In complexity from single macromolecules to pathways, organisms, popula tions, and ecosystems. The committee believes that we are so far from the goal of a predictive framework that it is premature to plan specific steps towards a Select Agent regulatory system based on predictive genome sequence analysis.Īs described in Chapter 2, it is a major goal of all biology to understand how DNA sequence determines the properties of biological systems, ranging The committee was charged to identify, supposing that the answer to these questions would be no, “the scientific advances that would be necessary to permit serious consideration” of such a predictive framework.
For the foreseeable future, the only reliable predictor of the hazard posed by a biological agent is actual experience with that agent. Reliable prediction of the hazardous properties of pathogens from their genome sequence alone will require an extraordinarily detailed understanding of host, pathogen, and environment interactions integrated at the systems, organism, population, and ecosystem levels. Chapter 2 described why accurate prediction of an organism’s pathogenicity from its genome sequence is not possible now, and will not be feasible in the foreseeable future-certainly not at the level of accuracy appropriate for statutory regulations. Second, the committee finds that even if it were possible to assign Select Agent status solely on the basis of genome-encoded biological properties, the answer would remain no. The previous chapter concluded that the primary answer to our charge is no- prediction of Select Agent status by genome sequence analysis is not feasible.įirst, in Chapter 1, the committee found that prediction of Select Agent status is not possible, because Select Agent status involves economic, historical, and policy considerations beyond the biological properties of the organism encoded in its genome. A Proposal for Consideration: Sequence-Based Classification of Select Agents
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