Science Magazine (pg. 161), January 13, 2006

MORE DETAILS SOUGHT IN ASSESSING HEALTH RISKS

[Rachel's introduction: New rules proposed for government "risk assessments" may stifle regulation. Toxicologist Jennifer Sass of the Natural Resources Defense Council suggests that scientists won't be able to meet the standards for risks for which there are little underlying data. "I'm concerned that regulations will die at OMB [Office of Management and Budget]" as a result, she says.]

By Jocelyn Kaiser

The Bush Administration this week proposed new federal standards for analyzing health and environmental risks underlying regulations that ask for more details on the evidence that a pollutant causes harm.

Experts agree that the changes should improve the quality of assessments, although one critic worries that the bar would be set so high that it could also slow the pace of new regulations.

The draft bulletin "provides clear, minimum standards for the scientific quality of federal agency risk assessments," says John Graham, the outgoing director of the Office of Management and Budget's (OMB's) Office of Information and Regulatory Affairs. Graham, a former Harvard University professor who in the past 5 years has bolstered the office's influence on agency rulemaking, says the standards should help risk assessments pass scientific review more quickly.

The proposed rules include steps that aren't always routine, such as requiring that agencies weigh both positive and negative studies. The document also asks agencies preparing assessments that could have a major economic or policy impact to look more closely at the uncertainties, including variability in the population and both middle estimates and the range of risks. Some agencies tend to emphasize the high end of risk, says an OMB official. "This is a big change in practice, especially for parts of EPA [the Environmental Protection Agency]," explains the official.

Kimberly Thompson, a risk expert at the Massachusetts Institute of Technology in Cambridge and president-elect of the Society for Risk Analysis, applauds the greater emphasis on quantitative tools. "This basically outlines things agencies should have been doing all along," agrees Granger Morgan of Carnegie Mellon University in Pittsburgh, Pennsylvania, who chairs EPA's scientific advisory board. But toxicologist Jennifer Sass of the Natural Resources Defense Council in Washington, D.C., suggests that scientists won't be able to meet the standards for risks for which there are little underlying data. "I'm concerned that regulations will die at OMB" as a result, she says.

Graham leaves next month to head the Pardee RAND Graduate School in Santa Monica, California. The comment period closes on 15 June, and the proposed bulletin will also be reviewed by the National Academies.

Copyright 2006 American Association for the Advancement of Science