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Date: Oct. 8, 2003
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Balanced Approach Needed to Mitigate Threats From Bioterrorism Without Hindering Progress in Biotechnology

WASHINGTON – Research in the life sciences has fueled advances that have fostered gains in public health and in the development of detection methods to improve America's defenses against biological threats. But some of the technologies that lead to medical benefits also could be used to create biological weapons. To minimize the potential for hostile nations or terrorists to misuse such research, the United States needs to build on existing measures within the scientific community to screen plans for certain types of experiments before they are conducted, says a new report from the National Academies' National Research Council.

The report recommends that the U.S. Department of Health and Human Services create an independent National Science Advisory Board for Biodefense to lead the new oversight system. Made up of top scientists and national-security experts, the board would serve a number of important functions for the scientific community and the federal government -- such as providing expert scientific advice on the relative risks and benefits of new technologies and alerting the government to new opportunities for the development of vaccines and antibiotics. It also would promote ongoing dialogue between scientists and security experts, and advise the federal government on how life scientists could continue to play a role in mitigating the risks of bioterrorism.

"This proposal is a key step in an evolving process to strike the right balance between national-security concerns and the openness necessary for America's research enterprise to thrive," said Gerald R. Fink, chair of the committee that wrote the report and member, Whitehead Institute for Biomedical Research, and American Cancer Society Professor of Genetics, Massachusetts Institute of Technology, Cambridge.

The report points out that the United States is one of many countries pursuing advanced biotechnology research. The techniques, reagents, and scientific know-how that could be misused are available across the globe. Without progress toward building international consensus and crafting guidelines for overseeing such research, U.S. restrictions in this area could undermine America's own national-security interests and scientific progress. For that reason, a coordinated international system to regulate the possession of dangerous pathogens and toxins also is needed. Oversight of research in biotechnology should be consistent from country to country. And current global efforts to tackle this issue should be strengthened, expanded, and coordinated. The scientific community should be a critical player in the consensus-building process; the recommended advisory board could help promote international cooperation.

Reviewing Planned Experiments

The report proposes a tiered system of review to identify experiments that raise concern because of their high potential for misuse. The phrase "misuse of biotechnology" describes a wide spectrum of potentially dangerous activities, such as spreading common pathogens or transforming them into the next "Andromeda Strain," as in the classic science-fiction novel. However, the committee focused on the most plausible dangers. It identified seven classes of experiments that illustrate the types of endeavors or discoveries that should be reviewed and discussed by experts in the scientific and medical communities. These are experiments that would:
The National Institutes of Health's current approach for reviewing experiments that involve recombinant DNA should be expanded to include the seven classes of experiments of concern, the committee said; some of the classes already fall under NIH's purview. The first tier of review begins with a research establishment's Institutional Biosafety Committee. All IBCs conduct their reviews using guidelines developed by NIH's Recombinant DNA Advisory Committee (RAC). With their expanded duties, it is anticipated that there would be only rare cases in which IBCs could not decide whether a proposed experiment should proceed. IBCs would refer such cases to RAC, and possibly to the director of NIH, who could consult with the National Science Advisory Board for Biodefense. RAC has an established track record of facilitating scientific research while protecting public safety.

Under the report's proposal, the IBC/RAC system would for the first time begin to review certain projects from all research institutions, regardless of their source of funding. Officially, RAC's current jurisdiction covers only research that is funded by NIH -- although a number of government agencies and private firms voluntarily participate in the current system. RAC would need additional funding and other resources for these expanded duties, including translating the categories of experiments of concern into detailed guidelines for IBCs. Also, both RAC and IBCs would likely need to add scholars with new areas of expertise to their memberships.

Reviewing and Publishing Research Results

The new system also would include the review of study results from any experiments of concern that are approved. But the issue of whether these results should be published needs to be resolved within the scientific community – not by government policy, the committee emphasized.

This self-governance approach to making decisions about publication is different from the federal government's restriction on public access to "sensitive but unclassified" information in the life sciences, the report notes. Experience shows that vague categories of this kind generate great uncertainties among both scientists and officials responsible for enforcing regulations. The inevitable effect is to stifle scientific creativity and weaken national security.
Ongoing discussion among people involved in publishing scientific journals – and between journal editors and national-security experts – is essential to creating a responsive, credible, and effective system of review and oversight, the committee said. A statement issued by a group of editors of major journals in the life sciences last February was an important step. The statement affirmed the benefits of open publication but acknowledged that some information might present enough potential risk of misuse by terrorists that it should not be published. The proposed National Science Advisory Board for Biodefense could be a resource for producers of journals in the life sciences that are published in the United States or abroad – for instance, to provide them with ready access to examples of review procedures that have been put into action by others.

On the broader issue of classification, the general principle of the federal government's National Security Decision Directive 189 remains valid and should continue to be the basis for U.S. policy, the report says. The policy, issued in 1985, states, "No restrictions may be placed upon the conduct or reporting of federally funded fundamental research that has not received national security classification, except as provided in applicable U.S. statutes."

Engaging the Scientific Community

Scientists cannot guarantee that the knowledge they generate will not play a role in advancing biowarfare or bioterrorism. However, they should take reasonable steps to minimize that possibility, the report says. The research community, including scientific societies and organizations, should create programs to educate life scientists about the risks involved in advanced biotechnology research and about scientists' responsibility to address and manage the risks.

To bring about significant and lasting change, the American scientific community must become more deeply engaged in this issue, the report says. At the same time, a commitment would be needed from the international scientific and policy-making communities to develop a counterpart to the committee's proposed oversight system for the United States, ultimately promoting greater security around the world.

The study was sponsored by the Sloan Foundation and the Nuclear Threat Initiative. The National Research Council is the principal operating agency of the National Academy of Sciences and the National Academy of Engineering. It is a private, nonprofit institution that provides science advice under a congressional charter. A committee roster follows.
Pre-publication copies of Biotechnology Research in an Age of Terrorism: Confronting the "Dual Use" Dilemma are available from the National Academies Press; tel. 202-334-3313 or 1-800-624-6242 or on the Internet at The cost of the report is $40.00 (prepaid) plus shipping charges of $4.50 for the first copy and $.95 for each additional copy. Reporters may obtain a copy from the Office of News and Public Information (contacts listed above).

Division on Policy and Global Affairs

Committee on Research Standards and Practices to Prevent
the Destructive Application of Biotechnology

Gerald Fink (chair)
Whitehead Institute for Biomedical Research, and
American Cancer Society Professor of Genetics
Massachusetts Institute of Technology

Ronald Atlas
Professor of Biology and Graduate Dean
University of Louisville
Louisville, Ky.

W. Emmett Barkley
Director of Laboratory Safety
Howard Hughes Medical Institute
Chevy Chase, Md.

R. John Collier
Maude and Lillian Presley Professor of Microbiology and Molecular Genetics
Harvard Medical School

Susan Cozzens
School of Public Policy
Georgia Institute of Technology

Ruth Faden
Philip Franklin Wagley Professor of Biomedical Ethics and Executive Director
The Phoebe R. Berman Bioethics Institute
Johns Hopkins University

David Franz
Vice President of Chemical and Biological Defense Division
Southern Research Institute
Frederick, Md.

Joseph Goldstein (ex officio)
Regental Professor and Chair
Department of Molecular Genetics
University of Texas Southwestern Medical Center

Barry Kellman
Director of the International Weapons Control Center
DePaul University College of Law

Marc Kirschner
Chair and Carl W. Walter Professor of Cell Biology
Department of Cell Biology
Harvard Medical School

Erin O'Shea
Professor and Vice Chair
Department of Biochemistry and Biophysics
University of California
San Francisco

Clarence Peters
Department of Microbiology and Immunology and Pathology
University of Texas Medical Branch

Judith Reppy
Department of Science and Technology Studies, and
Associate Director
Peace Studies Program
Cornell University
Ithaca, N.Y.

Elizabeth Rindskopf Parker
McGeorge School of Law
University of the Pacific
Sacramento, Calif.

Matthew Scharff
Professor of Cell Biology
Albert Einstein College of Medicine
Yeshiva University
Bronx, N.Y.

Edward Scolnick
President Emeritus
Merck Research Laboratories, and
Executive Vice President of Science and Technology
Merck and Co. Inc.
West Point, Pa.


Eileen Choffnes
Study Director