OMB proposes to harmonize risk assessments
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 5 years ago (Environ. Sci. Technol. 2003, 37, 365A–368A).
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.