Assessing Risk

Risk assessments compiled by federal agencies would have to meet new, government-wide standards under a Jan. 9 proposal from the White House Office of Management & Budget.

The proposal would affect risk assessments performed for regulation of pollutants, approval of new pharmaceuticals, and development of safety systems for nuclear and chemical plants, liquefied natural gas terminals, and space shuttles, OMB says.

"This [proposed] bulletin provides clear, minimum standards for the scientific quality of federal agency risk assessments," explains John D. Graham, administrator of OMB's Office of Information & Regulatory Affairs. The guidance would require agencies to describe the methods, assumptions, and uncertainties in a risk assessment and to provide a range of risk estimates.

Additional standards, including providing public access to original data used in an analysis, would apply to what OMB terms "influential risk assessments." Examples are risk assessments affecting National Toxicology Program chemical profiles, allowable pesticide residues in foods, and air quality standards.

OMB has asked the National Academy of Sciences to review its proposal and make recommendations for improving it.

Jennifer Sass, senior scientist for the Natural Resources Defense Council, says OMB, the White House's regulatory gatekeeper, could use the guidance to kill proposed health, safety, or environmental rules by finding fault in risk assessments supporting them. Risk assessment shouldn't be held to scientific standards, Sass says, because the field is not a science but relies on "expert judgment, extrapolation, and leaps of faith."

James Solyst, senior director for science policy at the American Chemistry Council, says OMB's proposal "is a good idea," complementing recent directives on peer review and quality of information disseminated by agencies.

OMB plans to finalize the risk assessment standards later this year.