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Winter/Spring 2007 Vol. 7 No. 1

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©Stephanie Carter/IMAGEZOO Back to the Drawing Board

Proposal to Standardize Risk Assessments Should Be Pulled

A White House Office of Management and Budget draft bulletin proposing new technical standards for federal risk assessments should be withdrawn, according to a National Research Council committee.

Risk assessments, which gauge the threat posed by such things as exposure to a chemical or the potential failure of a nuclear power plant, underpin many federal regulations. OMB issued the draft bulletin in January last year and soon after requested that the Research Council review the document. The bulletin's stated goal was to improve the quality and objectivity of federal risk assessments, but the review committee said that the bulletin was "fundamentally flawed" and would not meet this goal if implemented.

"We began our review figuring that we would only be recommending modifications to the bulletin, but the more we dug into it, the more we realized it should be withdrawn altogether," said committee chair John F. Ahearne, director of the ethics program at Sigma Xi, The Scientific Research Society, Research Triangle Park, N.C.

In particular, the bulletin's new definition of risk assessment was too broad -- "one size does not fit all" when it comes to risk assessments, the committee said -- and many of the document's proposals were inconsistent with past expert recommendations on risk assessments.

OMB also erred by focusing too heavily on human health risk assessments and neglecting assessments of technology and engineered structures, critical to agencies like NASA. Too little attention also is paid to the importance of risk communication and to the risks faced by sensitive populations such as children and pregnant women. And the bulletin's definition of an adverse health effect implies that only clinically apparent effects should be considered adverse, ignoring a fundamental public health tenet to control exposures before they cause functional impairment.

The committee also criticized OMB for not having established a baseline of each agency's proficiency at conducting risk assessments, making it difficult to measure the success of any changes to current practice. Nor was the cost of implementing the bulletin estimated, even though it would likely be significant.

The committee agreed with OMB that there is room for improvement in federal risk assessments. It recommended that after further study of agency practices and needs, OMB should issue a new type of bulletin with goals and general principles for risk assessments, but the development of technical guidelines to meet those goals and principles be left to the agencies.

Following release of the committee's review, an OMB spokesperson said that the bulletin would not be finalized in its current form.
  -- Bill Kearney

Scientific Review of the Proposed Risk Assessment Bulletin from the Office of Management and Budget. Committee to Review the OMB Risk Assessment Bulletin, Board on Environmental Studies and Toxicology, Division on Earth and Life Studies (2007, approx. 324 pp.; ISBN 0-309-10477-7; available from the National Academies Press, tel. 1-800-624-6242; $62.75 plus $4.50 shipping for single copies).

The committee was chaired by John F. Ahearne, director, ethics program, Sigma Xi, The Scientific Research Society, Research Triangle Park, N.C. The study was funded by the U.S. Environmental Protection Agency; U.S. departments of Agriculture, Defense, Energy, Health and Human Services, and Labor; and NASA.

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Copyright 2007 by the National Academy of Sciences