Research group finds flaws in proposed risk analysis guidelines

The National Research Council last week rejected a series of administration-proposed guidelines on how agencies should conduct scientific risk assessments, calling the proposals "fundamentally flawed."

Under the new guidelines, floated in January 2006 by the Office of Management and Budget, scientific agencies would for the first time have been subject to uniform rules on how to carry out risk analysis. The new guidelines would have shifted agencies' focus from estimates based on conservative projections and high-risk populations to data on "central" scenarios that would apply to more people, among other changes.

The National Research Council committee reviewing the guidelines recommended that OMB withdraw the proposed rules. Members unanimously agreed that the new rules would not enhance the quality and objectivity of federal risk analysis. The council, which is administered by the National Academy of Sciences, the National Academy of Engineering and the Institute of Medicine, provides scientific advice to the federal government.

An OMB spokeswoman said in light of the review, the proposal would not be adopted.

"OMB will use the [National Academy of Sciences] review, the public comments, and the information we have learned from the interagency review process, to develop improved guidance for increasing the quality and objectivity of risk assessments," the spokeswoman said.

Democrats leading the House committees on Science and Technology, Energy and Commerce, and Oversight and Government Reform welcomed the panel's opinion on the proposed rules.

"OMB's proposed changes to risk assessment analysis would enable agencies like the Environmental Protection Agency to ignore the needs of certain segments of the population such as infants, children, the elderly, low income and minority communities," said Albert Wynn, D-Md., chairman of the Energy and Commerce Subcommittee on Environment and Hazardous Materials. "These are the communities that need the safeguards of environmental laws the most."

In its assessment of the proposed rules, the National Research Council noted that OMB's bulletin was inconsistent with previous risk assessment recommendations and that it sought to set standards beyond the current state of science. "Any attempt to advance the practice of risk assessment that does not reflect the state of science is likely to produce the opposite effect," committee members wrote.

Panelists criticized OMB's focus on efficiency and cost-effectiveness over quality, and called the proposed guidelines problematic, because officials would not necessarily know in advance what the impacts of a particular case might be. They said proposed standards for contextualizing risk in terms of other, better known risks could lead to "meaningless and confusing risk estimates."

The OMB proposal was issued shortly before the departure of John Graham from its Office of Information and Regulatory Affairs. Observers say Graham radically transformed that office, taking it from a little-known center for highly technical analysis to a high-profile player in the federal government's regulatory decision-making process.

Since his resignation in early 2006 to head the Pardee RAND Graduate School, which is affiliated with the RAND Corp. research and policy institute, OMB's regulatory office has been led by an acting official. Susan Dudley went through a nomination hearing in November, but her candidacy did not reach a vote in light of poor support on the Senate Homeland Security and Governmental Affairs Committee.

Last week, the administration renominated Dudley for the post and appointed her as a senior adviser on regulatory policy at OMB, pending completion of the confirmation process.