*EPF517 09/10/2004
Text: U.S. Report Supports Unrestricted Access to Pathogen Genomes
(Bioterrorism better opposed by free flow of scientific information, report says) (1500)

Current policies that give scientists and the public unrestricted access to genome data on microbial pathogens should not be changed, says a new report from the National Academies' National Research Council (NRC), according to a National Academies September 9 press release.

The report, "Seeking Security: Pathogens, Open Access, and Genome Databases," was sponsored by the National Science Foundation, National Institutes of Health, Department of Homeland Security and CIA. It concludes that security against bioterrorism is better served by policies that facilitate rather than limit the free flow of such information.

Individuals or nations trying to develop bioweapons may be able to obtain data on pathogens, but restrictions that impede their access would probably also hinder efforts to develop vaccines, other bioterrorism countermeasures and scientific research. The report urges creating an advisory board to regularly review future developments in genome research and assess their security implications.

"Open access is essential if we are to maintain the progress needed to stay ahead of those who would attempt to cause harm," said Stanley Falkow, chair of the report committee and professor of microbiology and immunology at Stanford University in California.

Genome sequences of more than 100 microbial pathogens -- including smallpox, anthrax and Ebola hemorrhagic fever -- are publicly available in Internet-accessible databases around the world, the report notes.

The U.S. government requires that all genome data produced by federally funded research be made public, but several federal agencies are reconsidering this policy. They asked the NRC to report on how scientists view policies governing access, and the potential for misuse of the data.

The full report is available online at http://www.nap.edu/catalog/11087.html?onpi_newsdoc09092004

Text of the National Academy of Sciences press release follows:

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National Academy of Sciences
Press release, September 10, 2004

Unrestricted Public Access to Pathogen Genome Data Should Continue; Benefits to Public Health Outweigh Risk of Improper Use

WASHINGTON -- Current policies that allow scientists and the public unrestricted access to genome data on microbial pathogens should not be changed, says a new report from the National Academies' National Research Council, which concludes that security against bioterrorism is better served by policies that facilitate, not limit, the free flow of this information. While individuals or nations trying to develop bioweapons may be able to obtain data on pathogens, any restrictions tight enough to impede their access would probably also hinder efforts to develop vaccines and other countermeasures to bioterrorism, as well as other valuable scientific research. The report adds, however, that an advisory board should be created to regularly review future developments in genome research in order to assess their security implications.

"Open access is essential if we are to maintain the progress needed to stay ahead of those who would attempt to cause harm," said Stanley Falkow, chair of the committee that wrote the report, and professor of microbiology and immunology, Stanford University, Stanford, Calif. "The current vitality of the life sciences depends on a free flow of data and ideas, which is necessary if science is to deliver new biodefense capabilities and improve our ability to fight infectious disease."

The complete genome sequences of more than 100 microbial pathogens -- including those for smallpox, anthrax, and Ebola hemorrhagic fever -- are already publicly available in Internet-accessible databases around the world, and hundreds more pathogens will be sequenced in the next few years, the report notes. The U.S. government requires that all genome data produced by federally funded research be made public, with rare exceptions. But given that data on pathogens could potentially help terrorists engineer even deadlier versions of diseases, several federal agencies are considering whether this information should remain public. They asked the Research Council to report on how biological scientists view policies governing access, and the potential for misuse of the data.

The current policy of open access to genome information has served science and society remarkably well, the committee said, citing as an example the response to the 2003 epidemic of severe acute respiratory syndrome (SARS). Within six weeks of the outbreak, the genome of the SARS virus was sequenced and posted on the Internet, allowing scientists around the world to start work quickly on diagnostic tests and vaccines. At such times, when scientific and public health resources must be mobilized swiftly to combat a poorly understood disease, free and rapid exchange of data and ideas is essential, the report says.

Restrictions on access would slow this exchange of information, the committee said. Given the interconnections between different areas of life-science research, there is no clear way to predict which scientists need access to which genome data, so regulations could bar legitimate researchers from needed information. Deciding what data should be restricted also would be problematic, since even the gene sequences of nonpathogenic organisms -- such as humans or animals who are "hosts" for diseases -- could potentially aid a bioterrorist. If access to the sequences of all pathogens and all hosts were restricted, the report says, it would severely damage the fabric of the global scientific enterprise. The committee also considered the less-stringent option of requiring database users to register, but concluded that such a system would not stop a determined malefactor; it would, however, raise troubling questions about who could use registration data, and for what purposes.

In addition to impeding research, implementing effective curbs on access would be impractical, the report adds. Digital data are notoriously difficult to control, and files that contain entire genome sequences are small and therefore easily stored and transferred. And without a uniform international agreement, users who are denied access because of U.S. policy could simply turn elsewhere.

Instead of restricting access or classifying more data, policy-makers and researchers should focus on exploiting genome information fully to improve our defenses against infectious diseases of all types, said the committee, who noted that federal spending for biodefense has increased markedly since the 2001 terrorist attacks on the United States. It urged continued extensive genome research on threats to both human health and agricultural interests.

The ability to genetically manipulate pathogens will eventually be far more widespread than it is today, the committee said. Because of this, a new group with both scientific and security expertise should be formed to apprise government agencies of developments in genome science that may affect national security, and to review those advances for changes that may warrant additional monitoring of or restrictions on access to genome data. The committee also endorsed the creation of an international forum to work toward a common understanding of security concerns and, eventually, an international norm against misuse of genetic information.

The report builds on the findings of last year's Research Council report Biotechnology Research in an Age of Terrorism, which examined how to mitigate the potential for misuse of biological agents and technologies without unduly limiting progress in the life sciences. That report recommended improved screening of experiments before they are conducted, as well as educating scientists to be aware of the risks and benefits associated with their research and to balance them responsibly.

The new report was sponsored by the National Science Foundation, National Institutes of Health, U.S. Department of Homeland Security, and the Central Intelligence Agency. The National Reseach Council is the principal operating arm of the National Academy of Sciences and National Academy of Engineering. It is a private, nonprofit institution that provides scientific advice under a congressional charter. A committee roster follows.

Copies of Seeking Security: Pathogens, Open Access, and Genome Databases are available from the National Academies Press; tel. 202-334-3313 or 1-800-624-6242 or on the Internet at http://www.nap.edu. The cost of the report is $18.00 (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 Earth and Life Studies and Division on Policy and Global Affairs

Committee on Genomics Databases for Bioterrorism Threat Agents

Stanley Falkow, Ph.D. 1, 2 (chair) Professor of Microbiology and Immunology, and Professor of Medicine Stanford University Stanford, Calif.

Corrie Brown, Ph.D., D.V.M. Coordinator of International Veterinary Medicine College of Veterinary Medicine University of Georgia Athens

David R. Franz, Ph.D. Chief Biological Scientist Midwest Research Institute, and Director National Agricultural Biosecurity Center Kansas State University Frederick, Md.

Claire M. Fraser, Ph.D. President and Director The Institute for Genomic Research Rockville, Md.

Paul Keim, Ph.D. E. Raymond and Ruth Cowden Endowed Chair of Microbiology, and Regents Professor of Biology Northern Arizona University Flagstaff

Terence Taylor President and Executive Director International Institute for Strategic Studies, U.S. Office Washington, D.C.

RESEARCH COUNCIL STAFF

Kerry Brenner, Ph.D. Study Director
Eileen Choffnes, Ph.D. Senior Program Officer

1 Member, National Academy of Sciences 2 Member, Institute of Medicine

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(Distributed by the Bureau of International Information Programs, U.S. Department of State. Web site: http://usinfo.state.gov)

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