Transforming EPA's Process for Assessing and Controlling Toxic Chemicals
The Environmental Protection Agency’s (EPA) ability to effectively implement its mission of protecting public health and the environment is critically 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, 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 as a government program in need of broad-based transformation. The Frank R. Lautenberg Chemical Safety for the 21st Century Act, enacted on June 22, 2016, provides EPA with greater authority to address chemical risks, but implementing it will take time.
EPA has again met the criteria for leadership commitment, and its former administrator and top leadership publicly stated their focus on improving the IRIS program and implementing the 2016 TSCA reform legislation through its TSCA program. The agency has begun to align people and resources to address the current and future workload of these programs. For the IRIS program, EPA has partially met the criteria for capacity, an improvement over its previous rating, in part because it issued an IRIS Multi-Year Agenda in December 2015 that focused on the need for IRIS assessments over the next few years. EPA has again not met the criteria for capacity for its TSCA program, and with new TSCA authority, it is unclear if EPA has the people and resources to implement the new law. Overall, EPA needs to continue to determine for both the IRIS and TSCA programs if it has 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 reform activities. EPA has partially met the criteria for having a corrective action plan by issuing an IRIS Multi-Year Agenda. EPA has also partially met the criteria for having a corrective action plan by increasing its efforts to obtain chemical toxicity and exposure data, initiating chemical risk assessments, and reviewing certain new uses of chemicals, but it is too early to tell whether these actions will reduce chemical risks. EPA needs to continue to implement the TSCA reform legislation and define how it will implement corrective actions to assess and control toxic chemicals.
EPA has now met the criteria for monitoring the IRIS program by finalizing the IRIS Multi-Year Agenda and other actions, including continuing to submit IRIS assessments for independent review to entities with scientific and technical credibility. EPA has not met the criteria for monitoring the TSCA program; to help ensure that the resources dedicated to TSCA are sufficient for effectively implementing the new law, EPA needs to institute a program to monitor and independently validate the effectiveness and sustainability of its initiative to use the new TSCA authorities. For the IRIS program, EPA has now partially met the criteria for demonstrated progress by, among other things, issuing five IRIS assessments since fiscal year 2015—as of January 19, 2017—and making three assessments available for public comment in fiscal year 2016 in preparation for an external peer review meeting associated with that particular assessment. For the TSCA program, EPA has not met the criteria for demonstrated progress. Both the IRIS and TSCA programs need to continue to implement corrective actions to resolve this complex high-risk area.
Passing the Frank R. Lautenberg Chemical Safety for the 21st Century Act may facilitate EPA’s effort to improve its processes for assessing and controlling toxic chemicals in the years ahead. The new law provides EPA with greater authority and the ability to take actions that could help EPA implement its mission of protecting human health and the environment. Continued leadership commitment from EPA officials and Congress will be needed to fully implement reforms. Additional work will also be needed to issue a workload analysis to demonstrate capacity, complete a corrective action plan, and demonstrate progress implementing the new legislation.
Integrated Risk Information System
- We recommended that EPA periodically assess the level of resources that should be dedicated to the Integrated Risk Information System (IRIS) program to meet user needs and maintain a viable database. EPA determined the types of IRIS assessments to conduct, based on the needs of EPA’s Program Offices and other users, as reported in the IRIS Multi-Year Agenda and in deliberative documents provided to us in October 2016. However, EPA has not established a schedule for regularly revisiting its assessment of resource needs to ensure that priorities are consistent with user needs over time.
- We recommended two actions about EPA’s time frames for IRIS assessments. First, we recommended that EPA 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. Second, should different time frames be necessary, we recommended that EPA establish a written policy that clearly describes the applicability of the time frames for each type of IRIS assessment to provide greater predictability to stakeholders. In July 2013, EPA issued what the agency described as enhancements to the IRIS process to address, in part, these priority recommendations. EPA developed two sets of timelines for the IRIS assessment process and provided us with details about them and its online chemical information tracking system; however, EPA needs to determine whether different time frames should be established.
- We recommended three actions encouraging transparency about the status of planned and ongoing IRIS assessments. First, we recommended that EPA indicate in published IRIS agendas which chemicals it is actively assessing and when it plans to start assessments of the other listed chemicals. Second, we recommended that EPA update the IRIS Substance Assessment Tracking System (IRISTrack) including projected and actual start dates and other information, and to keep this information current. Third, we recommended that EPA publish the IRIS agenda in the Federal Register on an annual basis. In October 2016, EPA officials told us that they believed they had met the intent of these recommendations by publishing an IRIS Multi-Year Agenda in December 2015. However, EPA still needs to provide current and accurate information on chemicals that the agency plans to assess through the IRIS program for IRIS users on an annual basis. The Multi-Year Agenda does not identify projected start dates for new assessments, and therefore is not ensuring that current and accurate information on chemicals that EPA plans to assess through IRIS is available to IRIS users. Using the Federal Register to communicate these plans offers greater transparency to the public about the IRIS process than other forms of communication.
- We recommended that EPA develop a strategy to address the needs of its Program Offices and regions when IRIS toxicity assessments are not available. Officials from select EPA offices stated that, in the absence of agency-wide guidance, they used a variety of sources, other than IRIS toxicity assessments to meet their needs, including toxicity information from other EPA offices, or other state or federal agencies. IRIS program officials also stated that there is no agency-wide mechanism for EPA to ensure that chemicals without sufficient scientific data during one nomination period will have such information by subsequent nomination periods. We recognize that the development of EPA’s Multi-Year Agenda, issued in December 2015, was a productive effort that EPA told us included an extensive evaluation of user needs. However, the agency does not have a strategy for addressing data gaps or have assurance that its efforts will be sustainable over time. EPA needs to address this priority recommendation by developing: (1) an agency-wide strategy that addresses coordination across EPA offices and with other federal research agencies to help identify and fill data gaps that preclude the agency from conducting IRIS toxicity assessments, and (2) guidance that describes alternative sources of toxicity information and when it would be appropriate to use them when IRIS values are not available, applicable, or current.
Toxic Substances Control Act
After many years of congressional committees considering legislation aimed at reforming the Toxic Substances Control Act (TSCA), in June 2016, Congress passed and the President signed the Frank R. Lautenberg Chemical Safety for the 21st Century Act, which gave EPA greater authority to improve its processes for assessing and controlling toxic chemicals. EPA and Congress need to continue to ensure that the resources dedicated to TSCA activities are sufficient to effectively implement the new law.
- We made three priority recommendations to address challenges EPA has faced obtaining toxicity and exposure data, banning or limiting the use of chemicals, and identifying resource needs. First, we recommended that EPA issue a rule to obtain toxicity and exposure data that chemical companies have submitted to the European Chemicals Agency. Second, we recommended that EPA issue a rule to obtain exposure-related data from processors. Third, we recommended that EPA develop strategies for addressing challenges associated with obtaining these data, banning or limiting the use of chemicals, and identifying resource needs. Because EPA has used its authority to limit or ban only five chemicals since TSCA was originally enacted in 1976, in part, because it believed it didn’t have enough information, we made these recommendations to address these concerns. The Frank R. Lautenberg Chemical Safety for the 21st Century Act, enacted on June 22, 2016, provides EPA with greater authority to address chemical risks, but implementing it will take time.
With the implementation of the Frank R. Lautenberg Chemical Safety for the 21st Century Act, we believe EPA can make progress on these open recommendations. The act substantially revises TSCA and requires EPA to carry out numerous rulemaking and other activities within the next 2 years. In early 2016, we started a review of the TSCA program. With the passage of TSCA reform, we decided to suspend our review and give EPA time to implement the new law. In October 2016, as part of our recommendation follow-up process, we reviewed information on the new TSCA provisions. EPA officials told us that with new TSCA authority, the agency is better positioned to take action to require chemical companies to report chemical toxicity and exposure data. The new law authorizes EPA to order companies to develop new information relating to a chemical as necessary for prioritization and risk evaluation. This authority may help EPA to gather new information, as necessary, to evaluate hazard and exposure risks. TSCA reform legislation offers promise for EPA implementation of our recommendations and bringing the agency closer to achieving its goal of ensuring the safety of chemicals.
 GAO, Chemical Assessments: Low Productivity and New Interagency Review Process Limit the Usefulness and Credibility of EPA’s Integrated Risk Information System, GAO-08-440 (Washington D.C: Mar. 7, 2008).
 GAO, Chemical Assessments: Challenges Remain with EPA’s Integrated Risk Information System Program, GAO-12-42 (Washington, D.C.: Dec. 9, 2011).
 GAO, Chemical Assessments: An Agencywide Strategy May Help EPA Address Unmet Needs for Integrated Risk Information System Assessments, GAO-13-369 (Washington, D.C.: May 10, 2013).
 GAO, Toxic Substances: EPA Has Increased Efforts to Assess and Control Chemicals but Could Strengthen Its Approach, GAO-13-249 (Washington, D.C.: Mar. 22, 2013).
GAO-16-111R: Published: Oct 9, 2015. Publicly Released: Oct 9, 2015.
The foreign programs GAO reviewed—Canada’s Chemicals Management Plan (CMP), Australia’s Inventory Multi-tiered Assessment and Prioritisation (IMAP) framework, and the World Health Organization’s (WHO) International Agency for Research on Cancer (IARC) Monographs Programme and International Programme on Chemical Safety (IPCS)—assess the human health risks of chemicals using similar analyt...
GAO-14-763: Published: Sep 29, 2014. Publicly Released: Oct 29, 2014.
The federal agencies GAO reviewed—the Agency for Toxic Substances and Disease Registry (ATSDR), the Environmental Protection Agency (EPA), the National Institute for Occupational Safety and Health (NIOSH), the National Toxicology Program (NTP), and the Occupational Safety and Health Administration (OSHA)—undertake distinct chemical toxicity assessment activities that differ in type and purpose...
GAO-13-696T: Published: Jun 13, 2013. Publicly Released: Jun 13, 2013.
GAO reported in June 2005 that EPA has historically faced the following challenges in implementing the provisions of the Toxic Substances Control Act (TSCA):Obtaining adequate information on chemical toxicity and exposure. EPA has found it difficult to obtain such information because TSCA does not require companies to provide it; instead, TSCA requires EPA to demonstrate that chemicals pose certai...
GAO-13-369: Published: May 10, 2013. Publicly Released: Jun 10, 2013.
The Environmental Protection Agency (EPA) has not conducted a recent evaluation of demand for Integrated Risk Information System (IRIS) toxicity assessments with input from users inside and outside EPA. Specifically, 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, GAO did not find su...
GAO-13-249: Published: Mar 22, 2013. Publicly Released: Apr 29, 2013.
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...
GAO-12-42: Published: Dec 9, 2011. Publicly Released: Jan 9, 2012.
EPA's May 2009 revisions to the IRIS process have restored EPA's control of the process, increased its transparency, and established a new 23-month time frame for its less challenging assessments. Notably, EPA has addressed concerns GAO raised in its March 2008 report and now makes the determination of when to move an assessment to external peer review and issuance--decisions that were made by the...
GAO-08-440: Published: Mar 7, 2008. Publicly Released: Apr 29, 2008.
The Environmental Protection Agency's (EPA) Integrated Risk Information System (IRIS) contains EPA's scientific position on the potential human health effects of exposure to more than 540 chemicals. IRIS is a critical component of EPA's capacity to support scientifically sound environmental decisions, policies, and regulations. GAO was asked to examine (1) the outcome of steps EPA has taken to ens...