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Executive Summary
Pages 1-14

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From page 1...
... Within less than 30 years, the entire genomes of many hundreds of organisms, from viruses to bacteria to humans, have been sequenced, and partial sequences from many thousands more organisms have been deposited into databases freely accessible to scientists around the world. Modern biological research is a thriving international enterprise with enormous potential to benefit society.
From page 2...
... Furthermore, the culture of genomics is unique in its evolution into a global web of tools and information. The major Internet-based data repositories have policies that mandate free, unfettered, and anonymous access, and most scientific journals require that genome data be deposited into accessible databases as a prerequisite for publication.
From page 3...
... At the first meeting of the Committee on Genomics Databases for Bioterrorism Threat Agents, the sponsors indicated that they hoped the report would present the perspective of working biological scientists, so that readers in the policy and intelligence communities could use the report when considering potential changes in policy regarding access to genome sequence data. It was understood that the security community would then take this scientific perspective and use it in combination with their own knowledge of security issues to make decisions.
From page 4...
... and the creation of meningococcus B vaccine candidates -- that illustrate the power of genomics and openly accessible databases to help improve our understanding of and aid in the development of countermeasures for infectious diseases. The report also considers how genome data and related technologies might be misused for the development of genetically enhanced biological weapons, and it discusses potential malefactors.
From page 5...
... Categories of data that were discussed include primary genome sequences, annotated and analyzed sequences, sequences from select agents, and sequences from engineered microorganisms. In further discussions after the workshop, the committee concluded that assigning data to one of those categories would not be a significant help in determining risks.
From page 6...
... described contentious research as containing "fundamental biological or biomedical investigations that produce organisms or knowledge that could have immediate weapons implications and that therefore raise questions concerning whether and how that research should be conducted and disseminated." The conduct of such contentious research is beyond the charge to this committee, but the dissemination of the results falls within our purview. Workshop participants and committee members also considered possible mechanisms for controlling access to data.
From page 7...
... With a growing understanding of microbial pathogens and their interactions with the hosts they infect, national governments, subnational groups, or single individuals could attempt to apply such knowledge to destructive purposes and with potentially grave consequences. However, after careful deliberation, the committee concluded that preserving open access to genome data and free exchange of knowledge and ideas that flow from the data will facilitate scientific and medical advances that will improve health and society's ability to react to biological threats.
From page 8...
... It is notoriously difficult to control access to digital data, and files that contain entire genomes are not particularly large and therefore are easily stored, transferred, and exchanged. Also, in the absence of a uniform international agreement to impose similar control measures worldwide, potential users who are denied access because of U.S.
From page 9...
... It is important to remember that the focus here is on access to data pertaining to organisms, not on access to the organisms themselves; for example, U.S. government regulations on select agents apply to the possession of the organisms and not to their genome sequences.
From page 10...
... However, sequence data from some genetically engineered organisms could be very useful for a potential bioterrorist attempting to create a more dangerous pathogen. Regulations on the actual conduct of the experiments that might generate such an engineered organism are beyond the charge to this committee, although it is certainly an important issue.
From page 11...
... The committee believes firmly that the policies currently in place for genome data -- immediate release and free access -- are correct because openness is essential to maintain the progress needed to stay ahead of those who would attempt to cause harm. Recommendation 2: Genomics and genome sequence data should be exploited fully to improve our ability to defend against infec tious agents of all types, including those which contribute to epi demic diseases and infant mortality and the naturally occurring or genetically enhanced organisms that could be used in a bioterrorist attack.
From page 12...
... A well-informed body with both scientific and security expertise should review advances in genome science in case future developments warrant the creation of additional monitoring of or restrictions on access to genome data. Review should be scientifically broad because the effect of genomics on biosecurity goes far beyond the biology of biothreat organisms and includes both biomedical topics, such as drug and vaccine development, and topics pertaining to forensics, intelligence, agriculture, and the environment.
From page 13...
... The entity that becomes responsible for reviewing scientific advances in genome science for their potential effect on national security must be scientifically respected, have the ability to integrate information from diverse sources, and have a clear ability to influence discussions in numerous federal departments and agencies. Recommendation 4: The committee endorses Recommendation 7 of Biotechnology Research in an Age of Terrorism, which calls for an international forum to unify the discussion on the effect of genomics on biosecurity.
From page 14...
... Recommendation 5: The committee endorses Recommendation 1 of Biotechnology Research in an Age of Terrorism,which calls for national and international professional societies and related organizations to work to educate scientists about the risk that life-science research results will be misused and about scientists' responsibility to miti gate the risk. Recommendation 1 of Biotechnology Research in an Age of Terrorism calls for "national and international professional societies and related organizations and institutions [to]


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