Toxic Substances:

EPA Has Increased Efforts to Assess and Control Chemicals but Could Strengthen Its Approach

GAO-13-249: Published: Mar 22, 2013. Publicly Released: Apr 29, 2013.

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What GAO Found

Since 2009, the Environmental Protection Agency (EPA) has made progress implementing its new approach to managing toxic chemicals under its existing Toxic Substances Control Act (TSCA) authority; particularly by increasing efforts to obtain chemical toxicity and exposure data and initiating chemical risk assessments--which EPA uses, along with other information, to decide what regulatory or other actions, if any, are warranted. 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. Also, EPA has not pursued some opportunities to obtain chemical data that companies submit to foreign governments or to obtain data from chemical processors that prepare chemical substances after their manufacture for distribution in commerce--some of which could help support the agency's risk assessment activities. Of the 83 chemicals EPA has prioritized for risk assessment, it initiated 7 assessments in 2012 and plans to start 18 additional assessments in 2013 and 2014. However, it may take several years to complete these initial risk assessments and, at the agency's current pace, over a decade to complete all 83, especially as EPA does not have the toxicity and exposure data needed for 58 of the 83 chemicals prioritized for risk assessment. 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.

It is unclear whether EPA's new approach to managing chemicals within its existing TSCA authorities will position the agency to achieve its goal of ensuring the safety of chemicals. EPA officials said that the agency's new 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. Specifically, 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 new 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 new approach. Without a plan that incorporates leading strategic planning practices, EPA cannot be assured that its new 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.

Why GAO Did This Study

In 1976, Congress passed TSCA to provide EPA with the authority to obtain more information on chemicals and to regulate those chemicals that EPA determines pose unreasonable risks of injury to human health or the environment. GAO has 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. Of the thousands of chemicals listed for commercial use in the United States, EPA has used its authority to limit or ban five chemicals since TSCA was enacted. In 2009, EPA announced TSCA reform principles to inform ongoing efforts in Congress to strengthen the act. At that time, EPA also initiated a new approach for managing toxic chemicals with the goal of ensuring the safety of chemicals using its existing authorities.

GAO was asked to evaluate EPA's efforts to strengthen its management of chemicals. This report determines the extent to which (1) EPA has made progress implementing its new approach and (2) EPA's new approach positions it to achieve its goal of ensuring the safety of chemicals. GAO examined agency documents and TSCA rulemaking and interviewed agency officials and stakeholders from industry and environmental organizations.

What GAO Recommends

GAO recommends, among other things, that EPA develop strategies that address challenges impeding its ability to ensure chemical safety and identify the resources needed to so. EPA neither agreed nor disagreed with GAO’s recommendations.

For more information, contact David Trimble at (202) 512-3841 or trimbled@gao.gov.

Recommendations for Executive Action

  1. Status: Closed - Implemented

    Priority recommendation

    Comments: As of December 2018, this recommendation has been closed as implemented. Congress amended the Toxic Substances Control Act TSCA (TSCA) of 1976 by passing the Frank R. Lautenberg Chemical Safety for the 21st Century Act in 2016, in ways that fundamentally changed and expanded EPA's approach to domestic chemicals management, including authorizing EPA to review existing and new chemicals. According to EPA, the significant revisions to TSCA have allowed the agency to impose new mandates to prioritize and conduct risk evaluations on existing chemicals according to prescribed timeframes. The significant new requirements and timeframes for assessing new and existing chemicals under sections 5 and 6, the new authority to obtain toxicity and exposure-related data under section 4, and existing authorities under sections 8 and 11, each on their own and together, better position EPA to ensure chemical safety. In addition, according to EPA, as a result of TSCA reform legislation, EPA has used their expanded authority to require chemical companies to report chemical toxicity and exposure-related data they have submitted to the European Chemicals Agency. According to EPA, as of June 2018 the agency had been successful in obtaining toxicity data (equivalent to or surpassing) that was submitted to the European Chemicals Agency. In 2017, EPA identified toxicity data that had been submitted to the European Chemicals Agency for 1 of the first 10 chemicals undergoing risk evaluation under TSCA and initiated discussion with the United States manufacturer of the chemical. EPA told us that there was readily available information for the other 9 chemicals undergoing risk evaluation. However, full study reports were not available from the European Chemicals Agency--which EPA needs in order to evaluate their reliability and relevance. According to EPA, despite not being the data owner for CI Pigment Violet 29, the manufacturer worked with the overseas data owners and ultimately arranged for the full study reports on the toxicity tests to be submitted to EPA.

    Recommendation: To better position EPA to collect chemical toxicity and exposure-related data and ensure chemical safety under existing TSCA authority, while balancing its workload, the Administrator of EPA should consider promulgating a rule under TSCA section 8, or take action under another section, as appropriate, to require chemical companies to report chemical toxicity and exposure-related data they have submitted to the European Chemicals Agency.

    Agency Affected: Environmental Protection Agency

  2. Status: Closed - Implemented

    Priority recommendation

    Comments: As of December 2018, this recommendation has been closed as implemented. Congress amended the Toxic Substances Control Act TSCA (TSCA) of 1976 by passing the Frank R. Lautenberg Chemical Safety for the 21st Century Act in 2016, in ways that fundamentally changed and expanded EPA's approach to domestic chemicals management, including authorizing EPA to review existing and new chemicals. According to EPA, the significant revisions to TSCA have allowed the agency to finalize a section 8 rulemaking to collect data, including exposure-related data, from certain processors. According to EPA, processors may come from a wide range of sectors and consist of a variety of entities. EPA told us that any requests for processor data using the section 8 authority should be tailored to the appropriate and applicable processing activities. According to EPA, in 2017 and 2018, EPA requested and collected toxicity and exposure-related data for the first 10 chemicals to undergo risk evaluations under TSCA. As a part of this process, EPA indicated that the agency conducted outreach meetings with processors, as well as with chemical manufacturers and users. These meetings, as well as literature searches for relevant data and information and public comments submitted on chemical use dossiers and scope documents, resulted in exposure-related data focused on the conditions of use that EPA has identified as subject to the risk evaluations (including processing and use). According to EPA, the agency does not anticipate the need to use section 8 or other statutory authorities to collect exposure-related data for the first 10 risk evaluations under amended TSCA. In addition, according to EPA, TSCA section 6(b)(2)(D) requires that EPA give preference to chemicals on EPA's 2014 TSCA Work Plan when prioritizing chemicals for risk evaluation in the future. EPA told us they are also encouraging the submission of exposure-related data for these chemicals by opening dockets for each of the chemicals on the 2014 Work Plan, thereby providing a repository for chemical manufacturers, processors, users, or any other person, to provide exposure-related data to EPA.

    Recommendation: To better position EPA to collect chemical toxicity and exposure-related data and ensure chemical safety under existing TSCA authority, while balancing its workload, the Administrator of EPA should consider promulgating a rule under TSCA section 8, or take action under another section, as appropriate, to require chemical companies to report exposure-related data from processors to EPA.

    Agency Affected: Environmental Protection Agency

  3. Status: Open

    Priority recommendation

    Comments: As of December 2018, while there have been fundamental changes in EPA's approach to chemicals management, this recommendation remains open. Specifically, Congress amended the Toxic Substances Control Act TSCA (TSCA) of 1976 by passing the Frank R. Lautenberg Chemical Safety for the 21st Century Act in 2016 in ways that fundamentally changed and expanded EPA's approach to domestic chemicals management, including authorizing EPA to review existing and new chemicals. According to EPA, in carrying out the statutory requirements for conducting risk evaluations for chemicals, the Office of Chemical Safety and Pollution Prevention (OSCPP) (the EPA office that oversees the TSCA program) has engaged other EPA offices in a variety of ways to obtain information necessary to conduct risk evaluations and to leverage expertise and experience of other experts within EPA. In addition, according to EPA, OCSPP has implemented other ways of addressing challenges associated with the following, which were identified in our original recommendation: (1) obtaining toxicity and exposure data needed to conduct ongoing and future TSCA Work Plan risk assessments for existing chemicals; (2) gaining access to toxicity and exposure data provided to the European Chemicals Agency; (3) working with processors and processor associations to obtain exposure-related data; (4) banning or limiting the use of chemicals under section 6 of TSCA; and (5) identifying the resources needed to conduct risk assessments and implement risk management decisions in order to meet its goal of ensuring chemical safety. Although EPA officials believe that our 2013 findings and recommendations regarding impediments to the agency's ability to assess and control toxic chemicals under the previous statute have less relevance now than they did when issued, we have ongoing concerns about the sufficiency of resources to implement TSCA, as amended. In our report, we noted that many of the challenges EPA faced were rooted in TSCA's regulatory framework, and that we had previously suggested that Congress consider making statutory changes. Until such changes were made, we recommended that EPA take certain actions, but the statute has now been amended. EPA's implementation of the new law will determine whether this recommendation can be closed. We remain particularly concerned that EPA has not demonstrated a commitment to identify resources needed to conduct risk assessments and implement risk management decisions. The Lautenberg Act increased EPA's responsibility for regulating chemicals and in turn, its workload. Partially due to the increased workload, some EPA officials told us they have concerns about staff capacity. Staff in the office that implements TSCA said they do not have sufficient resources to do their work. This office is also drawing on the staff of other EPA offices such as the IRIS Program in order to meet deadlines. EPA recently used authority under the Lautenberg Act to finalize a rule collecting fees from companies, but EPA officials are uncertain how much the fees rule will generate the first year, though they believe that over the course of a few years, the amount of money generated should stabilize.

    Recommendation: To better position EPA to collect chemical toxicity and exposure-related data and ensure chemical safety under existing TSCA authority, while balancing its workload, and to better position EPA to ensure chemical safety under existing TSCA authority, the Administrator of EPA should direct the appropriate offices to develop strategies for addressing challenges that impede the agency's ability to meet its goal of ensuring chemical safety. At a minimum, the strategies should address challenges associated with: (1) obtaining toxicity and exposure data needed to conduct ongoing and future TSCA Work Plan risk assessments, (2) gaining access to toxicity and exposure data provided to the European Chemicals Agency, (3) working with processors and processor associations to obtain exposure-related data, (4) banning or limiting the use of chemicals under section 6 of TSCA and planned actions for overcoming these challenges--including a description of other actions the agency plans to pursue in lieu of banning or limiting the use of chemicals, and (5) identifying the resources needed to conduct risk assessments and implement risk management decisions in order to meet its goal of ensuring chemical safety.

    Agency Affected: Environmental Protection Agency

 

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