Transforming EPA's Process for Assessing and Controlling Toxic Chemicals

What We Found | What Needs to Be Done | Key Reports

Why It's High Risk

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 toxic 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.

GAO designated transforming EPA's processes for assessing and controlling toxic chemicals as a high risk area in 2009 because EPA has failed to develop sufficient chemical assessment information on the toxicity of many chemicals that may be found in the environment as well as on tens of thousands of chemicals used commercially in the United States. Lacking this information significantly limits the agency's ability to limit public exposure to many chemicals that may pose substantial health risks and fulfill its mission of protecting human health and the environment.

^ Back to topWhat We Found

EPA has failed to develop sufficient chemical assessment information largely because of shortcomings in its Integrated Risk Assessment Information System (IRIS) program and its assessments of industrial chemicals under TSCA.

IRIS. IRIS contains EPA's scientific position on the potential human health effects of exposure to more than 540 chemicals. Toxicity assessments in IRIS constitute the first two critical steps of the risk assessment process and provide the basic information EPA needs to determine whether it should establish controls to protect the public from exposure to toxic chemicals in the air and water and at hazardous waste sites, among other things. However, IRIS is at serious risk of becoming obsolete because EPA has not been able to keep its existing assessments current, complete assessments of the most important chemicals of concern, or decrease its backlog of 70 ongoing assessments. For example, as of December 2007, most of the 70 ongoing IRIS assessments had been in progress for more than 5 years and 17 percent had been in progress for more than 9 years. Some of the IRIS assessments that have been in progress the longest cover key chemicals likely to cause cancer or other significant health effects, including dioxin, formaldehyde, trichloroethylene, and tetrachloroethylene. For example, EPA's formaldehyde and dioxin assessments have been in progress for about 12 and 18 years, respectively.

EPA's efforts to finalize the assessments have been thwarted by a combination of factors, including:

two new OMB-required reviews of IRIS assessments by the Office of Management and Budget (OMB) and other federal agencies;
EPA management decisions, such as delaying some assessments to await new research or analyses; and
the compounding effect of delays—even one delay can have a domino effect, requiring the process to essentially be repeated to incorporate changing science.

Requiring that IRIS assessments be based on the best science available at the time of the assessment is a standard that would best support a goal of completing assessments with reasonable time periods and minimizing the need to conduct significant levels of rework. However, EPA waits for new research on key chemicals rather than relying on the best available scientific data at the time the assessment is conducted—as had been EPA's general approach in the 1990s. This decision can have a significant impact on assessment completion dates, delaying the agency's ability to protect the public from exposure to toxic chemicals.

Further, the two OMB-required reviews, which were not publicly available, were problematic because:

some of the agencies providing input into the assessments are those that may be affected by the assessments should they lead to regulatory or other actions that would place additional requirements on the agencies; and
the reviews lack transparency—a particular credibility concern in light of the involvement of agencies that may be affected by the outcome.

TSCA. EPA's assessments of industrial chemicals under TSCA provide limited information on health and environmental risks. TSCA generally places the burden of obtaining information about the roughly 80,000 chemicals already on the U.S. market on EPA, rather than on the companies that produce the chemicals. The act requires EPA to demonstrate that certain health or environmental risks are likely before it can require companies to further test their chemicals. As a result:

EPA does not routinely assess the risks of the roughly 80,000 industrial chemicals that are already in use in the United States.
For the approximately 700 new chemicals introduced into commerce annually, chemical companies provide EPA with certain information in premanufacture notices, and EPA can ban or limit their use if this information is inadequate.
Although 85 percent of the notices lack any health or safety test data, EPA does not often use its authority to obtain more information.
This approach contrasts with the one taken by the European Union, which generally places the burden on companies to provide data on the chemicals they produce and to address the risks they pose to human health and the environment.

^ Back to topWhat Needs to Be Done

With respect to IRIS, GAO recommended that EPA adopt a streamlined, more transparent assessment process (GAO-08-440). A revised process that EPA subsequently adopted in 2008 did not incorporate these recommendations and actually exacerbated the concerns about productivity and credibility that GAO identified. However, in May 2009, EPA again announced comprehensive reforms to its IRIS assessment process, citing GAO's designation of this program as high risk as well as key conclusions from GAO reports. Overall we believe that, if implemented effectively, these reforms will address GAO's recommendations and provide a sound framework for conducting IRIS assessments and significantly improve the IRIS process. EPA's implementation of the new process will determine whether the agency can overcome its long-standing productivity problems and complete credible and transparent assessments, therefore effective and sustained management and oversight of the IRIS assessment program will be essential, especially given the number of factors that can impede the progress of IRIS assessments.

Congress may wish to amend the Toxic Substances Control Act to provide EPA with explicit authority to (1) require chemical companies to conduct chemical testing, (2) require chemical companies to develop test data based on substantial production volume and the necessity for testing, and (3) authorize EPA to share with the states and foreign governments the confidential business information that chemical companies provide to EPA. On September 29, 2009, EPA announced goals for legislative reform of TSCA as well as plans for a major effort to strengthen EPA's current chemical management program and increase the pace of the agency's efforts to address chemicals that pose a risk to the public. While we have not evaluated these new proposals in detail, they appear to be aimed at seeking the additional authorities that GAO has recommended and at shifting more of the burden to chemical companies to demonstrate the safety of their chemicals. We encourage EPA to continue to work with Congress to effect the legislative changes the agency believes it needs to better protect the public health and to make the regulatory changes within its authority expeditiously.

Highlights of GAO-05-548 (PDF)

^ Back to topKey Reports

EPA Chemical Assessments: Process Reforms Offer the Potential to Address Key Problems: GAO-09-774T, June 11, 2009; Summary (HTML) Highlights Page (PDF) Full Report (PDF, 13 pages) Accessible Text

Biomonitoring: EPA Needs to Coordinate Its Research Strategy and Clarify Its Authority to Obtain Biomonitoring Data: GAO-09-353, April 30, 2009; Summary (HTML) Highlights Page (PDF) Full Report (PDF, 37 pages) Accessible Text Recommendations (HTML)

Chemical Regulation: Options for Enhancing the Effectiveness of the Toxic Substances Control Act: GAO-09-428T, February 26, 2009; Summary (HTML) Highlights Page (PDF) Full Report (PDF, 20 pages) Accessible Text

Chemical Assessments: Low Productivity and New Interagency Review Process Limit the Usefulness and Credibility of EPA's Integrated Risk Information System: GAO-08-440, March 7, 2008; Summary (HTML) Highlights Page (PDF) Full Report (PDF, 89 pages) Accessible Text Recommendations (HTML)

Chemical Regulation: Options Exist to Improve EPA's Ability to Assess Health Risks and Manage Its Chemical Review Program: GAO-05-458, June 13, 2005; Summary (HTML) Highlights Page (PDF) Full Report (PDF, 69 pages) Accessible Text Recommendations (HTML)