On the heels of the Union of Concerned Scientistsâ report on political interference with EPA scientists, the Government Accountability Office reports that the White House Office of Management and Budget is taking a major and non-transparent role in EPA toxic chemical assessments.
At issue is theÂ agency’sÂ Integrated Risk Information System (IRIS), which contains EPAâs scientific position on the potential human health effects of chemicals. There are 540 chemicals in the system now, but the process of adding them has slowed in recent years, and now thereâs a backlog of 70 chemicals. This slowdown has serious consequences, because IRIS assessments inform federal environmental standards and many environmental protection programs at the local, state, and even international level. NRDCâs Jennifer Sass notes that the IRIS database received an average of roughly 600 requests a day this month.
The GAO cites multiple reasons for the slowdown, including the growing complexity and scope of risk assessments, but the âinteragency review processâ requested and managed by the OMB is at the top of the list of problems. In this process, agencies that might be affected by the assessments get a chance to provide comments and questions to EPA. The GAO explains why OMB instituted this policy in the first place:
This process, initially conducted on an ad hoc basis, was put in place in response to interagency conflicts that EPA faced when it attempted to finalize some IRIS assessments for chemicals that became highly controversial, such as perchlorate, naphthalene, and TCEâchemicals that are or have been considered by some federal agencies, including DOD, DOE, and NASA, to be integral to their missions. Notably, EPAâs IRIS assessments of these chemicals could lead to regulatory actions that could, among other things, restrict the use of these chemicals, require agencies to provide protective gear to their employees exposed to the chemicals at work, or require agencies or their contractors to carry out or pay for cleanup of contamination at federal sites. The interagency conflicts about these IRIS assessments have contributed to their delaysâresulting, for example, in EPA having to essentially restart the naphthalene assessment after it had been drafted and peer reviewed.
Theoretically, EPA could just ignore the comments from agencies concerned about potential cleanup and worker-protection costs, though, right? Evidently not. The GAO reports that OMB and other non-agency staff can have a lot of influence in the process â even more than EPA scientists themselves:
Under the OMB/interagency review process for IRIS assessments, OMB identifies the federal agencies from which it will seek comments on the assessments and provides comments and questions to EPA from OMB and the other federal agencies. EPA then revises the assessments to address the comments and questions and also provides OMB with a document discussing how it has addressed each of the issues raised. According to EPA officials, this step is concluded when OMB verbally informs EPA that all of the issues are resolved. Thus, before EPA can provide its draft assessments to external peer reviewers, EPA, OMB, and the other federal agencies must reach agreement on (1) EPAâs revised IRIS assessment and (2) the scope of the external peer review, including specific questions reviewers will be asked.
The OMB reviews have primarily been conducted by a policy analyst in the Office of Information and Regulatory Affairs who, according to OMB officials, has a toxicology background and is qualified to conduct these reviews. If EPA does not agree with some of the proposed changes or peer review requirements, OMB officials said the assessment could be elevated to higher management levels within EPA for resolution. Thus, the framework of the OMB/interagency review process can essentially give more weight to OMB and the other federal agencies than to EPA chemical managers who have prepared the assessments and the many scientists and experts who have peer reviewed them. Further, in commenting on OMBâs proposed risk assessment bulletin in 2007, the National Academies stated its concern that scientific issues may be superseded by policy considerations to the extent that the technical aspects of risk assessments would be overseen by OMB and not by the peer review process or by agency technical managers. Similarly, an EPA official noted that the farther removed the scientists and experts who have prepared or peer reviewed the assessments are from the negotiations and decisions over assessment changes requested by OMB and other federal agencies, the decisions are based more on political rather than scientific considerations.
When concerns about this kind of bias arise, one way to address them is through transparency. Thatâs not part of this interagency review plan, though:
In addition to adding time to the IRIS assessment process, the OMB/interagency review process also affects the credibility of assessments primarily because the review process lacks transparency. According to EPAâs Risk Characterization Policy and Handbook, the risk assessment processâwhich includes the hazard identification and dose-response analysis that constitutes IRIS assessmentsâshould be transparent and its products should be clear, consistent, and reasonable. Transparency is particularly important in cases such as this when potentially affected parties are providing input into, and in some cases questioning, EPAâs scientific analyses supporting its IRIS assessments. Specifically, a transparent process allowing IRIS users and the public to see the comments from OMB and other federal agenciesâincluding those potentially impacted by the IRIS assessmentsâas well as EPAâs responses to them, could help alleviate concerns about potential bias in the assessments. However, under the OMB/interagency review process managed by OMB, the comments EPA receives from OMB and other federal agencies and EPAâs responses to them are not available to the public. OMB does not authorize their disclosure to the public on the basis that these communications are internal deliberations of the executive branch. Overall, because the rationale for changes to EPAâs scientific assessments stemming from OMB and the interagency review process are not disclosed, the credibility of the IRIS assessments is reduced. We note that the former Assistant Administrator for the Office of Research and Development has emphasized the importance of transparency in the IRIS assessment process. Specifically, he stated that the best cure for controversy surrounding IRIS assessments âis early and frequent visits to the experts, second opinions, and lots of sunshineâ (that is, transparency).
The Senate Environment and Public Works Committee held a hearing earlier today about EPA chemical policies, which should bring some attention to this issue. The best we can hope for may be the next administrationâs OMB removing these hurdles and letting the EPA fulfill its duty of informing lawmakers and the public about the risks chemicals pose to human health.