InsideEPA, a Washington trade publication, reports that criticism from federal agency officials could prevent the Office of Management and Budget from finalizing a bulletin on risk assessments.

On Jan. 9, 2006, the OMB released a draft bulletin governing how agencies perform risk assessments. If enacted, the new standards would create a one-size-fits-all standard, requiring more information and analysis before agencies could act to protect the public.

The Environmental Protection Agency and other federal agencies have been vocal in criticizing OMB's draft bulletin. Now, according to InsideEPA, industry officials are worried this criticism could delay OMB's ability to finalize the bulletin.

EPA Calls Bulletin Burdensome

In comments to the National Academies of Science (NAS), which is charged with peer reviewing the draft bulletin, EPA noted that OMB's bulletin would burden the agency with new analytical requirements and would require the use of assumptions that fail to adequately protect vulnerable populations, according to InsideEPA.

As OMB Watch noted in its comments on the bulletin, the draft bulletin requires that agencies consider expected risks and, therefore, conflicts with laws governing clean air, drinking water and pesticides, which explicitly require EPA to consider the harms imposed on the most susceptible populations, like children or the elderly.

"Discussion of the notion of expected risk, (not a specifically defined term, to our knowledge) in a risk assessment usually involves a particular exposure distribution and relies on a series of judgments about whom we expect to be exposed," according to the EPA comments obtained by InsideEPA.

Department of Labor and Other Agencies Raise Concerns

The Department of Labor (DOL) also commented that the risk assessment bulletin "could add significant time" to risk assessments by the Occupational Safety and Health Administration (OSHA) without improving the usefulness of the assessments, according to the BNA Daily Report for Executives. DOL pointed out that the broad scope of the document could require OSHA and MSHA to perform risk assessments on "non-regulatory informational products" including guidelines for employers and employees to avoid workplace hazards. The Center for Disease Control raised similar concerns.

The draft bulletin could also undermine the scientific integrity of OSHA's risk analysis, DOL said:

To make its determinations of the significance of the risk, OSHA relies on analyses of scientific and statistical information and data that describe the nature of the hazard associated with employee exposures in the workplace, and derive[s] estimates of lifetime risk assuming that employees are exposed to the hazard over their working life (usually taken to be 45 years).

The DOL comments went on to say that OMB's bulletin would require "all plausible assumptions and models be quantitatively evaluated," when possible. According to DOL, this standard could potentially have negative impacts on OSHA's evaluation of risk. "OSHA would prefer that the bulletin make clear that quantitative evaluation of risk be based on those assumptions and models that are clearly consistent with supporting scientific evidence, for example, regarding a chemical agent's mode of action," the comments stated.

The Consumer Product Safety Commission, the Food and Drug Administration, the Department of Transportation, and the Fish and Wildlife Service also raised concerns about the scope of the risk assessment guidelines. As FDA put it in comments, "risk assessment is a tool for addressing public health problems and should be scaled to fit the public health problem at hand." The level of scrutiny required under OMB's bulletin may not always be appropriate.

Risk Assessment Bulletin Puts the Public at Risk

As OMB Watch pointed out in comments submitted to OMB last month, if enacted, the risk assessment bulletin would so burden risk assessment and other risk-related determinations that agencies would wind up paralyzed, unable to establish a case for protecting the public.

Broad scope would drown agencies in analysis. The bulletin uses a definition of "risk assessment" that sweeps in a much broader universe of agency information than has ever been contemplated by any standard, widely accepted definition. In fact, the definition of risk assessment is so broad that it would include a large number of activities that would never normally be considered risk assessments, including heat and hurricane advisories from the National Weather Service and food preparation notifications provided by the Department of Agriculture.

"Expected" risk estimates ignores harms to most vulnerable populations. The bulletin also requires agencies to not only investigate how a particular harm would impact the most vulnerable individuals but also to determine the "expected" risk. The bulletin requires risk ranges, central estimates and efforts to downplay worst-case scenarios, and population-wide risk estimates, even though many risk management decisions require point estimates of risks to individuals in worst-case scenarios. These approaches are in some cases contradictory to the risk assessment approaches outlined in law. For instance, the Resource Conservation and Recovery Act specifically require that EPA consider the individuals most highly exposed to harm when setting standards.

In fact, preliminary analysis conducted by Reps. Bart Gordon (D-TN), John Dingell (D-MI), Henry Waxman (D-CA) and James Oberstar (D-MN) found that "the analytical approach mandated in [the bulletin] represents a significant departure from approaches contained in the many statutes governing health, safety, and the environment, and from statutory direction to federal agencies to protect human health, safety, and the environment." The representatives determined that the bulletin conflicts with statutory mandates including separation of cost-benefit analysis and risk analysis, and noted that Congress has traditionally guided agencies individually in their risk assessment practices.

Agencies must act in fact of uncertainty. OMB's approach to risk assessment demands that agencies identify all potential sources of harm when conducting risk assessments. In many cases, this would be an incredibly time-consuming task that would delay agency actions to prevent harm to the public, as adverse effects could be attributed to myriad different sources. The proposed bulletin would deprive agencies of the discretion to determine the best approach to risk assessments given the particular circumstances involved, such as the urgency for agency action. But the subject matter in risk assessments also varies widely between agencies, and what is the best approach to risk assessments for one agency may not be the best approach for another.

A free pass to industry. In contrast to the extensive requirements for agency risk assessment activities, the proposed bulletin gives a free pass to assessments used in characterizing risk on product labels if the label is required to be approved by a federal agency. This is despite the fact that such risk assessments are among the most in need of guidelines to ensure quality and objectivity. In many cases, the risk assessments used by agencies in approving labeling for a product are conducted or sponsored by the manufacturer of the product. Manufacturers clearly have an incentive to downplay the harm associated with their product, and a number of studies reveal bias in manufacturer assessments. This giveaway to manufacturers undermines the purpose and objectivity of the proposed bulletin.