than by transfer of existing stocks or wild isolates). The second proposed study became the origin of our committee. This recommendation proposed that:

… a group of experts from the scientific community be assembled to determine if an alternative framework based on predicted features and properties encoded by nucleic acids, such as virulence or pathogenicity, can be developed and utilized in lieu of the current finite list of specific agents and taxonomic definitions … (NSABB 2006).

Thus, this study was initiated with the title of “Scientific Milestones for the Development of a Gene Sequence-Based Classification System for Oversight of Select Agents” on the basis of this recommendation. The committee was specifically charged with identifying:

… the scientific advances that would be necessary to permit serious consideration of developing and implementing an oversight system for Select Agents that is based on predicted features and properties encoded by nucleic acids rather than a relatively static list of specific agents and taxonomic definitions (see Box 1.1 or Appendix A).

BOX 1.1

Scientific Milestones for the Development of a Gene Sequence-Based Classification System for Oversight of Select Agents

Statement of Task


NIH has requested the National Research Council to convene an ad hoc committee to identify the scientific advances that would be necessary to permit serious consideration of developing and implementing an oversight system for Select Agents that is based on predicted features and properties encoded by nucleic acids rather than a relatively static list of specific agents and taxonomic definitions. The committee is asked to address several questions:

  • What would be the key scientific attributes of a predictive oversight system?

  • What are the challenges in attempting to predict biological characteristics from sequence?

  • Does the current state of the science of predicting function from sequence support a predictive oversight system at this time?

  • If not, what are the scientific milestones that would need to be realized before a predictive oversight system might be feasible?

  • In qualitative terms, what level of certainty would be needed about the ability to predict biological characteristics from sequence data in order to have confidence in a predictive oversight system?

  • In what time frame might these milestones be realized? What kinds of studies are needed to achieve these milestones?



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