chemicals. For example, EPA has found it difficult to obtain adequate information on toxicity—that is, the degree to which the chemical is harmful or deadly—and exposure levels—the frequency and duration of contact with the chemical. Without this information, it is difficult for EPA to determine whether a chemical poses an unreasonable risk to human health or the environment and then take any action necessary to regulate such chemicals. TSCA generally places the burden on EPA to obtain data on the risks posed to human health and the environment by the chemicals industry produces. Even when EPA has toxicity and exposure information and determines that chemicals pose an unreasonable risk, the agency has had difficulty banning or placing limits on the production or use of chemicals due to a legal threshold that EPA has found difficult to meet. Consequently, EPA has used its authority to limit or ban the use of only five chemicals since TSCA was enacted in 1976. However, EPA has met the criteria for leadership commitment because of the Administrator’s explicit support for taking action on toxics, including modernizing TSCA. In addition, the EPA Administrator and top leadership have expressed support for implementing TSCA as it currently exists to the maximum extent possible in the near term and have provided views on key concepts that should be reflected in revised TSCA legislation.

Because EPA has not conducted a workload analysis, it is unclear if EPA’s TSCA program has the capacity—people and resources—to resolve the risk to the program. We have reported that EPA has found many provisions of TSCA cumbersome and time consuming to implement. EPA’s TSCA program continues to work on an action plan, but it is unclear if it includes the steps necessary to implement solutions we recommended. Specifically, we reported in March 2013 that since 2009, EPA has made progress implementing its new approach to managing toxic chemicals under its existing TSCA authority—particularly by increasing efforts to obtain chemical toxicity and exposure data and initiating chemical risk assessments. The results of EPA’s data collection activities, in most cases, have yet to be realized, and it may take several years before EPA obtains much of the data it is seeking. Of the 83 chemicals EPA prioritized in 2012 for risk assessment, 4 have been completed as of January 2015. As we previously reported, it may take several years to complete the initial risk assessments and, at the agency’s current pace, more than a decade to complete all 83. In addition to its risk assessment activity, EPA has initiated other actions—such as increasing review of certain new uses of chemicals—that may discourage the use of these chemicals. But, it is too early to tell whether these actions will reduce chemical risks.

The TSCA program does not have mechanisms in place to monitor and independently validate the effectiveness and sustainability of the program. EPA has expressed support for providing technical assistance in support of a bipartisan effort to modernize the 1976 law. A number of bills have been introduced and hearings held, but Congress has not yet passed any legislative changes. In addition, in 2009, the administration outlined core principles to strengthen U.S. chemical management laws and Congress has considered legislative changes to TSCA.

It is too soon to determine whether EPA’s approach to managing chemicals within its existing TSCA authorities will position the agency to achieve its goal of ensuring the safety of chemicals; therefore, EPA has not met the criteria for demonstrated progress. EPA officials said that the agency’s approach, summarized in its 2012 Existing Chemicals Program Strategy, is intended to guide EPA’s efforts to assess and control chemicals in the coming years. However, EPA’s strategy, which largely focuses on describing activities EPA has already begun, does not include leading federal strategic planning practices that could help guide its effort, and does not include corrective measures to resolve the high-risk area.

Integrated Risk Information System. EPA faces both long-standing and new challenges in implementing the IRIS program. First, EPA has not fully addressed recurring issues concerning the clarity and transparency of its development and presentation of draft IRIS assessments. In addition, EPA has not addressed other long-standing issues regarding the availability and accuracy of current information to IRIS users. These issues include EPA program offices, the status of IRIS assessments, including when an assessment will be started, which assessments are ongoing, and when an assessment is projected to be completed. In addition, 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.

Further, EPA needs to work with Congress to ensure that the resources dedicated to IRIS activities are sufficient to maintain a viable IRIS database of chemical assessments that are produced in a timely manner. Specifically, EPA needs to perform a workload analysis to determine the optimal number of staff needed, where they are needed, and what skills they must possess. It also must request funding and prioritize resources to enable EPA to maintain a viable IRIS database of chemical assessments that meets the needs of EPA’s program offices and other stakeholders. EPA is still responding to the National Academies’ suggestions by implementing changes to the way it develops draft IRIS assessments. As EPA demonstrates more progress toward its planned changes, we will continue to monitor its approach.

EPA should continue to use the Science Advisory Board’s Chemical Assessment Advisory Committee and, if needed, more regularly use the independent advisory board for EPA’s Office of Research and Development—the Board of Scientific Counselors—to monitor and independently validate the effectiveness and sustainability of EPA’s IRIS assessment process—including the changes made to the IRIS process in response to the National Academies’ suggestions.

Toxic Substances Control Act. For the past several years, congressional committees have considered legislation aimed at reforming TSCA, but Congress has not passed such legislation. In 2009, EPA announced principles for reforming TSCA to help inform efforts underway in Congress. EPA provided some further views concerning TSCA reform legislation in 2014 in testifying on a discussion draft of a House TSCA reform bill. Supporters of the draft bill testified that it would substantially improve EPA’s ability to protect human health and the environment, and that it would make chemical regulation more efficient and effective. EPA testified that the bill would not have (1) provided for the timely review of chemicals of concern; (2) significantly altered the current TSCA safety standard; or (3) kept the safety determination free of cost considerations. EPA stated that cost should be taken into account in making risk management decisions, but not in making the initial safety determination.

Along with the announcement in 2009 of its principles for reforming TSCA, EPA initiated a new approach to managing chemicals within the limits of existing authorities—which, according to agency documents, will transition the agency from an approach dominated by voluntary data submissions by industry to a more proactive approach. In this approach, EPA would use its data collection and other rulemaking authorities under TSCA to ensure chemical safety. In our 2013 report, we found that EPA had made progress in implementing its new approach, but it was unclear whether this approach would position the agency to achieve its goal of ensuring the safety of chemicals.

EPA and Congress need to ensure that the resources dedicated to TSCA activities are sufficient to effectively implement TSCA. Specifically, EPA needs to assess its current and future TSCA workload; determine the optimal number of staff needed, where they are needed, and what skills they must possess; and request funding and prioritize resources to enable EPA to effectively implement TSCA. EPA needs to institute a program to monitor and independently validate the effectiveness and sustainability of EPA’s initiative to use existing TSCA authorities.

EPA must also demonstrate progress toward fully utilizing existing TSCA authorities, identifying needed legislative changes, and continuing to work with Congress to facilitate these legislative changes to TSCA. For example, as we previously reported, EPA has not provided information on its planned approach to pursuing data submitted to the European Chemicals Agency from U.S. companies, and whether it may include voluntary or regulatory means to pursue such data.

EPA has not defined strategies that address challenges—many of which are rooted in TSCA’s regulatory framework—that may impede EPA’s ability to meet its long-term goal of ensuring chemical safety. Specifically, EPA has not clearly articulated how it will address challenges associated with obtaining toxicity and exposure data needed for risk assessments, and placing limits on or banning chemicals under existing TSCA authorities. In addition, EPA’s strategy does not describe the resources needed to execute its approach. For example, EPA’s strategy does not identify roles and responsibilities of key staff or offices, or identify staffing levels or costs associated with conducting the activities under its approach. As we previously reported, without a plan that incorporates leading strategic planning practices, EPA cannot be assured that its approach to managing chemicals, as described in its Existing Chemicals Program Strategy, will provide a framework to effectively guide its effort. Consequently, EPA could be investing valuable resources, time, and effort without being certain that its efforts will bring the agency closer to achieving its goal of ensuring the safety of chemicals.

In addition, EPA needs to continue to work with Congress to facilitate legislative changes needed to provide the agency with sufficient authority to assess and control toxic chemicals.

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  • portrait of Alfredo Gomez
    • Alfredo Gomez
    • Director, Natural Resources and Energy
    • gomezj@gao.gov
    • (202) 512-3841