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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and Budget prescribing technical standards for federal risk assessments is "fundamentally flawed" and should be withdrawn, according to a new National Research Council report.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but the more we dug into it, the more we realized that from a scientific and technical standpoint, it should be withdrawn altogether," said John F. Ahearne, chair of the committee that wrote the report, and director, ethics program, Sigma Xi, The Scientific Research Society,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).

 

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[ This news release and report are available at http://national-academies.org ]

 

NATIONAL RESEARCH COUNCIL

Division on Earth and Life Studies

Board on Environmental Studies and Toxicology

 

Committee to Review the OMB Risk Assessment Bulletin

 

John F. Ahearne1 (chair)

Director

Ethics Program

Sigma Xi, The Scientific Research Society

Research Triangle Park, N.C.

 

George V. Alexeeff

Deputy Director for Scientific Affairs

Office of Environmental Health Hazard Assessment

California Environmental Protection Agency

Oakland

 

Gregory B. Baecher1

Professor

Department of Civil and Environmental Engineering

University of Maryland

College Park

 

A. John Bailer

Distinguished Professor

Department of Mathematics and Statistics, and

Senior Researcher

Scripps Gerontology Center

Miami University

Oxford, Ohio

 

Roger M. Cooke

Chauncey Starr Senior Fellow

Resources for the Future

Washington, D.C.

 

Charles E. Feigley

Professor of Environmental Health Sciences

Arnold School of Public Health

University of South Carolina

Columbia

 

Baruch Fischhoff2

Howard Heinz University Professor

Department of Social and Decision Sciences and Department of Engineering and Public Policy

Carnegie Mellon University

Pittsburgh

 

Charles P. Gerba

Professor of Environmental Microbiology

Department of Microbiology and Immunology and Department of Soil, Water, and Environmental Science

University of Arizona

Tucson

 

Rose H. Goldman

Associate Professor of Medicine

Harvard Medical School, and

Associate Professor

Department of Environmental Health

Harvard School of Public Health

Boston

 

Robert H. Haveman

Professor Emeritus of Economics and Public Affairs, and

Research Affiliate

Institute for Research on Poverty

University of Wisconsin

Madison

 

William E. Kastenberg1

Daniel M. Tellep Distinguished Professor in Engineering

University of California

Berkeley

 

Sally Katzen

Visiting Professor of Law

George Mason University

Arlington, Va.

 

Eduardo Miranda

Assistant Professor

Department of Civil and Environmental Engineering

Stanford University

Stanford, Calif.

 

Michael Newman

Professor of Marine Science

Virginia Institute of Marine Science

College of William and Mary

Gloucester Point

 

Dorothy E. Patton

Retired

Chicago

 

Charles Poole

Associate Professor

Department of Epidemiology

School of Public Health

University of North Carolina

Chapel Hill

 

Danny D. Reible1

Bettie Margaret Smith Chair of Environmental Health Engineering

University of Texas, and

Co-Director

Hazardous Substance Research Centers/South and Southwest

U.S. Environmental Protection Agency

Austin

 

Joseph V. Rodricks

Founding Principal

ENVIRON International

Arlington, Va.

 

 

RESEARCH COUNCIL STAFF

 

Ellen K. Mantus

Study Director

 

                                                                     

1 Member, National Academy of Engineering

2 Member, Institute of Medicine