NOTE: The following is one of a series of case studies produced by the Union of Concerned Scientists' Scientific Integrity Program between 2004 and 2010 to document the abuses highlighted in our 2004 report, Scientific Integrity in Policy Making.
UPDATE: On May 21, 2009, EPA Administrator Lisa Jackson announced changes to the IRIS review process, overturning much of the Bush administration process which gave other federal agencies with conflicts of interest greater control over the database.
EPA's Toxicology Database
The Environmental Protection Agency (EPA) established the Integrated Risk Information System (IRIS) in 1985 as a single source of information on human health risks related to chemical exposure. IRIS integrates in-house research from EPA scientists, peer review by outside experts, and input and comments from the public. The database currently contains analyses of 540 chemicals, including the highly hazardous vinyl chloride, butadiene, benzene, lead, mercury, and asbestos. IRIS is a compilation of the best available science on hazardous chemicals and is not in itself a regulatory body. However, IRIS forms the basis for standards set by states, the EPA, and foreign governments for safe drinking water, air emissions, and toxic waste cleanups.
Consequences for Public Health
Despite its importance to public health, IRIS is becoming inaccurate and obsolete. Only four IRIS assessments have been completed in the past two years, and a backlog of 70 potentially harmful chemicals currently awaits assessment. To name just one example of how a weak IRIS jeopardizes public health, Hurricane Katrina survivors living in FEMA-issued trailers are at risk of death or severe illness from high levels of formaldehyde. The EPA began updating the IRIS listing of formaldehyde in 1997 to include mounting scientific evidence of greater health risks, and has still not finished a decade later.
Flawed Review Process
The EPA's review process is hampered by new policies that allow polluting agencies (such as the Department of Defense (DOD), Department of Energy, and NASA) multiple opportunities to influence IRIS listings or demand unreasonable degrees of scientific certainty before a listing can move forward. This review system can cause chemicals to remain stuck in the IRIS review process for upwards of six years, as the Government Accountability Office (GAO) found.
The GAO assessed the IRIS review process in the March 2008 report entitled "Low Productivity and New Interagency Review Process Limit the Usefulness and Credibility of EPA's Integrated Risk Information System" (pdf). The report evaluated the EPA's efforts to keep IRIS current and credible, address its backlog of chemical assessments, and respond to new requirements by the White House Office of Management and Budget (OMB), as well as the potential effects of the EPA's planned changes to the IRIS review process. The GAO report found that new OMB-required reviews, conducted by the OMB itself and by other agencies, compromise the efficiency and credibility of IRIS.
Decisions Behind Closed Doors
Not only do these reviews create time lags in the assessment process, they lack the openness needed for an independent scientific process. The OMB considers other agencies' comments during the process to be internal executive branch documents which can be kept secret. The GAO report emphasized the need for transparency, especially regarding comments from polluting agencies whose operations could be affected by regulations based on IRIS listings
In light of IRIS's problems and the EPA's failure to address them, the GAO report concluded that the new IRIS procedures would sacrifice public trust in open government, compromise scientific credibility, and delay or derail the public release of robust scientific assessments needed by governments to set health-protective limits for hazardous chemicals. Moreover, the GAO concluded that "given the importance of the IRIS program to EPA's ability to protect public health and the environment, Congress should consider requiring EPA to suspend its new process?"
Examples of Chemical Assessments
The GAO report included several examples of chemicals whose IRIS assessments were subject to interference by the EPA's political appointees, the DOD, or the OMB. They include:
- Naphthalene. Six years after initiating the IRIS review, the EPA has not finalized its assessment of naphthalene, a component of jet fuel that may be cancer-causing. After repeated objections from the OMB and the DOD, the EPA has sent the assessment back to the drafting stage.
- Royal Demolition Explosives (RDX). At the request of the DOD, the EPA delayed its review of RDX, a chemical used in munitions that leaches into groundwater. The DOD requested that their own research be included in the assessment, but some of that research has yet to be completed.
- Trichloroethylene. TCE, a solvent used as a degreasing agent linked to childhood cancer and birth defects, 7 is one of the most common contaminants of superfund sites. The IRIS draft was initiated in 1998, and in 2001 the EPA said TCE was 'highly likely' to cause cancer, specifically noting added health risks for exposure to children. Ten years later, the assessment is back at the draft stage.
Congress Speaks Out
The Senate Environment and Public Works Committee, under the leadership of Senator Barbara Boxer (D-CA), is scrutinizing the IRIS rules changes. In an April committee hearing, Senator Boxer outlined White House interference in the risk assessments of TCE, naphthalene, and formaldehyde. Boxer also referenced an unnamed EPA scientist with extensive knowledge of the IRIS program who told committee staff that "de facto, EPA can't go forward" on risk assessment without White House, DOD, and other agency signoff, and that resulting delays could have "significant impact on public health" as exposures to toxic chemicals "continue unabated." Boxer said that "the role of independent scientists at EPA must be restored, so that EPA can carry out its mission without secret interference" and called for a strengthening of toxics laws to protect public health.
Members of the House are also determined not to let IRIS fail. In a May 21 oversight hearing of a House panel, Subcommittee Chairman Brad Miller (D-NC) pushed for greater transparency and scientific integrity in the IRIS review process. Miller asked, "If the science appears to have been reworked behind closed doors to protect the interests of polluters, who can believe the science?"
Political Interference in IRIS
Political interference in the IRIS review process follows a trend of political appointees distorting EPA science on topics ranging from mercury pollution and climate change, to fine particulate matter in our air. We depend on our government to use the best available science to protect our health, safety, and environment. The IRIS review process should be revised to fulfill its original mission of honestly assessing the health risks of hazardous chemicals, regardless of political expediency.