Regulatory Developments

NAS Publishes Report on Biodefense in the Age of Synthetic Biology

July 2, 2018

On June 19, 2018, the National Academies of Sciences, Engineering, and Medicine (National Academies) published a press release announcing the availability of a final report entitled Biodefense in the Age of Synthetic Biology. According to the National Academies, the final report concludes that “[s]ynthetic biology expands the possibilities for creating new weapons -- including making existing bacteria and viruses more harmful -- while decreasing the time required to engineer such organisms.” Some malicious applications of synthetic biology that may not seem plausible right now could become achievable with future advances.

Synthetic biology, used here to refer collectively to concepts, approaches, and tools that enable the modification or creation of biological organisms, is being pursued “overwhelmingly” for beneficial purposes ranging from reducing the burden of disease to improving agricultural yields to remediating pollution. Because malicious uses could threaten U.S. citizens and military personnel, the U.S. Department of Defense (DoD), working with other agencies involved in biodefense, asked the National Academies to develop a framework to guide an assessment of the security concerns related to advances in synthetic biology, to assess the levels of concern warranted for such advances, and to identify options that could help mitigate those concerns.

The final report, which builds on and supersedes an interim report released in August 2017, explores and envisions potential misuses of synthetic biology, including concepts that are regularly discussed in open meetings. In the interim report, the Committee on Strategies for Identifying and Addressing Potential Biodefense Vulnerabilities Posed by Synthetic Biology proposed a strategic framework intended to identify and prioritize potential areas of concern associated with the field and to help biodefense analysts as they consider the current and future synthetic biology capabilities. The Committee designed the framework for analyzing existing biotechnology tools to evaluate the dangers at present, understand how various technologies compare with and complement each other, and assess the implications of new experimental outcomes.

In the final report, the Committee used this framework to analyze potential vulnerabilities enabled by synthetic biology. The Committee based the results on the availability and ease of use of the technologies, the challenges of producing an effective weapon, the expertise and resources required to carry out an attack, and both proactive and reactive measures that might be taken to help mitigate the effects of an attack.

The final report includes an “Overarching Recommendation” stating that biotechnology in the age of synthetic biology expands the landscape of potential defense concerns. DoD and its partnering agencies should continue to pursue ongoing strategies for chemical and biological defense; these strategies remain relevant in the age of synthetic biology. According to the final report, DoD and its partners also need to have approaches to account for the broader capabilities enabled by synthetic biology, now and into the future. The final report recommends that DoD and its interagency partners use a framework to assess synthetic biology capabilities and their implications. The framework developed in the report identifies the features of a synthetic biology-enabled capability that would increase or decrease the level of concern about a given capability being used for harm. As summarized in the figure below, the framework identifies factors to determine the relative levels of concern posed by advances in biotechnology. In addition to supporting the analysis conducted in this study, the Committee intends the framework to aid others in their consideration of current and future synthetic biology capabilities.

The final report states that synthetic biology expands what is possible in creating new weapons, and also expands the range of actors who could undertake such efforts and decreases the time required. Based on the Committee’s analysis of the potential ways in which synthetic biology approaches and tools may be misused to cause harm, it made the following specific observations (emphasis in original):

  • Of the potential capabilities assessed, three currently warrant the most concern: re-creating known pathogenic viruses; making existing bacteria more dangerous; and making harmful biochemicals via in situ synthesis;
     
  • With regard to pathogens, synthetic biology is expected to: (1) expand the range of what could be produced, including making bacteria and viruses more harmful; (2) decrease the amount of time required to engineer such organisms; and (3) expand the range of actors who could undertake such efforts;
     
  • With regard to chemicals, biochemicals, and toxins, synthetic biology blurs the line between chemical and biological weapons;
     
  • It may be possible to use synthetic biology to modulate human physiology in novel ways; and
     
  • Some malicious applications of synthetic biology may not seem plausible now, but could become achievable if certain barriers are overcome.
     

The final report acknowledges that synthetic biology concepts, approaches, and tools do not, in and of themselves, pose inherent harm. Rather, the final report states, concerns derive from the specific applications or capabilities synthetic biology might enable. The Committee applied the framework to assess the relative levels of concern posed by a set of synthetic biology capabilities. This assessment was undertaken in several steps. First, the Committee used the framework to analyze qualitatively each of the identified capabilities individually. Then, the Committee determined an overall level of concern for each capability relative to the other capabilities considered and an assessment of the landscape of capabilities and concerns presented. The following figure summarizes the results of this assessment.

According to the final report, while many of the traditional approaches to biological and chemical defense preparedness will be relevant to synthetic biology, synthetic biology will also present new challenges. The final report states that DoD and its partner agencies will need approaches to biological and chemical weapons defense that meet these new challenges. The final report includes the following recommendations:

  • DoD and its partners in the chemical and biological defense enterprise should continue exploring strategies that are applicable to a wide range of chemical and biodefense threats;
     
  • The potential unpredictability related to how a synthetic biology-enabled weapon could manifest creates an added challenge to monitoring and detection. DoD and its partners should evaluate the national military and civilian infrastructure that informs population-based surveillance, identification, and notification of both natural and purposeful health threats; and
     
  • The U.S. government, in conjunction with the scientific community, should consider strategies that manage emerging risk better than current agent-based lists and access control approaches.
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The final report suggests exploration of the following areas to address some of the challenges posed by synthetic biology:

  • Developing capabilities to detect unusual ways in which a synthetic biology-enabled weapon may manifest;
     
  • Harnessing computational approaches for mitigation; and
     
  • Leveraging synthetic biology to advance detection, therapeutics, vaccines, and other medical countermeasures.
     

The final report states that while addressing the potential concerns posed by synthetic biology in the age of biotechnology will remain a challenge for scientists and for the nation’s defense, “there is reason for optimism that, with continued monitoring of biotechnology capabilities and strategic biodefense investments, the United States can foster fruitful scientific and technological advances while minimizing the likelihood that these same advances will be used for harm.”

Commentary

The final report is an excellent summary of the enormous power of biotechnology, including the latest advances in the area, and thus a sobering reminder of the forces that this technology can both unleash and combat. That the products of synthetic biology can be weaponized is hardly new. The framework set out in the report and the recommendations made and summarized above are timely and important, especially since a great deal of attention is now focused on Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR) as the new darling in gene editing technology. The report is a good read for anyone, and ends on a somewhat uplifting positive note that with careful monitoring, this category of technology offers more hope for a better future than reasons for concern.


 
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