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Sequence-Based Classification of Select Agents: A Brighter Line (2010)

Chapter: Appendix A: Statement of Task

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Suggested Citation:"Appendix A: Statement of Task." National Research Council. 2010. Sequence-Based Classification of Select Agents: A Brighter Line. Washington, DC: The National Academies Press. doi: 10.17226/12970.
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Appendix A
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?

Suggested Citation:"Appendix A: Statement of Task." National Research Council. 2010. Sequence-Based Classification of Select Agents: A Brighter Line. Washington, DC: The National Academies Press. doi: 10.17226/12970.
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Suggested Citation:"Appendix A: Statement of Task." National Research Council. 2010. Sequence-Based Classification of Select Agents: A Brighter Line. Washington, DC: The National Academies Press. doi: 10.17226/12970.
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Page 135
Suggested Citation:"Appendix A: Statement of Task." National Research Council. 2010. Sequence-Based Classification of Select Agents: A Brighter Line. Washington, DC: The National Academies Press. doi: 10.17226/12970.
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Page 136
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Select Agents are defined in regulations through a list of names of particularly dangerous known bacteria, viruses, toxins, and fungi. However, natural variation and intentional genetic modification blur the boundaries of any discrete Select Agent list based on names. Access to technologies that can generate or 'synthesize' any DNA sequence is expanding, making it easier and less expensive for researchers, industry scientists, and amateur users to create organisms without needing to obtain samples of existing stocks or cultures. This has led to growing concerns that these DNA synthesis technologies might be used to synthesize Select Agents, modify such agents by introducing small changes to the genetic sequence, or create entirely new pathogens. Amid these concerns, the National Institutes of Health requested that the Research Council investigate the science and technology needed to replace the current Select Agent list with an oversight system that predicts if a DNA sequence could be used to produce an organism that should be regulated as a Select Agent.

A DNA sequence-based system to better define when a pathogen or toxin is subject to Select Agent regulations could be developed. This could be coupled with a 'yellow flag' system that would recognize requests to synthesize suspicious sequences and serve as a reference to anyone with relevant questions, allowing for appropriate follow-up.

Sequence-Based Classification of Select Agents finds that replacing the current list of Select Agents with a system that could predict if fragments of DNA sequences could be used to produce novel pathogens with Select Agent characteristics is not feasible. However, it emphasized that for the foreseeable future, any threat from synthetic biology and synthetic genomics is far more likely to come from assembling known Select Agents, or modifications of them, rather than construction of previously unknown agents. Therefore, the book recommends modernizing the regulations to define Select Agents in terms of their gene sequences, not by their names, and called this 'sequence-based classification.'

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