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8 Options for Mitigating Concerns
Pages 95-114

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From page 95...
... As discussed in Chapter 3, Potential for Mitigation, key elements that contribute to the potential for mitigation include deterrence and prevention capabilities, ability to recognize an attack, attribution capabilities, and consequence management capabilities. Broadly speaking, many of the same tools that are used to mitigate natural infectious disease outbreaks or exposure to chemicals (e.g., from environmental spills)
From page 96...
... . However, no country goes against the international norm to flaunt an offensive biological weapons program; even North Korea, which openly flouts international prohibitions against nuclear testing, has denied accusations that the country is developing biological weapons (Sampathkumar, 2017)
From page 97...
... Guided by a framework created by HHS in 2010, DNA providers are encouraged to screen orders for sequences of concern (e.g., DNA encoding Select Agents) and to screen customers to ensure that they are legitimate users of biology (HHS, 2010)
From page 98...
... Some of the procedures involved in disease surveillance and agent identification can also inform a determination of whether a health threat is the result of an intentional attack or a natural outbreak and potentially provide clues about the actor responsible. Figure 8-1 provides an overview of selected existing procedures and systems in place to identify emerging health threats affecting the U.S.
From page 99...
... Department of Homeland Security that monitors the air in public places for the presence of Select Agents (Firoved, 2016)
From page 100...
... These include devices such as personal protective equipment, along with vaccines, antibiotics, antivirals, antitoxins, and other drugs and therapeutics.1 HHS and the DoD share responsibilities for the development of medical countermeasures, targeted at agents on the Select Agent list, in conjunction with Material Threat Assessments provided by the U.S. Department of Homeland Security (see the Public Health Emergency Medical Countermeasures Enterprise Strategy and Implementation Plans [HHS, 2017b]
From page 101...
... Concerns about the weaknesses of these strategies have gained greater traction with the emergence of synthetic biology. The following sections discuss two areas in which synthetic biology has raised particular concern: the accessibility of modern biotechnology to a wider range of actors and the pitfalls of list-based screening to detect malicious activity.
From page 102...
... law enforcement agencies in the event of a problem, DNA synthesis is performed worldwide, and it is less clear that such processes are in place in all other nations. Importantly, in addition to DNA synthesis screening, lists such as the Select Agent list also form the basis of many of the downstream mitigation tools discussed in this chapter, including detection, diagnostics, and the development and prioritization of medical countermeasures.
From page 103...
... Despite the breadth and depth of available repository resources, there would not always be a reference specimen to use as comparator, particularly if the agent is markedly different from natural pathogens or toxins. Many current mitigation efforts are inherently list based (aimed at detecting Select Agents)
From page 104...
... Consequence Management Challenges If disease surveillance and laboratory infrastructure cannot detect, identify, and characterize the causative agent, it is also possible that current available medical countermeasures -- such as vaccines and therapeutics -- may be less effective or, in certain cases, ineffective. While existing medical countermeasures may be quite useful for containing or counteracting agents created with synthetic biology that are highly similar to existing pathogens of concern, not all agents may fit this model.
From page 105...
... It has been argued that emphasizing known pathogenic functions (as opposed to whole genomes of Select Agents; see IARPA, 2017b) would allow the curation of a more meaningful registry, one drawn directly from the DNA components responsible for causing harm.
From page 106...
... Sourcing materials Material transfer agreements already provide security Ordering reagents and equipment, such as mechanisms for the legitimate transfer of materials. genetic material, DNA synthesis equipment, Illicit transfers would be difficult to prevent and ordering and cell lines or animals  basic molecular biology reagents and equipment is of likely to be too prevalent to monitor.
From page 107...
...  toxin. In general, however, gene selection is likely too common a process to reliably detect or prevent malicious activity without unduly curtailing legitimate research.
From page 108...
... , aims to facilitate the design of better tools for screening DNA synthesis orders. • Finding Engineering-Linked Indicators (FELIX; IARPA, 2017a)
From page 109...
... open the possibility of new and more systematic approaches to the development of medical countermeasures and other mitigation tools and strategies. Synthetic biology approaches such as rapid DNA synthesis, protein design tools, cell-free expression systems, and automation may significantly advance consequence management capabilities, especially with regard to the development and testing of medical countermeasures.
From page 110...
... While outside the scope of this report, a comprehensive understanding of the feasibility of using synthetic biology to develop medical countermeasures would benefit from critical review of both commercial and regulatory considerations. New "Vaccine Strains" Through Controlled Attenuation of Viruses The replication cycle of viruses is complex, and the fitness of a given virus depends on many factors.
From page 111...
... Use of Synthetic Biology Tools to Develop New Therapeutics Synthetic biology is also contributing to the development of small-molecule medical countermeasures. The development of a yeast strain capable of producing artemisinic acid, the key precursor to the antimalarial drug artemisinin, demonstrated that complex plant-based natural products can be produced via synthetic biology (Westfall et al., 2012)
From page 112...
... Prevention and Deterrence • Risk management strategies based on defined lists of biological agents, such as the Federal Select Agent Program Select Agents and Toxins list, will be insufficient for managing risks arising from the application of synthetic biology. Similarly, while measures to control access to physical materials such as synthetic nucleic acids and microbial strains have merits, such approaches will not be effective in mitigating all types of synthetic biology–enabled attacks.
From page 113...
... Finally, synthetic biology is enabling advances in the rapid development and production of medical countermeasures that may be effective against synthetic biology–derived agents. However, many such efforts, which are being pursued in both industry and academia, are still in the research phase, and there remain complex barriers to widespread use of these novel approaches, including regulatory hurdles and hurdles to industry involvement.


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