> Policy News -February 15, 2006 > > OMB proposals aim to harmonize federal risk assessments > New proposals urge federal risk assessors to move away from worst-case > scenarios. > > On January 9, the White House Office of Management and Budget (OMB) > released a draft bulletin outlining, for the first time, proposals on > how federal regulatory agencies should assess the likelihood and > severity of risks before they issue rules, policies, or > recommendations. > > The draft proposals would apply to many controversial U.S. EPA risk > assessments, such as the reference dose for the rocket-fuel > contaminant perchlorate and national air quality standards. The new > guidelines would also encompass EPA's Integrated Risk Information > System data and the U.S. Food and Drug Administration's tolerances for > food contaminants. > > The bulletin's proposals specify that independent analysts must be > able to reproduce government assessments with the same data and > models. The changes would also place more emphasis on scientific > uncertainty and genetic variability and intensify the focus on > "middle" estimates of risk-the most likely scenario for most > people-rather than a worst-case scenario for small numbers of people. > For low-dose-chemical risks, the bulletin asks federal agencies to > make a stronger case that an actual adverse effect is observed and not > just a subtle marker of exposure. > > The bulletin focuses on the technical aspects of risk assessment, > rather than risk management or risk communication. OMB plans to > finalize the guidelines later this year after a National Academy of > Sciences review and public comment period, which ends on June 15. > > The proposals follow new guidelines for peer review, data quality, and > cost-benefit analyses of regulations, which have been put forth since > well-known risk assessment expert John Graham became the administrator > of OMB's Office of Information and Regulatory Affairs five years ago. > > Public-health interest groups and advocates of government efficiency > call this draft bulletin "significant". Former OMB official Jim Tozzi, > who is now president of the conservative policy analysis group Center > for Regulatory Effectiveness, says that the bulletin's recommendation > will make it harder for agencies to make risks sound scarier than they > really are. "Agencies will have to compare the risk they assess to a > risk that is familiar to most people," he says. "[That] reduces an > agency's flexibility to pick and choose to suit their agenda." > > But regulatory analyst Robert Shull with the liberal group OMB Watch > calls the bulletin troubling. "It is also the latest element in a > sequence of policy changes designed to undermine protective policies > by shifting attention away from polluters and onto the regulatory > protections themselves," he says. > > Experts also note that the bulletin defines "an adverse effect" as > implying "some functional impairment or pathologic lesion that affects > the performance of the whole organism or reduces an organism's ability > to withstand or respond to additional environmental challenges." This > significantly affects a determination crucial in risk analysis, says > Harvard Center for Risk Analysis director James Hammitt. "Reference > doses and other limits are often set on the 'most conservative' [i.e., > smallest] dose that shows an 'adverse effect' in laboratory animals," > he points out. "So defining what measurable effects count as adverse > can be very important." > > But Andrew Maier, the assistant director for the nonprofit group > Toxicology Excellence for Risk Assessment, says that this is an > ongoing problem for all risk assessments. "We are getting better at > understanding the biology, but that doesn't make it easier to > understand the risk. Often, it is not as simple as, 'Yes, it does > cause an adverse effect' or 'No, it doesn't,'" he says. > > Maier notes that most of the bulletin is consistent with evolving best > practices in risk assessment, which present risk numbers along with > upper and lower bounds. He adds that such an assessment is > "intellectually honest" but that what's missing is guidance on how > risk managers should use the range or interpret the number. > > -REBECCA RENNER http://pubs.acs.org/subscribe/journals/esthag-w/2006/feb/policy/rr_OMBproposals.html