|
This ignores a
fundamental public health goal to control
exposures well before they cause functional
impairment.
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
Michelle Strikowsky, Media Relations Assistant
Office of News and Public Information
202-334-2138; e-mail <news@nas.edu>
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be withdrawn, according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it should be withdrawn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 John 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
500 Fifth Street NW
Lockbox 285
Washington, DC 20055
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