Key Issues > High Risk > Transforming EPA's Process for Assessing and Controlling Toxic Chemicals
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Transforming EPA's Process for Assessing and Controlling Toxic Chemicals

This information appears as published in the 2013 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 and is authorized under TSCA to obtain information on the risks of chemicals and to control those it 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, GAO added this issue to the High Risk List in 2009.

IRIS. 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 March 2008, GAO reported that the viability of the IRIS program was at risk because EPA had been unable to keep its existing assessments current, decrease its ongoing assessments workload to a manageable level, or complete assessments of the most important chemicals of concern. For example, of the 70 assessments that were in progress as of December 1, 2007, 48 had been in progress for more than 5 years, and 12 of those for more than 9 years. A factor that contributed to EPA’s inability to complete IRIS assessments in a timely manner was a new interagency review process that limited EPA’s control over the IRIS assessment process. In response to GAO’s 2008 report and 2009 high-risk designation, EPA revised its IRIS assessment process in May 2009. In December 2011, GAO reported that EPA’s May 2009 revisions to the IRIS process restored EPA’s control of the process, increased transparency, and established a 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 Office of Management and Budget (OMB) under the prior IRIS process. In addition, EPA has increased the transparency of the IRIS process by making comments provided by other federal agencies during the interagency science consultation and discussion steps of the IRIS process available to the public.

Progress in other areas, however, has been limited. EPA’s initial gains in productivity under the May 2009 process have not been sustained. After completing 16 assessments within the first year and a half of implementing the revised process, EPA completed 4 assessments in fiscal year 2011, and 4 in fiscal year 2012. Further, the increase in productivity does not appear to be entirely attributable to the revised IRIS assessment process and instead came largely from (1) clearing the backlog of IRIS assessments that had undergone work under the previous IRIS process and (2) issuing assessments that were less challenging to complete. In addition, 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 users of IRIS information, such as EPA program offices, on 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. GAO is currently reviewing EPA’s efforts to evaluate demand for IRIS toxicity assessments and its approach for addressing any unmet users’ needs.

TSCA. EPA has found it difficult to regulate chemicals under TSCA. 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—that is, 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. In contrast to the approach taken by the European Union—which generally places the burden on companies to provide data on the chemicals they produce on the risks they pose to human health and the environment—TSCA generally places the burden on EPA to obtain such information. For example, before EPA can require companies to test chemicals and provide EPA with the resulting toxicity and exposure information, TSCA requires EPA to demonstrate that certain health or environmental risks are likely. Consequently, EPA’s reviews of approximately 1,000 new chemicals annually provide limited assurance that health and environmental risks are identified before they are introduced into commerce. Concerning the 80,000 chemicals previously introduced into commerce, EPA has not routinely assessed the risks of these chemicals and does not know how many are still in commerce. 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.

The EPA Administrator has expressed support for TSCA reforms and developed principles for addressing them. In parallel with the announcement of these principles, in 2009 EPA also initiated a new approach to managing chemicals within the limits of existing authorities. Under this approach, according to agency documents, EPA will use more proactive action-oriented approach obtaining toxicity and exposure data and ensuring chemical safety. GAO is currently reviewing EPA’s effort and the agency’s progress.

With regard to EPA’s IRIS program, the agency must demonstrate the ability to routinely complete timely, credible IRIS assessments. This will involve developing and achieving, over a sustained period of time, productivity goals for addressing its current backlog of assessments, routinely starting new assessments, and updating existing assessments. EPA must also fully address issues concerning the clarity and transparency of its development and presentation of draft IRIS assessments as well as issues regarding the availability and accuracy of current information to users of IRIS information on the status of IRIS assessments.

With regard to TSCA, EPA must demonstrate progress toward fully utilizing its existing authorities under the act to obtain the toxicity and exposure information, including information available from foreign governments, and take the necessary actions to regulate chemicals that pose an unreasonable risk to human health or the environment. In addition, EPA must identify and work with Congress to facilitate legislative changes needed to provide the agency with sufficient authority to effectively assess and control toxic chemicals, including the specific authorities and program requirements necessary for EPA to overcome limitations in it existing TSCA authorities.

Looking for our recommendations? Click on any report to find each associated recommendation and its current implementation status.

Chemical Assessments:

Challenges Remain with EPA's Integrated Risk Information System Program
GAO-12-42:
Published: Dec 9, 2011. Publicly Released: Jan 9, 2012.

High-Risk Series:

An Update
GAO-11-278:
Published: Feb 16, 2011. Publicly Released: Feb 16, 2011.

Chemical Regulation:

Observations on Improving the Toxic Substances Control Act
GAO-10-292T:
Published: Dec 2, 2009. Publicly Released: Dec 2, 2009.

EPA Chemical Assessments:

Process Reforms Offer the Potential to Address Key Problems
GAO-09-774T:
Published: Jun 11, 2009. Publicly Released: Jun 11, 2009.

Chemical Regulation:

Options for Enhancing the Effectiveness of the Toxic Substances Control Act
GAO-09-428T:
Published: Feb 26, 2009. Publicly Released: Feb 26, 2009.

High-Risk Series:

An Update
GAO-09-271:
Published: Jan 22, 2009. Publicly Released: Jan 22, 2009.

Toxic Chemicals:

EPA's New Assessment Process Will Increase Challenges EPA Faces in Evaluating and Regulating Chemicals
GAO-08-743T:
Published: Apr 29, 2008. Publicly Released: Apr 29, 2008.

Chemical Assessments:

  • portrait of Alfredo Gomez
    • Alfredo Gomez
    • Director, Natural Resources and Energy
    • gomezj@gao.gov
    • (202) 512-384