White House standards for risk assessment fundamentally flawed.

[Guest guest]

WASHINGTON -- A draft bulletin issued by the White House Office of

Management and Budget prescribing technical standards for federal risk

assessments is " fundamentally flawed " and should be withdrawn, according

to a new National Research Council report.

National Academy of Science press release

Scientific Review of the Proposed Risk Assessment Bulletin from the Office

of Management and Budget

http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=11811

Date: Jan. 11, 2007

Contacts: Bill Kearney, Director of Media Relations

Strikowsky, Media Relations Assistant

Office of News and Public Information

202-334-2138; e-mail <news@...>

FOR IMMEDIATE RELEASE

Report Recommends Withdrawal of OMB Risk Assessment Bulletin

WASHINGTON -- A draft bulletin issued by the White House Office of

Management and Budget prescribing technical standards for federal risk

assessments is " fundamentally flawed " and should be withdrawn, according

to a new National Research Council report.

Risk assessments are often used by the federal government to estimate the

risk the public may face from such things as exposure to a chemical or the

potential failure of an engineered structure, and they underlie many

regulatory decisions. Last January OMB issued the draft bulletin, which

included a new definition of risk assessment and proposed standards aimed

at improving federal risk assessments. OMB also requested that the

Research Council review the bulletin.

" We began our review of the draft bulletin thinking we would only be

recommending changes, but the more we dug into it, the more we realized

that from a scientific and technical standpoint, it should be withdrawn

altogether, " said F. Ahearne, chair of the committee that wrote the

report, and director, ethics program, Sigma Xi, The Scientific Research

Society, Research Triangle Park, N.C.

The committee agreed with OMB that there is room for improvement in

federal risk assessments and that additional guidance would help.

However, it concluded that the bulletin would not accomplish its stated

goal of enhancing the technical quality and objectivity of federal risk

assessments. OMB should instead issue a different type of bulletin that

outlines goals and general principles for risk assessments, but that

directs federal agencies to develop their own technical guidelines to meet

those goals and principles. " The new bulletin should draw on the risk

assessment expertise that exists in federal agencies and the organizations

that advise them, " Ahearne said.

Although the general thrust of the draft bulletin appears to be consistent

with past expert recommendations on risk assessments, a number of specific

proposals are inconsistent, the committee said. It added that the

bulletin attempts to move standards for risk assessment into " territory

beyond what previous reports have recommended and beyond the current state

of the science. " Also, OMB's definition of risk assessment is too broad

and in conflict with long-established concepts and practices.

Many of the standards proposed in the bulletin are unclear, the report

adds. In particular, OMB's proposal of separate standards for general

risk assessments and " influential " ones is problematic because agencies

may not know at the outset whether a risk assessment will be considered

influential. The committee also took issue with the bulletin's definition

of an adverse health effect because it implies that only clinically

apparent effects should be considered adverse. This ignores a fundamental

public health goal to control exposures well before they cause functional

impairment.

The bulletin also omits several topics, further limiting its usefulness,

the committee said. For example, OMB erred in focusing mainly on human

health risk assessments while neglecting risk assessments of technology

and engineered structures. The bulletin's incomplete and unbalanced

approach to engineering, ecological, and other types of risk assessments

contradicts its stated objective of improving the quality of risk

assessment throughout the federal government, the committee added. The

bulletin also gives little attention to the integral role of risk

communication, the importance of default assumptions in conducting risk

assessments, and the risks faced by sensitive populations, such as

children and pregnant women.

OMB has not established a baseline of each agency's proficiency at

conducting risk assessments, nor estimated the cost of implementing the

bulletin. However, the committee determined -- based on comments from the

agencies and its own knowledge of risk assessment practices -- that some

aspects of the bulletin's implementation could be beneficial but that the

costs are likely to be substantial. Overall, the committee concluded that

the potential for negative impacts on the practice of risk assessment in

the federal government would be very high.

The committee noted that risk assessment is not a monolithic process or

single method, adding that " one size does not fit all. " However, it

recommended that federal agencies addressing similar risks should work

together to develop common technical guidance, helping to ensure

appropriate consistency in federal risk assessment practices. The

technical guidance should be peer reviewed and include procedures for

ensuring compliance. Although OMB should determine whether the technical

guidance fully addresses the risk assessment principles OMB outlines,

development and peer review of the guidance should be left to the

agencies, the report states.

OMB requested the Research Council report, and it was sponsored by the

U.S. Environmental Protection Agency; U.S. departments of Agriculture,

Defense, Energy, Health and Human Services, and Labor; and NASA. The

National Academy of Sciences, National Academy of Engineering, Institute

of Medicine, and National Research Council make up the National Academies.

They are private, nonprofit institutions that provide science,

technology, and health policy advice under a congressional charter. The

National Research Council is the principal operating agency of the

National Academy of Sciences and the National Academy of Engineering. A

committee roster follows.

Copies of Scientific Review of the Proposed Risk Assessment Bulletin from

the Office of Management and Budget will be available from the National

Academies Press; tel. 202-334-3313 or 1-800-624-6242 or on the Internet at

http://www.nap.edu. Reporters may obtain a pre-publication copy from the

Office of News and Public Information (contacts listed above).

Scientific Review of the Proposed Risk Assessment Bulletin from the Office

of Management and Budget $62.75 324 pages paperback Washington DC:

National Academies Press. 1-800-624-6242 The National Academies Press

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